In mid-April, GlaxoSmithKline Consumer Healthcare (“GSK”) and a trio of research and advocacy organizations submitted a citizen petition to FDA that asks the Agency to prohibit structure/function claims for dietary supplements that expressly or impliedly reference weight loss. In addition to claims that expressly reference weight loss, the petition contends that the following categories of claims should be prohibited: energy expenditure, modulation of carbohydrate metabolism, increased satiety or suppression of appetite, increased fat oxidation or reduced fat synthesis, and blockage of fat absorption. The petition acknowledges FDA’s longstanding position that weight loss claims are permissible structure/function claims. However, the petition urges FDA to change its position on the ground that: (1) recent evidence establishes that overweight is a risk factor for disease; (2) consumers believe that there is a relationship between weight loss and a reduction of risk of disease; (3) claims that a product will reduce a risk factor for disease are disease claims; (4) the use of ineffective therapies can divert consumers from safe and effective therapies such as GSK’s weight loss drug AlliÒ; and (5) manufacturers of weight loss supplements should be forced to substantiate their claims through health claim petitions before going to market. Although the petition targets dietary supplements, the action it requests also would affect conventional foods.
The potential marketing value of the weight loss market and the food and dietary supplement industries’ major investment in weight loss products ensures that the petition will receive strong drug industry supported and vigorous food and dietary supplement industry opposition. Although the petition contends that the requested action will not require rulemaking, there are arguments that would support the need for rulemaking given FDA’s longstanding position that weight loss claims, as opposed to claims to treat obesity, do not imply disease treatment or prevention.