FDA Issues Warning Letter to Amazon to Remove Non-FDA approved Eye Drops Due to Public Health Concerns

On November 13, 2023, the US Food and Drug Administration (FDA) issued a warning letter to Amazon for selling several brands of non-FDA approved eye drops in violation of federal law. Several of the unapproved brands of eye drops included 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 warning letter was issued just days before widespread eye drop recalls were announced for risk of causing infection and/or blindness among users.

The FDA’s warning letter threatened potential legal action against Amazon for continuing to sell the unapproved eye drops, which were marketed as treatments for ophthalmic conditions such as pink eye, dry eyes, dust irritation, and cataracts. Due to the nature of these products, they have been classified as unapproved new drugs under federal law. Any new drugs must be considered generally recognized as safe and effective before being approved by the FDA for sale or introduction into the consumer market.

In general, ophthalmic drug products intended for administration into the eyes pose a greater risk of harm to users because administering products directly into and through the eyes can bypass some of the body’s natural defenses. Untested and unapproved eye drops are therefore considered to be especially concerning from a public health perspective according to the FDA.

To date, Amazon has removed the unapproved eye drops after confirming the products did not comply with applicable laws and regulations. However, for some consumers it may be too late. The FDA’s warning letter evidences yet another example of ongoing concerns with unsafe or untested products being introduced into the consumer market through Amazon.

If you or a loved one have been injured by use of non-FDA approved products sold on Amazon, please contact an attorney at Abraham Watkins, Nichols, Agosto, Aziz & Stogner by calling 713-222-7211 or toll free at 1‑800-870-9584.