Post Sponsor
Petitioners Ask FDA to Treat Weight Loss Claims as Disease Claims
2008-04-29 08:34:00
A group of petitioners have 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), the manufacturer of 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.
They cite a GSK-sponsored survey, which indicates a majority of respondents believed that weight loss supplements are tested and proven to be safe before sold to the public. A majority of the respondents also said they thought FDA requires warnings of side effects on labels for weight loss supplements.
Critics of the petition suggest GSK has a commercial agenda to eliminate the competition for Glaxo’s alli product (orlistat 60mg), which pulled in $141.6 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 Federal Trade Commission enforcement.
The Council for Responsible Nutrition said in 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.”
GlaxoSmithKline (GSK), the manufacturer of 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.
They cite a GSK-sponsored survey, which indicates a majority of respondents believed that weight loss supplements are tested and proven to be safe before sold to the public. A majority of the respondents also said they thought FDA requires warnings of side effects on labels for weight loss supplements.
Critics of the petition suggest GSK has a commercial agenda to eliminate the competition for Glaxo’s alli product (orlistat 60mg), which pulled in $141.6 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 Federal Trade Commission enforcement.
The Council for Responsible Nutrition said in 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.”
