FRESH GREEN recall about to go viral !

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

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.

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)

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.

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

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

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

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

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

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

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

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

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?

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

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

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

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

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?

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

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

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

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

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

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

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

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

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

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

2010-80
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.

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

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

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

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

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

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

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

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.

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

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

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

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

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

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

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

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

2010-14

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

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
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