The comments elaborate on four primary reasons why FDA should reject the citizens petition which was filed this April by GlaxoSmithKline Consumer Healthcare, the American Dietetic Association and two other organizations. CRN advised:
- FDA correctly decided in 2000 that weight loss claims (as opposed to claims to treat obesity) are appropriately structure/function claims under the Dietary Supplement Health and Education Act (DSHEA) based on the intended use of these products;
- The petitioners have not established the condition of being “overweight” as a validated modifiable risk factor for, or a surrogate endpoint for, disease;
- If FDA were to grant this petition, it would result in sweeping implications for weight-related claims for the entire category of “food,” and create a slippery slope for other structure/function claims that would essentially “disease-ify” many health conditions not currently considered to be diseases or surrogate endpoints for disease;
- Many dietary ingredients are well-substantiated for weight loss, and to the extent that unsubstantiated or misleading claims are being made for weight loss products, the petitioners’ concerns can and should be addressed through increased enforcement of the existing laws and regulations by both FDA and the Federal Trade Commission.
Noting that consumers overwhelmingly turn to various weight loss products for cosmetic reasons and immediate health benefits, not primarily to manage their risk of disease, CRN warned that if the petition were accepted it would “cripple the dietary supplement category as envisioned by Congress with the passage of DSHEA.” The association told FDA “the petitioners’ arguments are unsupported and therefore should not be accepted with respect to either dietary supplements or conventional foods intended to assist consumers in achieving weight loss.”