Recall Information Blog for Today's Progressive, Safe Consumer

UPDATE- Totseat/ Mobiseat recalls Chair Top BOOSTER SEATS---Germany RESCINDED

2011-08-02T21:06:00.000-07:00

The recall notice posted July 3/11 on totalrecallinfo.com has been rescinded.

The link follows: http://www.totalrecallinfo.com/freerecalls.php?id=25066

Please accept our apologies to all affected individuals.

The RAPEX rescind notice does not state the reason for this order.

Thank you.

Tenex Elbow Shock Absorber recall in Austria RESCINDED

2011-07-23T10:13:00.000-07:00

The Austrian RAPEX-contact-point would like to withdraw notification nr. 0812/10 Elbow Shock Absorber and asks you to remove the notification permanently from the RAPEX-System.

The reason is, that the Belgium authorities have classified this product as a medical device and the Austrian authority for medical devices does not think, that the notified problem has to be seen as a systematical failure of the product. The content of mercury is not seen as a problem.

The Austrian authorities, competent for general product safety, are still concerned about the high amount of mercury, but because of the classification as medical device, there is no further possibility to ban the product on the basis of the product safety act.

FEDERAL MINISTRY OF
LABOUR, SOCIAL AFFAIRS AND
CONSUMER PROTECTION

Stefanie LIPPECK
Unit III/2 Product Safety
Austrian RAPEX-Contact Point
Stubenring 1, 1010 Vienna
Phone: +43 (1) 711 00 - 2513
stefanie.lippeck@bmask.gv.at

CPSC Announces New, Lower Limit for Lead Content in Children’s Products

2011-07-19T20:13:00.001-07:00

The U.S. Consumer Product Safety Commission (CPSC) voted (3-2) that there was insufficient evidence to make a determination that manufacturers of children’s products sold in the United States could not meet a total lead content limit of 100 parts per million (ppm) for a product or product category. The new total lead content limit, which is called for in the Consumer Product Safety Improvement Act (CPSIA), goes into effect on August 14, 2011 for manufacturers, importers, retailers and distributors of children’s products.

Through the CPSIA, Congress set tough new levels for lead content in products designed or primarily intended for children 12 and younger. Lead is a heavy metal that is toxic for children, and associated with lowered levels of learning, impaired hearing, brain damage and, at high levels, can be fatal.

Congress directed CPSC to phase in the reduced levels for lead content over a three year period, starting with 600 ppm on February 10, 2009. The level dropped to 300 ppm on August 14, 2009. Finally, Congress directed the total lead content limit be set at 100 ppm, unless the Commission determined it was not technologically feasible for a product or product category.

The Commission was not able to determine that 100 ppm total lead content is not technologically feasible, as staff found that materials containing less than 100 ppm total lead content are commercially available in the marketplace for manufacturers. CPSC staff also found many products currently on the market, that have been tested by CPSC or other organizations, that are already in compliance with the new 100 ppm total lead content limit.

Starting on August 14, 2011, manufacturers, importers, retailers and distributors of children’s products must comply with the new 100 ppm federal limit for total lead content. CPSC will not enforce the CPSIA’s independent third party testing requirement for total lead content until December 31, 2011, due to a stay of enforcement that is already in place.

The stay of enforcement does not apply to children’s metal jewelry, which currently must undergo independent third party testing.

The new 100 ppm lead content limit does not apply to inaccessible (internal) parts of children’s products and certain component parts of children’s electronic devices, like electronic connectors and plugs, including headphone plugs.

Lead content levels for children’s products are different from the levels Congress set for lead in paint or surface coatings. The limit for lead in paint or surface coatings is .009 percent. The .009 percent level has been in place since August 14, 2009 and independent third party testing is required for all paints or surfaces coatings used on children’s products.

CPSC Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908

Only New, Safer Cribs will be Available for Consumer Purchase on June 28, 2011

2011-06-19T21:29:00.000-07:00

CPSC votes to grant extension of time to comply with new rules to crib rental companies

In less than two weeks, a new generation of safer cribs will be for sale in retail stores across the country. On June 28, 2011, anyone that manufactures or sells baby cribs will be required to meet new and improved crib safety standards approved by the U.S. Consumer Product Safety Commission on December 15, 2010.

Today, the Commission voted 4-0-1 to extend the length of time that short-term crib rental companies have to comply with the new mandatory standards for full-size and non-full-size baby cribs. This extension gives crib rental companies until December 28, 2012 to update their inventory with compliant cribs, which is the same deadline for the public accommodation facilities that these companies serve.

When the Commission approved the new rules in 2010, child care facilities, such as family child care homes and infant Head Start centers, and places of public accommodation, such as hotels and motels, were given until December 28, 2012 to have compliant cribs in their facilities.

Today’s vote by the Commission does not change the requirements on manufacturers or retailers of cribs. The Commission voted 3-2 today against granting an extension for retailers to comply with the new crib safety requirements. In turn, the Commission will continue to require companies that manufacture or sell cribs in the United States to comply with the new federal safety standards effective June 28, 2011.

Federal mandatory crib standards had not been updated in nearly 30 years and the new rule will usher in a safer generation of cribs. These mandatory standards will: 1) stop the manufacture and sale of dangerous, traditional drop-side cribs; 2) make mattress supports stronger; 3) improve slat strength, 4) make crib hardware more durable; and 5) make safety testing more rigorous.

The new safety standards aim to keep children safer in their cribs and prevent deaths resulting from detaching crib drop-sides and faulty or defective hardware.

These crib standards were mandated by the Consumer Product Safety Improvement Act of 2008 (CPSIA). For more information on crib safety and safe sleep environments for baby, visit CPSC’s crib information center at: www.cpsc.gov/cribs

CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908

New Food Recall Law May Catch Companies Napping, Food Safety Experts Warn

2011-05-19T22:57:00.000-07:00

Experts who follow food safety urged every business involved in putting meals on America's tables -- from growers to retailers -- to study the new Food Safety Modernization Act and then get the insurance they'll need to face a radically altered regulatory landscape.

The FSMA, signed by President Barack Obama, gives the federal Food and Drug Administration sweeping new authority to inspect, regulate and if needed, shut down any company along the food chain that is involved in product recalls and incidents of food-borne illness. It grants the FDA power to act if it suspects a "reasonable probability" of an outbreak occurring, and virtually unlimited authority in case of an actual outbreak.

Under a "phased approach" similar to the way the United Kingdom implemented its food-inspection regime in 1990, the FSMA's first two rules will take hold this summer, Steven Thompson, senior adviser at London-based red24 security consultancy, said during A.M. Best Co.'s webinar, Food Safety: What Agents and Brokers Need to Know About New FDA Recall Authority. It was sponsored by Liberty Underwriters International and hosted by Best's Review magazine.

The first rule allows the FDA to detain food it believes has been produced under unsanitary or unsafe conditions for 30 days while regulators determine whether further action is required. The second rule requires anyone importing food into the United States to inform the FDA if any country has refused entry to the same product, including animal feed.

FULL STORY:http://insurancenewsnet.com/article.aspx?id=261795&type=newswires

Consumers warned to avoid eating oysters from area 1642 in Apalachicola Bay, Florida

2011-05-10T22:07:00.000-07:00

Media Inquiries: Doug Karas: 301-796-2805; douglas.karas@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

Consumers warned to avoid eating oysters from area 1642 in Apalachicola Bay, Florida Warning follows bacterial illness outbreak

Fast Facts
• The U.S. Food and Drug Administration is advising consumers, restaurant operators, commercial shippers and processors of shellfish not to eat, serve, purchase, sell or ship oysters from Area 1642 in Apalachicola Bay, Fla. because the oysters may be contaminated with toxigenic Vibrio cholerae serogroup O75.
• Nine persons have been reported with illness. For eight, the illness was confirmed as caused by toxigenic Vibrio cholerae O75; laboratory confirmation is pending in the other person. No one was hospitalized or died.
• All ill persons reported consumption of raw or lightly steamed oysters.
• Traceback indicates that oysters harvested from Area 1642 in Apalachicola Bay, Fla., between March 21 and April 6, 2011, are associated with illness.
• Those who have recently purchased oysters should check with the place of purchase and ask if they were harvested from the affected growing area.

What is the problem?
Raw oysters harvested from Area 1642 in Apalachicola Bay, Fla. between March 21 and April 6, 2011, have been linked to eight confirmed and one possible case of toxigenic Vibrio cholerae O75 infection. The ill persons ate raw or lightly cooked oysters harvested from that area. Ill persons reside in Florida, Georgia, Louisiana and Indiana; all report consumption of oysters while in Florida. There are several designated harvest areas within Apalachicola Bay, Fla, and each of these has a unique numerical identifier. Area 1642 is a zone that stretches from north to south in Apalachicola Bay just on the east side of the bridge that goes from Eastpoint, Fla., to St. George Island, Fla. The zone is approximately two miles wide from east to west.

What are the symptoms of Vibrio illness?
Illness is typically characterized by nausea, vomiting and diarrhea. The symptoms begin from a few hours up to five days after consumption of raw or undercooked seafood, particularly shellfish, or after ingestion of surface waters.

Who is at risk?
Persons at risk are those who traveled to Florida and consumed oysters that were harvested from Area 1642 of Apalachicola Bay or who purchased oysters in a state to which these oysters or oyster product were distributed and ate them.

What do consumers need to do?
Those who have recently purchased oysters should check with the place of purchase and ask if they were harvested from the affected growing area. If the oysters were definitely or possibly harvested from Area 1642 in Apalachicola Bay, Fla., and have not yet been consumed, they should not be eaten. If the oysters were already consumed and no one became ill, no action is needed. If you develop a diarrheal illness within a week after consuming raw or undercooked shellfish, see your healthcare provider and inform the provider about this exposure.

Those with weakened immune systems, including people affected by AIDS, chronic alcohol abuse, liver, stomach, or blood disorders, cancer, diabetes, or kidney disease should avoid eating raw oysters, regardless of where they are harvested.

What product forms are included in the recall?
This advisory, which comes from an outbreak of illness caused by toxigenic Vibrio cholerae O75, applies to live in-shell and shucked fresh or frozen oysters from the area.

Where is it distributed?
These oysters or oyster product were initially distributed in Florida, Alabama, Georgia, Mississippi, and North Carolina. However, subsequent distribution to other states may have occurred.

What is being done about the problem?
The U.S. Food and Drug Administration is advising consumers, restaurant operators, commercial shippers and processors of shellfish not to eat, serve, purchase, sell or ship oysters harvested from Area 1642 in Apalachicola Bay, Florida because the oysters may be contaminated with toxigenic Vibrio cholerae O75.

The Florida Department of Agriculture and Consumer Services Division of Aquaculture closed Area 1642 on April 29 and has asked commercial oyster harvesters and dealers who obtained oysters from this area to recall them.

The FDA is sampling oysters from Area 1642 in Apalachicola Bay as part of a reopening strategy.

Who should be contacted?
The FDA encourages consumers with questions about seafood safety to call 1-888-SAFEFOOD or to write to consumer@fda.gov.

CPSC Approves New Mandatory Standard for Toddler Beds

2011-04-14T19:22:00.001-07:00

The U.S. Consumer Product Safety Commission (CPSC) unanimously approved (5-0) a new mandatory standard to improve the safety of toddler beds. The new federal standard builds upon the ASTM voluntary standard for toddler beds (F1821-09) and adds additional protections to prevent injuries to children.

The new federal standard requires the following:

The upper edge of the guardrail must be at least five inches above the toddler bed's mattress.

Spindle/slat strength testing for toddler beds must be consistent with the testing required for crib spindles/slats.

Separate warning labels to address entrapment and strangulation hazards must appear on toddler beds.

CPSC is aware of 122 incidents from 2005 through 2010, including four deaths and 43 injuries associated with toddler beds.

Cribs that convert into toddler beds also must comply with the new federal standard for toddler beds. The mandatory standard goes into effect six months after publication in the Federal Register for toddler beds manufactured or imported on or after that date.

Congress, as part of the Consumer Product Safety Improvement Act of 2008, required the Commission to issue a mandatory standard for toddler beds, as well as other durable infant and toddler products. In addition to toddler beds, CPSC has issued mandatory standards for cribs, infant walkers and infant bath seats.

The United States has announced it was barring some food imports from Japan

2011-03-23T23:58:00.000-07:00

The United States has announced it was barring some food imports from Japan due to fears of radiation and nuclear contamination in the wake of an earthquake and tsunami disaster.

The US Food and Drug Administration said it had placed an import alert on all milk, milk products, fresh vegetables and fruits from certain regions.

This means that no products of these types from the prefectures of Fukushima, Ibaraki, Tochigi and Gunma can enter the United States without first being shown to be safe.

"In addition, FDA will continue to flag all entries from Japan in order to determine whether they originated from the affected area. FDA will test all food and feed shipments from the affected area," an email statement said.

"FDA import investigators operating at ports of entry have radiation detection devices (radiation pagers) available to them for their personal safety," the statement added.

"These radiation pagers are extremely sensitive and can help to identify shipments of potential concern to target for laboratory analysis."

The twin quake and tsunami disaster, Japan's worst crisis since World War II, has left nearly 23,000 people dead or missing, with entire communities along the northeast coast swept away.

Shell-shocked Japan faces an invisible threat from radiation seeping from the Fukushima plant, which lies just 250 kilometers (155 miles) from the greater Tokyo area and its 30 million inhabitants.

Asked about the FDA ruling in an interview with Japan's NHK news network, Secretary of State Hillary Clinton said that "what is most important is making sure that we help Japan deal with the after-effects of whatever occurred inside the reactors and that we also make sure the Japanese people have all the food that they need during this transition period."

The ruling, she added, speaking before the announcement was made, would be "as much focused on determining what is or isn't safe for the Japanese people, not just what is safe for export."

Japan has halted shipments of some foodstuffs in nearby prefectures after the discovery of higher-than-normal levels of radiation in milk and certain vegetables, but it insists there is no health hazard.

Raw milk in Ibaraki prefecture and broccoli in Fukushima were the latest products to show levels of radioactive materials beyond legal limits, Kyodo News said.

France earlier Tuesday urged the European Commission to impose "systematic controls" on imports of fresh produce from Japan into the EU, amid fears of nuclear contamination.

France itself has already introduced such checks on food imports from Japan.

Full Story: http://www.rawstory.com/rs/2011/03/22/us-bars-some-japan-foods-over-radiation-fears/

Canadian Tire recalls 2008 BAJA 50CC STREET SCOOTERS---CanadaCanadian Tire recalls 2008 BAJA 50CC STREET SCOOTERS---Canada

2011-02-11T01:50:00.000-08:00

Canadian Tire recalls 2008 BAJA 50CC STREET SCOOTERS---Canada

Wednesday, February 2nd 2011 Recalls

2011-02-03T03:35:00.000-08:00

Shuckman’s Fish Co. updates CHEESE SPREAD/ CHEESE allergy alert

AFOD Ltd. issues allergy alert on Century Bicol Express TUNA---Canada

Les Volailles Et Gibiers Fernando issues allergy alert on Several SAUSAGES---Canada

Oriental Merchant updates Mas-River FRIED DACE recall---U.K.

Biofarm Products updates Acidophilus/ Bush Honey YOGURT recall---New Zealand

Bluesky/ Crossroads recalls Carrefour MINI OVENS---France

Harley Davidson recalls 2011 Softail MOTORCYCLES

Webasto expands Hollandia SUNROOF recall

Fairplay recalls 2010-2011 ELECTRIC LOW SPEED VEHICLES

Morgan recalls 2010 Penske TRAILERS

Suzuki recalls Several 2008-2011 ATV/ QUADS---Australia

Godi International recalls Fruta Planta CAPSULES

Pharmetics Inc. recalls Exact Multi Greens POWDER/ CAPSULES---Canada

Boehringer Ingelheim recalls Mobic SUPPOSITORIES---U.K.

Tuesday, February 1st Recalls

2011-02-01T20:23:00.000-08:00

Tomaso's issues allergy alert on CAESAR DRESSING

Magic Valley updates BREADED OKRA allergy alert

Casino issues allergy alert on Knacki Herta Halal SAUSAGES---France

Several Stores issue allergy alert on Gille Swedish COOKIES---INT.

Briggs & Stratton recalls Model 40 V-Twin ENGINES

HG Specialties recalls Wood Care VINYL ADHESIVES---Canada

Costco recalls True Innovations OFFICE CHAIRS---Canada

Dusk Ltd. recalls Frederick MoodFlame FIREPLACES---Australia

Ford recalls PJ/ PK Ranger VEHICLES---Australia

B. Braun updates Outlook 400ES Safety Infusion SYSTEM recall

Monday, January 31st Recalls

2011-02-01T01:26:00.001-08:00

Unified Grocers issues allergy alert on Mariegold/ Vallarta WHITE BREADS

Sabor Farms recalls Several Fresh CILANTRO PRODUCTS

Unfi Inc. issues allergy alert on Raw Organic FOOD BARS---Canada

The Co-operative issues allergy alert on Welsh/ British Extra Mature CHEESE---U.K.

Biofarm Pdcts. recalls Bush Honey YOGURT---New Zealand

Intel recalls Cougar Point SUPPORT CHIPS

Sassy Inc. updates Refreshing Rings Infant TEETHERS/ RATTLE recall---INT.

Ateco Automotive recalls Citroen C4/ Picasso/ C5II/ C5/ Dispatch VEHICLES---Australia

Novartis Pharma recalls Extavia PREP PADS

HC recalls Man Up Now SUPPLEMENTS---Canada

Sam Pharma recalls Tegretol Retard TABLETS---U.K.

DI-Antalvic recalls Propofan GENERIC DRUGS---France

Hoepharma Ltd. recalls T3 Actin CREAMS---Hong Kong

Weixin Biotechnology recalls Tiger King SUPPLEMENTS---INT.

Novacare updates Several SEXUAL ENHANCEMENT product recalls---INT.

Saturday, January 29th Recalls

2011-01-30T01:06:00.000-08:00

Publix issues allergy alert on Premium Light Tiramisu ICE CREAM

Tanimura and Antle Co. recalls Fresh CILANTRO

Spartan Stores recalls Spartan Frozen BREADED OKRA

Bavan Food Co. recalls Santra/ Mithi GOLI CANDY

Merrick Pet Care recalls Jr. Texas Taffy PET TREATS

Manna Pro Products recalls Family Farm HORSE FEED

CFIA issues allergy alert on Wally & Molly Salt Water TAFFY---Canada

European Food & Feed Recall LINK

Woolbro recalls Halloween MASKS---U.K.

Ai Xin recalls Mini LED Emergency LIGHTS---Luxembourg

Target recalls Target Electric SHAVERS---Luxembourg

Emjot recalls Combined PRAMS---Slovakia

Good Byke recalls BICYCLE HELMETS---Latvia

HM Studio Hracky recalls Giraffe ROCKING TOYS---Czech Republic

Andrea Moden recalls Carnival King COSTUMES---Slovenia

Vidal recalls Base 2 Polos WALL SOCKETS---Spain

KDE recalls Electric TABLE LAMPS---Spain

Neck & Neck recalls Baby's DRESSES---Spain

Blue Bear Toys recalls Elk PLUSH TOYS---Netherlands

Ceba recalls Farm Animal WOODEN PUZZLES---Netherlands

Spen recalls Dog/ Bear PLUSH TOYS---Finland

Venix recalls Children's JACKETS---Bulgaria

Bento/ Winner recalls Plastic LIGHTERS---Greece

Volkswagen recalls 2010 New Beetle VEHICLES

Think recalls 2011 Think City VEHICLES

Keystone recalls 2009-2011 Montana/ Big Sky TRAILERS

Renault recalls 2004-2006 Megane II RS VEHICLES---Greece

MS Fish Corp. recalls Ossie’s Schmaltz HERRING

2011-01-14T11:15:00.000-08:00

Some LISTERIA you may not want for the new year!

MS Fish Corp. recalls Ossie’s Schmaltz HERRING

Candy Dynamics recalls Toxic Waste/ Nuclear Sludge CHEW BARS

2011-01-13T23:13:00.000-08:00

This would be a great title for a book, maybe even a good joke, if it was not so DEADLY SERIOUS.

THIS CONTAINS TOXIC LEAD, PEOPLE...

Candy Dynamics recalls Toxic Waste/ Nuclear Sludge CHEW BARS

FRESH GREEN recall about to go viral !

2010-12-29T22:09:00.000-08:00

Here is the latest on the ongoing FRESH VEGETABLE/ HERB/ GREENS recall that you may be unaware of.

This WILL get bigger, although most of the product has been consumed already...

CFIA updates Little Bear FRESH GREENS recall---Canada

Boncheff Greenhouses recalls Fresh CILANTRO/ DILL/ PARSLEY Products---Canada

Wegmans recalls Food You Feel Good About CILANTRO/ PARSLEY

More Food Recalls

2010-12-01T00:34:00.000-08:00

Mincing Spice recalls Frontier Natural/ Whole Foods NUTMEG

Kensington Safeway recalls GROUND BEEF

Costco/ Lantic recall 2kg Rogers Golden Yellow SUGAR---Canada

Co-op/ ValuFoods/ RiteStop recall SANDWICHES/ SUBS/ WRAPS/ CHEESEBURGERS---Canada

Boots recall Gü Mug/ Chocolate Gift Set TRUFFLES---Ireland

Old recalls make it to Canada.

2010-12-01T00:18:00.000-08:00

Timeout CAPSULES

Revivexxx Extra Strength

Mr. Magic

Masxtreme

Goya–Bitter Melon - Miyura Fit'x Capsules So Hard for Men - Pulse8 for Women - The Rock - Tonic 66

Solo Slim

and more J & J recalls

Merck/ J&J recall Mylanta/ Alternagel LIQUID MEDICATIONS

Subject: Phenylpropanolamine (PPA)

2010-11-29T20:30:00.000-08:00

Hi Everyone
I am passing this email forwarded to me this morning. It's about a
medication that is familiar to many of us. Note also the FDA 's comments
at the end of the message.
.
Here are the details and I suggest you pass it on to your loved ones and others.

Subject: Phenylpropanolamine (PPA)

I urge you to review the list of medicines with PPA and avoid these medications. All drugs containing PHENYLPROPANOLAMINE are dangerous. You may want to try calling the 800 number listed on most drug boxes and inquire about a REFUND. Please read this CAREFULLY. Also, please pass this on to everyone you know. STOP TAKING anything containing this ingredient. It has been linked to increased hemorrhagic stroke (bleeding in brain) among women ages 18-49 in the three days after starting use of medication. Problems were not found in men, but the FDA recommended that everyone (even children) seek alternative medicine.

The following medications contain Phenylpropanolamine:

Acutrim Diet Gum Appetite Suppressant
Acutrim Plus Dietary Supplements
Acutrim Maximum Strength Appetite Control
Alka-Seltzer Plus Children's Cold Medicine Effervescent
Alka-Seltzer Plus Cold medicine (cherry or or ange)
Alka-Seltzer Plus Cold Medicine Original
Alka-Seltzer Plus Cold & Cough Medicine Effervescent
Alka-Seltzer Plus Cold & Flu Medicine
Alka-Seltzer Plus Cold & Sinus Effervescent
Alka Seltzer Plus Night-Time Cold Medicine
BC Allergy Sinus Cold Powder
BC Sinus Cold Powder
Comtrex Flu Therapy & Fever Relief
Day & Night Contac 12-Hour Cold Capsules
Contac 12 Hour Caplets
Coricidin D Cold, Flu & Sinus
Dexatrim Caffeine Free
Dexatrim Extended Duration
Dexatrim Gelcaps
Dexatrim Vitamin C/Caffeine Free
Dimetapp Cold & Allergy Chewable Tablets
Dimetapp Cold & Cough Liqui-Gels
Dimetapp DM Cold & Cough Elixir
Dimetapp Elixir
Dimetapp 4 Hour Liquid Gels
Dimetapp 4 Hour Tablets
Dimetapp 12 Hour Extentabs Tablets
Naldecon DX Pediatric Drops
Permathene Mega-16
Robitussin CF
Tavist-D 12 Hour Relief of Sinus & Nasal Congestion
Triaminic DM Cough Rel! ief
Triaminic Expectorant Chest & Head
Triaminic Syrup ! ! Cold & amp;am p; Allergy
Triaminic Triaminicol Cold & Cough

I just found out and called the 800# on the container for Triaminic and
they informed me that they are voluntarily recalling the following medicines
because of a certain ingredient that is causing strokes and seizures in children:

Orange 3D Cold & Allergy Cherry (Pink)
3D Cold & Cough Berry
3D Cough Relief Yellow 3D Expectorant

They are asking you to call them at 800-548-3708 with the lot number on
the box so they can send you postage for you to send it back to them, and
they will also issue you a refund. If you know of anyone else with small children,

PLEASE PASS THIS ON. THIS IS SERIOUS STUFF!

