FDA WARNING_LETTER - GLP-1 Solution - August 31, 2025

**FDA Warning Letter Summary**

**Company:** GLP-1 Solution **Location:** Berlin, Germany **Inspection Date:** August 2025 **Warning Letter Date:** September 9, 2025

**Key Violations/Issues:** The FDA reviewed GLP-1 Solution"s website and identified significant regulatory violations concerning their compounded drug products, including retatrutide, semaglutide, and tirzepatide. The main issues are:

1. **Unapproved New Drugs:** The compounded retatrutide products are classified as unapproved new drugs. They lack FDA approval, violating sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FDCA).

2. **Misbranding:** The retatrutide products are also misbranded under section 502(f)(1) of the FDCA because they lack adequate directions for use, making them unsuitable for self-diagnosis and treatment by non-medical practitioners.

3. **False or Misleading Claims:** Claims on the website regarding semaglutide and tirzepatide products are deemed false or misleading, implying equivalence to FDA-approved products, which violates sections 502(a) and 502(bb) of the FDCA.

**Regulatory Framework:** The violations fall under the FDCA, specifically sections 505(a), 502(f)(1), 301(a), and 301(d) for unapproved and misbranded drugs, and sections 502(a) and 502(bb) for false advertising.

**Required Actions:** GLP-1 Solution must cease the introduction of these unapproved and misbranded drug products into interstate commerce and correct the misleading claims on their website. Compliance with FDA regulations is mandatory to avoid further enforcement actions.