SemaBio – FDA Warning Letter, Aug 1, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to SemaBio on September 9, 2025, following a review of the company’s website content conducted in August 2025. The investigation focused on the marketing of compounded drug products, specifically those containing semaglutide. The primary violation identified is the misbranding of these products under the Federal Food, Drug, and Cosmetic Act (FDCA). SemaBio repeatedly used the term "generic semaglutide" in its online promotional materials. Under sections 502(a) and 502(bb) of the FDCA, a drug is considered misbranded if its labeling, advertising, or promotion is false or misleading. The FDA notes that compounded drugs are not FDA-approved; therefore, claiming they are "generic" versions of approved drugs is misleading as it implies equivalent regulatory standing. The FDA has classified the introduction of these misbranded products into interstate commerce as a prohibited act under section 301(a). SemaBio is required to take immediate action to address these violations, including ceasing the use of misleading language. The company must conduct an internal investigation to identify the causes of these violations and implement measures to prevent their recurrence. SemaBio must provide a written response to the FDA within 15 working days, detailing the specific steps taken to correct the issues and provide supporting documentation. Failure to address these concerns may result in legal action, such as product seizure or injunction.