Petition Requests Pre-market Approval For Supplement Weight-loss Claims

Alli-maker GlaxoSmithKline wants weight-loss claims treated as disease claims.

Manufacturers would need pre-market approval to make weight-loss claims for supplements, if FDA implements a rulemaking recommended by petitioners including GlaxoSmithKline, the manufacturer of OTC weight-loss drug alli.

The April 17 petition says FDA should consider weight-loss claims for supplements to be disease claims.

The agency should restrict such claims "because they purport to treat an unhealthy condition that is a risk factor for disease," such as diabetes, cardiovascular disease and some cancers, the petitioners maintain.

GSK and the other petitioners - the American Dietetic Association, the Obesity Society and Shaping America's Health - say "many Americans understand the health risks of being overweight and they rely on dietary supplements to lose weight."

However, "there is little, if any evidence, indicating that dietary supplements marketed for weight loss actually work," according to the petition. "As a result ... many Americans are being thwarted in their efforts to lose weight, and reduce the risk of disease, by ineffective weight-loss supplements."

Critics of the petition say concern for overweight consumers is not the impetus for the request.

Food and drug lawyer Marc Ullman said the petition "is designed with a commercial agenda in mind to eliminate the competition for Glaxo's alli product."

"The only reason that anyone would take the time and effort to submit this kind of preposterous petition is because they have a commercial motivation," said Ullman, of New York-based Ullman, Shapiro, and Ullman.

"If the makers of alli can have FDA remove all their competition from the market without having to worry about issues like anti-trust law, why not try it?" he said.

Indeed, if the petitioners' request is put into effect, GSK's alli most likely would attract some of the $236 million weight-control product sales that went to supplement firms during the 52-week period ending March 23, 2008, according to data from Information Resources, Inc.

As it is, alli (orlistat 60mg), which GSK launched last June, pulled in $141.6 million in sales - roughly 37.5 percent of the nonprescription weight-control product market, according to IRI data, which does not include sales from Wal-Mart and club stores.

To support their request that FDA limit weight-loss claims for supplements, the petitioners say the majority of respondents in a GSK-sponsored survey said they believed that weight-loss supplements are tested and proven to be safe before being sold to the public. A majority of the respondents also said they thought that FDA requires warnings of side effects on labels for weight-loss supplements, according to the petition.

During the over the counter switch application process for alli, GSK pitched the diversion of consumers from potentially ineffective or dangerous weight-loss supplements as a benefit of the product's approval (¹ (Also see "Alli Marketing: While Vitamins Are Friendly, Some Supplements Are Foes" - Pink Sheet, 14 Feb, 2007.)).

However, the regulatory changes suggested by the petition are unnecessary given current enforcement by FDA and the Federal Trade Commission, stakeholders say.

"FTC has a program dedicated to this particular area," Daniel Fabricant, VP of scientific and regulatory affairs for the Natural Products Association, told "The Tan Sheet."

It is clear "that if you are going to make obesity claims, you are making drug claims and the regulators are going to deal with that," Ullman said.

FDA is clear that "if you are going to make claims for assisting people in day-to-day weight management issues and you craft your claims appropriately, the notion that you are talking about a disease issue is preposterous," he added.

Fabricant pointed out FTC "has done more enforcement in the past 12 to 18 months ... with respect to these products" than in its history.

For example, in February 2008 FTC fined Sili Neutraceuticals more than $2.5 million to resolve allegations the firm falsely advertised the weight loss potential of its supplements.

FTC also recently fined marketers for TrimSpa , Slim Coffee and Nutrathin for similar allegations.

Even though FDA ruled in 2000 that overweight is not a disease, the petition asks the agency "to take action on the basis of substantial scientific evidence establishing that the condition of being overweight is not itself a disease but rather a risk factor for disease."

The petitioners add "nothing precludes" FDA from "finding, on the basis of new scientific information developed during the past decade, that weight-loss claims are disease claims under criteria in FDA's regulations that were not previously considered by the agency."

Further, "FDA must treat weight-loss claims as disease claims" because the agency's 2000 regulations say "a statement will be treated as a disease claim if it states, explicitly or implicitly, that the product 'has an effect on the characteristic signs or symptoms of a specific disease or class of diseases,'" according to the petition.

Ullman said FDA should "maintain the position that they have maintained all along ... if someone is going to make express or implied claims that they are treating obesity, that is a drug claim."

However, if a firm claims a product assists people "in their efforts to lose the few pounds they put on over the winter, then that is an appropriate structure/function claim. That has been FDA's position since they promulgated the pertinent regulations and it is a sensible position," he added.

-Elizabeth Crawford ([email protected])

[Editor's note: This story appears courtesy of the editorial staff of ² 'The Tan Sheet,' your source for coverage of nonprescription pharmaceuticals and nutritionals. For a sample copy, call customer service at 800-332-2181.]