DO PASS ALONG TO ALL ON YOUR MAILING LIST so people are informed. They can then pass it along to their families.

To confirm these findings please take time to check the following:
http://www.fda.gov/cder/drug/infopage/ppa

Gail Stenson
Public Health Clerk
St. James-Assiniboia
Health & Social Services Center
2015 Portage Avenue R3J 0K3
Phone: 940-2388 Fax: 940-2636
eMail: gstenson@wrha.mb.ca

Some Recalls you may be unaware of.

2010-11-25T23:07:00.000-08:00

Some important recalls announced today.

Westerly Shaw's Supermarket recalls Family Pack Lean GROUND BEEF

Lobby Shoppes Inc. issues allergy alert on Several Gourmet POPCORNS

Creative Food Products issues allergy alert on CINNAMON PASTRIES---Canada

Quantimpex Inc. recalls Baktat CHILLIES---Canada

Game Farm recalls Marinated Quail MEDALLIONS---Australia

Costco recalls Kirkland Signature Pre-Lit CHRISTMAS TREES

EPA issues alert on Fuji Lavender MOTH TABLETS

Home Depot recalls LED LIGHT STRINGS---Canada

Tesco recalls Value BATH MATS---Ireland

Phantom Recalls

2010-11-19T02:35:00.000-08:00

Consumers have been asking questions about hidden recalls. Their interest was piqued by a recent J & J recall.

To this end, we have decided to post several recalls you may not be aware of.

Good Earth Teas recalls Sweet & Spicy Herbal TEA BAGS-California

Loblaws Comp. recalls No Name OLIVES-Canada

Marcor Development recalls Brain POWDER-New Mexico/Canada

Avon recalls Healthy Makeup EYESHADOW

Big Al’s Aquarium recalls Aquarium LIGHTS---Canada

Emerge Technologies recalls iPod Retractable WALL CHARGERS---Canada

Silvercrest recalls MONITORS/ TV'S---INT.

Canberra Corp. recalls Instant HAND SANITIZER

McNeil Healthcare recalls Children's Benadryl Allergy FASTMELT TABLETS---INT.

Potential Risks of Consuming Vegetables and Herbs Stored in Oil

2010-11-16T21:46:00.000-08:00

Health Canada would like to inform Canadians of the importance of safe food handling practices when preparing and/or consuming vegetables and herbs stored in oil, such as garlic, onions, sun-dried tomatoes, hot peppers, mushrooms, rosemary, chives, sage, basil, and dill.

Vegetables and herbs stored in oil are a popular home-prepared food item and in some cases, are also prepared commercially. However, if food is improperly prepared, canned, heat-processed, bottled, or stored, it can cause serious illness, such as botulism.

Below are some easy-to-follow tips to help you reduce your risk:

•Home-prepared products stored in oil (e.g., vegetables, herbs and spices) should only be made using fresh ingredients, and should be kept in the refrigerator and discarded after one week.
•Commercially-prepared products should be refrigerated after opening and between each use.
•Consumers who purchase products such as those outlined above from fairs, farmers' markets or roadside stands or receive them as a gift should check when they were prepared and discard them if they are more than a week old.
•Date and label preserves and canned goods and strictly follow proper canning/bottling requirements.
•Wash your hands thoroughly with warm water and soap for at least 20 seconds, before and after handling food.
•Keep all work surfaces, food, utensils, equipment, and hands clean during all stages of the canning/bottling process.
•Refrigerate all foods labelled "keep refrigerated."
•If you experience symptoms of botulism, seek medical attention immediately.

Botulism is a serious illness that can result from eating improperly prepared and stored foods. Botulism is caused by a bacterium – called Clostridium botulinum – that naturally produces toxins as part of its normal life cycle. The toxin that causes botulism is colourless, odourless, tasteless and invisible to the naked eye and is not necessarily destroyed by cooking, so preventing the toxin from forming is essential.

Symptoms of botulism food poisoning can range from nausea, vomiting, fatigue, dizziness, double vision, dryness of throat, weakness to respiratory failure, paralysis and, in some cases, death. The onset of symptoms is generally from 12 to 36 hours after ingesting the toxin. The duration of illness may be 2 hours to 14 days, although some symptoms may linger much longer.

It's estimated that there are approximately 11 million cases of food-related illnesses in Canada every year. Many of these illnesses could be prevented by following proper food handling and preparation techniques.

For more information on food safety tips for vegetables and herbs stored in oil, please visit:

Health Canada's Food Safety Tips for Vegetables and Herbs stored in Oil

Canadian Food Inspection Agency's webpage on Vegetables and Herbs in Oil

It's Your Health on Garlic-in-oil

Partnership for Consumer Food Safety Education's Be Food Safe Canada Campaign

Media Inquiries:
Health Canada
(613) 957-2983

Public Inquiries:
(613) 957-2991
1-866-225-0709

FTC to crack down on car rentals not following recalls

2010-11-03T00:13:00.000-07:00

The nation's largest rental car company is being pressed to fix vehicles under recall before renting them out.

Consumer groups are asking the Federal Trade Commission to crack down Enterprise Holdings, Inc., That's the company that owns Enterprise, National and Alamo.

The groups want the company to stop renting cars that have been recalled, but not yet fixed.

FULL STORY: http://abclocal.go.com/kgo/story?section=news/7_on_your_side&id=7759765

Veron Foods recalls Several HEAD CHEESE/ SAUSAGE Products

2010-08-16T11:17:00.000-07:00

Louisiana's agriculture department says Veron Foods LLC of Prairieville is recalling 250 tons of ready-to-eat sausage and hog's head cheese because of possible contamination by bacteria.

The Department of Agriculture and Forestry says investigation of an illness revealed a sample contaminated with Listeria bacteria, which can cause an uncommon but potentially fatal disease.

FULL STORY: http://www.totalrecallinfo.com/freerecalls.php?id=19562

Wright County Egg recalls SHELLED EGGS

2010-08-16T11:16:00.000-07:00

The following statement was released by officials of Wright County Egg regarding the US Food and Drug Administration’s (FDA) on-farm records review and egg testing for Salmonella.

Wright County Egg of Galt, Iowa is voluntarily recalling specific Julian dates of shell eggs produced by their farms because they have the potential to be contaminated with Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections, endocarditis or arthritis.

Eggs affected by this recall were distributed to food wholesalers, distribution centers and foodservice companies in California, Illinois, Missouri, Colorado, Nebraska, Minnesota, Wisconsin and Iowa. These companies distribute nationwide.

FULL STORY: http://www.totalrecallinfo.com/freerecalls.php?id=19561

Carrefour recalls Frozen MINCED STEAK---Belgium

2010-08-16T11:11:00.000-07:00

CARREFOUR CALLS A LOT MINCED STEAK (FROZEN) OF THE MARK CARREFOUR DISCOUNT BACK

It only to products the next extreme expiry date: 18/06/2011

To occasion of a self Calls Carrefour a fate chopped steaks back that in the frozen section be sold under the mark Carrefour Discount in the Carrefour hypermarkets, Carrefour GB / Market supermarkets and Carrefour Express convenience stores.

During the usual control that Carrefour was performed bacteria Escherichia Coli 026 H11 observed.

FULL STORY: http://www.totalrecallinfo.com/freerecalls.php?id=19557

The Sheep Fjord recalls Silk Jersey CHEESE---Quebec

2010-08-16T11:10:00.000-07:00

Presence of Listeria monocytogenes in cheese

The Ministry of Agriculture , Fisheries and Food ( MAPAQ ) , in collaboration with the company " The sheep Fjord , located at 2992, Chemin du Plateau , Saguenay, warning people who have in their possession cheese " Silk Jersey purchased between July 16 and August 13, 2010 at various retail locations , do not eat it , because it may contain bacteria Lm.

The cheese is the subject of this notice is being sold in variable weight and size is on its packaging the name " Silk Jersey .

FULL STORY: http://www.totalrecallinfo.com/freerecalls.php?id=19558

Highland Farms Supermarket recalls GREEN ONIONS---Ontario

2010-08-16T11:08:00.000-07:00

CERTAIN GREEN ONIONS SOLD AT HIGHLAND FARMS SUPERMARKET, NORTH YORK, ONTARIO, MAY CONTAIN SALMONELLA BACTERIA

The Canadian Food Inspection Agency (CFIA) is warning consumers not to consume Green Onions described below as they may be contaminated with Salmonella.

The affected Green Onions were sold unwrapped with a rubber band. There is no lot code sticker, UPC or product name on the individual bunch of onions.

The product was sold from Highland Farms Supermarket, located at 4750 Dufferin Street in North York, Ontario on July 30, 31 and August 1, 2010.

FULL STORY: http://www.totalrecallinfo.com/freerecalls.php?id=19559

Questions about our recall policy?

2010-08-14T11:08:00.000-07:00

Many consumers have contacted us regarding recalls which are posted late, or are completed.

Here are 2 examples!

http://www.totalrecallinfo.com/freerecalls.php?id=19552

http://www.totalrecallinfo.com/freerecalls.php?id=19545

The first is for apple slices, the second for cosmetic creams.

The problem is NO-ONE knows about these recalls until we announce them. They cannot be found on the FDA recall page, nor could we get any comments on how to get these recalls when they are fresh.

It seems as though a conspiracy exists to announce some recalls while some get put on the back burner, and never get to the consumer.

We have contacted the relevant agencys, with no response.

So the fact that these are older recalls, do not dismiss them. No other government/private organization has these recalls in their database, so they need extra special attention, as some of these are very dangerous.

Please feel free to comment to the FDA about the "Phantom Recalls"

This notice is for all users of our services.

Understanding the Continuous Cause of Product Recalls & Product Liability Lawsuits

2010-08-14T11:07:00.001-07:00

We're not getting better at designing and launching reliable new products for the market place, as statistics prove, we're getting worse.

By Randall Goodden, author

Aug. 11, 2010

In our never ending effort to boost sales and profits and be the first to hit the competitive market with new products and technologies, streamlining production costs and improving efficiencies, and the constant search for new supply sources as well as new sales markets, we continue to fail to see our own deficiencies in new product development as related to design and engineering. Most of this is due to our common lack of knowledge as to what we really need to be doing, versus the common misconception that we already know what to do.

We're not getting better at designing and launching reliable new products for the market place, as statistics prove we're getting worse. Product recalls are at record numbers, and have been growing every year for the past six years

FULL STORY: http://www.industryweek.com/articles/understanding_the_continuous_cause_of_product_recalls__product_liability_lawsuits_22492.aspx

FDA Seeks Injunction Against Colorado Manufacturer of Cultured Cell Product

2010-08-09T17:59:00.000-07:00

Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

FDA Seeks Injunction Against Colorado Manufacturer of Cultured Cell Product

Violations of current good manufacturing practice and labeling requirements cited

The U.S. Food and Drug Administration is seeking an injunction in federal court against Regenerative Sciences LLC, of Broomfield, Colo., citing violations of current good manufacturing practice (cGMP) that cause its cultured cell product to be adulterated. The product is also misbranded due to the lack of adequate directions for use and the failure to bear the “Rx only” symbol.

The company’s cultured cell product is derived from a patient’s bone marrow or fluid surrounding the patient’s joints (synovial fluid). The cells are grown, processed, and mixed with drug products outside the body before being injected back into the patient.

Regenerative Sciences’ cultured cell product is not approved by the FDA, and no adequate and well-controlled studies have been done to demonstrate its safety or effectiveness for any indication.

“FDA recognizes the importance of the development of novel and promising new therapies,” said Karen Midthun, M.D., acting director of FDA’s Center for Biologics Evaluation and Research. “However, when companies like Regenerative Sciences fail to comply with FDA laws and regulations, they put the public’s health at risk.”

The complaint for the injunction was filed Aug. 6, 2010, by the Justice Department on behalf of the FDA in the U.S. District Court for the District of Columbia, against Regenerative Sciences and three of its employees, Christopher J. Centeno, M.D., John R. Schultz, M.D., and Michelle R. Cheever. The injunction would permanently prevent the company and cited individuals from adulterating and misbranding the cultured cell product while the product, or one or more of its components, is held for sale after shipment in interstate commerce.

Regenerative Sciences has agreed to cease production of the cultured cell product while the case is pending.

The FDA warned Regenerative Sciences about its cGMP violations as recently as June 2010. The company failed to make sufficient corrections, and the conduct of the individuals cited in the complaint demonstrates refusal to comply with the law.

BPA Found in Grocery, Restaurant and Other Receipts

2010-07-28T20:02:00.000-07:00

BPA Found in Grocery, Restaurant and Other Receipts

Suspect chemical used to coat thermal paper for register receipts

Bisphenol A, or BPA, is a chemical used in plastic containers that some studies suggest is a health hazard. Now, it turns out BPA can even be found in the receipt you get after a trip to the store, a fast-food outlet or even the Post Office.

Laboratory tests commissioned by the Environmental Working Group (EWG), a consumer group, have reportedly found high levels of BPA on 40 percent of receipts sampled from major U.S. businesses and services, including outlets of McDonald's, CVS, KFC, Whole Foods, WalMart, Safeway and the U.S. Postal Service.

Receipts from Target, Starbucks, Bank of America ATMs and other important enterprises were BPA-free or contained only trace amounts.

The total amounts of BPA on receipts tested were 250 to 1,000 times greater than other, more widely discussed sources of BPA exposure, including canned foods, baby bottles and infant formula, the group said.

READ MORE....http://www.consumeraffairs.com/news04/2010/07/bpa_grocery_receipts.html

CPSC Announces Pool and Spa Kids Safety Education Effort

2010-07-28T20:01:00.000-07:00

CPSC Announces Pool and Spa Kids Safety Education Effort

Hundreds of pool and spa incidents since Memorial Day Weekend

Houston - Halfway through the summer swimming season, the U.S. Consumer Product Safety Commission (CPSC) has seen news reports of more than 210 child drowning and non-fatal submersion incidents in pools and spas around the country since Memorial Day Weekend. In an effort to reduce these preventable incidents, CPSC and partners Safe Kids USA and the National Drowning Prevention Alliance (NDPA) joined forces today to introduce a new kids safety education program. The centerpieces of the program are a multi-part educational video and an online activity, which are part of CPSC’s national Pool Safely campaign.

“Just one incident is one too many,” said Inez M. Tenenbaum, Chairman of the CPSC. “These statistics are a wake up call and a reminder that these tragic incidents are preventable. Our kids safety program is designed to teach parents and children simple water safety steps so that everyone will Pool Safely this summer.”

The educational video highlights individual experiences and uses seven simple Pool Safely steps to encourage safe and responsible behavior in and around pools and spas. It is introduced by actress Ming-Na, the voice of Mulan in Disney animated films and star of the NBC drama “ER.” The video series is available to view at www.youtube.com/poolsafely and on the websites of Safe Kids (www.safekids.org) and the NDPA (www.ndpa.org)

The new Pool Safely interactive online activity is designed for parents and young children. It highlights unsafe behaviors around the pool in a variety of real-world settings such as backyard, hotel and community pools. Game players are encouraged to identify the trouble spots and behaviors. The online activity is aimed at children seven and under and will be available for play on the Pool Safely website and on the websites of the NDPA and Safe Kids.

“Safe Kids is proud to work with the CPSC on the creation of a kids safety education program,” said Mitch Stoller, president and CEO, Safe Kids Worldwide. “Children and families can learn valuable water safety messages – that may ultimately help save a life – through a new online activity and educational videos made possible by the Pool Safely campaign.”

“The NDPA is proud to be a Pool Safely Campaign Safety Partner,” said Kristin Goffman, Founding Board Member and Executive Director of NDPA. “Our members are dedicated drowning prevention and water safety advocates who will be able to use the educational video and Pool Safely campaign materials to help families learn how to prevent the needless tragedy of child drownings. We are excited to work with the CPSC and the other campaign partners to spark a national conversation about how we can all help keep kids safe around pools and spas."

“I fully support the new Pool Safely campaign and the efforts to increase public awareness about preventing drowning deaths and injuries,” said Harris County Judge Ed Emmett. “Harris County residents should visit the Pool Safely website and review the water safety tips with their children before heading out to the pool. A little time spent online can possibly make a life-saving difference in the water.”

The Pool Safely campaign is CPSC’s national information and education program associated with the Virginia Graeme Baker Pool and Spa Safety Act (P&SS Act). The Pool Safely campaign is designed to raise public awareness, support industry compliance with safety standards, and improve safety at pools and spas. The campaign was launched in Fort Lauderdale, Florida prior to Memorial Day.

Last month, the Pool Safely campaign released a series of public service announcements that remind the American public how to stay safe in and around pools and spas. They can be viewed by visiting www.youtube.com/poolsafely

Rental companies hiring out recalled cars?

2010-07-12T21:55:00.000-07:00

Published: July 7, 2010 at 1:22 PM

Enterprise, the biggest U.S. car-rental company, says it will no longer routinely give customers cars that are subject to safety recalls.

But executives said recalls have to be evaluated individually, because there are so many, ABC News reported.

Earlier this year a California jury awarded $15 million to the parents of two sisters who died in a head-on collision with a truck while driving home for a visit in 2004. Raechel and Jacquie Houck, both in their early 20s, had rented a PT Cruiser that was under recall because of a defect that could cause engine fires.

Enterprise managers said in affidavits that it was company policy to rent recalled vehicles, depending on what was available. Hertz and Avis said they deal with recalls on a case-by-case basis while working closely with car companies to get repairs done.

Critics say most rental companies are too casual about recalls.

READ MORE: http://www.upi.com/Top_News/US/2010/07/07/Rental-companies-hiring-out-recalled-cars/UPI-15151278523348/

Officials worry about consumers lost among the recalls

2010-07-05T21:52:00.000-07:00

By Lyndsey Layton
Washington Post Staff Writer
Friday, July 2, 2010

McDonald's asked customers to return 12 million glasses emblazoned with the character Shrek. Kellogg's warned consumers to stop eating 28 million boxes of Froot Loops and other cereals. Campbell Soup asked the public to return 15 million pounds of SpaghettiOs, and seven companies recalled 2 million cribs.

As product recalls pile up, consumers risk getting lost

And that was just a fraction of the products recalled in the United States last month alone.

Government regulators, retailers, manufacturers and consumer experts are concerned that recall notices have become so frequent across a range of goods -- foods, consumer products, cars -- that the public is suffering from "recall fatigue."

In many cases, people simply ignore urgent calls to destroy or return defective goods.

One recent study found that 12 percent of Americans who knew they had recalled food at home ate it anyway. After Hasbro recalled the iconic Easy Bake Oven in 2007 because about two dozen children had gotten fingers stuck in the door, the toymaker received 249 more reports of injuries over the following six months. One 5-year-old girl was so seriously burned that doctors had to partially amputate a finger.

"It's a real issue," said Jeff Farrar, associate commissioner for food protection at the Food and Drug Administration, who said even his wife has complained about the difficulty of keeping pace with recalls. "That number is steadily going up, and it's difficult for us to get the word out without oversaturating consumers."

The problem is twofold: Some people never learn that a product they own has been recalled, and others know they have a recalled product but don't think anything bad will happen.

"The national recall system that's in place now just doesn't work," said Craig Wilson, assistant vice president for quality assurance and food safety at Costco. "We call it the Chicken Little syndrome. If you keep shouting at the wind -- 'The sky is falling! The sky is falling!' -- people literally become immune to the message."

Exactly why this service was created....An Analogy...

Most of us fear Tigers, but don't worry about them...We would if they were in our cupboards/fridge/etc.

JUST LIKE RECALLS!

READ MORE: http://www.washingtonpost.com/wp-dyn/content/article/2010/07/01/AR2010070106504.html

Industry Launches New Initiative to Secure Drop Sides with Free Immobilization Devices

2010-06-24T23:37:00.000-07:00

Seven Manufacturers Announce Recalls to Repair Cribs to Address Entrapment, Suffocation and Fall Hazards

Industry Launches New Initiative to Secure Drop Sides with Free Immobilization Devices

WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC), with the cooperation of seven firms, is announcing voluntary recalls of more than two million cribs to address drop-side hazards and other hazards that affect the safety of young children. The recalling firms are providing consumers with free repair kits to immobilize the drop sides or other remedies. Do not attempt to fix these cribs with homemade remedies.

The drop-side and fixed-side crib recalls announced today are of units manufactured between 2000 and 2009 by the companies listed below. Consumers should contact these firms directly for the appropriate remedy:

Child Craft, (this firm is out of business): Fixed-Side | Drop-Side
Delta Enterprise Corp., of New York, N.Y.
Evenflo, of Miamisburg, Ohio
Jardine Enterprises, of Taipei, Taiwan
LaJobi, of Cranbury, N.J.
Million Dollar Baby, of Montebello, Calif.
Simmons Juvenile Products Inc. (SJP), of New London, Wis.

“Cribs should be the safest place in the home for infants and toddlers,” said CPSC Chairman Inez Tenenbaum. “CPSC is committed to addressing the hazards with cribs and to restoring parents’ confidence that their child will have a safe sleep.”

CPSC continues to actively investigate various cribs for potential drop-side and other hazards as part of a larger effort by the agency to rid the marketplace and homes of unsafe cribs. CPSC staff is also working on a new mandatory standard to make cribs safer, which is targeted for completion in 2010.

The Juvenile Products Manufacturers Association (JPMA) has also launched a new crib safety initiative. The listed manufacturers are providing free drop-side crib immobilization kits to prevent the drop side from detaching, plus replacement hardware and assembly instructions for cribs manufactured by participating firms. These materials are available free to any consumer by request.

The firms involved in today’s recalls are providing immobilization devices or other remedies as part of JPMA’s crib safety initiative. Consumers can visit JPMA’s website, www.cribsafety.org, for a list of participating manufacturers and for downloadable materials about ensuring that children have a safe sleep.

The immobilization devices, which will be available in the next few weeks, should be attached to keep the drop side from detaching from the cribs. Immobilization devices are not a solution for cribs with broken or damaged drop-side hardware. If your drop-side hardware is broken, contact the manufacturer for an alternative remedy.

CPSC issued a warning last month alerting parents and caregivers that there can be deadly hazards associated with drop-side cribs. Nine million drop-side cribs have been recalled over the past five years. CPSC staff has determined drop-side cribs generally have a tendency to be less structurally sound than cribs with four fixed sides.

Drop-side crib incidents can also occur due to incorrect assembly or age-related wear and tear. Age is a factor in the safety of any crib. At a minimum, CPSC staff recommends that you not use a crib that is older than 10 years. Many older cribs do not meet current voluntary standards and can have numerous safety problems.

