AHPA disputes FDA’s handling of weight-loss supplement assertions as disease claims
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.”
Walgreens gives customers direction on cough-cold OTC dosing for children
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.
More parents confused about cough-cold treatments for kids, survey suggests
SOUTHBOROUGH, Mass. News coming out of the recent Food and Drug Administration public meeting on pediatric cough-cold medicines sold over-the-counter, as well as the recent announcement from Consumer Healthcare Products Association that manufacturers would voluntarily cease recommending use of their cough-cold products in children under the age of four, could compound pre-existing confusion among parents.
According to a survey of 606 parents (conducted by Survey.com) released by Kaz Monday, the majority of parents had already been considering not giving their children cough-cold medicine when they become sick with a cold. According to the survey, conducted six months after the FDA announced a ban of the sale of cough-cold products to children under the age of two, 70 percent of parents with children under the age of four reported they give their children cold medicine when they were sick, as do 74 percent of parents with kids under six and 80 percent of parents with children between the ages of seven and 12 old.
When asked in June if they plan to change the way they treat their children’s colds this coming season due to the January FDA warnings, more than half (64 percent) of parents who currently give their children cold medicine either plan to stop (34 percent) or are considering it (30 percent).