FDA and FTC Team up to Target HCG Weight Loss Products

Dec 22, 2011   

On December 6, 2011, the U.S. Food and Drug Administration (FDA) announced the issuance of seven Warning Letters to companies marketing human chorionic gonadotropin (HCG) products for weight loss. Found here, the announcement highlights the various ways in which current marketing of these products is not compliant with federal law.

First, because these products are intended for use in the diagnosis, cure, mitigation or treatment of disease, they are considered drugs by the FDA. Noting that HCG is a FDA-approved prescription drug, FDA has found that these products are “new drugs” within the meaning of the Federal Food, Drug & Cosmetic Act (FDCA). Under the FDCA, a “new drug” is defined as:

[a]ny drug . . . the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the condition prescribed, recommended, or suggested in the labeling thereof.

21 U.S.C. § 321(p).

In targeting these HCG diet products, the FDA has determined that they constitute “new drugs” under the FDCA because companies marketing the products do not possess any evidence showing that the drugs are recognized as safe for their intended uses.

Further, with cooperation from the Federal Trade Commission (FTC), the agencies have targeted these companies for making unsubstantiated claims regarding the effectiveness of HCG products. While both agencies require that promotional statements be truthful and non-misleading, the recent Warning Letters allege that these companies do not possess the necessary scientific evidence to support their weight loss claims.

Under the FTC Act, the FTC has shared jurisdiction with the FDA over claims made in the marketing of FDA-regulated products. Thus, when FDA-regulated products, like the HCG diet products in the present circumstances are at issue, the agencies often work together to target non-compliant parties, with both being able to require companies to take corrective action. For more information about FDA and FTC cooperative efforts, see our previous report here.

For more information regarding FDA and FTC enforcement measures or compliance, please contact us at contact@fidjlaw.com