Tuesday, September 29, 2009

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

Consumers Union Opposes USDA Proposal On Salad Safety

Group urges Congress to pass FDA food safety program

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

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

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

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


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

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

Sunday, September 27, 2009

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

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

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

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

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

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

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

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

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

Tuesday, September 22, 2009

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

Contact: Kathleen K. Quinn, 301-796-4617, kathleen.quinn@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

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

The U.S. Food and Drug Administration announced today a ban on cigarettes with flavors characterizing fruit, candy, or clove. The ban, authorized by the new Family Smoking Prevention and Tobacco Control Act, is part of a national effort by the FDA to reduce smoking in America.

Smoking is the leading preventable cause of death in America.

The FDA's ban on candy and fruit-flavored cigarettes, effective today, highlights the importance of reducing the number of children who start to smoke, and who become addicted to dangerous tobacco products. The FDA is also examining options for regulating both menthol cigarettes and flavored tobacco products other than cigarettes.

"Almost 90 percent of adult smokers start smoking as teenagers. These flavored cigarettes are a gateway for many children and young adults to become regular smokers," said FDA
Commissioner Margaret A. Hamburg, M.D. "The FDA will utilize regulatory authority to reduce the burden of illness and death caused by tobacco products to enhance our Nation's public health."

Flavors make cigarettes and other tobacco products more appealing to youth. Studies have shown that 17 year old smokers are three times as likely to use flavored cigarettes as smokers over the age of 25.1

"Flavored cigarettes attract and allure kids into lifetime addiction," said U.S. Department of Health and Human Services Assistant Secretary for Health Howard K. Koh, M.D., M.P.H. "FDA's ban on these cigarettes will break that cycle for the more than 3,600 young people who start smoking daily."

The FDA is taking several steps to enforce the ban. A letter recently sent to the tobacco industry provided information about the law, and explained that any company who continues to make, ship or sell such products may be subject to FDA enforcement actions.

The FDA has also made available today an advisory to parents on the risks associated with flavored tobacco products.

"Youth are twice as likely to report seeing advertising for these flavored products as adults are," said Dr. Joshua Sharfstein, a pediatrician and the FDA Principal Deputy Commissioner.

"Marketing campaigns for products with sweet candy and fruit flavors can mislead young people into thinking that these products are less addictive and less harmful."

The FDA encourages consumers to report continuing sales of flavored cigarettes through a special tobacco hotline (1-877-CTP-1373) and Web site (www.fda.gov/flavoredtobacco).

Parents and consumers can learn more about the risks of flavored tobacco products at www.fda.gov/ .

CPSC Urges Parents to Inspect and Secure TVs, Furniture, and Appliances to Prevent Tip-Over Deaths and Injuries

The Tipping Point: CPSC Urges Parents to Inspect and Secure TVs, Furniture, and Appliances to Prevent Tip-Over Deaths and Injuries

WASHINGTON, D.C. - For young children, the home is a playground, and while many parents childproof to ensure that their home is a safe place, some may not be aware that unsecured TVs, furniture and appliances are hidden hazards lurking in every room. Today, the U.S. Consumer Product Safety Commission (CPSC) is urging parents once again to take simple, low-cost steps to prevent deaths and injuries associated with furniture, TV, and appliance tip-overs.

CPSC staff estimates that in 2006, 16,300 children 5 years old and younger were treated in emergency rooms because of injuries associated with TV, furniture, and appliance tip-overs, and between 2000 and 2006, CPSC staff received reports (pdf) of 134 tip-over related deaths.

Additionally, CPSC staff is aware of at least 30 media reports of tip-over deaths since January 2007 involving this same age group.

“Many parents are unaware of the deadly danger of this hidden hazard. I urge parents to include securing TVs, furniture, and appliances in their childproofing efforts,” said CPSC Chairman Inez Tenenbaum. “Taking a few moments now can prevent a tip-over tragedy later.”

“You may think your home is safe, but everyday things like a television can hurt your child. I was right there and it happened,” said Sylvia Santiago, of West Haven, Connecticut who lost her two-year old daughter in 2008.

Typically, injuries and deaths occur when children climb onto, fall against, or pull themselves up on television stands, shelves, bookcases, dressers, desks, chests, and appliances. In some cases, televisions placed on top of furniture tip over and cause a child to suffer traumatic and sometimes fatal injuries. “The most devastating injuries that we see resulting from furniture tipping on children are injuries to the brain and when a child is trapped under a heavy piece of furniture and suffocates,” said Gary Smith, MD, DrPH, Director of the Center for Injury Research and Policy at Nationwide Children’s Hospital in Columbus, Ohio.