Important Message from CPSC:
The safest place for your baby to sleep is in a crib or bassinet depending on their age. If your crib has been recalled or it has missing, broken or loose parts, find an alternate safe sleep environment intended for a baby. If your baby is less than six months old and is not yet able to push up to his/her hands and knees, you can put your baby to sleep in a bassinet. Make sure your bassinet has not been recalled. Here’s a list. Also, you can use a play yard.

Do not put additional bedding such as pillows, thick quilts, comforters or anything plush into your baby’s sleeping space. More babies die every year from suffocation in plush sleeping environments than from defective cribs. Always place your baby on his or her back to reduce the risk of Sudden Infant Death Syndrome (SIDS).

Vitamin D Supplement Products: Medication Use Error

2010-06-15T20:31:00.000-07:00

Vitamin D Supplement Products: Medication Use Error

Audience: Pediatrics, Family Practice, Consumer

ISSUE: Some liquid Vitamin D supplement products are sold with droppers that could allow parents to accidentally give harmful amounts of Vitamin D to their infant. Excessive amounts of Vitamin D can be harmful to infants, and may be characterized by nausea and vomiting, loss of appetite, excessive thirst, frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, and fatigue, as well as more serious consequences like kidney damage.

BACKGROUND: The American Academy of Pediatrics has recommended a dose of 400 International Units (IU) of Vitamin D Supplement per day to breast-fed and partially breast-fed infants (AAP Pediatric Nutrition Handbook, 6th edition, p.466).

RECOMMENDATION: The easiest way to insure that an infant will not get more than the recommended dose is to use a product supplied with a dropper that will give no more than 400 IU per dose. If a caregiver cannot clearly determine the dose of Vitamin D that should be given to an infant or has any other questions, FDA recommends consulting with a healthcare provider before giving any of these products to an infant.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Online: www.fda.gov/MedWatch/report.htmPhone: 1-800-332-1088
Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
Fax: 1-800-FDA-0178

FDA Seizes More Than $32,000 Worth of Bulk Honey from Philadelphia Distribution Center

2010-06-11T23:56:00.000-07:00

Media Inquiries: Elaine Gansz Bobo, 301-796-7567, elaine.bobo@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Seizes More Than $32,000 Worth of Bulk Honey from Philadelphia Distribution Center
Agency acts after finding potent antibiotic in bulk honey

At the request of the Food and Drug Administration, federal marshals seized 64 drums of imported bee’s honey from a Philadelphia distribution center on June 4 because it contained a potent antibiotic that could lead to serious illness or death.

The seizure occurred at the Delaware Avenue Distribution Center, 700 Pattison Avenue, in Philadelphia. The bulk honey was imported by Sweet Works Inc., of Monterey Park, California from Cheng Du Wai Yuan Bee Products Company Limited of Chengdu, China. Subsequently, it was sold to Alfred L. Wolff Inc. of Chicago, which placed it in storage.

The FDA estimates the value of the seized goods to be more than $32,000. U.S. Marshals executed this seizure pursuant to a warrant issued by the U.S. District Court for the Eastern District of Pennsylvania. The honey is adulterated within the meaning of 21 U.S.C. 342(a)(2)(C) of the federal Food, Drug & Cosmetic Act, because it contains an unsafe food additive.

FDA testing of a sample of this product at the storage facility showed that it contained chloramphenicol, which is not approved for use in food, animal feed, or food-producing animals in the United States.

Chloramphenicol is a potent antibiotic drug that is approved only for use in humans with serious infections when other less toxic drugs won’t work. People who are sensitive to chloramphenicol can develop a type of bone marrow depression called aplastic anemia, which can be fatal.

"Unapproved food additives in the U.S. food supply are of significant concern to the agency,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “The FDA took this action because of the potential serious public health effects of this product.”

The FDA is now in the process of inventorying the seized goods.

This case is being investigated by FDA Philadelphia District with the assistance of the U.S. Marshals Service.

Salmonellosis linked to Subway restaurants

2010-06-09T21:43:00.000-07:00

Salmonellosis linked to Subway restaurants continues to plague the
state line with 2 cases now reported in Winnebago County. Those who
got sick ate at a Subway in Machesney Park. That now brings the total
to 60 cases of salmonellosis related to this outbreak in Illinois.
Normally this specific serotype is only seen in one or two cases a
year in the state.

http://www.promedmail.org/pls/apex/f?p=2400:1001:3307752478437061::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1000,83150

FDA Takes Action Against California Soy-Product Manufacturer Lifesoy

2010-06-07T23:41:00.001-07:00

Media Inquiries: Rita Chappelle, 301-796-4672 or 240-753-8603, rita.chappelle@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

FDA Takes Action Against California Soy-Product Manufacturer Lifesoy

Products made under conditions that violated federal law

Lifesoy Inc., a San Diego-based manufacturer of ready-to-eat soy products cited by the U.S. Food and Drug Administration for preparing, packing, and holding articles of food under insanitary conditions, has entered into a consent decree of permanent injunction in the U.S. District Court for the Southern District of California. The consent decree requires Lifesoy to stop manufacturing and distributing food products until the company registers with the FDA and complies with federal laws regarding sanitary practices.

Lifesoy made sweetened and unsweetened soy milk, fried tofu, fresh tofu, soybean pudding, and other soy products for human consumption. The government’s complaint further alleges that Lifesoy did not hold and store the foods under proper refrigeration conditions to prevent the growth of microorganisms.

U.S. District Judge Jeffrey T. Miller entered a consent decree of permanent injunction on June 2, 2010, against the company, and its owner, Long H. Lai. The consent decree permanently restrains and enjoins Lifesoy and Mr. Lai from directly or indirectly receiving, preparing, processing, packing, holding, and distributing any article of food, unless and until they come into compliance with the terms of the consent decree and the law.

“Today’s action shows that the FDA will seek enforcement action against companies that continue to violate federal laws designed to protect the safety of the nation’s food supply,” said FDA Acting Associate Commissioner for Regulatory Affairs Michael Chappell. “Food facilities such as Lifesoy are required by law to register with the FDA and follow current good manufacturing practices and other laws, including maintaining a sanitary facility.”

As part of the consent decree, Lifesoy must retain a qualified sanitation expert, with no personal or financial ties to the defendants, to develop and implement a written sanitation program to assure that the operations comply with current Good Manufacturing Practices. Before the company may reopen it must, among other things, receive FDA approval of its sanitation program and have the agency re-inspect the facility.

The government’s complaint alleged that Lifesoy and Mr. Lai caused articles of food to be adulterated under federal law by preparing, packing, and holding foods in such conditions that the products may be rendered injurious to health or may have become contaminated.

The complaint further alleged that Lifesoy did not hold and store the foods under proper refrigerated conditions to prevent the growth of microorganisms.

Lifesoy was first inspected by the FDA in November 2007. The Agency attempted to help the company come into compliance with appropriate food safety laws, however Lifesoy failed to comply resulting in this action.

CPSC Issues Final Mandatory Rule on Infant Baby Walkers

2010-05-28T20:49:00.001-07:00

The U.S. Consumer Product Safety Commission (CPSC) voted (5-0) to issue a final mandatory rule under section 104(b) of the Consumer Product Safety Improvement Act (CPSIA) for infant walkers.

The rule adopts the applicable voluntary industry standard, ASTM F 977-07, Standard Consumer Safety Specification for Infant Walkers, and adds the following more stringent requirements:

using the actual weight of a walker in a calculation to determine the launching distance for the stair fall test,
specifying equipment used in the stair fall test,
adding a parking brake test for walkers equipped with parking brakes.
These changes were made to strengthen the standard and reduce the risk of injury from these products. There has been an 88% reduction in injuries from 1994 to 2008, which may be attributed to the addition of a stair fall requirement included in the 1997 version of the ASTM voluntary standard.

The final infant walker rule would take effect six months after publication in the Federal Register. This is the effective date that was proposed in the Notice of Proposed Rulemaking (NPR). Consistent with the proposed rules recently published for toddler beds and bassinets, the effective date would apply to products manufactured or imported on or after that date.

Section 104 of the CPSIA, Standards and Consumer Registration of Durable Nursery Products, requires the CPSC to study and develop safety standards for certain infant and toddler products, including infant walkers.

CPSC Approves New Federal Safety Standard for Infant Bath Seats

2010-05-27T18:02:00.003-07:00

The U.S. Consumer Product Safety Commission (CPSC) has approved a new federal safety standard for infant bath seats. The vote on the final rule was 5-0.

The federal standard for infant bath seats is the first mandatory standard issued by CPSC as required under the Consumer Product Safety Improvement Act (CPSIA) for a range of infant and toddler durable products.

The new federal requirements for infant bath seats enhance the current ASTM voluntary standard by adding stricter stability requirements to prevent the bath seat from tipping over, tighter leg opening requirements to prevent children from slipping through the leg openings and a larger permanent warning label alerting parents and caregivers that bath seats are not safety devices and that infants should never be left unattended in a bath seat. The federal standard incorporates current voluntary standard provisions requiring latching and locking mechanisms, and compliance with CPSC’s standards for sharp points and edges, small parts, and lead in paint.

Infant bath seats are used in a sink or tub to provide back and front support to a seated infant while he or she is being bathed. They are marketed for use with infants between five and 10 months of age.

From 1983 through November 2009, there were 174 reported deaths involving bath seats and 300 reported non fatal bath seat incidents. Many of the deaths and incidents involve babies left unattended while bathing.

Young children can drown quickly, even in small amounts of water. Never leave a child alone, even for a moment, near any water. Always keep a young child within arm's reach in a bathtub. And never leave a baby or toddler in a bathtub under the care of another young child.

Information gathered by CPSC staff indicates that no baby bath seat currently on the market complies with the new mandatory standard.

The final rule on infant bath seats goes into effect six months after publication in the Federal Register. Bath seats manufactured or imported on or after that date will be required to meet the new mandatory standard.

CPSC staff is working to develop federal standards for nearly 20 other durable juvenile products, including bassinets, cribs, and infant walkers.

CPSC Identifies Manufacturers of Problem Drywall Made in China

2010-05-27T18:01:00.000-07:00

The U.S. Consumer Product Safety Commission (CPSC) is releasing today the names of the drywall manufacturers whose drywall emitted high levels of hydrogen sulfide in testing conducted for the agency by Lawrence Berkeley National Laboratory (LBNL). There is a strong association between hydrogen sulfide and metal corrosion.

Of the samples tested, the top ten reactive sulfur-emitting drywall samples were all produced in China. Some of the Chinese drywall had emission rates of hydrogen sulfide 100 times greater than non-Chinese drywall samples.

"Homeowners who have problem drywall in their homes are suffering greatly", said CPSC Chairman Inez Tenenbaum. "I appeal to these Chinese drywall companies to carefully examine their responsibilities to U.S. families who have been harmed and do what is fair and just".

At the U.S.-China Strategic and Economic Dialogue meetings in Beijing May 24-25, U.S. officials pressed the Chinese government to facilitate a meeting between CPSC and the Chinese drywall companies whose products were used in U.S. homes, and which exhibit the emissions identified during the testing procedures. The Strategic and Economic Dialogue represents the highest-level bilateral forum to discuss a broad range of issues between the two nations.

The following list identifies the top 10 drywall samples tested that had the highest emissions of hydrogen sulfide, along with the identity of the manufacturer of the drywall and the year of manufacture, from highest to lowest.

Knauf Plasterboard (Tianjin) Co. Ltd.: (year of manufacture 2005) China
Taian Taishan Plasterboard Co. Ltd.: (2006) China
Shandong Taihe Dongxin Co.: (2005) China
Knauf Plasterboard (Tianjin) Co. Ltd.: (2006) China
Taian Taishan Plasterboard Co. Ltd.: (2006) China
Taian Taishan Plasterboard Co. Ltd.: (2006) China
Shandong Chenxiang GBM Co. Ltd. (C&K Gypsum Board): (2006) China
Beijing New Building Materials (BNBM): (2009) China
Taian Taishan Plasterboard Co. Ltd.: (2009) China
Shandong Taihe Dongxin Co.: (2009) China
Other Chinese drywall samples had low or no detectable emissions of hydrogen sulfide as did the drywall samples tested that were manufactured domestically. They include: Knauf Plasterboard Tianjin: (2009) China; Tiger ***ShiGao JianCai***liangpianzhuang: (2006) China; USG Corporation: (2009) U.S.; Guangdong Knauf New Building Material Products Co. Ltd.: (2009) China; 3/8" drywall manufacturer uncertain (date uncertain): China; Knauf Plasterboard (Wuhu) Co. Ltd.: (2009) China; CertainTeed Corp.: (2009) U.S.; Georgia Pacific Corp.: (2009) U.S.; Dragon Brand, Beijing New Building Materials Co. Ltd.: (2006) China; CertainTeed Corp.: (2009) U.S.; Pingyi Baier Building Materials Co. Ltd.: (2009) China; Sample purchased in China, manufacturer unknown: (2009) China; Panel Rey S.A.: (2009) Mexico; Lafarge North America: (2009) U.S.; National Gypsum Company: (2009) U.S.; National Gypsum Company: (2009) U.S.; Georgia Pacific Corp.: (2009) U.S.; Pabco Gypsum: (2009) U.S.; Temple-Inland Inc.: (2009) U.S.; and USG Corporation: (2009) U.S.

Last month, CPSC released the results of drywall emissions tests by LBNL. The studies showed a connection between certain Chinese drywall and corrosion in homes. In addition, the patterns of reactive sulfur compounds emitted from drywall samples show a clear distinction between certain Chinese drywall samples manufactured in 2005/2006 and other Chinese and non-Chinese drywall samples.

To date, CPSC has spent over $5 million to investigate the chemical nature and the chain of commerce of problem drywall. Earlier this year, CPSC and HUD issued an identification protocol to help consumers identify problem drywall in their homes. Last month, CPSC and HUD issued remediation guidance to assist impacted homeowners.

See the chart (pdf) listing drywall chamber test results.

Consumers Warned of High Levels of Lead in Children's Jewellery

2010-05-17T20:24:00.000-07:00

2010-80
May 17, 2010
For immediate release

The issue
Health Canada is advising consumers that high levels of lead continue to be found in a wide variety of children's jewellery products sold in Canada. Children can ingest harmful amounts of lead when they chew, suck or swallow jewellery items containing lead, as lead is very toxic to children even at low exposure levels. Simply wearing a jewellery item with lead does not present a serious risk to health because there is minimal lead absorption through the skin. In addition to lead, Health Canada is also concerned that cadmium, which is a carcinogen, may be increasingly substituted for lead in inexpensive children's jewellery.

Who is affected
Consumers purchasing inexpensive children's jewellery.

What consumers should do
•If you suspect your children's jewellery may contain lead or cadmium, throw it out in your regular household garbage. Consumers can also contact their municipality for instructions on disposing items containing lead.
•Do not give young children adult jewellery to wear or play with; it may contain lead or other heavy metals.
•Do not allow children to suck or chew on any jewellery.
•If your child has sucked or chewed regularly on jewellery which you think may contain lead or cadmium, ask your doctor to test your child's blood for lead or other heavy metals.
•A child who swallows a jewellery item containing lead is at high risk of developing severe poisoning. Contact an emergency medical service if you believe your child has swallowed an item containing lead or cadmium.
•Check for product recalls by contacting the retailer, manufacturer or Health Canada at www.healthcanada.gc.ca/cps-recalls.
•Additional information on lead in jewellery can be found on-line on the Consumer Product Safety web page.
Symptoms of Lead Poisoning
For more information on the risks and symptoms of lead exposure, visit Health Canada's: It's Your Health: Effects of Lead on Human Health.

Background
Several voluntary recalls for children's jewellery products have been published in the last few weeks. The sampling and testing phase of Health Canada's 2009/2010 Cyclical Enforcement testing on children's jewellery products concluded in March 2010 and the Department continues to work with industry to take the appropriate action on non-compliant products.

Under item 42, Part I of Schedule I of the Hazardous Products Act, it is illegal to import, advertise or sell jewellery items that appeal primarily to children under 15 years of age and contain more than 600 mg/kg total lead and 90 mg/kg migratable lead, which is the proportion of lead that is released from the product into the body under certain conditions, such as chewing, sucking, or swallowing of the product.

Lead contamination is not exclusive to metallic jewellery. Lead can be found in different materials used in jewellery manufacturing, such as some surface coatings as well as plastics like polyvinyl chloride (PVC). The level of lead found in a product can not be determined visually. Products labelled as "lead free" have been found to violate Health Canada's lead requirements.

For more information
Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

How to report problems with consumer products
Health Canada would like to remind Canadians to report any health or safety incidents related to the use of a consumer product or cosmetic. An easy-to-use incident report form is now available on the Department's website.

•E-mail: CPSR-RSPC@hc-sc.gc.ca
•Mail: Incident Report - Consumer Product Safety Directorate
Health Canada
123 Slater Street
Ottawa, ON, Canada, K1A 0K9

The insanity of our times! A Comment.

2010-05-06T20:30:00.001-07:00

We have gone over the cliff! Here is a clip from Progressive Grocer.

CSPI Threatens to Sue Safeway for Not Using loyalty Data for Recall Warnings

May 6, 2010

The Center for Science in the Public Interest (CSPI) yesterday notified Safeway that it would file a lawsuit against the grocery chain if it fails to adopt a policy to notify Club Card members who purchased contaminated food subject to recalls.

According to the Washington-based nonprofit health advocacy group, focuses on nutrition, food safety, and pro-health alcohol policies, even though Safeway collects phone numbers and e-mail addresses from its Club Card members, it won’t use that data to contact people who bought contaminated food.

“It shocks the conscience that a major retailer would sit on its hands, even though it has easy access to the e-mails, addresses and phone numbers of those who have purchased food that might be contaminated,” said CSPI litigation director Steve Gardner. “Perhaps Safeway saves a few pennies by remaining silent. But why would you knowingly risk letting your customers fall ill or, worse, die?”

CSPI said that many retailers use customer contact information generated by their bonus card programs to notify consumers when they’ve purchased recalled food, via letters and automated phone calls.

DO WE WANT EVERY COMPANY TO ISSUE THESE CARDS?

WHERE DO WE PUT ALL THESE CARDS?

Read more at:

http://www.progressivegrocer.com/progressivegrocer/content_display/supermarket-industry-news/e3i8af56baccdd2a1c6fc2c2578e87b4fbb

Information on Investigation into Pampers Dry Max Diapers

2010-05-06T15:06:00.000-07:00

Information on Investigation into Pampers Dry Max Diapers

2010-68

May 5, 2010
For immediate release

OTTAWA - Health Canada has recently received two complaints of rashes that may have resulted from the use of Pampers Dry Max Diapers. Health Canada officials immediately contacted Procter and Gamble to follow up, and the investigation is now ongoing. Health Canada is also aware of the ongoing investigation in the United States, and is working cooperatively with US officials. Health Canada will post additional information as soon as it is available.

Media Inquiries:
Health Canada
(613) 957-2983

Public Inquiries:
(613) 957-2991
1-866 225-0709

FDA Obtains Consent Decree to Stop Marketing of Unapproved Sterilization System

2010-05-06T15:05:00.000-07:00

Media Inquiries: Dick Thompson, 301-796-7566; dick.thompson@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

FDA Obtains Consent Decree to Stop Marketing of Unapproved Sterilization System

Steris agrees to stop selling SS1 tabletop system for endoscopes, other devices

The U.S. Food and Drug Administration today announced that a consent decree has been filed against the device manufacturer, STERIS Corp. of Mentor, Ohio. The decree stops the company from distributing unapproved and misbranded devices used to sterilize heat-sensitive instruments and medical devices. It prohibits the distribution of the STERIS System 1 Processor, or SS1, a tabletop liquid chemical system marketed to disinfect certain devices, such as endoscopes, that cannot withstand steam sterilization.

As part of the consent decree of permanent injunction, STERIS has developed a transition plan and rebate program for its U.S. customers to ease the transitioning to legally-marketed alternatives. The transition plan allows STERIS to continue to support existing customers who are using the SS1, but requires these customers to obtain a Certificate of Medical Necessity to get parts, components, accessories, and service during the transition period which ends on August 2, 2011.

“FDA’s oversight of medical devices helps ensure that patients are protected from unsafe or ineffective devices,” said Assistant Attorney General Tony West, who heads the Justice Department’s Civil Division. “When device manufacturers fail to comply with FDA’s regulations, they put patients at increased risk. As this consent decree shows, we will take whatever steps are necessary to make sure that all manufacturers are complying with FDA’s regulations.”

In May 2008, the FDA advised STERIS in a Warning Letter that significant changes made to the SS1 caused the device to be adulterated and misbranded. In December 2009, the FDA sent a letter to health care facilities and infection control practitioners advising them that the agency had not cleared the current version of the SS1. The letter recommended users transition to a legally-marketed alternative.

Under the consent decree, STERIS agreed to destroy used SS1 devices, components, parts, and accessories in the company’s possession within the United States by September 30, 2011. Some specified unused devices and component can, with FDA approval, be retained.

The decree was filed in the U.S. District Court, Northern District of Ohio on April 19, 2010, and is subject to court approval.

User facilities, including hospitals, are required to report suspected device-related deaths to the FDA and to the manufacturer, and serious injuries to the manufacturer or to FDA1.

In addition, healthcare professionals and consumers are encouraged to report serious adverse events that may be related to the use of unapproved and misbranded products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

On April 5, 2010, the FDA cleared the STERIS System 1E (SS1E), which is an alternative to the SS1. The SS1E is a liquid chemical sterilant processing system. Liquid chemical sterilization is not equivalent to traditional sterilization (such as steam, ethylene oxide, and gamma irradiation). The SS1E can be used to process reusable heat-sensitive devices such as endoscopes and their accessories that cannot be processed using steam.

Voluntary Reporting may be done:

Online2
Via Regular Mail: use postage-paid, pre-addressed Form FDA 35003. Mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 800-FDA-0178
Phone: 800-332-1088

E. COLI VTEC NON-O157 - USA (02): (MICHIGAN, OHIO, NEW YORK) O145

2010-05-06T15:04:00.000-07:00

E. COLI VTEC NON-O157 - USA (02): (MICHIGAN, OHIO, NEW YORK) O145
*****************************************************************
A ProMED-mail post

ProMED-mail is a program of the
International Society for Infectious Diseases

Date: Mon 3 May 2010
Source: CIDRAP (Center for Infectious Disease Research & Policy) News [edited]

The strain of non-O157 _Escherichia coli_ that has caused recent illnesses
in Ohio, Michigan, and New York has been identified, but the food source
remains unknown, according to health officials. The Centers for Disease
Control and Prevention (CDC) has identified the strain as O145, which, like
O157, produces Shiga toxin, according to Jennifer House, spokeswoman for
the Ohio Department of Health.

A CDC team arrived in Ohio yesterday [2 May 2010] to assist in the
investigation, House told CIDRAP News.

http://www.promedmail.org/pls/apex/f?p=2400:1001:2227548857986884::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1000,82570

The Lazy Man’s Way to Prevent Diabetes Trough Blood Glucose Test

2010-04-14T20:50:00.000-07:00

The Lazy Man’s Way to Prevent Diabetes Trough Blood Glucose Test

One of the main parts of the body that is affected by Type 2 diabetes is the pancreas. Many people eat foods that contain high doses of sugar, which turns into glucose in the blood stream. When glucose enters the blood cells, insulin is released by the pancreas so that the glucose becomes a type of fuel for the body to run on. For a person who is living with Type 2 diabetes, all of this makes it difficult for the body to produce the insulin it needs and to use what little is produced. At this point, there is plenty of glucose to be used as fuel for the body, but the cells are not able to find it.

The American Diabetes Association has the duty of looking for information regarding this important medical condition. 23.6 million individuals living in America currently have diabetes, and because of this the country is seen as very unhealthy. Ninety percent of this figure has been diagnosed with Type 2 diabetes. Diabetes and the tendency to be overweight usually run in the family. If there is too much glucose in your body, it could result in serious internal organ damage and affect one’s nervous system.

