FDA Issues Warning Letter to Amazon with Concerns About Eye Drop Sales

On November 13, 2023, the United States Food and Drug Administration (FDA) publicly published a warning letter issued to Andrew Jassy, CEO of Amazon.com, identifying violations in seven over-the-counter eye drops sold by the website. This warning letter may necessitate product recalls, adding to the seemingly never-ending catalog of ophthalmic recalls.

As part of post-market surveillance efforts, the FDA purchased and evaluated the following eyedrops from Amazon.com:

• 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
• Manzanilla Sophia Chamomile Herbal Eye Drops

According to the warning letter, the intended uses marketed for these products are in the FDA’s purview under the Federal Food, Drug, and Cosmetic Act, which includes any products meant to diagnose, cure, mitigate, treat, or prevent diseases. Additionally, the act covers any products intended to change bodily structures or functions.

For example, Similasan Pink Eye Relief claims in the product name and the drug facts label that it could relieve symptoms including excessive clear discharge, gritty sensations, redness, and burning. Additionally, TRP Natural Eyes Floater Relief asserts that it can address floaters, squiggly lines, dark dots, and dust particles. However, neither of these products has proven their claims. A comprehensive list of claims made by these products can be found on the FDA’s website.

The FDA notes that all seven products listed are not generally recognized as safe and effective (GRASE) for the indications they document in their product descriptions and drug fact labels.

Beyond that, these products are classified as new drugs under section 201(p) of the FD&C, which means that they “may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).”

However, since no application has been submitted, distributing these products violates federal law.

The FDA is giving Amazon.com 15 days from receiving the letter to respond to these violations with a written statement outlining how the company will address the violations in detail.