FDA WARNING_LETTER - Amazon.com, Inc. - November 14, 2023

The FDA issued a Warning Letter to Amazon.com on November 13, 2023, regarding the distribution of several ophthalmic drug products, including "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."

The FDA purchased these products via Amazon's website, www.amazon.com, and determined they were introduced or delivered into interstate commerce through Amazon's Fulfillment by Amazon (FBA) service. The FDA considers these products to be drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), due to their intended use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or function of the body, as evidenced by claims on their labels and labeling.

The primary violation is that these products are unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), because they are not generally recognized as safe and effective (GRASE) for their intended uses and lack FDA-approved applications. The letter clarifies that homeopathic drugs are subject to the same