On Nov. 13, the FDA issued a warning letter to Amazon.com, Inc. for the firm’s distribution of “Similasan Pink Eye Relief,” “The Goodbye Company Pink Eye,” “Can-C Eye Drops,” “Optique 1 Eye Drops,” “OcluMed Eye Drops,” “TRP Natural Eyes Floaters Relief” and “Manzanilla Sophia Chamomile Herbal Eye Drops” products.
These products are not generally recognized as safe and effective for their claimed uses, including temporary relief of minor eye symptoms such as excessive watery (clear) discharge, sensation of grittiness, redness and burning, or pink eye. Therefore, these products are categorized as “new drugs” under the Federal Food, Drug & Cosmetic Act. Ophthalmic drug products are especially concerning from a public health perspective. Products intended for use in the eyes generally pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.
FDA has the warning letter.
