FTC maintains momentum in dietary supplement regulation
The FDA and FTC have recently issued another joint warning letter, this time to Telledent, LLC, a dietary supplement manufacturer in Miami, Florida. In the letter, FDA and FTC cite Telledent for unlawful promotion involving treatment for Herpes, Epilepsy, Diabetes, Gonorrhea, Syphilis and Chlamydia. While it is certainly not groundbreaking news when companies get cited by the FDA or FTC for health claims, typically in these situations, the FDA targets enforcement of the FDCA and the FTC targets violations of the FTC Act under separate cover. What is interesting here is the joint enforcement by FDA and FTC and the cross-organizational targeting implicit in the letter.
Additionally, the FTC appears to be gaining momentum in the regulation of dietary supplements. Just recently, the FTC appears to have developed a new standard for claims associated with dietary supplements requiring, “competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made.” This is an important departure from the previous FTC benchmark imposed over the last twenty years. Current litigation, as previously addressed in our blog, is targeting the FTCs authority to institute such a benchmark and the application of this new standard to practice.
Also, the warning letter states that “Violations of the FTC Actmay require (the company) pay back money to consumers.” The FDA is unable to take such an enforcement approach as it is not within its jurisdiction to do so. Accordingly, this warning letter represents an important enforcement tool for the government and may provide the FTC with even greater momentum in the regulation of dietary supplements and an important complement to the FDA.
For information on FTC regulations and substantiation requirements, please contact us at email@example.com.