FDA WARNING_LETTER - Green Vitality dba Gr33n - September 02, 2025

The FDA issued a warning letter to the company operating at 1630 Peachtree Industrial Blvd, Suwanee, GA, regarding their product, "Jimerito Honey Eye Drops," sold on their website, https://www.gr33n.com, and promoted via their Instagram account. The inspection occurred in June 2025. The FDA identified that the product is marketed as an unapproved new drug, violating sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 331(d) and 355(a). The eye drops are concerning due to the potential health risks associated with ophthalmic products, which bypass some of the body"s natural defenses.

The product is considered a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), as it is intended for diagnosing, curing, mitigating, treating, or preventing disease. It is not generally recognized as safe and effective (GRASE) for its intended uses, classifying it as a "new drug" under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). The company lacks an FDA-approved application for this product, thus violating federal regulations.

The FDA requires the company to respond within fifteen working days, detailing corrective actions taken to address these violations and prevent recurrence. Failure to comply may result in legal action, including seizure and injunction. The response should be sent to the FDA"s Office of Unapproved Drugs and Labeling Compliance, including the firm name and identifier "710151."