FDA WARNING_LETTER - Life Enthusiast Co-op - September 02, 2025

The FDA issued a warning letter to Life Enthusiast, located at 711 S Carson Street Suite 4, Carson City, NV, on August 25, 2025, following a review of their website in May 2025. The review identified that the company markets "Amazing Colyrio," "Fulvic Eyes," and "MSM Gold Drops" as unapproved new drugs, 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). These products are intended for use in the eyes, posing significant public health risks due to their route of administration, which bypasses natural bodily defenses.

The FDA highlighted that "MSM Gold Drops" are incorrectly marketed as a dietary supplement, as they are intended for topical use rather than ingestion, failing to meet the FD&C Act"s definition of a dietary supplement. The products are classified as drugs under section 201(g)(1) of the FD&C Act because they are intended for diagnosis, cure, mitigation, treatment, or prevention of disease.

Life Enthusiast is required to cease the interstate commerce introduction of these products without FDA-approved applications. The company must respond within fifteen working days, detailing corrective actions taken to address the violations and prevent recurrence. Failure to comply may lead to legal actions, including product seizure and injunction. The response should be directed to the FDA"s Office of Unapproved Drugs and Labeling Compliance.