Amazon to Stop Selling Seven Eyedrops After F.D.A. Warning

Amazon said on Wednesday that it was removing seven eyedrops products from its website after the Food and Drug Administration warned the company that the eyedrops had not been recognized as safe and effective.

The F.D.A. said in a letter to Andrew Jassy, Amazon’s chief executive, on Monday that Amazon had violated federal regulations by selling the eyedrops, which claimed to help with problems including pink eye, dry eyes, eyestrain and floaters.

“These products are especially concerning from a public health perspective,” the F.D.A. 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 defenses.”

The eyedrops 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 eyedrops appeared to be available for purchase on Amazon on Wednesday morning.

The company said in an emailed 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 F.D.A. 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 eyedrops have been pulled from shelves this year 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 F.D.A. advised consumers to stop using more than two dozen over-the-counter eyedrops 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 eyedrops 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 eyedrops sold on Amazon were not included in either of those recalls and warnings.

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

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

Sumber: www.nytimes.com

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