FDA WARNING_LETTER - Belmont Eyecare LLC - October 25, 2023

On December 1, 2023, the FDA issued a Warning Letter to Golie Keovan, following an October 2023 review of the website https://www.chicagoashlandeyecare.com/. The FDA observed the sale of "Colloidal Silver Eye Drops," "MSM Eye Drops," "Organic Daytime Oil Eye Drops," "Organic Daytime Oil Eye Drops Small," "Organic Evening Oil Eye Drops," and "Organic Evening Oil Eye Drops Small."

These products are deemed unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), and their 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). Ophthalmic products pose a high risk due to their administration route. The products are classified as drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), based on claims indicating intended use for disease treatment or affecting body structure/function.

These products are not generally recognized as safe and effective (GRASE) and lack FDA approval, violating new drug regulations. The letter requires a written response within fifteen