A Diabetic Life
Healthy living can be the best way to treat Type 2 diabetes. The things that healthy people do on a regular basis can have a huge effect on diabetics. This includes actions that are as simple as exercising and eating good, healthy foods.

Those who have diabetes may be able to avoid health complications by doing their best to keep the glucose levels in their blood within the recommended range. One of the most common ways to check blood glucose is to use a finger prick test. However, many physicians have indicated that these tests are as sufficient for tracking glucose fluctuations over time as the HbA1c test.

The percentage of glycated hemoglobin in the blood is gauged by the HbA1c test and can show when glucose levels are particularly high. Tests have shown that diabetics should usually maintain less than a 7% level according to the A1c. According to the CDC, the risks of many types of diseases would reduce by up to 40% if people would reduce their a1c levels to 7 percent.
Too Much Control

One of these studies, conducted at the Lancet and Swedish Medical Center in Seattle, has found that people who have median levels may be at a far greater risk of death, especially for those taking insulin. However, other tests have indicated that A1c levels of 7 percent is still perfectly healthy. Matt Davies, An accredited Endocrinologist, has stated that maintaining a 7% A1c level is healthy according to recent studies, but that physicians should always take the individual patient's history into account prior to planning treatment.

About the Author - Kristina V. Ridley writes on diabetes meters .org , her personal hobby blog focused on helping people get free information to prevent diabetes and test blood glucose at home.

(Special Thank You to guest blogger Kristina)

Triclosan: What Consumers Should Know

2010-04-08T15:41:00.000-07:00

What is triclosan?
Triclosan is an ingredient added to many consumer products to reduce or prevent bacterial contamination. It may be found in products such as clothing, kitchenware, furniture, and toys. It also may be added to antibacterial soaps and body washes, toothpastes, and some cosmetics—products regulated by the U.S. Food and Drug Administration (FDA).

What is known about the safety of triclosan?
Triclosan is not currently known to be hazardous to humans. But several scientific studies have come out since the last time FDA reviewed this ingredient that merit further review.

Animal studies have shown that triclosan alters hormone regulation. However, data showing effects in animals don’t always predict effects in humans. Other studies in bacteria have raised the possibility that triclosan contributes to making bacteria resistant to antibiotics.

In light of these studies, FDA is engaged in an ongoing scientific and regulatory review of this ingredient. FDA does not have sufficient safety evidence to recommend changing consumer use of products that contain triclosan at this time.

Does triclosan provide a benefit in consumer products?
For some consumer products, there is clear evidence that triclosan provides a benefit. In 1997, FDA reviewed extensive effectiveness data on triclosan in Colgate Total toothpaste. The evidence showed that triclosan in this product was effective in preventing gingivitis.

For other consumer products, FDA has not received evidence that the triclosan provides an extra benefit to health. At this time, the agency does not have evidence that triclosan in antibacterial soaps and body washes provides any benefit over washing with regular soap and water.

What consumers should know:
Triclosan is not known to be hazardous to humans.
FDA does not have sufficient safety evidence to recommend changing consumer use of products that contain triclosan at this time.
In light of questions raised by recent animal studies of triclosan, FDA is reviewing all of the available evidence on this ingredient’s safety in consumer products. FDA will communicate the findings of its review to the public in spring 2011.
At this time, FDA does not have evidence that triclosan added to antibacterial soaps and body washes provides extra health benefits over soap and water. Consumers concerned about using hand and body soaps with triclosan should wash with regular soap and water.
Consumers can check product labels to find out whether products contain triclosan.
How can I tell if there is triclosan in a product that I am using?
Antibacterial soaps and body washes, and toothpastes are considered over-the-counter drugs. If an over-the-counter drug contains triclosan, it will be listed as an ingredient on the label, in the Drug Facts box. If a cosmetic contains triclosan, it will be included in the ingredient list on the product label.

What is FDA doing to evaluate the safety of triclosan?
We are engaged in an ongoing scientific and regulatory review of the safety of triclosan in FDA-regulated products. We also have partnered with other Federal Agencies to study the effects of this substance on animal and environmental health (see http://www.epa.gov/oppsrrd1/REDs/factsheets/triclosan_fs.htm4; http://www.epa.gov/endo/5).

FDA is working to incorporate the most up-to-date data and information into the regulations that govern the use of triclosan in consumer products. FDA will communicate the findings of its review to the public in spring 2011.

This article appears on FDA's Consumer Updates page6, which features the latest on all FDA-regulated products.

It’s called the Consumer Recall Notification Act – and it has the potential to drastically change the way you have to manage a recall

2010-03-29T16:09:00.000-07:00

It’s called the Consumer Recall Notification Act – and it has the potential to drastically change the way you have to manage a recall. This bill is just one more of the many reasons why food manufacturers and retailers must pay attention to changes in the rules governing their business on a daily basis. It is critical that food manufacturers heed this warning and revisit their recall plans to make sure they are ready to manage a recall effectively and in compliance with fast changing recall regulations.

Introduced by Senator Kristen Gillibrand (D-NY), the proposed legislation would change several aspects of the recall process that many say need repair. Lawmakers, regulators, and consumer activists are increasingly concerned about food safety issues, such as the increasing health-related costs of food-borne illness.

The Gillibrand proposal could end up as part of the Food Safety Modernization Act that would have a major impact on recall execution for food manufacturers and retailers alike. Specifically, Senator Gillibrand’s bill seeks to improve recall notification measures for food recalls in three areas: consumer notification, distribution of information to restaurants and food retailers, and distribution of information to health workers.

FULL STORY: http://www.expertrecall.com/senator-proposes-changes-to-recall-notification-requirements/

Public Health Agencies Warn of Outbreaks Related to Drinking Raw Milk

2010-03-28T17:44:00.000-07:00

Media Inquiries: Siobhan DeLancey, 301-796-4668, siobhan.delancey@fda.hhs.gov

Stephanie Kwisnek, 301-436-1856, stephanie.kwisnek@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

Public Health Agencies Warn of Outbreaks Related to Drinking Raw Milk

Latest outbreak of campylobacteriosis in Midwest is linked to unpasteurized product

The U.S. Food and Drug Administration, along with several state agencies, is alerting consumers to an outbreak of campylobacteriosis associated with drinking raw milk. At least 12 confirmed illnesses have been recently reported in Michigan. Symptoms of campylobacteriosis include diarrhea, abdominal pain and fever.

The FDA is collaborating with the Michigan Department of Community Health (MDCH), the Illinois Department of Public Health, the Indiana State Board of Animal Health and the Indiana State Health Department, to investigate the outbreak. MDCH reports that, as of March 24, 2010, it received reports of 12 confirmed cases of illness from Campylobacter infections in consumers who drank raw milk. The raw milk originated from Forest Grove Dairy in Middlebury, Ind.

Raw milk is unpasteurized milk from hoofed mammals, such as cows, sheep, or goats. Raw milk may contain a wide variety of harmful bacteria – including Salmonella, E. coli O157:H7, Listeria, Campylobacter and Brucella -- that may cause illness and possibly death. Public health authorities, including FDA and the Centers for Disease Control and Prevention, have expressed concerns about the hazards of drinking raw milk for decades.

Symptoms of illness caused by various bacteria commonly found in raw milk may include vomiting, diarrhea, abdominal pain, fever, headache and body ache. Most healthy individuals recover quickly from illness caused by raw milk. However, some people may have more severe illness, and the harmful bacteria in raw milk can be especially dangerous for pregnant women, the elderly, infants, young children and people with weakened immune systems.

If consumers of raw milk are experiencing one or more of these symptoms after consuming raw milk or food products made from raw milk, they should contact their health care provider immediately.

Since 1987, the FDA has required all milk packaged for human consumption to be pasteurized before being delivered for introduction into interstate commerce. Pasteurization, a process that heats milk to a specific temperature for a set period of time, kills bacteria responsible for diseases, such as listeriosis, salmonellosis, campylobacteriosis, typhoid fever, tuberculosis, diphtheria and brucellosis. FDA’s pasteurization requirement also applies to other milk products, with the exception of a few aged cheeses.

From 1998 to 2008, 85 outbreaks of human infections resulting from consumption of raw milk were reported to CDC. These outbreaks included a total of 1,614 reported illnesses, 187 hospitalizations and 2 deaths. Because not all cases of foodborne illness are recognized and reported, the actual number of illnesses associated with raw milk likely is greater.

Proponents of drinking raw milk often claim that raw milk is more nutritious than pasteurized milk and that raw milk is inherently antimicrobial, thus making pasteurization unnecessary. There is no meaningful nutritional difference between pasteurized and raw milk, and raw milk does not contain compounds that will kill harmful bacteria.

Information for Food Manufacturers - Recall of Hydrolysed Vegetable Protein (HVP) by Basic Flavors Inc.

2010-03-08T13:21:00.000-08:00

Information for Food Manufacturers - Recall of Hydrolysed Vegetable Protein (HVP) by Basic Flavors Inc., Las Vegas, Nevada

The Canadian Food Inspection Agency (CFIA) is providing this information to industry regarding the hydrolysed vegetable protein (HVP) made by Basic Food Flavors Inc. of Las Vegas, Nevada.

This ingredient is subject to recalls in the United States, has been imported into Canada and may be contaminated with Salmonella. The CFIA is working with its counterparts in the U.S. to determine the situation in Canada. To date, no illnesses have been associated with this recall, either in the U.S. or Canada. The Public Health Agency of Canada (PHAC) will continue to actively monitor for illnesses as recall activities continue.

This information is intended to facilitate industry assessment of the current situation and the determination of appropriate steps to mitigate the risk of exposure of consumers to Salmonella related to the use of HVP in product manufacture.

Background Information
The U.S. Food and Drug Administration (FDA) was informed of Salmonella contamination in HVP made by Basic Food Flavors Inc. of Las Vegas, Nevada. Further investigation identified Salmonella contamination in the manufacturing facility. On February 25, 2010, Basic Food Flavors Inc. issued a voluntary recall of all powder and paste HVP made since September 17, 2009.

The CFIA has determined that HVP from Basic Food Flavors is imported into Canada and may be used in the manufacture of a variety of foods.

HVP is an ingredient commonly used as a flavour enhancer or seasoning in many food products. In many cases, HVP is incorporated at low levels in processed foods which are made using processes that kill Salmonella. In addition, many foods that contain HVP are cooked by consumers in ways that would kill Salmonella. However, certain ready-to-eat foods which incorporate HVP can be produced using processes which would not destroy Salmonella and may therefore pose a risk to consumers if the recalled HVP has been used in their production.

Food contaminated with Salmonella may not look or smell spoiled. Consumption of food contaminated with these bacteria may cause salmonellosis, a foodborne illness. In young children, the elderly and people with weakened immune systems, salmonellosis may cause serious and sometimes deadly infections. In otherwise healthy people, salmonellosis may cause short-term symptoms such as high fever, severe headache, vomiting, nausea, abdominal pain and diarrhoea. Long term complications may include severe arthritis.

Information for Manufacturers
Based on information available at this time, the CFIA is providing information on several risk-appropriate steps for recalled HVP or products containing recalled HVP made by Basic Food Flavors Inc. on or after September 17, 2009.

In general, the risk-appropriate steps can be divided into four categories:

1.Bulk HVP recalled by Basic Food Flavors Inc.
Canadian manufacturers who have unused HVP which has been recalled should stop using the product, unless it will be used in a finished product which involves a process which will kill Salmonella.

2.Ready-to-eat foods manufactured with recalled HVP.
These products may contain Salmonella and may be subject to a recall where the products have not been subjected to an adequate kill step for Salmonella.

3.Ready-to-cook foods manufactured with recalled HVP:
Cooking instructions on the product labels should be assessed to ensure they include an adequate kill step for Salmonella. If cooking / heating instructions are adequate to kill Salmonella, no action is required. If cooking instructions are not adequate, these products may need to be recalled.

4.Other potential uses
Industry should also consider how their product may be used by the consumer. For example, a powdered soup mix, when prepared according to instructions on the label which include an adequate kill step, may be considered safe. However, the same product may have recipe ideas on the label, or, is widely used by consumers to make a dip for chips without any kill step and is therefore considered ready-to-eat. If the recalled HVP has been incorporated, such products may be subject to recall.

If firms do not know, or do not have the expertise to know if their process includes a kill step they should engage an expert for advice. The CFIA does not provide a list of qualified experts, however, such specialists may often be found through industry associations, universities, etc. Please note that thermal processing times and temperatures will vary depending on the particular food.

If a manufacturer decides to voluntarily recall products, please contact the local CFIA office or the Area Recall Coordinator with details.

Area Recall Coordinator Contact Information

Ontario
416-665-5049

Atlantic
506-381-7683

Quebec
1-866-806-4115

BC and Yukon
604-978-1120

Manitoba
204-797 4501

Saskatchewan
306-529 0671

Alberta, NWT and Nunavut
403-661-7505

Consumer agency tells industry to put safety first

2010-02-18T17:21:00.000-08:00

WASHINGTON — One of the nation's top safety officials is delivering a stern warning to the makers of toys, cribs and other children's products, telling them to put safety first — or face potential fines, lawsuits or other actions.

"If you resist our efforts to recall children's products, be forewarned: This commission stands ready to be creative in the use of our enforcement authorities," Consumer Product Safety Commission Chairwoman Inez Tenenbaum said Wednesday.

It was her sharpest admonition to industry officials since taking over as chairman eight months ago. It follows pointed questions from Congress about the months-long lag time to tell the public about recalls of defective products.

In a speech to the International Consumer Product Health and Safety Organization, Tenenbaum said safety legislation passed in 2008 gives the commission new powers, "and we are not afraid to use them."

The product safety bill set strict limits on lead paint, lead and chemicals called phthalates that are used to soften plastics. It also called for new rules governing cribs, ATVs and other products.

At a crib safety hearing last month, House lawmakers wanted to know why it took CPSC more than six months to negotiate a record recall in November of more than 2 million Stork Craft drop-side cribs. The suffocation deaths of four infants were linked to the cribs.

Tenenbaum said at the time that CPSC and manufacturers need to investigate allegations of defects and then work together on the exact wording of the announcement to the public — a process that can take months. The alternative could be litigation, which might take even longer.

Several lawmakers appeared skeptical, but Tenenbaum pledged to renew efforts to hasten safety recalls.

On Wednesday, Tenenbaum also promised new safety rules for cribs, expected at the end of this year. Since 2007, about 7 million cribs have been recalled — cribs tied to a dozen deaths of infants.

The commission's mandatory standards governing cribs haven't been updated since 1982

FDA Urges Safe Use of Certain Inhaled Asthma Medicines

2010-02-18T17:20:00.000-08:00

FDA Urges Safe Use of Certain Inhaled Asthma Medicine

The Food and Drug Administration (FDA) has issued recommendations on how inhaled medications called Long-Acting Beta-Agonists (LABAs) should be used to treat asthma.

On Feb. 18, 2010, the agency said

LABAs should never be used alone in the treatment of asthma in children or adults
when LABAs are needed, they be used for the shortest time possible to achieve asthma control. They are then to be discontinued, if possible, to limit the long-term use
FDA's actions are based on agency analyses of studies showing an increased risk of severe worsening of asthma symptoms, leading to hospitalization in pediatric and adult patients—as well as death in some patients—using the treatment for asthma.

LABAs are available as single ingredient products, or in combination with a corticosteroid medication. (The reason that some LABAs are offered as single-ingredient products is that not all asthma controller medicines are able to be made into a combination product.)

The drugs affected by FDA's announcement include

the single-ingredient products Serevent (generic name: salmeterol) and Foradil (formoterol)
the combination medications Advair (salmeterol and fluticasone) and Symbicort (formoterol and budesonide)

How LABAs Work
LABAs help people with asthma or a lung condition called chronic obstructive pulmonary disease (COPD) breathe easier. They are also used for exercise-induced bronchospasm, which is asthma that is triggered by vigorous physical activity.

Taken through the mouth using an inhaler or a nebulizer, LABAs relax the muscles of the airways to allow more air to flow into and out of the lungs. Their effects last for at least 12 hours.

FDA's recommendations only apply to the use of LABAs in the treatment of asthma.

“Although these medicines play an important role in helping some patients control asthma symptoms, our review of the available clinical trials determined that their use should be limited, whenever possible, due to an increased risk of serious asthma exacerbations and death,” says Badrul Chowdhury, M.D., director of FDA's Division of Pulmonary and Allergy Products.

“The risks of hospitalization and poor outcomes are of particular concern for children," says Dianne Murphy, director of FDA’s Office of Pediatric Therapeutics. "Parents need to know that their child should not be on a LABA alone.”

Additional Advice
In addition to following the recommendations issued on Feb. 18, FDA advises patients to

know that LABAs do not relieve sudden-onset asthma symptoms. Patients should always have a rescue inhaler, such as an albuterol inhaler, to treat sudden-onset asthma symptoms
know that, if they need a LABA plus an asthma controller medication that is not available as a combination product, they should work with their health care professionals to ensure that each individual medication is taken correctly
read the Medication Guide included in each LABA
talk with their health care professionals to learn the warning signs of worsening asthma, and to discuss any questions they have about the use of LABAs

Other FDA Actions
On Feb. 18, FDA also required that the product labels for LABAs reflect the agency's recommendations
called on manufacturers of LABAs to conduct additional studies to further evaluate the safety of these medicines when used in combination with inhaled corticosteroids
said it will work with public and private partners under the agency’s ongoing Safe Use Initiative to study LABA prescribing practices
required a risk management program—called a Risk Evaluation and Mitigation Strategy (REMS)—to help ensure the safe use of these products. The program requires the manufacturers to better inform health care professionals and patients about the risk of LABAs for patients with asthma and ways to decrease that risk while maintaining the benefits of the drug
This article appears on FDA's Consumer Updates page1, which features the latest on all FDA-regulated products.

Health Canada proposes LABELLING changes

2010-02-18T17:19:00.000-08:00

Health Canada is launching a consultation with stakeholders and the Canadian public on proposed changes to improve the labelling requirements for food colours in Canada.

The consultation, which will be posted on the Health Canada website and open for comments from February 18th until May 4th, is intended to seek input on several options for future labelling requirements.

The Canadian Food and Drug Regulations currently allow manufacturers to use the general term “colour” to specify one or more food colours. For the majority of prepackaged foods, manufacturers may voluntarily declare individual colours by name at their own discretion.

However, there is some evidence suggesting a link between consumption of certain food colours and adverse reactions in sensitive individuals. More recently, certain food colour mixtures have been associated with behavioural effects in children. For these reasons, Health Canada considers it prudent to improve labelling requirements for food colours.

Health Canada's proposed changes would eliminate the option of using the general term "colour" and require that individual colours be identified on food ingredient labels for many, if not all, colours. By improving food colour labelling requirements, Health Canada's goal is to enable consumers to make more informed choices which could contribute to the reduction of adverse reactions.

Health Canada will continue to update Canadians on the progress of this issue once the consultation period has concluded. Please visit the Health Canada website for more information on the proposal to improve the food colour labelling requirements in Canada.

In addition, please visit Health Canada's Allergen Labelling Page for information on another recent Health Canada initiative to improve prepackaged food labels,

National Institutes of Health discuss Long-lasting LEAD DAMAGE

2010-02-10T16:43:00.000-08:00

Long-lasting lead damage

From the U.S. Department of Health and Human Services.

A study indicates people may never outgrow the damage that lead does to the brain. At Cincinnati Children’s Hospital Medical Center, Kim Cecil saw that in brain imaging of adults who were exposed to high levels of lead when they were children.

Cecil says adults who had higher lead exposure as children were more likely to have decreased activity in parts of the brain associated with attention and controlling impulses.

``What our study is showing is that, long after this exposure is over, the effects are irreversible.’’

Cecil says it’s another reason to keep kids free of things like lead-based paint.

The research, which was supported by the National Institutes of Health, was presented at a meeting of the Radiological Society of North America.

The science behind the SULPHITES story

2010-02-09T15:52:00.000-08:00

The science behind the story

Sulphites are used as preservatives in a wide range of foods, in particular soft drinks, sausages, burgers, and dried fruit and vegetables. These additives maintain food colour and prolong shelf-life by preventing the growth of micro-organisms.

When the gas sulphur dioxide is dissolved in a liquid, such as wine, it is known as a sulphite.

Sulphur dioxide is produced naturally when wine and beer are made and it is often added to wine to stop it from continuing to ferment in the bottle. Usually, most of the ‘head space’ in a bottle of wine (the part of the bottle not filled with wine) is sulphur dioxide.

Some people who have asthma may react to inhaling sulphur dioxide. A very few people with asthma have had an attack after drinking acidic drinks (such as fruit-based drinks) containing sulphites, but this is not thought to be very common.

Read more about intolerance to sulphites and other additives at eatwell.gov.uk/healthissues/foodintolerance/foodintolerancetypes/foodadditiv/.

United States Seizes more than 1,500 Cases of Food from Wisconsin Distribution Warehouse

2010-02-04T14:43:00.000-08:00

Media Inquiries: Tom Gasparoli, 301-796-4737, thomas.gasparoli@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

United States Seizes more than 1,500 Cases of Food from Wisconsin Distribution Warehouse

FDA acts after inspections reveal filthy, rodent-infested facility

At the request of the U.S. Food and Drug Administration, U.S. Marshals on Tuesday seized a wide range of human and animal food products stored under insanitary conditions at Mid-States Closeouts, a distribution warehouse in Ellsworth, Wis. The products were seized under a warrant issued by the U.S. District Court for the Western District of Wisconsin.

U.S. Marshals seized all FDA-regulated human and animal food susceptible to rodent and pest contamination or other filth. The products are adulterated under the Federal Food, Drug, and Cosmetic Act (the Act) because they have been held under insanitary conditions whereby they may have become contaminated with filth.

During an FDA inspection of Mid-States Closeouts conducted in November and December 2009, the agency found widespread and active rodent infestation, numerous gnawed packages of human and animal food, rodent excreta pellets on, in, and around food packages and rodent nesting material. The facility also had structural defects permitting easy pest access to the entire facility, and rodent harborage areas near the warehouse.

"The violations at Mid-States Closeouts are widespread and significant,” said Michael Chappell, the FDA’s acting associate commissioner, Office of Regulatory Affairs. “The FDA took this action because the company failed to provide adequate safeguards to ensure that products they hold for sale remain free of contamination.”

The FDA has not received any reports of human or pet illness or death associated with consumption of food distributed by Mid-States Closeouts. However, the seized products were in permeable packages and held under conditions that could compromise the food’s quality.

Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator. Contact information for coordinators is located at http://www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators.

More tainted milk products found in China shops

2010-02-04T14:42:00.000-08:00

Melamine-laced milk products have been found on sale in China, state media said on Monday, more than a year after the chemical was blamed for six deaths in a huge scandal over contaminated dairy goods.

Three Chinese companies have been found selling food products tainted with melamine, the chemical blamed for the deaths of six babies in a huge dairy scandal in 2008, state media said Monday.

Authorities in the southwestern province of Guizhou found that products made by three food companies contained illegally high levels of the toxic substance, the China Daily said.

It quoted a former dairy industry official as saying it was likely more tainted goods remained in supermarkets despite a major recall after the 2008 scandal, which highlighted China's persistent product safety problems.

The suspect products in Guizhou have been pulled from stores, the China Daily said, adding that the firms involved blamed milk powder bought from suppliers.

The report illustrated the apparent continued threat from tainted dairy goods long after the 2008 scandal when it was revealed that the industrial chemical -- which can, in large quantities, cause kidney failure and death -- was being abused by food producers.

At that time, melamine was found to have been added to milk to give the appearance of a higher protein content and was blamed for killing six infants and making nearly 300,000 others sick, according to official figures.