Recent revisions to the voluntary safety standards for clothes storage units provide for the inclusion of warning labels and additional hardware to secure the furniture to the floor or wall.

To help prevent tip-over hazards, CPSC offers the following safety tips:

Furniture should be stable on its own. For added security, anchor chests or dressers, TV stands, bookcases and entertainment units to the floor or attach them to a wall.

Place TVs on a sturdy, low-rise base. Avoid flimsy shelves.

Push the TV as far back as possible.

Place electrical cords out of a child’s reach, and teach kids not to play with them.

Keep remote controls and other attractive items off the TV stand so kids won’t be tempted to grab for them and risk knocking the TV over.

Make sure free-standing ranges and stoves are installed with anti-tip brackets.

Friday, September 18, 2009

Warning on Stolen Albuterol Sulfate Inhalation Solution and Ipratropium Bromide Inhalation Solution

Warning on Stolen Albuterol Sulfate Inhalation Solution and Ipratropium Bromide Inhalation Solution

On September 17, 2009, the U.S. Food and Drug Administration (FDA) advised consumers not to use certain respiratory medications purchased after Sept. 8, 2009 and manufactured by Dey L.P., a subsidiary of Mylan Inc., because the medications might have been part of a shipment being transported on a tractor-trailer stolen in Tampa, Fla., on Sept. 8, 2009.

The respiratory medications, Ipratropium Bromide Inhalation Solution, 0.02%, and Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials, have not been recovered and may be dangerous to use because the drugs may not have been stored and handled properly.

Dey issued an advisory on Sept. 11, 2009 regarding the theft. Although FDA is not aware of any reports of adverse events, the agency is advising patients who use these respiratory medications to check to see if products received or purchased after Sept. 8, 2009 are from one of the following lots:

Albuterol Sulfate Inhalation Solution (892,000 doses; all lots contain 3.0 ml vials and display the brand name “Dey”)
Lot number 9G04, NDC # 49502-697-29
Lot number 9FD8, NDC # 49502-697-61
Lot number 9FD9, NDC # 49502-697-61
Lot number 9FE1, NDC # 49502-697-61

Ipratropium Bromide Inhalation Solution (432,000 doses; all lots contain 2.5 ml vials and display the brand name “Dey”)
Lot number F09089, NDC # 49502-685-31
Lot number C09119, NDC # 49502-685-62
Lot number C09120, NDC # 49502-685-62

Advice for Consumers
Do not use Albuterol Sulfate Inhalation Solution or Ipratropium Bromide Inhalation Solution if it is from one of these lots above and was purchased or received after Sept. 8, 2009. Replace it with the same product from another lot.

Notify your health care professional of any adverse effects you may have experienced as a result of taking these medications.

Bring products from these lots back to the pharmacy where you received the medicine to exchange for products from a different lot or call Dey customer service at 800-527-4278.

Contact your health care professional if you must switch to another product for any reason for possible dose adjustments.

Report any information regarding the stolen Dey products to FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).

Tuesday, September 8, 2009

Kohl’s Department Stores Agrees to Pay $425,000 Civil Penalty for Failing to Report Drawstrings in Children’s Sweatshirts

Kohl’s Department Stores Agrees to Pay $425,000 Civil Penalty for Failing to Report Drawstrings in Children’s Sweatshirts

WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) announced today that Kohl’s Department Stores Inc., of Menomonee Falls, Wis. has agreed to pay a civil penalty of $425,000. The penalty settlement (pdf), which has been provisionally accepted by the Commission, resolves CPSC staff allegations that Kohl’s Department Stores knowingly failed to report to CPSC immediately, as required by federal law, that children’s hooded sweatshirts it sold had drawstrings at the neck.

Children’s upper outerwear with drawstrings, including sweatshirts, poses a strangulation hazard to children which can result in serious injury or death. In March 2009, CPSC and the sweatshirts’ importer announced a recall of the products.

CPSC issued drawstring guidelines (pdf) in 1996 to help prevent children from strangling or getting entangled on the neck and waist drawstrings in upper outerwear, such as jackets and sweatshirts. In 1997, industry adopted a voluntary standard for drawstrings that incorporated the CPSC guidelines. In May 2006, CPSC’s Office of Compliance announced (pdf) that children’s upper outerwear with drawstrings at the hood or neck would be regarded as defective and as presenting a substantial risk of injury to young children.

