FDA WARNING_LETTER - EyeTech One, LLC - July 15, 2025

The FDA issued a warning letter to Mr. Arenas regarding the EYELIVIO lubricant eye ointment, marketed by the company located at 8833 Cypress Preserve PL, Fort Meyers, FL. The inspection and review of the product"s labeling and promotional materials, conducted on September 26, 2024, revealed significant regulatory violations. The EYELIVIO product is classified as an unapproved new drug under sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as it is marketed without an FDA-approved application. Furthermore, it is misbranded under section 502(ee) of the FD&C Act.

The product"s labeling and promotional claims suggest it is intended for use as an ophthalmic emollient, but it does not conform to the conditions specified in the applicable OTC Monograph M018 for ophthalmic drug products. Specifically, the inclusion of botanical extracts like Aloe vera, Arnica montana, and Calendula officinalis as active ingredients is not permitted, and the concentrations of mineral oil and white petrolatum are not disclosed as required.

The FDA requires the company to cease the interstate marketing of the product until it complies with the necessary regulatory approvals. The company must address these violations promptly to avoid further enforcement actions.