FDA WARNING_LETTER - MedClub by Dr. Jenn - June 01, 2025

On September 9, 2025, the FDA issued a warning letter to Dr. Jenn Guthrie, MD, of MedClub by Dr. Jenn, following an inspection of the company’s website conducted in June 2025. The FDA found that the Florida-based clinic was marketing compounded drug products, specifically retatrutide and semaglutide, in violation of the Federal Food, Drug, and Cosmetic Act.

The agency determined that MedClub’s retatrutide products are unapproved new drugs and are misbranded. Under federal law, drugs compounded using bulk substances must meet specific criteria, such as being a component of an FDA-approved drug or appearing on an authorized list for compounding. Retatrutide does not meet these requirements. Furthermore, because these products are for conditions that require a medical diagnosis, they lack adequate directions for safe use by a layperson.

Additionally, the FDA cited the company for making false and misleading claims regarding semaglutide. MedClub marketed its compounded semaglutide as “FDA Approved” and “Generic Ozempic.” The FDA clarified that compounded drugs are not FDA-approved, and implying they are identical to approved brand-name drugs is deceptive.

MedClub is required to take immediate action to correct these violations and must provide a written response to the FDA within 15 working days. This response must detail the specific steps taken to address the issues and prevent their recurrence. Failure to comply may lead to legal action, including product seizure or an injunction.