HEALTH

AHPA disputes FDA’s handling of weight-loss supplement assertions as disease claims

BY Michael Johnsen

SILVER SPRING, Md. The American Herbal Products Association on Wednesday filed a report to the Food and Drug Administration highlighting “serious flaws in the rationale of a Citizen Petition requesting that the FDA treat weight loss claims for dietary supplements as disease claims.”

“The FDA has correctly ruled that claims are allowed for supplements that may have a benefit in assisting normal and overweight persons to lose weight, and that claims for treatment of the disease of obesity are not allowed,” stated AHPA president Michael McGuffin.

“The petitioners’ argument that the FDA was unaware of information presented in their petition when it developed the existing rule is unsupported. It should also be noted that the petition relies to a large degree on data from a consumer survey that had significant flaws in its design, and that has been poorly interpreted by the petitioners,” he added.

GlaxoSmithKline Consumer Healthcare, marketer of non-prescription weight-loss drug alli, filed the petition April 17 along with the American Dietetic Association, the Obesity Society and Shaping America’s Health. The petitioners claim that being overweight, while not a disease in and of itself, is a significant risk factor for other serious diseases. They request that FDA ban dietary supplements from making weight loss claims as structure/function claims under the Dietary Supplement Health and Education Act, and instead require dietary supplement weight loss claims to be limited to FDA-approved health claims.

“If the FDA granted this petition it would contravene Congressional intent and public policy, and would be unconstitutional under the First Amendment,” McGuffin said. “AHPA requests that FDA deny the petition.”

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Walgreens gives customers direction on cough-cold OTC dosing for children

BY Jenna Duncan

DEERFIELD, Ill. Walgreens has said that it will advise its customers on the proper, safe use of over-the-counter cough and cold remedies by adding in-store signage to shelves and making its pharmacists available for consultations.

After the announcement from the CHPA Tuesday that cough-cold remedies should not be administered to children under age 4, many cough-cold remedy makers are revising their product labels to reflect the new dosing recommendations before the upcoming cold season. Walgreens has made a commitment to make sure the most current labeled cough and cold remedies will be available during the label-upgrading swap, and newly labeled products will be on shelves as soon as they are available.

The FDA has issued a statement that parents should take precautions when administering cough-cold medicines to children, including, checking active ingredients on the Drug Facts product labeling, avoiding given children two products with the same active ingredients at the same time, following directions, using the appropriate measuring instruments, selecting cough-cold medicines with child-proof caps, recognizing that cough-old remedies do not shorten the length of illness but only treat symptoms, not using cough-cold products for sedation and calling a doctor or pharmacist if any adverse reactions occur after administering.

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CHPA advises parents not to give cough-cold remedies to infants, toddlers

BY Michael Johnsen

WOONSOCKET, R.I. The Consumer Healthcare Products Association on Tuesday announced that the industry will voluntarily advise parents not to administer cough-cold medicines to children under the age of four. CHPA members last year voluntarily removed from the market any medicines marketed or merchandised to infants under the age of two; the under-four label change will be sold-through this cough-cold season, however.

CVS/pharmacy released a statement Tuesday morning supporting the label changes. “The health and safety of our customers is our highest priority and we support CHPA’s voluntary action,” stated Michael Bloom, senior vice president of merchandising at CVS/pharmacy. “As pediatric cough and cold medicines have been declared safe and effective by the FDA, it is also important that our customers have access to these products during cough and cold season while our suppliers transition to labels with new pediatric dosing directions.”

CVS/pharmacy is working with its suppliers to ensure that the OTC medicines will be available in its stores with new pediatric dosing directions as quickly as possible, the pharmacy operator stated. In the meantime, CVS will continue to keep the current versions of the 130 products it offers available for customers who rely on these medicines to treat their families’ cold and allergy symptoms.

“Research shows that dosing errors and accidental ingestions—not the safety of the ingredients themselves when properly dosed—are the leading causes of rare adverse events in young children,” stated Linda Suydam, president of CHPA. “As a result, the leading manufacturers of oral OTC pediatric cough and cold medicines are moving forward on both the design and implementation of initiatives aimed at encouraging the appropriate use of these medicines.”

CHPA consulted with FDA in the aftermath of last week’s public meeting regarding whether or not several monographed cough/cold medicines were appropriate for use in children under the age of six. After that meeting, the FDA promised action, however acknowledged that that action, in the form of rulemaking, could take several months before a proposed rule change to the governing monographs would be introduced.

In addition to the marketing ban on children under the age of four, CHPA manufacturers are voluntarily adding new language that warns parents not to use antihistamine products to sedate or make a child sleepy.

Throughout the 2008-2009 cough and cold season, manufacturers will be transitioning onto store shelves oral OTC pediatric cough and cold medicines with the new labels and packaging. “As with other OTC labeling changes in the past, FDA has indicated it does not believe this labeling change warrants the removal of products with the existing labeling from store shelves during this time of transition,” Suydam said.

CHPA has also expanded its national education program aimed at parents, caregivers, and healthcare professionals on appropriate dosing and use of OTC medicines in children.

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