The scare led to foodstuffs containing dairy products being taken off shelves around the world. A total of 21 people were reportedly convicted of wrongdoing, with two executed and others sentenced to jail terms.

But other cases have since surfaced.

FULL STORY: http://www.bangkokpost.com/news/health/166430/more-tainted-milk-products-found-in-china-shops

Important Information Concerning Medication for Parkinson's Disease Information Update

2010-01-28T03:31:00.000-08:00

2010-14

OTTAWA - Health Canada is aware that two Canadian companies that manufacture and/or distribute medications for Parkinson's Disease have posted information on their websites concerning the availability of some of the drugs they manufacture and/or distribute.

Bristol Myers Squibb Canada, the Canadian distributor of Sinemet CR (200/50) has information on its website: www.bmscanada.ca or call the Bristol Myers Squibb Canada Information Line at 1-800-267-0005.

Apotex Inc. has information on its generic product, Apo-Levocarb CR (200/50) on its website or call 1-877-427-6839.

Patients who are currently using Apo-Levocarb CR (200/50) or Sinemet CR (200/50) and have concerns about the supply of their medication may want to check the information provided by these companies or call the companies. Patients may also consult their health care professional in order to explore alternative treatments if they are unable to maintain an uninterrupted supply of their medication.

Follow-Up to the November 2009 Early Communication about an Ongoing Safety Review of Sibutramine, Marketed as Meridia

2010-01-28T03:30:00.000-08:00

The U.S. Food and Drug Administration (FDA) has reviewed additional data that indicate an increased risk of heart attack and stroke in patients with a history of cardiovascular disease using sibutramine, marketed as the weight loss medication Meridia. The sibutramine drug label already includes warnings against the use of sibutramine in patients with cardiovascular disease. However, based on the serious nature of the review findings, FDA requested and the manufacturer agreed to add a new contraindication to the sibutramine drug label.

The contraindication will state that sibutramine is not to be used in patients with a history of cardiovascular disease, including:

History of coronary artery disease (e.g., heart attack, angina)
History of stroke or transient ischemic attack (TIA)
History of heart arrhythmias
History of congestive heart failure
History of peripheral arterial disease
Uncontrolled hypertension (e.g., > 145/90 mmHg)

Patients currently using sibutramine should talk with their healthcare professional to determine if continued use of sibutramine is appropriate and discuss any questions they may have about their treatment.

Healthcare professionals should regularly monitor the blood pressure and heart rate of patients using sibutramine and if sustained increases in blood pressure and/or heart rate are observed, sibutramine should be discontinued. Additionally, sibutramine should be discontinued in patients who do not lose at least 5% of their baseline body weight within the first three to six months of treatment, as continued treatment is unlikely to be effective and exposes the patient to unnecessary risk.

The Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT) study was designed to show that weight loss with sibutramine and standard care was more effective in reducing the number of cardiovascular events compared to weight loss from a placebo and standard care. Patients included in the study were 55 years of age or older, overweight or obese, and had a history of cardiovascular disease or type 2 diabetes plus one additional cardiovascular risk factor. Patients who recently had a heart attack or stroke, or had poorly controlled congestive heart failure were not included in the study. Approximately 10,000 patients enrolled in the study.

The November 2009 Early Communication from FDA described preliminary results from the SCOUT study indicating cardiovascular events occurred in 11.4% of patients using sibutramine compared to 10% of patients using a placebo. This difference was higher than expected, suggesting that sibutramine was associated with an increased cardiovascular risk in the study population.

The additional data from the SCOUT study reviewed by FDA indicate that the increased risk for cardiovascular events with sibutramine occurred only in patients with a history of cardiovascular disease.

The results for cardiovascular events for each subgroup of the SCOUT study are found in the table below.

TABLE 1. Cardiovascular Events in the SCOUT Study by Predefined Subgroups

Study Group † Placebo
(% of patients) Sibutramine
(% of patients) Hazard Ratio
(95% Confidence Interval) p-value
DM Only Group

Total patients (n) Cardiovascular Events*
1,178 77

(6.5%)
1,207 79

(6.5%)
1.010 (0.737, 1.383) 0.951
CV Only Group

Total patients (n) Cardiovascular Events*
793 66

(8.3%)
759 77

(10.1%)
1.274 (0.915, 1.774) 0.151
CV + DM Group

Total patients (n) Cardiovascular Events*
2,901 346

(11.9%)
2,906 403

(13.9%)
1.182 (1.024, 1.354) 0.023††

† Patients in the SCOUT study comprised 3 subgroups: 1) History of type 2 diabetes but no cardiovascular disease (DM only subgroup); 2) History of cardiovascular disease (CV only subgroup); 3) History of cardiovascular disease and type 2 diabetes (CV + DM subgroup).
* Defined as heart attack, stroke, resuscitated cardiac arrest, or cardiovascular death.
†† Statistically significant result.

Once FDA completes its review of the full study report for SCOUT, which is expected to be submitted to the FDA by the sponsor in March 2010, and other relevant information related to sibutramine’s potential benefits and risks, an open public advisory committee meeting will be convened to discuss sibutramine’s benefit/risk profile and to determine if additional regulatory actions should be taken to ensure safe use of the medication.

-Related Information
Information for Meridia (sibutramine hydrochloride)
Early Communication about an Ongoing Safety Review of Meridia (sibutramine hydrochloride)
11/20/2009
Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review
1/21/2010
- Contact UsReport a Serious Problem

1-800-332-1088
1-800-FDA-0178 Fax
MedWatch Online

Regular Mail: Use postage-paid FDA Form 3500

Mail to: MedWatch 5600 Fishers Lane

Rockville, MD 20852-9787

Public Citizen to FDA: Pull Fibromyalgia Drug from the Market

2010-01-28T03:28:00.000-08:00

Medication has limited efficacy, risky effects, group says

Public Citizen is calling on the Food and Drug Administration (FDA) to pull the fibromyalgia drug Savella from the market immediately.

In its petition to the FDA, Public Citizen notes that the European Medicines Agency (EMEA), which regulates drugs on the Continent, rejected Savella's approval for fibromyalgia in July 2009, stating that its benefits were "marginal" and "did not outweigh its risks." This was shortly after the FDA approved the drug in January 2009.

Since the drug went on the market in the U.S., approximately 250,000 prescriptions have been filled, with doctors writing more prescriptions every month.

In two randomized clinical trials, Savella, also known by its generic name milnacipran, was found to increase blood pressure, heart rate and suicidal thoughts, Public Citizen's petition said. Among patients who had normal blood pressure at the beginning of the study, 19.5 percent of those who took Savella developed hypertension, compared with 7.2 percent of those on a placebo.

"Because Savella is a drug that produces only a marginal effect on pain, the main problem for which patients seek treatment, and has the potential to be quite dangerous, it is clear that it should not be sold," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "The FDA never should have approved Savella for fibromyalgia and should now immediately order the drug company to remove it from the market before large numbers of people suffer serious harm," Wolfe said.

Read more: http://www.consumeraffairs.com/news04/2010/01/pubcit_fda_fibromyalgia.html#ixzz0dIrfRCay

CPSC Approves Final Rule on Guidelines for Mandatory Recall Notices

2010-01-12T00:29:00.000-08:00

The U.S. Consumer Product Safety Commission (CPSC) unanimously approved a new rule setting guidelines and requirements for information in mandatory recall notices. A mandatory recall can be ordered by the Commission or a U.S. District Court.

Each section of the rule is either required by Section 214 of the Consumer Product Safety Improvement Act (CPSIA), or CPSC has determined it will likely increase recall effectiveness by helping consumers:

(a) Identify the product subject to a recall
(b) Understand the hazard identified with the product
(c) Understand what remedy is offered regarding the product.

Information required by the rule includes: product description, action being taken, number of units, identification of the substantial product hazard and reason for the action, identification of manufacturers and significant retailers, dates when product was manufactured and sold, number and description of any injuries or deaths, the ages of anyone injured or killed, remedy available to consumers and other information the Commission deems appropriate. The Commission could determine some of the information is unnecessary or inappropriate for a particular recall.

The rule does not contain requirements for voluntary recall notices but will serve as a guide for those notices. If CPSC decides to extend these requirements to voluntary recall notices, it would proceed with separate rulemaking.

In 2009, 100 percent of the recalls announced to consumers were done voluntarily and cooperatively with impacted firms. As more products get recalled each year, the high rate of cooperative recall announcements negotiated by CPSC staff is a benefit to the safety of consumers.

The requirement to create a mandatory recall rule was proposed as an amendment to the CPSIA by President Barack Obama when he was a member of the Senate.

The final rule goes into effect upon publication in the Federal Register.

EPA Delays Report on Flea and Tick Products That May Harm Pets

2010-01-07T20:54:00.000-08:00

EPA Delays Report on Flea and Tick Products That May Harm Pets

Pet owners continue to report adverse effects on animals

Pet owners worried about the adverse reactions thousands of animals nationwide have experienced to topical flea and tick products will have to wait a little longer for any action from the Environmental Protection Agency (EPA).

The agency previously told ConsumerAffairs.com that it planned to issue a report last fall about "spot-on" flea and tick products, which pet owners say have triggered "horrific" reactions in their dogs and cats. But according to the EPA, the agency is still reviewing reports and other "complex technical issues" regarding the problem, and will likely not take any action for weeks.

"[The] EPA has been evaluating the data submitted on adverse incidents associated with the spot-on flea and tick pet products and is nearing completion of its review," the agency's spokesman, Dale Kemery, said. "Due to the large amount of data and the complex technical
issues associated with the review of the data, our report is not ready for public release."

Read more: http://www.consumeraffairs.com/news04/2010/01/fleatick02.html#ixzz0bzey59NW

FDA Takes Action Against New Jersey Cheese Manufacturer Quesos Mi Pueblito

2010-01-04T10:19:00.000-08:00

FDA Takes Action Against New Jersey Cheese Manufacturer

Company failed to correct violations despite federal, state warnings

The U.S. Food and Drug Administration today announced intentions to ask a federal court to shut down a New Jersey cheese manufacturer with an alleged history of operating under insanitary conditions and producing cheese contaminated with Listeria monocytogenes.

The U.S. Department of Justice filed a complaint for permanent injunction against Quesos Mi Pueblito and two of its officers, Felix Sanchez and Jesus Galvez. The complaint alleges that recent inspections by the FDA and the New Jersey Department of Health and Senior Services found Listeria-contaminated cheese and insanitary conditions at the Passaic company.

If entered by the court, the injunction would stop the company and its officers from manufacturing and distributing food until they can bring their operations into full compliance with FDA food safety regulations and produce cheese that does not test positive for the presence of Listeria.

The complaint for permanent injunction was filed in the U.S. District Court - District of New Jersey."FDA’s work with federal and state partners to root out or remedy food manufacturers not compliant with food safety laws ensures safer foods get to our dinner tables," said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs.

Quesos Mi Pueblito currently manufactures and distributes a variety of soft, semi-soft, and hard Mexican cheeses in grocery stores and supermarkets in Connecticut, Massachusetts, New York, North Carolina, Florida, Virginia and the District of Columbia. Among Quesos Mi Pueblito’s products are queso oaxaca, queso fresco, queso requeson and queso cotija molido.

Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.

Company’s Record on Beef Treatment Questioned

2009-12-31T00:03:00.000-08:00

Eight years ago, federal officials were struggling to remove potentially deadly E. coli from hamburgers when an entrepreneurial company from South Dakota came up with a novel idea: injecting beef with ammonia.

The company, Beef Products Inc., had been looking to expand into the hamburger business with a product made from beef that included fatty trimmings the industry once relegated to pet food and cooking oil. The trimmings were particularly susceptible to contamination, but a study commissioned by the company showed that the ammonia process would kill E. coli as well as salmonella.

Officials at the United States Department of Agriculture endorsed the company’s ammonia treatment, and have said it destroys E. coli “to an undetectable level.” They decided it was so effective that in 2007, when the department began routine testing of meat used in hamburger sold to the general public, they exempted Beef Products.

With the U.S.D.A.’s stamp of approval, the company’s processed beef has become a mainstay in America’s hamburgers. McDonald’s, Burger King and other fast-food giants use it as a component in ground beef, as do grocery chains. The federal school lunch program used an estimated 5.5 million pounds of the processed beef last year alone.

FULL STORY: http://www.nytimes.com/2009/12/31/us/31meat.html?_r=1

CPSC Renews Crib Warning After Another Death

2009-12-17T20:23:00.000-08:00

CPSC Renews Crib Warning After Another Death

All cribs have been recalled but death toll rises to 11

The warning is increasingly urgent. The U.S. Consumer Product Safety Commission is telling parents not to use the recalled Simplicity drip side crib after the report of yet another infant who became trapped and suffocated.

The death toll is now 11, the agency says.

The crib is made by Simplicity Inc. and SFCA of Reading, Pa. The CPSC says the firm has ceased day-to-day operations and presumably has gone out of business.

In September the agency recalled about 600,000 Simplicity drop-side cribs because of an entrapment and suffocation hazard. At the time, two infant deaths had been attributed to the beds.

The recall notice said that, due to sizing problems with the crib's hardware, the drop side can come off the tracks. When the drop side detaches or partially detaches, it creates a hazardous gap, which can lead to infant entrapment and suffocation.

CPSC said it is also is aware of an additional 25 incidents involving the drop side detaching from the crib. To date, CPSC has recalled over 2 million Simplicity drop side cribs due to problems with the crib's plastic hardware.

Read more: http://www.consumeraffairs.com/news04/2009/12/simplicity_cpsc03.html#ixzz0a0ir0eKx

Test results on formaldehyde in Noodlefish---Hong Kong

2009-12-17T16:40:00.000-08:00

Test results on formaldehyde in noodlefish

The Centre for Food Safety (CFS) recently conducted a targeted food surveillance exercise to assess the situation of formaldehyde in noodlefish.

Results showed that one of the 10 samples taken contained formaldehyde at a level of 1,200ppm. The samples had been collected from retail outlets for testing.

"We believe formaldehyde was added as a preservative after the fish were caught, or during transportation or storage," a CFS spokesman said today (December 17).

"At the level of formaldehyde detected in the noodlefish sample, health effects such as abdominal pain and vomiting and kidney problems cannot be ruled out for high consumers," the spokesman said.

"Consumption of noodlefish by the general public with the same detected level as this sample on a long-term basis might have effects on the gastro-intestinal tract. The main health concern of formaldehyde is its cancer-causing potential through exposure via inhalation. According to the World Health Organization, there is not sufficient evidence showing that formaldehyde is carcinogenic through exposure through the oral route."

The CFS called on the trade not to add formaldehyde to fish or other marine products. Under the law, formaldehyde is not permitted for use as a food preservative. Contravention of the law could lead to a maximum fine of $50,000 and six months' imprisonment.

"Regarding the unsatisfactory sample, the CFS issued warning letters to the stall operator concerned asking him to stop selling the affected products. We are tracing the source of the fish in question. We are also collecting sufficient evidence for prosecution," he added.

The CFS also advised the public to take note of the following when buying or cooking marine products (e.g. noodlefish):

* Avoid buying noodlefish that are stiff (formaldehyde could stiffen flesh of fish);* Choose only fish that are fresh and avoid those with an unusual smell;* Wash and cook marine products thoroughly as formaldehyde is water soluble and could dissipate upon heating.

Excelligence Learning Corp. to Pay $25,000 Civil Penalty Due to Violation of Lead Paint Ban

2009-12-05T18:13:00.000-08:00

Excelligence Learning Corp. to Pay $25,000 Civil Penalty Due to Violation of Lead Paint Ban

WASHINGTON, D.C.- The U.S. Consumer Product Safety Commission (CPSC) announced today that Excelligence Learning Corp, of Monterey, Calif. DBA Discount School Supply has agreed to pay a $25,000 civil penalty for allegedly violating the federal lead paint ban. The penalty settlement has been provisionally accepted by the Commission.

The settlement resolves CPSC staff allegations that Excelligence imported more than 33,000 units of children’s products that contained lead paint above the 0.06 percent legal limit at different intervals between August 2000 and August 2007. In 1978, a federal ban was put in place which prohibited toys and other children’s articles from having more than 0.06 percent lead (by weight) in paints or surface coatings. As a result of the Consumer Product Safety
Improvement Act of 2008, the regulatory limit was reduced to 0.009 percent on August 14, 2009. These products were recalled in November 2007, December 2007and January 2008.

In agreeing to the settlement, Excelligence denies that it knowingly violated federal law, as alleged by CPSC staff.

Important Information on Changes to Heparin Potency

2009-11-26T15:27:00.001-08:00

Important Information on Changes to Heparin Potency

2009-191

OTTAWA - Health Canada is informing health care professionals and Canadians of recent changes to heparin manufacturing standards in the United States that will result in a decrease in the potency of certain heparin products by about 10 per cent.

Heparin is a common anti-clotting drug mainly used in health care settings such as hospitals. It is used, for example, as part of kidney dialysis or to prevent blood clots. Most heparin products on the Canadian market use the same potency standard as is used in the U.S. As a result, the changes to the U.S standard will also affect heparin products available in Canada.

Given that heparin dosage and treatment is determined on a case-by-case basis using frequent blood testing, the change in potency is not expected to have a significant impact in most situations where heparin is used. However, there may be specific situations in a hospital setting that will require health care professionals to take this change in heparin potency under consideration, such as procedures where heparin is used as a single dose to achieve an immediate anti-clotting effect. In such procedures, blood monitoring may not necessarily occur.

When administering the drug, health care professionals should be aware of the potential difference in potency between heparin made under the old system and heparin made under the new system.

Patients requiring heparin may notice they are receiving a higher-than-usual dose or number of units of heparin because of the reduced potency of the product. As well, following a heparin treatment, patients may notice they are being monitored more than before. This monitoring may include blood testing that is commonly used to check heparin treatment, and will likely be temporary as the newer product replaces the old product on the market.

As in the U.S., there will be a transition period in Canada of approximately two years starting in December 2009 when products manufactured under both the old and new systems will be available at the same time. This is necessary to ensure that there is no heparin shortage and patients can continue to receive treatments as scheduled. Health Canada is currently working with manufacturers to ensure that heparin products using the new standard are clearly identified during this transition.

Health Canada issued a Notice to Hospitals on November 25, 2009 with more specific recommendations and information on when this transition will be implemented in Canada.
This document can be found on the Health Canada website.

Patients with questions or concerns about heparin should speak to their health care professional.
Consumers requiring more information about this advisory can contact Health Canada's public inquiries line at (613) 957-2991, or call toll free at 1-866-225-0709.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

Report online at the MedEffect™ Canada section of the Health Canada website

Call toll-free at 1-866-234-2345 Complete a Canada Vigilance Reporting Form and either: Fax toll-free to 1-866-678-6789

Mail to: Canada Vigilance ProgramHealth CanadaAL 0701COttawa, ON K1A 0K9 To have postage pre-paid, download the postage paid label from the MedEffect™ Canada section of the
Health Canada website.

Media Enquiries:Health Canada(613) 957-2983

Public Enquiries:(613) 957-29911-866 225-0709

FDA Seeks Permanent Injunction Against Sharkco Seafood International Inc.

2009-11-24T16:29:00.000-08:00

Media Inquires: Siobhan DeLancey, siobhan.delancey@fda.hhs.gov, 301-796-4668

Consumer Inquires: 1-888-INFO-FDA

FDA Seeks Permanent Injunction Against Sharkco Seafood International Inc. Sharkco’s History of Violations Prompts FDA to Seek Court Action

The U.S. Food and Drug Administration (FDA) is seeking a permanent injunction against Sharkco Seafood International Inc., located in Venice, La. The injunction is intended to stop the seafood processing company from distributing scombrotoxin-forming fish in interstate commerce. Consumption of scombrotoxin-forming fish that are not properly preserved or refrigeratedcan result in scombroid food poisoning, a foodborne illness that results from eating spoiled or decayed fish. Scombrotoxin-forming fish most commonly include mackerel, sardines, tuna, bluefish, and mahi mahi.

The government’s complaint, filed today by the United States Attorney’s Office for the Eastern District of Louisiana charges Sharkco Seafood and its owners, Khai Q. Nguyen and Tuan Q. Nguyen, with violating the Federal Food, Drug, and Cosmetic Act by failing to establish and implement an adequate Hazard Analysis and Critical Control Point (HACCP) plan for their scombrotoxin-forming fish. FDA requires all seafood processors and distributors to have a HACCP plan that determines and monitors food safety hazards associated with their products.
“FDA repeatedly warned and tried to work with Sharkco Seafood,” said Michael Chappell, acting associate commissioner for regulatory affairs at FDA. “The company had ample time to take correction action, which it failed to do. An effective seafood HACCP plan is critical to safeguard the health of the American people. We will take prompt action against companies whose poor business practices could jeopardize the public health.”

According to the government’s complaint, FDA inspections showed that the defendants failed to have an adequate written HACCP plan for their scombrotoxin-forming fish operation, despite numerous warnings by FDA. The formation of scombrotoxin can be adequately controlled when fish are appropriately preserved or refrigerated. Once formed, however, scombrotoxin cannot be removed or destroyed by washing, freezing, or cooking the affected fish.

No illnesses have been associated with Sharkco Seafood’s scombrotoxin-forming fish products.

The company produces other seafood products, which are not affected by this action.

Press Statement on Corrosion in Homes and Connections to Chinese Drywall

2009-11-23T16:28:00.000-08:00

U.S. Consumer Product Safety Commission

November 23, 2009

Press Statement on Corrosion in Homes and
Connections to Chinese Drywall

Results from a major indoor air study of 51 homes are being released today along with
initial reports from two studies of corrosion in homes with Chinese drywall. We now can
show a strong association between homes with the problem drywall and the levels of
hydrogen sulfide in those homes and corrosion of metals in those homes.

By identifying this association, the Interagency Drywall Task Force can now move
forward to develop protocols that will identify homes with this corrosive environment
and can determine the effectiveness of remediation methods. The Task Force continues to
work with Congressional and White House officials to determine the best approaches to
design and fund these identification and remediation efforts to help the families dealing
with this issue.

“We now have the science that enables the Task Force to move ahead to the next phase –
to develop both a screening process and effective remediation methods. Ongoing studies
will examine health and safety effects, but we are now ready to get to work fixing this
problem,” said U.S. Consumer Product Safety Commission Chairman Inez Tenenbaum.
The Studies

The 51 home study contracted by CPSC was done by Environmental Health &
Engineering (EH&E), an internationally known environmental testing firm based in
Massachusetts.

In addition, today two preliminary reports on corrosion safety issues are being released.
The Sandia National Laboratories’ (SNL) Materials and Engineering Center is studying
the long-term electrical safety hazards of conductor metal components. The National
Institute of Standards and Technology (NIST) is studying the corrosion effects on fire
safety components taken from complaint homes.

Findings
EH&E compared 41 “complaint” homes in five states selected from CPSC’s consumer
incident report database, with 10 noncomplaint homes built around the same time in the
same area as the complaint homes. Homes were sampled between July and September
2009.

The EH&E findings are that hydrogen sulfide gas is the essential component that causes
copper and silver sulfide corrosion found in the complaint homes. Other factors,
including air exchange rates, formaldehyde and other air contaminants contribute to the
reported problems.

In ways still to be determined, hydrogen sulfide gas is being created in homes built with
Chinese drywall. Earlier studies found large amounts of elemental sulfur in the Chinese
drywall. CPSC is investigating drywall from other sources that may mimic the problems
found with Chinese drywall. CPSC is meeting with drywall manufacturers and others
who are studying this issue to take their findings into consideration.

