CRN attacks disease in GSK weight loss petition

29-Jul-2008 - Last updated on 30-Jul-2008 at 16:51 GMT

Related tags Weight loss Dietary supplement

Reclassifying weight loss claims as disease claims will unfairly "disease-ify" many health conditions, according to the Council for Responsible Nutrition (CRN).

Responding to GlaxoSmithKline's April petition to the Food and Drug Administration (FDA) which seeks to do exactly that - CRN president and CEO Steve Mister noted many dietary supplement ingredients were proven to benefit weight loss.

The argument for classifying the state of being overweight as a disease had not been proven by GSK's petition, Mister said.

He said a reclassification of such claims would fly in the face of the Dietary Supplements Health Education Act (DSHEA), established in 1994 in part to provide a space where dietary supplements could communicate their various health benefits, outside of often inappropriate pharmaceutical measures.

Disease-ification

DSHEA mandated weight loss claims as structure/function claims and not disease claims, and this was subsequently confirmed and clarified by FDA in 2000.

If the petition were to succeed it would have "sweeping implications for weight-related claims" and "create a slippery slope for other structure/function claims that would essentially 'disease-ify' many health conditions not currently considered to be diseases or surrogate endpoints for disease."

"This would cripple the dietary supplement category as envisioned by Congress with the passage of DSHEA," Mister said in his 19-page response.

The petition undervalued the ability of FDA and the Federal Trade Commission (FTC) to police the category, he said.

"To the extent that unsubstantiated or misleading claims are being made for weight loss products (and indeed any FDA-regulated products), the petitioners' concerns can and should be addressed through increased enforcement of existing laws and regulations by both FDA and the Federal Trade Commission (FTC)," Mister wrote.

"Many dietary ingredients are well substantiated for weight loss, and a few outrageous examples of claims that already violate both FDA and FTC requirements for the substantiation of labeling and advertising do not justify removal of weight loss claims from the structure/function category altogether."

FTC had taken the proactive step in 2004 of launching "Operation Big Fat Lie", which cracked down on false weight-loss claims.

CRN said if FDA accepted GSK's assertion that weight loss ingredients such as chromium, hoodia, garcinia cambogia and Conjugated Linolenic Acid (CLA) typically found in dietary supplements should be barred from making weight loss claims, a commercial advantage would be granted to GSK as significant competition would be removed to its alli OTC weight loss drug.

Since its launch in 2007, alli had notched sales of $100m and was well on its way to becoming a pharma "blockbuster".

Behind bars

Making weight loss claims disease claims was unfair because it subjected dietary supplement weight loss claims to the 'significant scientific agreement (SSA)' standard that was not appropriate for many dietary supplements and their active ingredients.

"…It would likely lead to removal of many (if not all) weight loss claims made by dietary supplements - not because they fail to possess reasonable scientific evidence to substantiate their weight loss claims, but because of the high bar that FDA has created for the SSA standard," said CRN.

The Washington DC-based industry group pointed to the fact weight loss supplements were commonly used for cosmetic reasons and not to cure disease.

"The degree and extent of weight loss desired varies tremendously, depending on circumstances and personal preferences."

A consumer survey found less than half of those who take weight loss supplements took them to improve their health.

Mister said conventional foods would also be affected if the petition succeeded. "Products ranging from meal replacement beverages and bars to cereals and frozen dinners would be required to receive FDA approval prior to making weight loss claims."

He wondered if treadmills and weight systems would also be classified as medical devices under a new regime and have their weight loss claims restricted.

"CRN acknowledges that there is a small segment of both the dietary supplement and food industries whose products are associated with unsubstantiated weight loss claims."

In response it had instigated schemes with advertising watchdogs to better police claims and said authorizing the petition would not help the FDA and FTC police such claims.

To see CRN's response click here.