The citizen petition was filed at the end of last month by drug firm GlaxoSmithKline (GSK) together with the American Dietetic Association, The Obesity Society and Shaping America's Health, an association for weight management. The petitioners are asking the Food and Drug Association (FDA) to prevent dietary supplement products from claiming they can promote, assist or otherwise help in weight loss. Such claims, they say, should be considered disease claims. The petition is hinged on the fact that although obesity is not a disease in itself, it is a significant risk factor for ailments like diabetes, cancer and heart disease. No conflict, no comment
As such, the petitioners claim the action they are requesting would not conflict with FDA's determination in 2000 that weight loss claims are not disease claims because overweight is not a disease. Essentially, the petition also emphasizes that FDA does not need to initiate a notice and comment rulemaking - which means that, in theory, the change could slip into regulatory language without warning. "Notice and comment rulemaking is only required when regulations are changed," said 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. Science
This science, say the petitioners, includes studies published since 2000 that highlight the risk between overweight and developing diabetes, cardiovascular disease, and cancer. In addition, the petition claims the dietary supplement industry does not have sufficient science supporting the use of its products for weight loss. "There is no credible scientific evidence that would support any type of a claim accompanying a weight loss supplement. Indeed, during the past decade, several independent scientific teams have uniformly concluded that there is little, if any, evidence to support the efficacy of supplements marketed for weight loss," writes the petition. Opposition
This statement in specific and the petition in general has already generated a heated response from the dietary supplement industry, which is preparing to fiercely protect its market. Trade group Council for Responsible Nutrition (CRN) has said it will oppose the petition, and will "vigorously defend the industry's rights in this area". Weight loss claims are "legitimate and appropriate" for use on dietary supplements, as long as they are substantiated, it said. Individual companies are also up in arms. "The petition says there is no science behind the weight loss supplements industry. This is false. There is a tremendous amount of clinical and non-clinical science," said John Alkire, president and CEO of ingredient supplier AHD International. "It is the action of a drug company trying to control the weight loss industry," he told NutraIngredients-USA.com, adding that his company was already talking to its attorneys about the petition. Drug-supplement battle
Indeed, the petition does appear to continue the ongoing battle between the drug and supplement industries for market share. It comes at a targeted time for GSK, which has recently launched the only FDA-approved weight loss drug available over-the-counter. The non-prescription product - alli - comes into direct competition with weight loss supplements. FDA has confirmed receipt of the petition, and in accordance with its practice, it is expected to respond within 180 days. Under the President's eRulemaking initiative, all FDA dockets are migrated to regulations.gov. To access the full GSK petition, click here. In follow-on articles this week, NutraIngredients-USA.com will examine the petition in more detail, with particular attention to the weight loss supplement ingredients it highlights. In addition, we will provide an overview of the weight loss market, and the drug-supplement conflict.