The wider implications of GSK's weight loss petition

Filed last month with the US Food and Drug Administration (FDA), the petition claims 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.

"The specific issue at the moment is weight loss.

The larger issue is what is a disease?" said Loren Israelsen, executive director of the United Natural Products Alliance (UNPA), a trade association for the supplement industry.

Disease definition "The definition of disease establishes the boundary line of market opportunities," he told NutraIngredients-USA.com.

The petition could therefore open up a larger can of worms, as the overall definition of a 'disease' hangs in the balance.

"This extends far beyond current understanding of the definition of disease, and would have ramifications for many other product categories within the supplement industry," said Israelsen.

The American Botanical Council expressed similar ideas.

"Many in the natural health and natural products community have already expressed their concerns that this petition is a disturbing trend," said Mark Blumenthal, founder and executive director.

"They ask, what condition might be next?

For example, with type 2 diabetes being so prevalent, many herbs and other supplements are being researched and promoted to help with glycemic control.

With respect to some of these ingredients, will this area be one of the next targets for being put off limits for a DSHEA structure-function claim due to 'diseasification'?"

he wrote to NutraIngredients-USA.com.

Flip side However, the fact that the issue has such far-reaching implications could actually end up working in industry's favor.

The reason is that FDA is sure to consider the wider picture when examining the petition, and may well be reluctant to change the face of disease definition with one fell swoop.

According to Israelsen, this could be a major sticking point for the petition.

The chance of its success, he believes, is "relatively low".

"This is such a sensitive issue and FDA well knows that should it approve the petition it would trigger a vociferous and aggressive response from consumers, the supplement industry and a large array of organizations that would view this a decision by FDA to grant this petition as establishing a new definition of disease," he said.

Thorough petition Nevertheless, the threat of the petition still looms.

Sent on April 17 and posted on the regulations.gov website on April 22, FDA is in theory expected to provide some form of response within 180 days - by the end of October 2008.

There are no doubts as to the thoroughness of the petition.

According to Israeslen, it is a "very very well-crafted and well-referenced" petition.

Blumenthal also called it "well written and very well-thought out".

This is part of the reason why the supplement industry has been slow to formulate a formal response.

Caught off-guard by the petition's thoroughness, the industry's best defense is to withdraw until it can retaliate with force.

But it has already hinted that the retaliation is on the way.

The Council for Responsible Nutrition (CRN), which is for the time being holding its tongue, has said simply that it will oppose the petition, and will "vigorously defend the industry's rights in this area".

Comments GSK specifically points out in the petition that FDA does not need to initiate a notice and comment rulemaking period.

"Notice and comment rulemaking is only required when regulations are changed ," explained Bruce Manheim of Ropes & Gray, the legal firm representing GSK.

"The petition is effectively asking FDA to implement and apply its existing regulations to weight loss claims in light of new science and consumer research developed since the structure/function rule in 2000," he told NutraIngredients-USA.com.

However, this does not prevent comments from being submitted.

In an e-mail to this publication, an FDA spokesperson confirmed that "nothing in the (CFR 10.30) precludes FDA from soliciting comment.

Depending on the issue and the need or desirability for further public comment, FDA could on its own volition issue a notice asking for comment."

"However, the entire reason for posting a petition publicly in a docket is to allow for interested parties to comment.

(…)

Anyone can submit a comment to a petition by sending it to the relevant docket via the regulations.gov web site."

Other articles in this series: Drug petition could strip supplements of weight loss claims GSK petition claims weight loss supplements have no science Why weight loss supplements don't work, according to GSK Alli and the weight loss drug market Weight loss market already suffering from skepticism, Mintel