Weight Loss as a Disease Claim?

A citizen’s petition filed by GlaxoSmithKline and consumer health groups seeks to change FDA’s perspectives on weight loss supplements.

By
Joanna Cosgrove
Online Editor

With America’s obesity epidemic at an all-time code red, consumers hoping to shed excess weight want faster results than diet and exercise can often provide. Even though there is little evidence to prove diet pills and supplements actually work, consumers continue to clamor for them. One of the hottest selling supplements is alli, (orlistat 60 mg), from GlaxoSmithKline (GSK), which has tallied $141.6 million in sales since its launch last June and currently represents about 37.5% of the nonprescription weight control product market.

In a surprise move, GSK teamed with the American Dietetic Association (ADA), The Obesity Society and Shaping America’s Health in April to file a citizen’s petition requesting that FDA consider weight loss as a disease claim.

The petition has many in the nutritional supplement segment wondering how the petition’s outcome will balance consumer benefit while preserving the line that divides nutritional supplements and OTC/Rx medications.

In response to the filing, the Council for Responsible Nutrition (CRN) made clear its intentions to oppose the petition to re-classify weight loss claims as either disease claims or health claims requiring FDA approval. Steve Mister, CRN’s president and CEO said, “We believe weight loss claims are legitimate and appropriate claims for products in the dietary supplement category, provided these products have substantiation to support the truthfulness of these claims. FDA has made it clear that it considers weight loss claims appropriate and permissible under the Dietary Supplement Health & Education Act (DSHEA)—meaning that manufacturers should not have to seek the agency's approval before making these claims. Therefore, CRN intends to vigorously defend the industry's rights in this area.”

Loren Israelsen, executive director, United Natural Products Alliance (UNPA), Salt Lake City, UT, said that the chances of the petition being approved are “remote,” and “modest, at best.” But if it does succeed, it will officially open the door for even greater competition between pharmaceuticals and dietary supplements, spanning a variety of already accepted disease claims.

“In my judgment, if this petition were to be approved by FDA, this would require further notice and comments, as this would significantly amend FDA's 2000 final regulation on structure/function claims,” he said. “Approval of this petition would suggest that the definition of disease has been changed. This would clearly be a victory for pharmaceutical products and a major loss for supplements. If weight loss claims were to be regulated as drug claims, this would only be the beginning. What about blood pressure, cholesterol levels and blood sugar levels? These are all surrogate markers of diseases, and now the markers themselves become the disease definition. This is the big issue.”

In addition to containing multiple citations linking obesity with disease risk factors, the petition also contains citations from a GSK-sponsored Landmark Survey regarding the public’s perception of weight loss supplements. Among the callout statistics, a majority of respondents said they believed weight loss supplements to be “tested and proven to be safe” and “tested and proven to be effective” before they can be sold to the public. Moreover, half of the respondents acknowledged that they believed weight loss supplements were indeed effective for weight loss.

Mr. Israelsen likened the depth of the petition’s documentations to that of a white paper. “It would appear to me to be the ‘white paper’ that would be given to anyone in a position of influence who agrees with GSK and ADA that something should be done about supplement weight loss claims. It is hard to argue that there are not bogus weight loss claims seen widely on TV, radio and in print. Who should enforce this? That is the question.

Ulterior Motives?

One interesting citation from the GSK Landmark Survey was the mention that 37% of respondents believed that “herbal supplements are safer than over-the counter and prescription medicines.” Now, while it’s not unusual for companies to partner with non profit and/or trade associations to address common issues, GSK’s participation in the petition gives rise to a glaring question, namely, the true motivation behind GSK’s involvement. Industry insiders wonder if GSK is gluttonously banking on the petition to strip away the competitors to its already successful alli weight loss supplement.

“I was indeed surprised to see this petition filed, partly because it is audacious, but also because it suggests to me a level of confidence on the part of GSK that the dietary supplement weight loss sector is vulnerable to both negative media attention as well as FTC action,” commented Mr. Israelsen. “It may be that GSK's strategy is to use the citizens petition process as a vehicle to create the media story, thus raising the prospect that FTC will feel obliged to take further action against dietary supplement weight loss claims, which in turn continues to spin the negative media environment.”

Nutraceuticals World contacted GSK multiple times in an effort to allow the company to elaborate on its interests in the filing, but GSK declined to reply.

The ADA acknowledged that although it has a relationship with GSK, the primary focus of the relationship has been on orlistat and the studies supporting it—something the ADA has been actively involved in for the past decade. “Our relationship on the subject of orlistat is one that goes back a lot of years,” said Stephanie Patrick, the ADA’s policy initiatives and advocacy vice president. “It is the only over the counter product that has been subject to testing in ways that other products haven’t.

“For more than 10 years we’ve also been involved with the FTC work on weight loss products [because] we’ve been concerned with claims over the years,” she continued. “And nine years ago we embraced evidence-based practice. We set aside our perceptions that best practices were good enough. The standards that we are held to by the federal government, as we talk about issues related to food, nutrition and health, are to show the evidence.”

Ms. Patrick, who admitted that she “didn’t have a clue” how FDA would respond to the petition, doesn’t believe the possible passage of this petition would adversely affect the nutritional supplement industry, rather, she said her association viewed its participation in the petition as a way to reframe the issue of weight loss. “Although we advocate ‘food first,’ dieticians also are interested in vitamin and nutrient supplements. We don’t have any bias against supplements. It is not our intention to change the marketplace [or] rearrange the regulatory system.”

As evidenced by past motions put to FDA, the time table of this petition is questionable. Although the petition makes a clear and thoughtful case for qualifying weight loss as a disease claim, the passage or dismissal of it could take decades. And what about the ripple effect into other corners of the supplement industry, should the petition pass? That could take a lifetime.