FDA WARNING_LETTER - Good Girl LLC dba GoodGirlRX - December 31, 2025

On February 20, 2026, the FDA issued a Warning Letter to Good Girl LLC dba GoodGirlRX, following a December 2025 review of its website. The letter addresses significant violations concerning the promotion and sale of compounded semaglutide and tirzepatide drug products. The primary issues identified include misbranding under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), and prohibited acts under section 301(a) of the FDCA. GoodGirlRX falsely presented itself as the compounder of these drugs on product labels depicted on its website. Furthermore, the company made unsubstantiated claims such as "FDA-approved meds," "FDA-approved options," and "Clinically proven GLP-1 results." Compounded drugs are not FDA-approved, and these claims misleadingly imply that the products have been evaluated for safety and effectiveness. The FDA requires GoodGirlRX to take immediate corrective action. The company must provide a written response within 15 working days, detailing steps taken to rectify the violations and prevent recurrence. Specific requirements include identifying the actual entities compounding the products, submitting representative product labeling, and either demonstrating the basis for other website claims or confirming their modification or removal to comply with FDCA regulations. Failure to address these issues promptly may lead to legal action.