FDA WARNING_LETTER - Covalent Medical - September 27, 2024

**FDA Warning Letter Summary**

**Company:** Focus Vitamins **Inspection Date:** September 27, 2024 **Main Violations/Issues:** The FDA reviewed Focus Vitamins" product labeling and online presence, identifying that their FOCUS PI Post-Injection Eye Drops are marketed as an unapproved new drug. The product is available for purchase in the U.S. without a prescription, violating sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Additionally, the product is misbranded under section 502(ee) of the FD&C Act. The eye drops are intended for use as an ophthalmic demulcent, but do not conform to the conditions specified in OTC Monograph M018, which governs nonprescription ophthalmic drug products. Claims made on the product"s labeling and online platforms, such as relief from post-injection irritation, are not permitted under the applicable monograph.

**Regulatory Framework:** The violations pertain to sections 505(a), 301(d), and 502(ee) of the FD&C Act, which regulate the introduction of new drugs and the marketing of nonprescription drugs without an approved application.

**Required Actions:** Focus Vitamins must investigate and rectify the causes of these violations to prevent recurrence. The company is responsible for ensuring compliance with all federal laws and FDA regulations. The letter serves as a notification of the FDA"s concerns, providing Focus Vitamins an opportunity to address the issues identified. Failure to adequately address these concerns could result in further regulatory action.