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Natural Ophthalmics, Inc. was cited for marketing six unapproved ophthalmic drug products—including Women's Tear Stimulation Dry Eye Drops, Allergy Desensitization Eye Drops, Ortho-K Thin and Thick Eye Drops, Tear Stimulation Forté Dry Eye Drops, and Cataract Eye Drops with Cineraria—in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. The company failed to obtain FDA approval before introducing these products into interstate commerce through its website. The FDA determined these products met the definition of drugs based on disease treatment and body function claims, and emphasized heightened public health concerns given the direct ocular route of administration, which bypasses natural body defenses.