by Mitchell Clute

In late April, pharmaceutical giant GlaxoSmithKline filed a citizen's petition with the U.S. Food and Drug Administration asking the agency to treat dietary supplements' weight-loss claims as disease claims. The petition, filed jointly with the American Dietetic Association and other groups, may have implications for other dietary supplements categories as well.

Disease claims are not permitted on dietary supplements, so any product making a statement classified as a disease claim could be pulled from the market.

The petition was denounced by supplements industry groups, many of which see it as an attempt to quash competition for GSK's over-the-counter diet pill Alli, a low-dose version of the prescription drug Xenical that was approved for sale last June.

"This is not a shot in the dark; this is a broad-daylight, frontal attack," said Loren Israelsen, president of LDI Group, an industry consulting firm based in Salt Lake City. Steven Mister, president of the Council for Responsible Nutrition, issued a statement saying, "We believe weight-loss claims are legitimate and appropriate claims for products in the dietary supplements industry, provided these products have substantiation to support the truthfulness of these claims."

Currently, dietary supplements are allowed to make structure/function claims regarding weight loss, but not to claim that a supplement can eliminate a disease state, such as obesity. Using consumer surveys to bolster its argument, the petition tries to establish that, because consumers read structure/function claims regarding weight loss as implied disease claims, they should be treated as disease claims by the FDA.

The petition also questions the efficacy of weight-loss supplements currently on the market. Using exhaustive footnotes and referencing dozens of studies, the petition concludes: "There is no credible scientific evidence [italics from original document] to support any type of qualified health claim for a weight-loss supplement."

"Their motivation is purely economic," said Mark Ullman of Ullman, Shapiro and Ullman, a New York-based law firm specializing in dietary supplements regulation. "Their OTC product is required to carry claims very similar to those used by responsibly marketed dietary supplements, and Glaxo is seeking to eliminate competition to Alli from store shelves. The only problem Glaxo has with their product is that it causes anal leakage, so consumers might tend to stay away from it."

Indeed, though Alli has had $141 million in sales since its launch, representing more than a third of the total nonprescription weight-control market, the Mayoclinic.com Web site lists side effects including "hard-to-control bowel movements" and "gas and oily anal discharge."

Given these drawbacks, some supplements-industry insiders say it's clear why Glaxo would benefit from eliminating the competition from dietary supplements, which don't have the same side effects. "[Glaxo has] thoroughly scrutinized the category, and has drawn the conclusion that the weight-loss dietary supplements sector is vulnerable to both regulatory enforcement and media scrutiny," Israelsen said. "This petition appears to be an effort to affect both, and in my view it's exceptionally well-crafted and well-argued."

Glaxo representatives did not return calls seeking comment before press time.

Ultimately, the effect of Glaxo's petition depends on whether the FDA recognizes it or not. If not, then the primary impact will likely be in the media. If the petition is accepted, however, then the stakes are much higher. In either case, the repercussions of the petition may stretch far beyond the category of weight-loss supplements.

"Glaxo built their whole case around consumer surveys, and the petition is incredibly unique, but I don't believe it will stand," said Michael McGuffin, president of the nonprofit American Herbal Products Association. "FDA has drawn a bright line between claims for weight loss as opposed to claims for the treatment of obesity, and it strikes me as highly unlikely that FDA will say that everything they said about the issue back in 2001 is now wrong. We will certainly work hard to prevent the petition from being accepted by FDA, but frankly I think it's unlikely that Glaxo will get what they're asking for. If you can make the argument that this sort of health maintenance is actually a disease claim, then you can make it with any kind of product for health maintenance."

GSK's Alli is the first weight-loss drug to make the move from prescription to OTC, but likely won't be the last, and pharmaceutical companies would benefit from minimized competition not just in the weight-loss area, but in other claim areas as well.

"The bigger picture here is, what happens if FDA agrees and recognizes the petition? Is that the end of it, or does it open up the bigger question of other categories of claims that would be vulnerable to similar petitions, including claims about blood sugar, blood pressure and cholesterol?" Israelsen asked. "If the petition is accepted, we would really be reopening the 2000 final regulation on structure/function claims. The pharma people would like to extend the line out as far as possible to include surrogate markers of diseases. For example, cholesterol levels are not a disease, but a surrogate marker of disease. If we systematically have the door to these other categories slammed, our playground is going to shrink dramatically."

Mitchell Clute is a Fort Collins, Colo.-based freelance writer.

Natural Foods Merchandiser volume XXVIII/number 6/p. 15