EH&E exposed copper and silver test strips, known as coupons, in homes for a period of
about two weeks. The coupons showed significantly higher rates of corrosion in
complaint homes than in the control homes. The dominant species of corrosion on the
coupons was copper sulfide and silver sulfide, as determined by additional laboratory
tests. Visual inspection and evaluation of ground wire corrosion also revealed
statistically significant greater ground wire corrosion in complaint homes compared to
non-complaint homes.

The EH&E study also found that by using hand-held x-ray fluorescence (XRF) and
Fourier Transform Infrared (FTIR) instruments, they were able to detect markers that
could identify Chinese-made dry wall at a sheet-by-sheet level.

While drywall-related corrosion is clearly evident, long term safety effects are still under
investigation. Like the EH&E study, initial reports available today from SNL and NIST
show copper and silver sulfide corrosion on samples of metal taken from homes with
problem drywall. These ongoing investigations will help the CPSC identify the nexus of
problem drywall and long term safety issues.

In addition, the EH&E study found elevated formaldehyde readings in both the control
and complaint homes. This is typical for new, more air-tight homes due to items such as
cabinets and carpets which emit formaldehyde. Both formaldehyde and hydrogen sulfide
are known irritants at sufficiently high levels. The concentrations measured in this study
were below those levels. Investigators believe that the additive or synergistic effects of
these and other compounds in the subject homes could cause irritant effects evident in the
homes.

Next Steps
First, CPSC continues to search for homes exhibiting the corrosion and health effects
under study. In addition to a direct call to consumers, CPSC is contacting governors of all
states, all territories and the District of Columbia, to ensure that all homes with these
problems have been reported to CPSC.

Second, the Interagency Task Force established an Identification and Remediation
Protocol Team of scientists and engineers. This Team will use the results of the EH&E
study and other information to design a cost-effective screening protocol to identify
homes with this problem. Professional air sample testing, and destructive testing of
drywall can carry high costs. The Protocol Team will develop quick, cost-efficient
evaluation methods to identify homes with these problems. The Protocol Team will also
look at remediation protocols, to see what cost-efficiency improvements to current
remediation practices, if any, may be available, and what guidance should be issued on
doing the work safely.

Third, investigations currently underway by Lawrence Berkeley Laboratories, SNL and
NIST and others will continue toward identifying additional information on any possible
long-term health and safety issues.

The Identification and Remediation Protocol Team will use information from the EH&E
study and other information to begin evaluating remediation protocols. Homes that have
undergone remediation are expected to yield valuable information that will be helpful for
homeowners.

The Interagency Task Force is actively talking to Congressional and White House
officials about the best approaches to design and fund both the Identification and
Remediation efforts.

Other Ongoing Efforts
The Interagency Task Force, working with U.S. Customs and Border Protection, is
monitoring imports of possible Chinese drywall. We believe that no new Chinese drywall
has entered the United States in 2009. Owners of known U.S. inventories of Chinese
drywall have been notified of this ongoing investigation. They have indicated that the
drywall boards will not be sold. Further, CPSC has secured the cooperation of the
Chinese Government to help identify the sources and causes of this problem.
CPSC is working with an ASTM committee that has just initiated discussions on the
formulation of a proposed new standard on inspection of drywall for air quality issues.
Recommendations to Affected Homeowners

To date, CPSC has received more than 2000 reports from 32 states, the District of
Columbia and Puerto Rico from consumers and homeowners concerned about problem
drywall in their homes.

Homeowners who believe they may have problem drywall should immediately report to
CPSC by calling 800-638-2772 or logging on to www.CPSC.gov. Hearing- or speechchallenged
individuals may access the phone number through TTY by calling the toll-free
Federal Relay Service at 800-877-8339.

Federal and state health experts suggest these steps to improve indoor air quality and to
reduce exposure to substances that can cause health concerns:
o Open windows as much as possible to let in fresh air.
o Keep the temperature inside homes at the lowest comfortable setting.
o Run the air conditioner or dehumidifier.
o Also, spend as much time outdoors in fresh air as possible.
o Do not smoke, and especially do not smoke indoors. Cigarette smoke contains,
among other contaminants, formaldehyde.

To read the technical research reports or for more information, log on to
www.DrywallResponse.gov.

FDA Takes Action Against Maryland Veal Calf Dealer, Sold animals for human consumption that contained illegal drug residues

2009-11-19T14:31:00.000-08:00

Media Inquiries: Rita Chappelle, 301-796-4672, rita.chappelle@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

FDA Takes Action Against Maryland Veal Calf Dealer
Man allegedly sold animals for human consumption that contained illegal drug residues

The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against William F. Nickle of North East, Md., for allegedly selling veal calves for human consumption that contained illegal drug residues in edible tissues.

The complaint, filed Nov. 13, 2009, in the U.S. District Court for the District of Maryland, also alleges that Mr. Nickle caused drugs to become adulterated while held for sale after shipment in interstate commerce, used animal drugs in an “extralabel” manner without a valid veterinarian-client-patient relationship, and used drugs in animals in which such drugs are expressly forbidden.

Mr. Nickle is a dealer and hauler of calves and the sole owner and employee of a private unincorporated business. He buys and sells more than 1,200 calves a year for human consumption. The complaint is based, in part, on illegal flunixin drug residues in the edible tissue of Mr. Nickle’s veal calves sampled by the U.S. Department of Agriculture.

Flunixin is a non-steroidal anti-inflammatory drug approved for injection into cattle to control abnormal rise in body temperature associated with bovine respiratory disease and endotoxemia.

It also is indicated for the control of inflammation in endotoxemia.

The sale of animals for human food that may contain illegal levels of drugs is a concern because of the potential for adverse effects on human health. The FDA requirements for animal drugs include a specified time to withdraw an animal from treatment prior to slaughter, so that a drug is depleted from edible tissue to levels safe for humans.

Mr. Nickle has a long history with both the FDA and the USDA. He has received numerous oral and written warnings from both agencies. Most recently, the FDA conducted an inspection of Mr.
Nickle’s operations between February and April of 2009. In June 2004, the FDA issued a warning letter to Mr. Nickle. Despite these warnings, Mr. Nickle failed to comply with the law.

Consumers Warned Against Buying Fraudulent H1N1 Flu Virus Products Online

2009-11-05T16:01:00.001-08:00

Consumers Warned Against Buying Fraudulent H1N1 Flu Virus Products Online

2009-179

OTTAWA - Health Canada and the Competition Bureau are advising Canadians not to purchase unauthorized products that claim to fight or prevent the H1N1 flu virus, from the Internet or other sources. Health Canada is working with the Competition Bureau and the Royal Canadian Mounted Police (RCMP) to address unauthorized products, including those with fraudulent claims to treat or prevent the H1N1 flu virus.

There are only three products authorized by Health Canada that should be used against the H1N1 flu virus: the H1N1 vaccine Arepanrix, and the antiviral drugs Tamiflu (oseltamivir) and Relenza (zanamivir). In addition, the distribution of 200,000 doses of unadjuvanted H1N1 vaccine Panvax from Australia has been authorized for use in pregnant women. Antivirals should only be purchased with a prescription from a health care practitioner who has examined the patient. The vaccines should be administered by a qualified health care practitioner, and are not available for sale to the public.

While there are legitimate Canadian Internet pharmacies, consumers should be aware of the risks associated with buying drugs online. For more information on the subject, Health Canada has published an It's Your Health article on Buying Drugs over the Internet. Health Canada will continue to monitor the Internet and to take action against Canadian Web sites selling unauthorized products for the treatment or prevention of the H1N1 flu virus, or any other health condition.

Combating health fraud also remains a priority for the Competition Bureau, a law enforcement agency that regularly monitors the Internet and takes enforcement action against false and misleading advertising. For information on the Bureau's activities in the area of health fraud, please visit: www.competitionbureau.gc.ca/healthfraud.

Health Canada and the Competition Bureau would also like to share the following advice with Canadians to avoid becoming victims of health fraud:

Beware of ads that "promise too much." Think twice before buying a product that claims it can "do it all." Steer clear of a product that claims to be a "scientific breakthrough." Don't be swayed by a questionable "success story" or so-called "patient testimonial." Consult your health care practitioner before trying any new treatment. Taking unapproved or counterfeit drugs could pose serious risks to health. These products may contain ingredients not listed on the label or dangerous additives, and could cause serious side effects. Authorized health products will display either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN), or a Homeopathic Medicine Number (DIN-HM) on the label.* This authorization indicates that the products have been assessed by Health Canada for safety, effectiveness and quality.

Canadians are encouraged to stay informed on the H1N1 flu virus by visiting the Public Health Agency of Canada's website, or calling the toll-free public information line at 1-800-454-8302.
Canadians with questions or complaints about counterfeit drugs and/or drugs purchased over the Internet can call Health Canada's toll-free line at 1-800-267-9675.

The Competition Bureau urges Canadians who come across a Web site promoting a treatment or cure that seems too good to be true, to call toll free (1-800-348-5358) or go to www.competitionbureau.gc.ca/info.

Health Canada issued an advisory about the online purchase of Tamiflu in December 2005.

* The manufacturer of Arepanrix has been exempted from the DIN labelling requirement to
avoid delays in the labelling and delivery of the vaccine.

Media Enquiries:Health Canada(613) 957-2983

Competition Bureau(819) 953-4257

Public Enquiries (Health Canada):(613) 957-29911-866 225-0709

Public Enquiries (Competition Bureau):1-800-348-5358

The Government of Canada Reminds Canadians about the Risks of Eating Raw Sprouts

2009-11-04T21:42:00.001-08:00

The Government of Canada Reminds Canadians about the Risks of Eating Raw Sprouts

2009-178

Health Canada and the Canadian Food Inspection Agency are reminding Canadians that raw or undercooked sprouts should not be eaten by children, the elderly, pregnant women or those with weakened immune systems.

Sprouts, such as alfalfa and mung beans, are a popular choice for Canadians as a low-calorie, healthy ingredient for many meals. Onion, radish, mustard and broccoli sprouts, which are not to be confused with the actual plant or vegetable, are also common options.

These foods, however, may carry harmful bacteria such as Salmonella and E. coli O157:H7, which can lead to serious illness.

Fresh produce can sometimes be contaminated with harmful bacteria while in the field or during storage or handling. This is particularly a concern with sprouts. Many outbreaks of Salmonella and E. coli infections have been linked to contaminated sprouts. The largest recent outbreak in Canada was in the fall of 2005, when more than 648 cases of Salmonella were reported in Ontario.

Children, the elderly, pregnant women and those with weakened immune systems are particularly vulnerable to these bacteria and should not eat any raw sprouts at all. They should also avoid eating cooked sprouts unless they can be sure the sprouts have been thoroughly cooked.

Healthy adults who choose to eat sprouts should take precautions to reduce their risk of exposure to sprout-borne bacteria. When purchasing sprouts, always select crisp ones that have been refrigerated and avoid those that appear dark or smell musty. Always use tongs or a glove to place the sprouts in a plastic bag. If possible, when eating in a restaurant, always make sure that the sprouts are fully cooked.

Symptoms from Salmonella usually occur 12 to 36 hours after eating contaminated food while symptoms from E. coli O157:H7 can occur within two to 10 days. Symptoms can include nausea, diarrhea, vomiting, fever and stomach cramps. People who experience these symptoms should contact a doctor immediately. In extreme cases, E. coli O157:H7 can lead to acute kidney failure or even death.

Health Canada and the Canadian Food Inspection Agency continue to work with producers to develop and implement best practices that will reduce the chances of sprouts becoming contaminated. Health Canada's Policy on Managing Health Risks Associated with the Consumption of Sprouted Seeds and Beans was released with this in mind.

More information, including Health Canada's policy on sprouts, can be found on Health Canada's Sprouts Information Page.

Media Enquiries:Health Canada(613) 957-2983

Canadian Food Inspection Agency(613) 773-6600

Public Enquiries:(613) 957-29911-866 225-0709

CPSC/EPA/HUD/CDC/ATSDR Press Statement on Initial Chinese Drywall Studies

2009-10-30T23:02:00.000-07:00

CPSC/EPA/HUD/CDC/ATSDR Press Statement on Initial Chinese Drywall Studies

Since the early spring, the federal government has dedicated significant resources to helping families affected by the drywall issue in their homes. The government has been and continues to be committed to providing answers and solutions to these homeowners. The U.S. Consumer Product Safety Commission (CPSC), U.S. Environmental Protection Agency (EPA), U.S. Department of Housing and Urban Development (HUD), Centers for Disease Control and Prevention (CDC), Agency for Toxic Substance and Disease Registry (ATSDR), and numerous state departments of health have been working together to investigate and analyze how Chinese made drywall entered into the country, where it was used, what is in it, and what impact it may have on human health and corrosion of electrical and fire safety components.

This is a complicated problem, and we have several studies and other activities underway to help bring the best possible science to bear. The first sets of data released today start to explain differences between Chinese and non-Chinese drywall, but more remains to be learned. We are sharing what we know at this point and are outlining the next steps as we continue to work to answer homeowners’ questions about what is causing the effects reported and observed.
Initial Results of 3 Studies of Chinese and Non-Chinese made drywall

The studies summarized below have discovered certain differences between Chinese and non-Chinese drywall. Further studies must be completed, however, to determine the nexus between the drywall and the reported health and corrosion issues. Preliminarily, the studies show:

1. Elemental and Chemical Testing: Federal scientists analyzed pieces of drywall to discover what chemicals it contains. Some differences were found between the Chinese and non-Chinese drywall. Of the samples tested, the study shows the presence of elemental sulfur in Chinese but not in non-Chinese drywall, and it also shows higher concentrations of strontium in Chinese drywall than in non-Chinese drywall. Testing conducted over the summer by federal and state agency radiation laboratories found no radiation safety risk to families in homes built with manufactured drywall. The strontium found in this drywall does not pose a radiological risk.

2. Chamber Studies: The second set of tests is being conducted by the nationally-respected Lawrence Berkeley National Laboratory (LBL), which is carrying out chamber testing on emissions from samples of Chinese and non-Chinese drywall into the air. These tests are still underway, but we are sharing preliminary findings. Early results show that Chinese drywall emits volatile sulfur compounds at a higher rate than the U.S. made drywall. More tests and analyses are underway at LBL to determine the specific chemical compounds that are being emitted.

3. Indoor Air Studies: In analyzing indoor air results in 10 homes in Florida and Louisiana, federal and Florida Department of Health researchers were looking for hydrogen sulfide, carbon disulfide and carbonyl sulfide, which have been suspected of causing "rotten egg" smells and sulfur-like corrosion of copper and other metals in the homes.

The study found that sulfur gases were either not present or were present in only limited or occasional concentrations inside the homes, and only when outdoor levels of sulfur compounds in the air were elevated.

The indoor air study did lead to a preliminary finding of detectable concentrations of two known irritant compounds, called acetaldehyde and formaldehyde. These irritant compounds were detected in homes both with and without Chinese drywall, and at concentrations that could worsen conditions such as asthma in sensitive populations, when air conditioners were not working or turned off. The levels of formaldehyde were not unusual for new homes and were higher in homes where air conditioners were not working or turned off.

Although formaldehyde was found, when the air conditioning was turned on, it was not at levels that have been found to cause health symptoms.

The initial indoor air studies were conducted on a small and limited sample of homes in Florida and Louisiana to identify and measure contaminants and to inform the development of a federal and state indoor air testing protocol. The studies released today, and the additional study reports scheduled for release next month, once completed, will collectively help to develop a final standard federal and state protocol for testing homes and to identify a nexus between the presence of Chinese drywall and the reported health and corrosive issues.

Next Steps
Although we know more now than we did just a few weeks ago, we are continuing to learn as much as we can in order to respond to homeowners’ concerns with the best scientific information. We expect to have more information to share in late November. At that time, we will have more information from CPSC’s 50-home air sampling project conducted through Environmental Health and Engineering (EH&E), a nationally-respected environmental testing firm based in Massachusetts. The report of our 50-home indoor air study will include additional testing results, including the exposure of small copper and silver metal strips. These strips are being used to help determine if there is a relationship between homes with Chinese drywall and corrosion of metal components in those homes. This study is also looking for certain sulfur gases at lower levels than could be detected in the initial studies.

Also in November, we expect to release a preliminary engineering analysis of potential electrical and fire safety issues related to corrosion.

All of the federal and state partners will continue to work on behalf of the families affected by this Chinese drywall issue. We are committed to providing answers to homeowners. As new information becomes available, we will share it as quickly as possible.

The federal interagency working group is actively talking to Congressional and White House officials to consider legislative and other means of helping families affected by and struggling with this issue.

Recommendations to Affected Homeowners
To date, CPSC has received nearly 1900 reports from 30 states, the District of Columbia and Puerto Rico from consumers and homeowners concerned about problem drywall in their home. Homeowners who believe they may be affected by this issue should immediately report the problem to CPSC by calling 800-638-2772 or logging on to www.CPSC.gov.

Federal and state health experts suggest these steps to improve indoor air quality and to reduce exposure to substances that can cause health concerns:
Open windows as much as possible to let in fresh air.
Keep the temperature inside homes at the lowest comfortable setting.
Run the air conditioner or dehumidifier.
Also, spend as much time outdoors in fresh air as possible.
Do not smoke, and especially do not smoke indoors. Cigarette smoke contains, among other contaminants, formaldehyde.

To read the technical research reports or for more information, log on to www.DrywallResponse.gov

STRYKER BIOTECH AND ITS TOP MANAGEMENT INDICTED FOR ILLEGAL PROMOTION OF MEDICAL DEVICES USED IN INVASIVE SURGERIES

2009-10-30T22:57:00.000-07:00

CONTACT: CHRISTINA DiIORIO-STERLING
PHONE: (617)748-3356 WWW.USDOJ.GOV/USAO/MA
E-MAIL: USAMA.MEDIA@USDOJ.GOV

STRYKER BIOTECH AND ITS TOP MANAGEMENT INDICTED FOR ILLEGAL PROMOTION OF MEDICAL DEVICES USED IN INVASIVE SURGERIES

Stryker Biotech, LLC, a corporation based in Hopkinton, Massachusetts, and its former president, Mark Philip of Lexington, Massachusetts, and its current sales managers, William Heppner of Illinios, David Ard of California, and Jeff Whitaker of North Carolina, were charged today in federal court with participating in a fraudulent marketing scheme of medical devices used during invasive spinal and long bone surgeries.
Stryker Biotech and Mark Philip were also charged with making false statements to the United States Food and Drug Administration (“FDA”). Acting United States Attorney Michael K. Loucks; Mark Dragonetti, Resident Agent in Charge of the Food & Drug Administration - Office of Criminal Investigations; Susan J. Waddell, Special Agent in Charge of Health and Human Services, Office of the Inspector General - Office of Investigations; and Warren T. Bamford, Special Agent in Charge of the Federal Bureau of Investigation - Boston Field Division, announced today that STRYKER BIOTECH, LLC, MARK PHILIP, WILLIAM HEPPNER, DAVID ARD and JEFF WHITAKER were charged in an Indictment with five counts of wire fraud and one count of conspiracy. STRYKER BIOTECH, DAVID ARD and JEFF WHITAKER were also charged with misbranding. In addition, STRYKER BIOTECH and MARK PHILIP were charged with making false statements to the FDA.

The Indictment alleges that all of the defendants participated in an illegal marketing scheme to promote medical devices used during invasive surgeries, and in doing so having defrauded medical professionals and the FDA. In particular, the defendants are alleged to have promoted devices known as OP-1 Implant and OP-1 Putty. These devices were used to stimulate bone growth in long bones and the spine. These devices were approved by the FDA only pursuant to a highly restrictive Humanitarian Device Exemption (“HDE”).

One of the restrictions was that the device could only treat a condition that affected fewer than 4,000 patients in the United States, and could not be sold for a profit. The Indictment charges that the defendants promoted the use of these devices in a manner that was different from its FDA approved use; namely they promoted a combination of the devices with a bone void filler, called Calstrux, and in furtherance of that promotion provided “recipes” to surgeons, medical technicians and others as to how to mix the OP-1 products with Calstrux. It is alleged that some of these untested “recipes” called for medical personnel to mold the combined product into “cigars,” “tootsie rolls” or “vienna sausages.”

The Indictment charges that the defendants knew that such a combination had never been studied in a clinical trial and had never been presented to or approved by the FDA. It is alleged that the reason the defendants promoted the OP-1 products in a mixture with Calstrux was because without a mixing agent, the OP-1 products were at a competitive disadvantage with other legal products. The Indictment also alleges that serious medical problems arose in a number of patients from this untested mix of products.

The Indictment also charges that defendants STRYKER BIOTECH, LLC and MARK PHILIP made false statements to the FDA about the number of patients that STRYKER BIOTECH was treating on an annual basis with OP-1 Putty.

If convicted of the wire fraud, conspiracy, misbranding or false statements charges, STRYKER BIOTECH faces fines of the greater of $500,000 or twice the gross gain or loss from the offense, on each count.

If convicted on the wire fraud charges, MARK PHILIP, WILLIAM HEPPNER, DAVID ARD and JEFF WHITAKER each face up to 20 years imprisonment, to be followed by 3 years of supervised release and a fine of the greater of $250,000 or twice the gross gain or loss from the offense, on each count. If convicted on the conspiracy charges, MARK PHILIP, WILLIAM HEPPNER, DAVID ARD and JEFF WHITAKER each face up to 5 years imprisonment, to be followed by 3 years of supervised release and fine of the greater of $250,000 or twice the gross gain or loss from the offense, on each count.

If convicted on the misbranding charges, DAVID ARD and JEFF WHITAKER each face up to 3 years imprisonment, to be followed by 1 year of supervised release and fine of the greater of $250,000 or twice the gross gain or loss from the offense on each charge. If convicted on the false statement charge, MARK PHILIP faces up to 5 years imprisonment, to be followed by 3 years supervised release and fine of the greater of $250,000 or twice the gross gain or loss from the offense.

The case was investigated by the Food & Drug Administration - Office of Criminal Investigations, the Department of Health and Human Services - Office of Inspector General and the Federal Bureau of Investigation. It is being prosecuted by Assistant U.S. Attorney Jeremy Sternberg of Loucks’ Health Care Fraud Unit.

The details contained in the Indictment are allegations. The defendants are presumed to be innocent unless and until proven guilty beyond a reasonable doubt in a court of law.

Procter & Gamble Unlawfully Marketing Two Vicks Cold and Flu Medicines Containing Vitamin C

2009-10-30T22:53:00.000-07:00

Media Inquiries: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

FDA: Procter & Gamble Unlawfully Marketing Two Vicks Cold and Flu Medicines Containing Vitamin C

The U.S. Food and Drug Administration today sent a warning letter to Procter & Gamble notifying the company that its Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C are illegally marketed combinations of drug ingredients and a dietary ingredient.

Both of the over-the-counter (OTC) medicines, which contain vitamin C in addition to several drug ingredients, are marketed as treatments for cold and flu symptoms. The FDA took the action against the Cincinnati-based company:

To clarify that these single dosage form combinations of drug ingredients and dietary ingredients legally cannot be marketed because they have not been proven safe and effective, and Because the agency previously determined that there are insufficient data to show that vitamin C is safe and effective in preventing or treating the common cold.Under its OTC monograph system, the FDA allows some OTC drugs to be marketed without agency approval. Such drugs must comply with applicable monographs, which are regulations that set requirements for the drugs' labeling, formulations and indications. The two Vicks products do not comply with the applicable FDA monograph and must first be evaluated and approved under the FDA’s new drug approval process to be legally marketed.

The FDA’s position on the regulatory status of OTC drug products that combine drug ingredients with dietary ingredients in a single dosage form has been described in previous warning letters issued in 2001 and 2008. The agency’s position on the marketing of vitamin C for preventing or treating the common cold also has been stated in a number of previous warning letters.

