May 13, 2008 — Three organizations and a drug company have joined forces in petitioning the Food and Drug Administration to treat weight-loss claims for dietary supplements as disease claims. The Council for Responsible Nutrition (CRN) immediately announced it would fight the petition.
The citizens’ petition to the FDA was filed on behalf of the American Dietetic Association, The Obesity Society, Shaping America’s Health, and GlaxoSmithKline Consumer Healthcare LP. The petition, dated April 17, asks the FDA commissioner to consider that:
• Obesity is a significant risk factor for serious chronic diseases; and
• Overweight Americans are diverted from effective ways to lose weight by “exaggerated and unsubstantiated claims accompanying weight-loss supplements.”
The petition says “FDA must find that weight-loss claims are ‘disease claims’ under its existing regulations and on the basis of substantial legal precedent.”
The petition says, “We believe that the actions requested in this petition would substantially advance the public health by requiring manufacturers of weight-loss supplements to obtain FDA review of their claims before rushing to market.”
CRN President and CEO Steve Mister responded: “CRN plans to oppose this petition to reclassify weight-loss claims as either disease claims or health claims requiring FDA approval.
“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 and 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.”