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Talk to a SpecialistTalk to a SpecialistMy Holistic Honey was cited for marketing "Holistic Honey Eye Drops" as an unapproved new drug in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. The product label and website contained drug claims including statements that it "quickly relieves eye dryness and fatigue and restore[s] eye comfort," establishing intended use for treating disease and affecting body function without FDA approval. The violation was considered especially serious because ophthalmic products administered directly to the eyes pose greater public health risk by bypassing natural body defenses.