FDA WARNING_LETTER - Prime Vitality, Inc. dba Prime Peptides - December 10, 2024

The FDA issued a Warning Letter to Curtis Miller regarding products offered on primepeptides.co, and associated social media (Facebook, Instagram, YouTube). The FDA reviewed these sites in October 2024 and found that "Semaglutide" and "Retatrutide" products are marketed as "peptides" but are unapproved new drugs.

Despite disclaimers stating "research purposes only" and "not for human consumption," the FDA determined the products are intended for human use as drugs, based on numerous claims. Examples include "Semaglutide reduces cardiovascular events," "Semaglutide improves insulin resistance," "Retatrutide improves glycemic control," and "Retatrutide reduces liver fat." Social media posts and YouTube videos also promote these products for weight loss, blood sugar control, and cardiovascular benefits, often citing customer testimonials and clinical trial statistics.

These products are considered "new drugs" under section 201(p) of the FD&C Act because they are not generally recognized as safe and effective for their intended uses. Consequently, their introduction into interstate commerce without an FDA-approved application violates sections 505(a) and 301(d) of the FD&C Act. The letter requires a written response within fifteen working days detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction.