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Supply Center USA was selling multiple unapproved ophthalmic drug products, including various Similasan and Boiron eye relief formulations, in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. The FDA determined these products qualified as drugs because they were intended to treat, mitigate, or prevent eye-related conditions, yet the company had not obtained FDA approval for them. The agency emphasized that ophthalmic products pose greater public health risk due to direct eye administration, which bypasses the body's natural defenses, making regulatory compliance particularly critical for this product category.