FDA

FDA plans crackdown on non‑approved compounded GLP‑1 products

February 11, 2026

In a new statement, FDA announced plans to restrict the use of GLP‑1 active pharmaceutical ingredients (APIs) in non‑FDA‑approved compounded drugs that are being marketed as alternatives to approved GLP‑1 therapies. The agency cited concerns that these compounded products—promoted by companies such as Hims & Hers and various compounding pharmacies—are being sold without verified quality, safety, or efficacy. FDA also reiterated that promotional materials cannot claim compounded GLP‑1 products are generic equivalents, contain the same active ingredients as approved drugs, or are clinically proven. The agency plans to use its full enforcement authority to address misleading marketing and violations of the Federal Food, Drug, and Cosmetic Act. Entities involved in producing or distributing unapproved compounded GLP‑1 products may face actions including seizure or injunction if violations persist.

Source:

(2026, February 6). Makary, MA. FDA. FDA Intends to Take Action Against Non‑FDA‑Approved GLP‑1 Drugs. https://www.fda.gov/news-events/press-announcements/fda-intends-take-action-against-non-fda-approved-glp-1-drugs