FTC: Dietary Supplements Need Clinical Trials to Support Health Claims
(Thursday, January 19, 2023)
The Federal Trade Commission (FTC) recently updated its guidance for advertisements for dietary supplements to define several terms commonly used for such products and specify compliance expectations for the supporting information for health claims. The guidance formalizes about 25 years of FTC enforcement actions based on these expectations and is a must-read for dietary supplement marketers. Dietary supplements are co-regulated by the FDA and FTC with FDA regulating the manufacturing practices and FTC regulating the consumer facing activities such as advertisements. Together the two agencies assure that dietary supplements do not make disease-specific claims and only make general health claims supported by “credible” data. In the “Health Products Compliance Guidance”, FTC described the definition and requirements for acceptable supporting information for health claims. FTC defines health products as those that are marketed as dietary supplements, over-the-counter drugs, and medical devices. The guidance emphasizes that advertising and marketing be truthful and non-misleading by ensuring that claims are supported by scientific evidence. Specifically, companies must support health-related claims with high quality, randomized, controlled human clinical trials (RCTs). Clinical trials must meet scientifically acceptable quality standards regarding the use of control groups, randomization, double blinding, and statistical analysis of the “complete” datasets and not selected subsets. The results must be both statistically significant between the treatment and control groups, and clinically meaningful. Other than the clinical trial requirement, the rest of the guidance remains unchanged such as those for the integrity and transparency of endorsements and testimonials, disclosure of ingredients, and warnings about potential adverse effects. While there is no mention of IRB approval, independent review, and FDA submissions are not required for such trials, FTC would reserve the right to verify the quality of clinical trials and the truthfulness of the claims based on them, as they have done over the last 25 years. The guidance does not require that each sponsor do their own clinical trial so the current practice of relying on published reports will continue. Companies can also continue to use copy claims for similar products.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC