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Life Enthusiast Co-op was cited for distributing three unapproved ophthalmic drug products—"Amazing Colyrio," "Fulvic Eyes," and "MSM Gold Drops"—through their website in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. The company failed to obtain FDA approval for these products despite marketing them with disease treatment and prevention claims that classify them as drugs rather than dietary supplements. The FDA noted particular concern due to the ophthalmic route of administration, which bypasses natural body defenses and poses elevated safety risks. Additionally, "MSM Gold Drops" was improperly marketed as a dietary supplement when the product was formulated for topical use rather than ingestion, disqualifying it from dietary supplement classification.