SILVER SPRING, Md.—Amazon is in the process of removing seven eye drop products from its e-commerce site after the U.S. Food and Drug Administration (FDA) issued a warning letter to the company that the products were unapproved. The FDA issued the warning letter to Amazon.com, Inc. regarding the sale of seven unapproved eye drops on the company's e-commerce platform. In the letter dated Nov. 13, 2023 and addressed to Andrew Jassy, chief executive officer of Amazon, the FDA said Amazon was selling eye drops which have not been recognized as safe and effective for providing temporary relief from eye symptoms such as excessive watery discharge, redness, burning or pink eye.

In response to the letter, Amazon said on Wednesday the products are in the process of being removed from their e-commerce website.

“Safety is a top priority at Amazon. We require all products offered in our store to comply with applicable laws and regulations. The products in question have been investigated and are in the process of being removed,” an Amazon company spokesperson said.

The letter from the FDA warned against seven eye drop products fulfilled by the Amazon website, 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 letter further explained that Amazon is responsible for introducing or delivering for introduction into interstate commerce these products, which are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”), 21 U.S.C. 355(a).

The letter warned Amazon, “You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.”

As reported in VMAIL, the warning to Amazon comes weeks after the agency recommended consumers not to use 26 over-the-counter eye drop products due to risk of infection and some cases of possible vision loss. In a recent feature in VMAIL Weekend, the optical community weighed in on this latest eye drop warning. Additionally, back in August, the FDA warned consumers not to use two brands of eye drops due to possible contamination.

This latest warning letter from the FDA put Amazon on notice that it is responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. The letter states, “This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction.”