Natural Ophthalmics, Inc. – FDA Warning Letter, Sep 11, 2023

The FDA issued a Warning Letter to Linda Axelrod following an August 2023 review of her website, https://natoph.com/. The FDA observed that the website offers several ophthalmic products for sale, including “Women’s Tear Stimulation Dry Eye Drops,” “Allergy Desensitization Eye Drops,” “Ortho-K Thin (Daytime) Eye Drops,” “Ortho-K Thick (Night) Eye Drops,” “Tear Stimulation Forté Dry Eye Drops,” and “Cataract Eye Drops with Cineraria.” The FDA determined these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). Introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). The products are considered drugs due to their intended use and are deemed "new drugs" because they are not generally recognized as safe and effective (GRASE) under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), with no FDA-approved application in effect. The letter highlights the increased public health risk associated with ophthalmic products. The firm must respond in writing within fifteen working days, detailing corrective actions and steps to prevent recurrence. Failure to comply may result in legal action, including seizure and injunction.