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.”