Amazon to stop selling seven eye drops after FDA warning

SILVER SPRING – Amazon on Wednesday said it was removing seven eye drop products from its website after the US Food and Drug Administration (FDA) warned the company that the eye drops had not been recognised as safe and effective.

The FDA said in a letter to Amazon chief executive Andrew Jassy on Monday that Amazon violated federal regulations by selling the eye drops, which claimed to help with problems including pink eye, dry eyes, eye strain and floaters.

“These products are especially concerning from a public health perspective,” the FDA letter said.

“Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defences.”

The eye drops named in the letter are: 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.

None of the eye drops appeared to be available for purchase on Amazon on Wednesday morning.

The company said in an e-mailed statement on Wednesday that “safety is a top priority”.

“We require all products offered in our store to comply with applicable laws and regulations,” the statement said.

“The products in question have been investigated and are in the process of being removed.”

The FDA said Amazon had 15 working days after receipt of the letter to tell the agency what steps it had taken to address the violation and to ensure Amazon does not sell unapproved new drug products for eyes in the future.

Dozens of eye drops have been pulled from shelves in 2023 either out of caution after regulatory agencies raised concerns about their production or after consumers reported negative health effects from the products.

In late October, the FDA advised consumers to stop using more than two dozen over-the-counter eye drop products because of a potential risk of eye infection that could lead to partial vision loss or blindness.

In January and February, two brands of eye drops were recalled after they were linked to a drug-resistant bacteria strain that has been found to have caused at least four deaths and serious health issues in several others.

The unapproved eye drops sold on Amazon were not included in either of those recalls and warnings.

About 117 million Americans used eye drops and eyewash in 2020, according to Statista, a market research firm.

Eye drops are generally safe, according to experts, who recommend people speak with their eye doctors to get recommendations for safe products. NYTIMES