FDA WARNING_LETTER - MedClub by Dr. Jenn - June 30, 2025

**FDA Warning Letter Summary**

**Company:** Dr. Guthrie

**Location:** 333 Southern Blvd, Suite 404, West Palm Beach, FL, United States

**Inspection Dates:** June 2025

**Main Violations/Issues:** 1. **Unapproved New Drugs:** The company offers compounded drug products, including retatrutide, which are unapproved and misbranded under the Federal Food, Drug, and Cosmetic Act (FDCA). These products do not meet the exemptions provided under sections 503A and 503B of the FDCA due to the absence of a United States Pharmacopeia (USP) or National Formulary (NF) monograph, lack of FDA approval, and non-inclusion on the 503A or 503B bulks list.

2. **Misbranding:** Claims about compounded semaglutide products on the company"s website are false or misleading. The products are labeled as "FDA Approved," "USA Compounded," or "Generic Ozempic," which implies equivalence to FDA-approved products when they are not. This misbranding violates sections 502(a) and 502(bb) of the FDCA.

**Regulatory Framework:** - Violations of sections 505(a), 502(f)(1), 301(a), and 301(d) of the FDCA [21 U.S.C. §§ 355(a), 352(f)(1), 331(a), and 331(d)]. - Misleading claims under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)].

**Required Actions:** - Cease the introduction or delivery for introduction into interstate commerce of unapproved and misbranded drug products. - Correct false or misleading claims on the website concerning compounded drug products. - Ensure compliance with FDA regulations regarding drug compounding and marketing.

The FDA emphasizes the importance of addressing these