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Boiron, Inc. was cited for distributing "Optique 1 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 company marketed the product through its website and social media platforms (Facebook and Instagram) with claims indicating drug use, including "eye irritation relief" for dry eyes, allergies, and eyestrain, without obtaining FDA approval. The FDA emphasized that ophthalmic products pose heightened public health risk due to direct eye administration, which bypasses natural body defenses.