Wednesday, May 07, 2008

GlaxoSmithKline Petitions FDA to Prohibit Weight Loss Structure/Function Claims

GlaxoSmithKline Consumer Healthcare (GSK) and others submitted a citizen petition to the Food and Drug Administration (FDA) asking the agency to prohibit weight-loss structure/function claims for dietary supplements. In addition to prohibiting weight loss claims, the petition asks FDA to prohibit claims for energy expenditure, modulation of carbohydrate metabolism, increased satiety or suppression of appetite, increased fat oxidation or reduced fat synthesis, and blockage of fat absorption.

FDA’s longstanding position has been 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 Alli; and (5) manufacturers of weight loss supplements should be forced to substantiate their claims through health claim petitions before going to market.

Hat tip to Ricardo Carvajal for this information.

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