FDA WARNING_LETTER - Trew Balance - September 02, 2025

The FDA issued a warning letter to Trew Balance, located at 7558 W. Thunderbird Rd., Suite 1-489, Peoria, AZ, regarding their product "Trew Vision CBD Eye Drops." The inspection, conducted in May 2025, revealed that this product is marketed as an unapproved new drug under the Federal Food, Drug, and Cosmetic Act (FD&C Act), specifically violating sections 301(d) and 505(a). The product poses significant public health concerns due to its ophthalmic nature, which bypasses the body"s natural defenses.

The FDA determined that the eye drops are intended for diagnosing, curing, mitigating, treating, or preventing disease, classifying them as a drug under section 201(g)(1) of the FD&C Act. Despite being labeled as a homeopathic drug, it lacks FDA approval, making its interstate commerce introduction unlawful.

The letter mandates that Trew Balance investigate and rectify these violations within fifteen working days. They must provide a detailed plan of corrective actions and prevent future occurrences. Failure to comply could lead to legal actions, including product seizure or injunction. Trew Balance is required to communicate their response and corrective measures to the FDA"s Office of Unapproved Drugs and Labeling Compliance via email, including the unique identifier "709880" in their correspondence.