Federal law requires manufacturers, distributors, and retailers to report to CPSC immediately (within 24 hours) after obtaining information reasonably supporting the conclusion that a product contains a defect which could create a substantial product hazard, creates an unreasonable risk of serious injury or death, or fails to comply with any consumer product safety rule or any other rule, regulation, standard, or ban enforced by CPSC.

In agreeing to the settlement, Kohl’s Department Stores denies CPSC's allegations that it knowingly violated the law.

In 2008, Kohl’s paid a $35,000 civil penalty for failing to report drawstrings in children’s sweatshirts.

Hill Sportswear Agrees To Pay $100,000 Civil Penalty For Failing To Report Drawstrings In Children’s Sweatshirts

Hill Sportswear Agrees To Pay $100,000 Civil Penalty For Failing To Report Drawstrings In Children’s Sweatshirts

WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) announced today that Hill Sportswear Inc., of Paramount, Calif. has agreed to pay a civil penalty of $100,000. The penalty settlement (pdf), which has been provisionally accepted by the Commission, resolves CPSC staff allegations that Hill Sportswear knowingly failed to report to CPSC immediately, as required by federal law, that children’s hooded sweatshirts it manufactured and sold had drawstrings at the neck.

Children’s upper outerwear with drawstrings, including sweatshirts, poses a strangulation hazard to children which can result in serious injury or death. In November 2008, a 3-year-old boy died in Fresno, Calif. when the drawstring on his Hill Sportswear hooded sweatshirt reportedly became stuck on a playground set strangling him. Hill Sportswear and CPSC announced a recall of the sweatshirts in February 2009.

CPSC issued drawstring guidelines (pdf) in 1996 to help prevent children from strangling or getting entangled on the neck and waist drawstrings in upper outerwear, such as jackets and sweatshirts. In 1997, industry adopted a voluntary standard for drawstrings that incorporated the CPSC guidelines. In May 2006, CPSC’s Office of Compliance announced (pdf) that children’s upper outerwear with drawstrings at the hood or neck would be regarded as defective and as presenting a substantial risk of injury to young children.

About 120,000 of these Hill Sportswear sweatshirts were sold at various small retailers in California and Texas from 2003 through December 2008 for approximately $8. Due to the serious nature of this hazard, parents are urged to immediately remove the drawstrings from the sweatshirts or return the garment to either the place of purchase or to Hill Sportswear for a full refund.

Federal law requires manufacturers, distributors, and retailers to report to CPSC immediately (within 24 hours) after obtaining information reasonably supporting the conclusion that a product contains a defect which could create a substantial product hazard, creates an unreasonable risk of serious injury or death, or fails to comply with any consumer product safety rule or any other rule, regulation, standard, or ban enforced by CPSC.

In agreeing to the settlement, the firms deny CPSC’s allegations that they knowingly violated the law.

Firms Agree to Pay $85,000 in Civil Penalties for Failing to Report Drawstrings in Children’s Outerwear

Firms Agree to Pay $85,000 in Civil Penalties for Failing to Report Drawstrings in Children’s Outerwear

WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) announced today that two firms, Maran Inc., of North Bergen, N.J. and K.S. Trading Corp., of Moonachie, N.J., have agreed to pay a total of $85,000 in civil penalties. The penalty settlements (Maran and K.S. Trading, pdf), which have been provisionally accepted by the Commission, resolve CPSC staff allegations that the firms knowingly failed to report to CPSC immediately, as required by federal law, that children’s hooded sweatshirts or jackets they sold had drawstrings at the neck.

Children’s upper outerwear with drawstrings, including sweatshirts or jackets, poses a strangulation hazard to children which can result in serious injury or death. CPSC and the firms announced recalls (Maran and K.S. Trading) of the products.

CPSC issued drawstring guidelines (pdf) in 1996 to help prevent children from strangling or getting entangled on the neck and waist drawstrings in upper outerwear, such as jackets and sweatshirts. In 1997, industry adopted a voluntary standard for drawstrings that incorporated the CPSC guidelines. In May 2006, CPSC’s Office of Compliance announced (pdf) that children’s upper outerwear with drawstrings at the hood or neck would be regarded as defective and as presenting a substantial risk of injury to young children.

Federal law requires manufacturers, distributors, and retailers to report to CPSC immediately (within 24 hours) after obtaining information reasonably supporting the conclusion that a product contains a defect which could create a substantial product hazard, creates an unreasonable risk of serious injury or death, or fails to comply with any consumer product safety rule or any other rule, regulation, standard, or ban enforced by CPSC.

In agreeing to the settlement, the firms deny CPSC’s allegations that they knowingly violated the law.