The US 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 supplements category, according to the Council for Responsible Nutrition.
The petition, lodged by a group of organisations including pharma giant GlaxoSmithKline Consumer Healthcare, would also have implications for food products sold on the basis of weight loss claims, the CRN warned. This was because "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 the CRN's response to the petition, 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", said Mister.
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.
"With the support of three non-profit organizations, GlaxoSmithKline is essentially asking FDA to eliminate the claims for dietary supplement weight loss products that compete with its non-prescription drug alli," said Mister. "Since the OTC introduction of Alli a year ago, the product has become a $100 million revenue stream to GSK, one that would grow even more if dietary supplement options for weight management were eliminated."
In conclusion, he said: "The petitioners' arguments are unsupported and therefore should not be accepted with respect to either dietary supplements or conventional foods intended to assist consumers in achieving weight loss."
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 agreed, it would mean approval would have to be sought for claims before they could be made.
The CRN's standpoint was backed by Paul Dijkstra, CEO of California-based Interhealth Nutraceuticals, which manufactures the Super-CitriMax weight-loss ingredient for supplements and functional foods.
"We fully support CRN's submission and the arguments that they use are very valid," he said. "We believe that weight loss claims are legitimate and appropriate for dietary supplements when supported by well-designed, peer-reviewed studies that show products to be both safe and efficacious."
Read the full CRN submission at http://www.crnusa.org/pdfs/CRNcommentsweightlosspetition072808.pdf