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Glaxo and others ask FDA to treat weight loss claims as disease claims.

A group of petitioners has requested that FDA consider weight loss claims for supplements as disease claims since they purport to treat an unhealthy condition that is a risk factor for diseases, such as diabetes and cardiovascular disease. GlaxoSmithKline (GSK), manufacturer of the over-the-counter (OTC) weight loss drug alli, filed the petition along with the American Dietetic Association, the Obesity Society and Shaping America's Health. Petitioners say that little evidence suggests dietary supplements marketed for weight loss actually work, even though Americans continue to rely on supplements to lose weight. Critics of the petition suggest GSK has a commercial agenda to eliminate the competition for Glaxo's alli product (orlistat 60 mg), which generated over $141 million in sales since its launch last June, representing about 37.5% of the nonprescription weight control product market. Other opponents believe the petitioners have failed to understand current FDA and FTC enforcement. Following the announcement, CRN issued a statement: "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."

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Title Annotation:TOP OF THE NEWS
Publication:Nutraceuticals World
Date:Jun 1, 2008
Words:233
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