FDA WARNING_LETTER - OcluMed LLC - September 12, 2023

The FDA issued a Warning Letter to AgentOf LLC (OcluMed LLC) following a July 2023 review of their website, oclumed.com. The FDA determined that the "OcluMed Nutritional/Lubricant Eye Drops" offered for sale are an unapproved new drug under section 505(a) of the FD&C Act (21 U.S.C. 355(a)). The introduction or delivery of this product into interstate commerce is a violation of sections 301(d) and 505(a) (21 U.S.C. 331(d) and 355(a)). The product is classified as a drug under section 201(g)(1) due to therapeutic claims on the website, including reversing cataracts and improving vision for macular degeneration. Since the product is not generally recognized as safe and effective (GRASE) for its intended uses, it is considered a "new drug" under section 201(p) of the FD&C Act, requiring an approved FDA application, which OcluMed Eye Drops lacks. The FDA highlighted the public health risk associated with unapproved ophthalmic products. AgentOf LLC must respond within fifteen working days, detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may lead to legal actions such as seizure and injunction.