(Editor’s note: The warning letter sent to Procter & Gamble today concerns the same products as the letter mistakenly posted on the FDA Web site on Oct. 14, 2009, due to a computer error.)

For more information
FDA Warning Letter to Procter & Gamblehttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm188361.htm

FDA Drug Safety Initiativehttp://www.fda.gov/cder/drugSafety.htm

Basic Information on H1N1 Preventative Measures

2009-10-28T17:37:00.000-07:00

Seriously....what's a person to do??? Get the shot...don't get theshot.....get the shot.....don't get the shot! Geeze enuf already. So confusing! Who should we believe is telling the truth?

This is great simple information ... Take heed and avoid getting sick.....

Dr. Vinay Goyal is an MBBS,DRM,DNB (Intensivist and Thyroid specialist),having clinical experience of over 20 years. He has worked ininstitutions like Hinduja Hospital,Bombay Hospital, Saifee Hospital,Tata Memorial, etc.
Presently, he is heading our Nuclear MedicineDepartment and Thyroid clinic at Riddhivinayak Cardiac and CriticalCentre, Malad (W).The following message is given by him; I feel it makes a lot of senseand is important for all to know

The only portals of entry are the nostrils and mouth/throat. In a global epidemic of this nature, it's almost impossible not coming intocontact with H1N1 in spite of all precautions.

Contact with H1N1 is not so much of a problem as proliferation is. While you are still healthy and not showing any symptoms of H1N1infection, in order to prevent proliferation, aggravation of symptoms and development of secondary infections, some very simple steps, not fully highlighted in most official communications, can be practiced(instead of focusing on how to stock N95 or Tamiflu):
1. Frequent hand-washing (well highlighted in all officialcommunications).
2. "Hands-off-the-face" approach. Resist all temptations to touch anypart of face until you have washed your hands.
3. *Gargle twice a day with warm salt water (use Listerine if you don'ttrust salt). *H1N1 takes 2-3 days after initial infection in thethroat/nasal cavity to proliferate and show characteristic symptoms.Simple gargling prevents proliferation. In a way, gargling with saltwater has the same effect on a healthy individual that Tamiflu has on aninfected one. Don't underestimate this simple, inexpensive and powerfulpreventative method.
4. Similar to 3 above, *clean your nostrils at least once every daywith warm salt water. Not everybody may be good at using a Neti pot,but blowing the nose hard once a day and swabbing both nostrils withcotton swabs dipped in warm salt water is very effective in bringingdown viral population.*
5. Boost your natural immunity with foods that are rich in Vitamin C.*If you have to supplement with Vitamin C tablets, make sure that italso has Zinc to boost absorption.
6. Drink as much of warm liquids (tea, coffee, etc) as you can.*Drinking warm liquids has the same effect as gargling, but in thereverse direction. They wash off proliferating viruses from the throatinto the stomach where they cannot survive, proliferate or do any harm.

I suggest you pass this on to your entire e-list; you never know who might pay attention to it - and STAY ALIVE because of it

- Neti pots and sinus rinse kits are available at the drug store andrelatively inexpensive under $15.

CPSC Announces ANPR for Recreational Off-Highway Vehicles (ROVs) to Address Rising Death Toll

2009-10-22T16:11:00.000-07:00

CPSC Announces ANPR for Recreational Off-Highway Vehicles (ROVs) to Address Rising Death Toll

WASHINGTON, D.C. - Furthering its commitment to improve the safety of Recreational Off-Highway Vehicles (ROVs) and reduce the number of deaths and serious injuries nationwide, the U.S. Consumer Product Safety Commission voted to publish an advance notice of proposed rulemaking (ANPR) to address safety hazards associated with vehicle ROVs.

CPSC staff’s preliminary evaluations indicated that the vehicles may exhibit inadequate lateral stability, undesirable steering characteristics, and inadequate occupant protection during a rollover crash. The staff reviewed the Recreational Off-Highway Vehicle Association (ROHVA) draft proposed American National Standard for Recreational Off-Highway Vehicles, ANSI/ROHVA 1-200X and found preliminarily that it does not adequately address the deaths and injuries associated with ROV rollovers and collisions.

The ANPR invites written comments from the public regarding the risks of injury associated with ROVs and ways in which these risks could be addressed. Following publication of the ANPR, the public will have 60 days to provide comments to the Commission. Comments can be submitted at www.regulations.gov

FDA Warns of Unapproved and Illegal H1N1 Drug Products Purchased Over the Internet

2009-10-16T18:51:00.000-07:00

Media Inquiries: Christopher Kelly, 301-796-4676 christopher.kelly@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

FDA Warns of Unapproved and Illegal H1N1 Drug Products Purchased Over the Internet

The U.S. Food and Drug Administration today warned consumers to use extreme care when purchasing any products over the Internet that claim to diagnose, prevent, treat or cure the H1N1 influenza virus. The warning comes after the FDA recently purchased and analyzed several products represented online as Tamiflu (oseltamivir), which may pose risks to patients.

One of the orders, which arrived in an unmarked envelope with a postmark from India, consisted of unlabeled, white tablets taped between two pieces of paper. When analyzed by the FDA, the tablets were found to contain talc and acetaminophen, but none of the active ingredient oseltamivir. The Web site disappeared shortly after the FDA placed the order. At the same time, the FDA also purchased four other products purported to diagnose, prevent, treat or cure the H1N1 influenza virus from other Web sites.

These products contained various levels of oseltamivir but were not approved for use in the United States. Several of the products purchased did not require a prescription from a health care professional. Additionally, the products did not arrive in a timely enough fashion to treat someone infected with the H1N1 influenza virus, or with an immediate exposure to the virus.

“Products that are offered for sale online with claims to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus must be carefully evaluated,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “Medicines purchased from Web sites operating outside the law put consumers at increased risk due to a higher potential that the products will be counterfeit, impure, contaminated, or have too little or too much of the active ingredient.”

Consumers may not know exactly what they are getting when buying such antiviral products on the Internet from an unfamiliar company. Patients who buy prescription drugs from Web sites operating outside the law are at increased risk of suffering life-threatening adverse events, such as side effects from inappropriately using prescription medications, dangerous drug interactions, contaminated drugs, and impure or unknown ingredients found in unapproved drugs. This may particularly be the case in the event of a public health emergency, such as an influenza outbreak, where approved treatment options would be in high demand and expensive, and where drug shortages could occur.

Drugs that are in high demand are vulnerable to counterfeiting and diversion because buyers may be desperate to stock the product, and criminals capitalize on the situation.

The FDA urges consumers to only purchase FDA-approved products from licensed pharmacies located in the United States. Consumers should contact their health care provider if they have any questions or concerns about medical products or personal protective equipment.

The two antiviral drugs approved by the FDA for treatment and prophylaxis of the 2009 H1N1 influenza virus are Tamiflu (oseltamivir phosphate) and Relenza (zanamivir).

Tamiflu and Relenza, in addition to their approved label, have Emergency Use Authorizations that describe specific authorized uses during this public health emergency.

The FDA actively monitors the Internet, and where appropriate, will purchase and analyze drug products

2 indicted for sending more than 15,000 misbranded drugs to customers

2009-10-14T17:03:00.000-07:00

United States Department of Justice United States Attorney’s Office District of Minnesota
David Anderson, Public Affairs Specialist

(612) 664-5684; cell: (612) 730-2251

WWW.USDOJ.GOV/USAO/MN

2 indicted for sending more than 15,000 misbranded drugs to customers

A federal grand jury has returned an indictment against two Twin Cities men for allegedly releasing more than 15,000 misbranded drugs to customers.

In an indictment filed with the court earlier today, Nicholas David Lundsten, 26, Spring Lake Park, and Patrick James Barron, 29, Fridley, were charged with one count of introduction into interstate commerce of misbranded drugs and one count of importation of non-narcotic Schedule IV controlled substances. The indictment alleges the defendants caused the introduction and delivery of 3,600 pills falsely labeled as Cialis, 1,582 pills falsely labeled as Propetia, 10,419 pills falsely labeled as Viagra; and 340 pills falsely labeled as Levitra. In fact, all of the drugs contained the active pharmaceutical ingredients of the drugs they imitated but were not the authentic product as labeled and were not made by the respective manufacturer. The indictment alleges this occurred from an unknown date through December 2008.

The indictment also alleges the defendants knowingly imported into the United States 39,288 pills purporting to be Xanax, a sedative that contains Alprazolam, a non-narcotic Schedule IV controlled substance, and 27,336 pills purporting to be Phentermine, a weight-loss drug, that contained Sibutramine, another non-narcotic Schedule IV controlled substance, rather than Phentermine.

If convicted, the introduction count carries a maximum penalty of one year in prison, and the importation count carries a maximum penalty of five years in prison. All sentences are determined by a federal district court judge.

This case is the result of an investigation by the U.S. Food and Drug Administration-Office of Criminal Investigation, U.S. Immigration and Customs Enforcement and the U.S. Postal Inspection Service, with assistance from U.S. Customs and Border Protection. It is being prosecuted by Assistant U.S. Attorney David J. MacLaughlin.

An indictment is a determination by a grand jury that there is probable cause to believe that offenses have been committed by a defendant. A defendant, of course, is presumed innocent until he or she pleads guilty or is proven guilty at trial.

FDA Takes Enforcement Action against Ready-to-Eat Sandwich Manufacturer

2009-10-08T19:34:00.000-07:00

Media Inquiries: Stephanie Kwisnek, 301-796-4737, Stephanie.Kwisnek@fda.hhs.gov

Consumer Inquiries: 1-888-INFO-FDA

FDA Takes Enforcement Action against Ready-to-Eat Sandwich Manufacturer

Company allegedly failed to correct violations

The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Rel's Foods Inc. (Rel's), of Oakland, Calif., seeking to stop the company from manufacturing, producing, and selling adulterated food products.

The complaint also names Rel's Vice President, Peder Scott Sorensen, and two managers, Patrick O'Malley and Timothy E. Ault. Rel's prepares, processes, and distributes a variety of ready-to-eat sandwiches to convenience stores, deli markets, liquor stores, mini-marts, and gas stations in Nevada and California.

The government's complaint, filed this week in the U.S. District Court, Northern District of California, alleges that Rel's has an extensive history of operating under insanitary conditions. The complaint states that Rel's has produced and distributed ready-to-eat sandwiches contaminated with Listeria monocytogenes (L. mono). Listeriosis, the illness caused by L. mono, can cause fatal infections in young children, the elderly, and individuals with weakened immune systems, and pregnant women may suffer miscarriages or stillbirths as a result of the infection.
The complaint alleges that FDA investigators have found L. mono inside Rel's production facility on numerous occasions since 2002. Additionally, routine laboratory testing by the Department of Defense and the California Department of Public Health, Food and Drug Branch (CFDB) found L. mono in the company's processing plant and finished sandwiches. Based on recent laboratory analyses, CFDB has embargoed and seized all in-process and finished products inside the facility.
The FDA and CFDB inspections also revealed that the company repeatedly violated the current Good Manufacturing Practice (cGMP) requirements for foods. Investigators found poor employee sanitation practices and inappropriately maintained facility and manufacturing equipment, including excessive condensation dripping onto food contact surfaces.

“Rel's lack of effective measures to bring its food processing operations into compliance with the law poses a serious public health threat,” said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. “The company's failure to comply with good manufacturing practice also demonstrates the potential for the company to continue to manufacture contaminated products.”

No illnesses have been reported so far from Rel's products. Individuals who have eaten the products and who experience symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea, should contact their health care professional.Consumers can report problems with FDA-regulated products to their district office consumer complaint
coordinator.

Important Safety Information Regarding the Use of Sleep Aid Drugs and the Risk of Complex Sleep-Related Behaviours

2009-10-07T15:50:00.000-07:00

Important Safety Information Regarding the Use of Sleep Aid Drugs and the Risk of Complex Sleep-Related Behaviours

2009-161

OTTAWA – Health Canada is informing consumers and health professionals of recent changes to the labelling information of prescription sleep aid medications used in the short-term treatment of insomnia.

Sleep aid drugs are used for short-term treatment of insomnia characterized by difficulty in falling asleep, or waking up often during the night or in the early morning hours. The new labelling describes reports of complex sleep-related behaviours that have occurred while patients using these drugs were not fully awake, such as talking, walking, cooking, eating, and driving. Patients typically did not remember these events afterwards.

The new labelling also emphasizes the proper use of these medications. In particular, sleep aid medications (also called sedative-hypnotic medications) should not be taken with alcohol, and patients should not take more than the prescribed dose. Caution should be used when taking sleep aid medications at the same time as other drugs that can cause drowsiness, such as other tranquilizers or sleeping pills, antihistamines that cause drowsiness, anticonvulsants, painkillers that contain narcotics, and medicines used to treat depression or anxiety.

Patients and people close to them are encouraged to be aware of these types of sleep-related behaviours. Patients should report any suspected events to their health care professional. Discontinuing sleep aid medication should be considered for patients who report complex sleep-related behaviours, due to the risk of harm to the patient and to others. These medications should only be discontinued by an individual after consulting with their health care professional, as abrupt discontinuation may cause symptoms of withdrawal.

The sleep-aid medications with potential risk of complex sleep-related behaviours include flurazepam, nitrazepam, temazepam, triazolam, zopiclone, zolpidem, and zaleplon. While authorized by Health Canada, zolpidem and zaleplon are not currently sold in Canada but may become available in the future.

Health Canada has worked with manufacturers to update the labelling of the following brand-name sleep aid drugs:

•Dalmane, Som Pam (flurazepam)
•Mogadon, Nitrazadon (nitrazepam)
•Restoril (temazepam)
•Apo-Triazo (triazolam)
•Imovane, Rhovane (zopiclone)

The updated Canadian product monographs for these drugs can be found by search of the Drug Product Database on the Health Canada website. The product monographs for the generic formulations (see the following list of Authorized sleep-aid medications in Canada for a list of generic sleep-aid drugs) will be updated in the future; patients taking generic sleep-aid drugs may at this time consult the Product Monographs of the brand-name products for the updated information.

Patients should typically not take sleep aid drugs for more than 7 to 10 days in a row. The drugs affected by this labelling change are all available by prescription only in Canada.

Any patient who has concerns or questions about the use of sleep-aid drugs should talk to their health care professional.

Consumers requiring more information about this Information Update can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

•Report online at the MedEffect™ Canada section of the Health Canada website
•Call toll-free at 1-866-234-2345
•Complete a Canada Vigilance Reporting Form and either: Fax toll-free to 1-866-678-6789 Mail to: Canada Vigilance ProgramHealth CanadaAL 0701C Ottawa, ON K1A 0K9

Media Enquiries:Health Canada(613) 957-2983

Public Enquiries:(613) 957-29911-866 225-0709

FDA Issues Strategic Plan for Risk Communication

2009-10-04T17:00:00.001-07:00

Media Inquiries: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

FDA Issues Strategic Plan for Risk Communication

Establishes framework for communicating with public about FDA-regulated products

The U.S. Food and Drug Administration today issued its Strategic Plan for Risk Communication, which outlines the agency’s efforts to disseminate more meaningful public health information. The plan also lays out a framework for the FDA to provide information about FDA-regulated products to health care professionals, patients and consumers in the form they need it and when they need it, and for how the agency oversees industry communications.

“We are committed to improving communications the public receives about the products we regulate,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “The FDA must communicate frequently and clearly about risks and benefits and inform patients and consumers about ways to minimize risk as they become increasingly involved in managing their health and well-being.”

The plan defines three key areas–FDA’s science base, its operational capacity and its policy and processes – in which strategic actions can help improve the FDA’s communication about the risks and benefits of regulated products. The plan also identifies over 70 specific actions for the FDA to take over the next five years, including 14 that the agency commits to accomplishing over the next year.

They include:
Designing a series of surveys to assess the public’s understanding of, and satisfaction with, FDA communications about medical products
Producing a research agenda for public dissemination
Creating and maintaining a useful, easily accessible internal database of FDA and other relevant risk communication research
Developing an expert model to characterize tobacco-use related consumer decision-making and better understand the likely impact of FDA oversight of tobacco products
Developing a “library” of multi-media communications on safe food practices for general education purposes and for use with crisis communications concerning food contamination episodes

Posting pictures of FDA- regulated products affected by Class I or high-priority Class II recalls as part of recall notices/information

Developing detailed action plans at the agency and center levels for implementing and achieving the proposed action steps, including timelines, responsibilities and resource needs
The plan reflects the FDA’s belief that risk communications must be adapted to the needs of different audiences and should be evaluated to ensure effectiveness. The plan also focuses on improving two-way communication through enhanced partnerships with government and non-government organizations, and focuses on policies that affect areas of high public health impact.

FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency

2009-10-04T16:58:00.001-07:00

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency

Adjustments may be needed to achieve desired anticoagulant effect in some patients

New Heparin to Ship Starting October 8

The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common anti-clotting drug.

To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP), a nonprofit standards-setting organization, adopted new manufacturing controls for heparin. These changes include a modification of the reference standard for the drug’s unit dose.

Manufacturers in the United States label the amount of heparin included in their products based on USP standards. The changes adopted by the USP for the heparin unit dose match the World Health Organization’s International Standard (IS) unit dose definition that has been in use in Europe for many years. The revised USP reference standard and unit definition for heparin is about 10 percent less potent than the former USP unit.

A unit is the measure of a drug’s activity in the body. For heparin, a unit dose is the measure of the drug’s ability to block the blood’s natural clotting ability (anticoagulation). Heparin’s potency is determined by the dose of the drug required to produce a specific level of anticoagulation.
Manufacturers for the U.S. market have begun to make heparin using the new USP standard. While the USP manufacturing controls take effect Oct. 1 for production, the FDA has asked that they not ship this new product to customers until Oct. 8, 2009, or later. The delay will give health care providers and facilities time to learn about the changes and to make adjustments to their pharmacy procedures and dosing practices, according to John Jenkins, M.D. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.

“Although the FDA-approved labeling for heparin has not changed, including the recommended doses, it is essential that health care professionals be aware of the potential difference in potency between the old and new vials of heparin when administering the drug,” said Jenkins.

Four companies market heparin in the United States. APP, the largest manufacturer, markets heparin in vials; Hospira markets heparin in intravenous bags, vials, and syringes; Baxter markets heparin in intravenous bags, and B. Braun markets heparin in intravenous bags. The FDA has asked that all manufacturers identify their new products to help pharmacies and health care professionals differentiate it from the former product.

Prescription and over–the–counter medicines available in the United States must generally meet USP's public standards, when such standards exist. The revised standards for heparin are contained in a new USP monograph.

The monograph was revised, in part, in response to a 2007- 2008 incident of heparin contamination involving a manufacturing step in China. The contaminated heparin was associated with deaths and other adverse events in the United States. The monograph was changed to include a test for the contaminant.

For more information
FDA Alert to Health Care Professionalshttp://www.fda.gov//Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm184502.htm

USP Heparin Informationhttp://www.usp.org/hottopics/heparin.html

Information for Consumers: What You Should Know about Changes to Heparinhttp://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm184504.htm

Consumers Union Opposes USDA Proposal On Salad Safety- Group urges Congress to pass FDA food safety program

2009-09-29T21:55:00.000-07:00

Consumers Union Opposes USDA Proposal On Salad Safety

Group urges Congress to pass FDA food safety program

Consumers Union is voicing opposition to a proposed national USDA Leafy Green Marketing Agreement, claiming the pact will fail to adequately improve the safety of raw spinach and other salad ingredients.

"We urgently need improvements in the safety of many kinds of food, from spinach and other leafy greens to peanut butter to imported fish," said Elisa Odabashian, Director of Consumers Union's west coast office. "But this USDA Marketing Agreement approach is the wrong way to go about it.

Consumers Union claims the agreement amounts to industry self-regulation, wrapped up in a USDA package, so consumers think the government is insuring that their food is safe. "But," points out Odabashian, "all the safety standards will be developed by the big food processors and other members of the industry. There will be only one consumer member on their
Administrative Committee, and that consumer member will be chosen by the food processors."

At issue is whether the California Leafy Greens Marketing Agreement, which has set food safety standards for California growers and processors, should be expanded nationally. While the agreement has imposed new safeguards on its participants, it is voluntary.

Read more: http://www.consumeraffairs.com/news04/2009/09/salad_safety.html#ixzz0SSQIElNb

http://www.consumeraffairs.com/news04/2009/09/salad_safety.html

Prescribers and pharmacists should be alert for potential dosing errors with Tamiflu (oseltamivir) for Oral Suspension

2009-09-27T23:35:00.000-07:00

FDA Public Health Alert: Potential Medication Errors with Tamiflu for Oral

SuspensionPrescribers and pharmacists should be alert for potential dosing errors with Tamiflu (oseltamivir) for Oral Suspension.

U.S. health care providers usually write prescriptions for liquid medicines in milliliters (mL) or teaspoons, while Tamiflu is dosed in milligrams (mg). The dosing dispenser packaged with Tamiflu has markings only in 30, 45 and 60 mg. The Agency has received reports of errors where dosing instructions for the patient do not match the dosing dispenser.

Health care providers should write doses in mg if the dosing dispenser with the drug is in mg.Pharmacists should ensure that the units of measure on the prescription instructionsmatch the dosing device provided with the drug.

If prescription instructions specify administration using mL, the dosing device accompanying the product should be replaced with a measuring device (e.g., a syringe) calibrated in mL.

Specific Considerations for Tamiflu Dosing for Children over 1 Year of Age:

Dosing should be prescribed in mg according to information provided in the table below.

Caregivers for children should use the dosing dispenser packaged with the medication, unless otherwise directed by a health care provider.If the dosing dispenser packaged with Tamiflu oral suspension is lost or damaged, or if the prescriber wishes to use volume-based dosing, appropriate dosages in mL are also provided in the table. In these cases the prescriber and pharmacist should ensure that a dosing dispenser, such as an oral syringe calibrated in mL, is given to the patient or caregiver with instructions for use. The dosing dispenser packaged with the product should be discarded.Prescribers should avoid prescribing Tamiflu oral suspension in teaspoons. This can lead to inaccurate dosing. If a prescription is written in teaspoons, the pharmacist should convert the volume to mL and ensure that an appropriate measuring device, such as an oral syringe calibrated in mL, is provided. The dosing dispenser packaged with the product should be discarded.

Candy and Fruit Flavored Cigarettes Now Illegal in United States; Step is First Under New Tobacco Law

2009-09-22T16:13:00.000-07:00

Contact: Kathleen K. Quinn, 301-796-4617, kathleen.quinn@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

Candy and Fruit Flavored Cigarettes Now Illegal in United States; Step is First Under New Tobacco Law

The U.S. Food and Drug Administration announced today a ban on cigarettes with flavors characterizing fruit, candy, or clove. The ban, authorized by the new Family Smoking Prevention and Tobacco Control Act, is part of a national effort by the FDA to reduce smoking in America.

Smoking is the leading preventable cause of death in America.

The FDA's ban on candy and fruit-flavored cigarettes, effective today, highlights the importance of reducing the number of children who start to smoke, and who become addicted to dangerous tobacco products. The FDA is also examining options for regulating both menthol cigarettes and flavored tobacco products other than cigarettes.

"Almost 90 percent of adult smokers start smoking as teenagers. These flavored cigarettes are a gateway for many children and young adults to become regular smokers," said FDA
Commissioner Margaret A. Hamburg, M.D. "The FDA will utilize regulatory authority to reduce the burden of illness and death caused by tobacco products to enhance our Nation's public health."

Flavors make cigarettes and other tobacco products more appealing to youth. Studies have shown that 17 year old smokers are three times as likely to use flavored cigarettes as smokers over the age of 25.1

"Flavored cigarettes attract and allure kids into lifetime addiction," said U.S. Department of Health and Human Services Assistant Secretary for Health Howard K. Koh, M.D., M.P.H. "FDA's ban on these cigarettes will break that cycle for the more than 3,600 young people who start smoking daily."

