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Homeopathic Educational Services was cited for marketing Cineraria Maritima Eye Drops as an unapproved new drug in violation of the Federal Food, Drug, and Cosmetic Act, specifically sections 301(d) and 505(a). The company made disease claims on its website stating the product was "the most common indication for cataracts," establishing it as a drug product intended to treat disease rather than a cosmetic. The ophthalmic formulation posed particular public health concern due to direct eye administration bypassing natural body defenses, and the product was not established as generally recognized as safe and effective (GRASE) for its indicated use.