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Trew Balance was cited for marketing "Trew Vision CBD Eye Drops" as an unapproved new drug in violation of the Federal Food, Drug, and Cosmetic Act. The product made therapeutic claims including treating macular degeneration, diabetic retinopathy, glaucoma, and pink eye, which caused it to be classified as a drug requiring FDA approval. The violation was particularly serious because ophthalmic products administered directly to the eyes pose greater health risks since they bypass the body's natural defenses.