FDA WARNING_LETTER - HealBerry - August 31, 2025

The FDA issued a warning letter to HealBerry on September 9, 2025, following a review of their website in August 2025. The inspection revealed that HealBerry was offering compounded drug products, including semaglutide, with misleading claims. These claims suggested that the compounded products were equivalent to FDA-approved drugs, which they are not. This misrepresentation violates sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), rendering the products misbranded and their interstate commerce introduction a violation of section 301(a) of the FDCA.

The FDA emphasized that the violations noted are not exhaustive and urged HealBerry to investigate, rectify, and prevent future violations. Immediate corrective actions are required, including ceasing misleading advertising. HealBerry must respond within 15 working days, detailing steps taken to address the issues and prevent recurrence, along with supporting documentation. Failure to comply may result in legal actions such as seizure or injunction without further notice. The FDA also warned that misbranded products could face detention or refusal of admission if HealBerry operates internationally. Correspondence should be directed to the Office of Compounding Quality and Compliance, with the subject line indicating a response to the warning letter.