CEO Mister warns the FDA that proposal would 'cripple' the supplements category
The Food & Drug Administration should reject a petition to treat weight-loss claims made for dietary supplements as disease claims because it would be a "slippery slope" to "disease-ifying" a host of other conditions and could "cripple" the dietary-supplements category, according to the Council for Responsible Nutrition (CRN).
It would also have implications for food products sold on the basis of weight-loss claims, the trade body warned, on the grounds that "to officially exempt conventional foods from being affected by this petition, if it were to move forward, would require amending the Food Drug & Cosmetic Act."
In its response to the petition, CRN president and CEO Steve Mister said the FDA had "correctly decided" in 2000 that weight-loss claims — as opposed to claims to treat obesity — were structure/function claims under the Dietary Supplement Health and Education Act of 1994, based on the intended use of such products for cosmetic reasons and not primarily to manage risk of disease.
In addition, the condition of being 'overweight' had not been established by the petitioners as "a validated modifiable risk factor for, or surrogate endpoint for, disease," Mister said.
Any false claims made for supplements related to weight loss could be dealt with through existing regulations enforced by the FDA and Federal Trade Commission, he added.
The petition was filed in April by a group made up of the American Dietetic Association, The Obesity Society, Shaping America's Health and GlaxoSmithKline Consumer Healthcare. They argue weight-loss claims made for supplements "purport to prevent or treat an abnormal or unhealthy condition that, while not itself a disease, is a significant risk factor for disease."
If the FDA agrees, approval would have to be sought for claims before they could be made.