The FDA is taking several steps to enforce the ban. A letter recently sent to the tobacco industry provided information about the law, and explained that any company who continues to make, ship or sell such products may be subject to FDA enforcement actions.

The FDA has also made available today an advisory to parents on the risks associated with flavored tobacco products.

"Youth are twice as likely to report seeing advertising for these flavored products as adults are," said Dr. Joshua Sharfstein, a pediatrician and the FDA Principal Deputy Commissioner.

"Marketing campaigns for products with sweet candy and fruit flavors can mislead young people into thinking that these products are less addictive and less harmful."

The FDA encourages consumers to report continuing sales of flavored cigarettes through a special tobacco hotline (1-877-CTP-1373) and Web site (www.fda.gov/flavoredtobacco).

Parents and consumers can learn more about the risks of flavored tobacco products at www.fda.gov/ .

CPSC Urges Parents to Inspect and Secure TVs, Furniture, and Appliances to Prevent Tip-Over Deaths and Injuries

2009-09-22T16:11:00.000-07:00

The Tipping Point: CPSC Urges Parents to Inspect and Secure TVs, Furniture, and Appliances to Prevent Tip-Over Deaths and Injuries

WASHINGTON, D.C. - For young children, the home is a playground, and while many parents childproof to ensure that their home is a safe place, some may not be aware that unsecured TVs, furniture and appliances are hidden hazards lurking in every room. Today, the U.S. Consumer Product Safety Commission (CPSC) is urging parents once again to take simple, low-cost steps to prevent deaths and injuries associated with furniture, TV, and appliance tip-overs.

CPSC staff estimates that in 2006, 16,300 children 5 years old and younger were treated in emergency rooms because of injuries associated with TV, furniture, and appliance tip-overs, and between 2000 and 2006, CPSC staff received reports (pdf) of 134 tip-over related deaths.

Additionally, CPSC staff is aware of at least 30 media reports of tip-over deaths since January 2007 involving this same age group.

“Many parents are unaware of the deadly danger of this hidden hazard. I urge parents to include securing TVs, furniture, and appliances in their childproofing efforts,” said CPSC Chairman Inez Tenenbaum. “Taking a few moments now can prevent a tip-over tragedy later.”

“You may think your home is safe, but everyday things like a television can hurt your child. I was right there and it happened,” said Sylvia Santiago, of West Haven, Connecticut who lost her two-year old daughter in 2008.

Typically, injuries and deaths occur when children climb onto, fall against, or pull themselves up on television stands, shelves, bookcases, dressers, desks, chests, and appliances. In some cases, televisions placed on top of furniture tip over and cause a child to suffer traumatic and sometimes fatal injuries. “The most devastating injuries that we see resulting from furniture tipping on children are injuries to the brain and when a child is trapped under a heavy piece of furniture and suffocates,” said Gary Smith, MD, DrPH, Director of the Center for Injury Research and Policy at Nationwide Children’s Hospital in Columbus, Ohio.

Recent revisions to the voluntary safety standards for clothes storage units provide for the inclusion of warning labels and additional hardware to secure the furniture to the floor or wall.

To help prevent tip-over hazards, CPSC offers the following safety tips:

Furniture should be stable on its own. For added security, anchor chests or dressers, TV stands, bookcases and entertainment units to the floor or attach them to a wall.

Place TVs on a sturdy, low-rise base. Avoid flimsy shelves.

Push the TV as far back as possible.

Place electrical cords out of a child’s reach, and teach kids not to play with them.

Keep remote controls and other attractive items off the TV stand so kids won’t be tempted to grab for them and risk knocking the TV over.

Make sure free-standing ranges and stoves are installed with anti-tip brackets.

Warning on Stolen Albuterol Sulfate Inhalation Solution and Ipratropium Bromide Inhalation Solution

2009-09-18T18:00:00.000-07:00

Warning on Stolen Albuterol Sulfate Inhalation Solution and Ipratropium Bromide Inhalation Solution

On September 17, 2009, the U.S. Food and Drug Administration (FDA) advised consumers not to use certain respiratory medications purchased after Sept. 8, 2009 and manufactured by Dey L.P., a subsidiary of Mylan Inc., because the medications might have been part of a shipment being transported on a tractor-trailer stolen in Tampa, Fla., on Sept. 8, 2009.

The respiratory medications, Ipratropium Bromide Inhalation Solution, 0.02%, and Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials, have not been recovered and may be dangerous to use because the drugs may not have been stored and handled properly.

Dey issued an advisory on Sept. 11, 2009 regarding the theft. Although FDA is not aware of any reports of adverse events, the agency is advising patients who use these respiratory medications to check to see if products received or purchased after Sept. 8, 2009 are from one of the following lots:

Albuterol Sulfate Inhalation Solution (892,000 doses; all lots contain 3.0 ml vials and display the brand name “Dey”)
Lot number 9G04, NDC # 49502-697-29
Lot number 9FD8, NDC # 49502-697-61
Lot number 9FD9, NDC # 49502-697-61
Lot number 9FE1, NDC # 49502-697-61

Ipratropium Bromide Inhalation Solution (432,000 doses; all lots contain 2.5 ml vials and display the brand name “Dey”)
Lot number F09089, NDC # 49502-685-31
Lot number C09119, NDC # 49502-685-62
Lot number C09120, NDC # 49502-685-62

Advice for Consumers
Do not use Albuterol Sulfate Inhalation Solution or Ipratropium Bromide Inhalation Solution if it is from one of these lots above and was purchased or received after Sept. 8, 2009. Replace it with the same product from another lot.

Notify your health care professional of any adverse effects you may have experienced as a result of taking these medications.

Bring products from these lots back to the pharmacy where you received the medicine to exchange for products from a different lot or call Dey customer service at 800-527-4278.

Contact your health care professional if you must switch to another product for any reason for possible dose adjustments.

Report any information regarding the stolen Dey products to FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).

Kohl’s Department Stores Agrees to Pay $425,000 Civil Penalty for Failing to Report Drawstrings in Children’s Sweatshirts

2009-09-08T15:17:00.000-07:00

Kohl’s Department Stores Agrees to Pay $425,000 Civil Penalty for Failing to Report Drawstrings in Children’s Sweatshirts

WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) announced today that Kohl’s Department Stores Inc., of Menomonee Falls, Wis. has agreed to pay a civil penalty of $425,000. The penalty settlement (pdf), which has been provisionally accepted by the Commission, resolves CPSC staff allegations that Kohl’s Department Stores knowingly failed to report to CPSC immediately, as required by federal law, that children’s hooded sweatshirts it sold had drawstrings at the neck.

Children’s upper outerwear with drawstrings, including sweatshirts, poses a strangulation hazard to children which can result in serious injury or death. In March 2009, CPSC and the sweatshirts’ importer announced a recall of the products.

CPSC issued drawstring guidelines (pdf) in 1996 to help prevent children from strangling or getting entangled on the neck and waist drawstrings in upper outerwear, such as jackets and sweatshirts. In 1997, industry adopted a voluntary standard for drawstrings that incorporated the CPSC guidelines. In May 2006, CPSC’s Office of Compliance announced (pdf) that children’s upper outerwear with drawstrings at the hood or neck would be regarded as defective and as presenting a substantial risk of injury to young children.

Federal law requires manufacturers, distributors, and retailers to report to CPSC immediately (within 24 hours) after obtaining information reasonably supporting the conclusion that a product contains a defect which could create a substantial product hazard, creates an unreasonable risk of serious injury or death, or fails to comply with any consumer product safety rule or any other rule, regulation, standard, or ban enforced by CPSC.

In agreeing to the settlement, Kohl’s Department Stores denies CPSC's allegations that it knowingly violated the law.

In 2008, Kohl’s paid a $35,000 civil penalty for failing to report drawstrings in children’s sweatshirts.

Hill Sportswear Agrees To Pay $100,000 Civil Penalty For Failing To Report Drawstrings In Children’s Sweatshirts

2009-09-08T15:16:00.000-07:00

Hill Sportswear Agrees To Pay $100,000 Civil Penalty For Failing To Report Drawstrings In Children’s Sweatshirts

WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) announced today that Hill Sportswear Inc., of Paramount, Calif. has agreed to pay a civil penalty of $100,000. The penalty settlement (pdf), which has been provisionally accepted by the Commission, resolves CPSC staff allegations that Hill Sportswear knowingly failed to report to CPSC immediately, as required by federal law, that children’s hooded sweatshirts it manufactured and sold had drawstrings at the neck.

Children’s upper outerwear with drawstrings, including sweatshirts, poses a strangulation hazard to children which can result in serious injury or death. In November 2008, a 3-year-old boy died in Fresno, Calif. when the drawstring on his Hill Sportswear hooded sweatshirt reportedly became stuck on a playground set strangling him. Hill Sportswear and CPSC announced a recall of the sweatshirts in February 2009.

CPSC issued drawstring guidelines (pdf) in 1996 to help prevent children from strangling or getting entangled on the neck and waist drawstrings in upper outerwear, such as jackets and sweatshirts. In 1997, industry adopted a voluntary standard for drawstrings that incorporated the CPSC guidelines. In May 2006, CPSC’s Office of Compliance announced (pdf) that children’s upper outerwear with drawstrings at the hood or neck would be regarded as defective and as presenting a substantial risk of injury to young children.

About 120,000 of these Hill Sportswear sweatshirts were sold at various small retailers in California and Texas from 2003 through December 2008 for approximately $8. Due to the serious nature of this hazard, parents are urged to immediately remove the drawstrings from the sweatshirts or return the garment to either the place of purchase or to Hill Sportswear for a full refund.

Federal law requires manufacturers, distributors, and retailers to report to CPSC immediately (within 24 hours) after obtaining information reasonably supporting the conclusion that a product contains a defect which could create a substantial product hazard, creates an unreasonable risk of serious injury or death, or fails to comply with any consumer product safety rule or any other rule, regulation, standard, or ban enforced by CPSC.

In agreeing to the settlement, the firms deny CPSC’s allegations that they knowingly violated the law.

Firms Agree to Pay $85,000 in Civil Penalties for Failing to Report Drawstrings in Children’s Outerwear

2009-09-08T15:13:00.000-07:00

Firms Agree to Pay $85,000 in Civil Penalties for Failing to Report Drawstrings in Children’s Outerwear

WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) announced today that two firms, Maran Inc., of North Bergen, N.J. and K.S. Trading Corp., of Moonachie, N.J., have agreed to pay a total of $85,000 in civil penalties. The penalty settlements (Maran and K.S. Trading, pdf), which have been provisionally accepted by the Commission, resolve CPSC staff allegations that the firms knowingly failed to report to CPSC immediately, as required by federal law, that children’s hooded sweatshirts or jackets they sold had drawstrings at the neck.

Children’s upper outerwear with drawstrings, including sweatshirts or jackets, poses a strangulation hazard to children which can result in serious injury or death. CPSC and the firms announced recalls (Maran and K.S. Trading) of the products.

CPSC issued drawstring guidelines (pdf) in 1996 to help prevent children from strangling or getting entangled on the neck and waist drawstrings in upper outerwear, such as jackets and sweatshirts. In 1997, industry adopted a voluntary standard for drawstrings that incorporated the CPSC guidelines. In May 2006, CPSC’s Office of Compliance announced (pdf) that children’s upper outerwear with drawstrings at the hood or neck would be regarded as defective and as presenting a substantial risk of injury to young children.

Federal law requires manufacturers, distributors, and retailers to report to CPSC immediately (within 24 hours) after obtaining information reasonably supporting the conclusion that a product contains a defect which could create a substantial product hazard, creates an unreasonable risk of serious injury or death, or fails to comply with any consumer product safety rule or any other rule, regulation, standard, or ban enforced by CPSC.

In agreeing to the settlement, the firms deny CPSC’s allegations that they knowingly violated the law.

CPSC, Goodman Manufacturing Co. Announce Changes to 1998 Recall Program to Replace Dangerous Home Heating Vent Pipes

2009-08-26T20:52:00.000-07:00

CPSC, Goodman Manufacturing Co. Announce Changes to 1998 Recall Program to Replace Dangerous Home Heating Vent Pipes

WASHINGTON, D.C. - The CPSC and Goodman Manufacturing Company, of Houston, TX, are urging consumers who have not yet responded to the previously-announced 1998 recall to do so immediately. After October 1, 2009, the remedy consumers receive will change to be identical to modifications recently announced for a related recall.

The recall included about 10,000 Plexvent and Ultravent HTPV pipe systems attached to certain Goodman mid-efficiency furnaces manufactured from October 1988 to July 1994 (models GUP, GDP, GUPS, GDPS, GUPI, GDPI, GUPX, GDPX, GMP and GMPV for the following brands manufactured by Goodman: Janitrol, GMC, Hamilton Electric, Franklin, Liberty and Sears/Kenmore). The HTPV pipe used for these vents could be susceptible to corrosion, cracking and joint separation, which could result in the release of carbon monoxide (CO) into living areas, posing a danger to consumers. Goodman did not manufacture the HTPV pipe.

The following table describes the different remedies available to consumers with qualifying furnaces that use the two leading brands of HTPV pipe – Plexvent and Ultravent.

Plexvent owners Ultravent owners Valid claims initiated on or before October 1, 2009, with remediation completed and required documentation submitted by January 1, 2010. Will receive a new, professionally-installed venting system free of chargeor a new, high-efficiency Goodman furnace and suitable vent for the manufacturer's price (of just the furnace), with no charge for labor, associated materials or dealer markup. Valid claims initiated after October 1, 2009 A rebate up to $400 toward either an HTPV replacement system, or a new, high-efficiency furnace from Goodman that does not require HTPV. A rebate up to $250 toward either an HTPV replacement system, or a new, high-efficiency furnace from Goodman that does not require HTPV.

Consumers who register after October 1, 2009 and who choose to repair their systems will be responsible for up-front payment of parts, labor and permits, and will be responsible for arranging to have the work performed.

Consumers should determine whether they have a recalled HTPV pipe system by checking the vent pipes attached to their natural gas furnace. Vent pipes subject to this recall can be identified as follows:

the vent pipes are plastic;

the vent pipes are colored gray or black;

"Plexvent," "Plexvent II" or "Ultravent" is stamped on the vent pipe or printed on stickers placed on pieces used to connect the vent pipes; and

the vent pipes are located on furnaces and the pipes go through the sidewalls of structures.Other plastic vent pipes, such as white PVC, are not included in the recall.

Owners of Goodman furnaces that are vented with HTPV pipe should immediately call Goodman at (800) 394-8084 from 8 a.m. to 4:30 p.m. CT Monday through Friday. CPSC reminds all consumers to have fuel-burning appliances professionally inspected each year to check for cracks or separations in the vents that could allow CO to leak into the home. In addition, CPSC recommends that every home should have at least one CO alarm.
------------------------------------------------------------------------------------------------

Owners of previously recalled Goodman Manufacturing Co. plexvent and ultravent high temperature plastic vent (HTPV) pipe systems for furnaces that pose a risk of carbon monoxide leaks who do not respond by Oct. 1, 2009, will be responsible for up-front payment of parts, labor and permits, as well as for arranging to have the work performed. The recall was initially announced in 1998. Details: by Web at http://www.cpsc.gov

Safety Update on TNF Blockers and Risk of Cancer in Children and Young Adults

2009-08-20T14:25:00.000-07:00

Safety Update on TNF Blockers and Risk of Cancer in Children and Young Adults

2009-137

Health Canada is informing health care professionals and Canadians that it is working with manufacturers to further strengthen product labelling for the class of drugs known as tumour necrosis factor (TNF) blockers with respect to an increased risk of cancer in children and young adults.

This communication comes in light of similar labelling updates undertaken by the U.S. FDA following their review, which concluded that there is an increased risk of lymphoma and other cancers associated with the use of TNF blocker drugs in children and adolescents. Health Canada has also been reviewing this issue and is currently working with the manufacturers to strengthen existing warnings in the prescribing information for these drugs.

TNF blockers are used to treat patients with chronic inflammatory diseases including juvenile idiopathic arthritis (JIA), rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn's disease, and ankylosing spondylitis (a type of arthritis). They suppress the activity of tumour necrosis factor, a protein that, when overproduced in the body, can cause inflammation and damage to bones, cartilage and tissue, and lead to immune system-related diseases. There are currently five prescription TNF blockers authorized in Canada : Enbrel (etancercept) , Remicade (infliximab), Humira (adalimumab), Simponi (golimumab), and Cimzia (certolizumab pegol).

Currently the labels for all TNF blockers include warnings and precautions on the risk of lymphomas and other cancers. The labels will be updated to highlight the risk of specific cancers, particularly in the younger patient groups. As well, the label updates will include other new safety information based on reviews conducted by Health Canada , including the risk of new-onset psoriasis in patients treated with TNF blockers. Health Canada will inform health care professionals and Canadians again once these updates are complete.

The role of TNF blockers in the development of cancer is not known. Health Canada has communicated in the past on the risk of the development of certain types of cancers, including lymphoma, associated with the use of these drugs.

Health Canada recommends that patients should not stop taking their TNF blocker without first speaking to their doctor. Patients should contact their health care professional if they have any concerns about any medicines they are taking.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

Report online at the MedEffect ™ Canada Web site

Call toll-free at 1-866-234-2345

Complete a Canada Vigilance Reporting Form and either: Fax toll-free to 1-866-678-6789

Mail to: Canada Vigilance Program Health CanadaAL 0701C Ottawa , ON K1A 0K9

Media Enquiries:Health Canada(613) 957-2983

Public Enquiries:(613) 957-29911-866-225-0709

FDA Issues Warning Letters to Marketers of Topical Ibuprofen Drug Products

2009-08-20T14:24:00.000-07:00

Media Inquiries: Siobhan DeLancey, 301-796-4668, siobhan.delancey@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

FDA Issues Warning Letters to Marketers of Topical Ibuprofen Drug Products

The U.S. Food and Drug Administration today announced that the agency issued warning letters to eight companies marketing unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen.

The products, which contain ibuprofen in combination with a variety of other active ingredients and are marketed for pain relief, are unapproved new drugs that require an approved new drug application in order to be legally marketed. Under its OTC drug monograph system, the FDA allows some OTC drugs to be marketed without first obtaining agency approval. These drugs must comply with applicable monographs, that is, regulations that set requirements for the drugs' labeling, formulations, and indications. Ibuprofen is not included in any OTC drug monograph. Companies wishing to market OTC drugs that do not meet the monograph requirements can submit and receive approval of a new drug application.

“These companies have an obligation to the public to demonstrate to the FDA that their products are safe and effective, and they have failed to do so,” said Deborah M. Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research.

Orally administered ibuprofen has been approved as a safe and effective treatment for pain and inflammation. There are no approved applications for topical ibuprofen products. Although the FDA has proposed to add orally administered ibuprofen to the applicable OTC monograph, it has never proposed that topical ibuprofen be added to any OTC monograph. Topical ibuprofen is often promoted as a “safer” alternative that can be used in place of oral ibuprofen because of certain side effects, such as stomach ulcers and cardiovascular effects that are associated with prolonged use of oral ibuprofen. However, these safety claims for topical ibuprofen have not been reviewed by the FDA, nor has the agency evaluated what side effects might be associated with such products.

The names of the products and manufacturers that received warning letters are:Emuprofen (Progressive Emu, Inc.)BioEntopic 15% Ibuprofen Crème (BioCentric Laboratories, Inc.)Ibunex Topical Ibuprofen (Core Products International, Inc.)LoPain AF 15% Ibuprofen Crème (Geromatrix Health Products)IB-RELIEF (MEKT LLC)Profen HP (Ridge Medical Products)IbuPRO-10 Plus (Meditrend, Inc. dba Progena Professional Formulations)IBU-RELIEF 12 (Wonder Laboratories)

The FDA warning letters advise the companies that they may not continue to market their products without FDA approval. The FDA is requesting a written response from the companies within 15 business days of receipt of the warning letters stating how they will correct these violations and prevent similar violations in the future.

The warning letters are available on FDA’s Web site at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/default.htm

CPSC to Enforce New CPSIA Requirements for Children’s Products Effective August 14

2009-08-13T15:25:00.000-07:00

CPSC to Enforce New CPSIA Requirements for Children’s Products Effective August 14

WASHINGTON, D.C. - On August 14, 2009, new requirements of the Consumer Product Safety Improvement Act (CPSIA) will take effect that are aimed at making children’s products safer and increasing consumer confidence in the marketplace. The U.S. Consumer Product Safety Commission (CPSC) is educating domestic and overseas manufacturers, importers, and distributors of children’s products and other consumer goods of these important new safety requirements.

CPSC Chairman Inez Tenenbaum said the CPSIA’s new requirements will help protect families and she urged businesses to comply. “I will ensure that these requirements are enforced vigorously and fairly,” said Tenenbaum. “By ensuring that toys and other children’s products meet strict lead limits and can be tracked in the event of a recall, I believe children will be better protected in their homes.”

The requirements that become effective on August 14 include:
Lead Content
The limit for lead in children’s products drops from 600 parts per million (ppm) to 300 ppm.

After August 14, it will be unlawful to manufacture, import, sell, or offer for sale, a children’s product that has more than 300 ppm of lead in any part (except electronics) that is accessible to children.
Lead in Paint and Similar Surface Coating Materials

The limit for lead in paint and similar surface-coating materials for consumer use drops from 600 ppm to 90 ppm. The lead paint limits also apply to toys and other articles intended for children as well as certain furniture products. Products subject to these limits cannot be sold, offered for sale, imported or manufactured after August 14 unless they meet the new lower lead limits.

Civil Penalties
Civil penalties increase substantially to a maximum of $100,000 per violation and up to a maximum of $15 million for a related series of violations. Previously, civil penalties were a maximum of $8,000 per violation and up to a maximum of $1.825 million for a related series of violations.

Tracking Labels
Manufacturers must place permanent distinguishing marks (tracking label) on any consumer product primarily intended for children 12 and younger made on or after August 14, 2009. The permanent marks must enable consumers to ascertain basic information, including the manufacturer or private labeler, location, the date of manufacture, and more detailed information on the manufacturing process such as a batch or run number. The permanent distinguishing marks must appear on the product itself and its packaging to the extent practicable. Learn more about the tracking label requirement at www.cpsc.gov/about/cpsia/sect103.html#faqs

Catalog Advertising
Advertising for certain toys and games intended for use by children from three to six years old must have warnings regarding potential choking hazards to children younger than three. The requirement to include warnings in Internet advertisements went into effect on December 12, 2008. There was a grace period for the requirement for catalogues and other printed materials, but this grace period expired August 9, 2009. All catalogues and other printed materials distributed on or after August 9, 2009, regardless of when they were printed, must include the appropriate warnings.

Visit CPSC’s Web site at www.cpsc.gov/about/cpsia/cpsia.html for more information about the agency’s successful implementation of the CPSIA.

U.S. FDA devices chief steps down

2009-08-12T15:20:00.000-07:00

U.S. FDA devices chief steps down

The head of the U.S. Food and Drug Administration's device center stepped down on Tuesday, a move that follows a raft of scandals over safety recalls, concerns over the agency's device approval process and other controversial issues.

Daniel Schultz, who served at the agency's Center for Devices and Radiological Health for 15 years, resigned after reaching an agreement with FDA Commissioner Margaret Hamburg "that my stepping down at this time would be in the best interest of the center and the agency.

"His departure follows a string of problems at the center, such as recalls of various products including those made by top device makers Medtronic Inc and Boston Scientific Corp thought to have met certain standards.

Agency scientists have also complained about pressure from top managers at the device center.

In a separate letter to FDA staff, Hamburg said she had appointed Jeff Shuren, the agency's current associate commissioner for policy and planning, to lead the device center on an acting basis.