The petition, submitted by drug firm GlaxoSmithKline (GSK) together with the American Dietetic Association, The Obesity Society and Shaping America's Health (an association for weight management) was sent on April 17 and filed on April 22, 2008.
In theory, FDA has 180 days to respond, which means an answer is expected at the end of this month.
The petitioners are asking FDA to prevent dietary supplement products from claiming they can promote, assist or otherwise help in weight loss.
They maintain that although obesity is not a 'disease' in itself, it can lead to a host of conditions including diabetes and heart disease, and weight loss products should therefore carry disease claims rather than health claims.
Bigger than weight loss
If the petition is approved, it would have wide reaching implications for the dietary supplement industry as a whole, as it would set a precedent for what the FDA considers a 'disease', and would push back the boundaries of the supplement market.
The dietary supplement industry in the US has responded aggressively, both through comments submitted to FDA and through statements in the media.
And comments continue to come through just a few weeks before FDA is expected to issue its response.
Earlier this month, the American Herbal Products Association (AHPA) filed comments highlighting what it calls “serious flaws in the rationale” of the petition.
“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,” said AHPA President Michael McGuffin.
“The petitioners’ argument that 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.
Knock out
Supplement ingredient manufacturer Sabinsa this week submitted comments to FDA, re-iterating concerns that the petition is a continuation of the battle against supplements by the drug industry; GSK currently sells the only other-the-counter weight loss drug, which competes directly with supplements.
“It is unacceptable for GSK to use the FDA to try to knock any competition out of the market and deny consumers a choice of products,” said Sabinsa.
Sabinsa’s comments, written by industry regulatory attorney Marc Ullman, contain references to clinical studies on the company’s ForsLean product, which is marketed for weight loss.
Regulations
Although the petition has generally been recognized as being extremely thorough, its claims do not stand up to the facts, some industry members have said.
According to Steve Mister, president and CEO of the supplement trade group Council for Responsible Nutrition (CRN), the argument for classifying the state of being overweight as a disease had not been proven by GSK's petition
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.
FDA would not comment on whether it will respond to the petition on time.
A spokesperson told NutraIngredients-USA.com: “I cannot speculate on when FDA will issue its response. In the event that FDA does not reach a final decision in 180 days, FDA will advise the petitioner, continue working on it, and respond once a decision is made.”