FDA WARNING_LETTER - Mel Honey US - September 02, 2025

The U.S. Food and Drug Administration (FDA) issued a warning letter to Josue Carias regarding Mel Honey, located at 152 Wapiti Loop, Hyrum, UT, on August 25, 2025. The FDA"s review, conducted in June 2025, identified significant regulatory violations on Mel Honey"s website and Instagram account, which promote the sale of "Jimerito (Melipona) Honey" as an unapproved new drug. This product is marketed for ophthalmic use, posing potential public health risks due to the sensitive nature of its application.

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), specifically sections 505(a), 301(d), and 201(g)(1), the product is considered a new drug because it is intended for disease diagnosis, cure, mitigation, treatment, or prevention, and affects body structure or function. However, it lacks FDA approval, violating sections 301(d) and 505(a) of the FD&C Act.

The FDA requires Mel Honey to investigate and rectify these violations, ensuring compliance with federal law. The company must respond within fifteen working days, detailing corrective actions and preventive measures, or provide justification and a timeline if unable to meet this deadline. Failure to comply may lead to legal actions, including product seizure or injunction. Responses should be directed to the FDA"s Office of Unapproved Drugs and Labeling Compliance via email, including the firm"s name and identifier "709535."