FDA WARNING_LETTER - Lipotriad LLC - March 30, 2021

The FDA issued a Warning Letter to Lipotriad following a November 2020 review of their website and social media, identifying that products like Lipotriad Visionary, Adult 50+, Dry Eye, and Vision Support Plus are marketed with claims establishing them as "drugs" under section 201(g)(1)(B) of the FD&C Act. These claims indicate the products are intended for the cure, mitigation, treatment, or prevention of disease. Consequently, these products are deemed "new drugs" under section 201(p) because they are not generally recognized as safe and effective for their claimed uses. Introducing or delivering these unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the Act. Furthermore, the products are misbranded under section 502(f)(1) because they fail to bear adequate directions for their intended uses, as they address conditions requiring professional supervision, making it impossible to provide adequate directions for layperson use (21 CFR 201.5). The introduction of these misbranded drugs into interstate commerce also violates section 301(a) of the Act. Lipotriad is required to respond within 15 working days, detailing corrective actions, recurrence prevention, and supporting documentation. Failure to comply may lead to legal actions such as seizure and injunction.