Amazon announced Wednesday that it will remove seven eye drops from its website after the Food and Drug Administration warned the company that the drops have not been found to be safe or effective.
The FDA stated: letter Amazon CEO Andrew Jassy said Monday that Amazon violated federal regulations by selling eye drops that it claims can help with problems such as blurred vision, dry eye, eye strain and floaters. He said he did.
“These products are of particular concern from a public health perspective,” the FDA letter states. “Ophthalmic medicines are intended for administration to the eye and generally pose a higher risk of harm to the user because their route of administration bypasses some of the body’s natural defenses.”
The names of the eye drops mentioned 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 Sofia Chamomile Herbal. It’s an eye drop.
None of the eye drops appeared to be available for purchase on Amazon Wednesday morning.
“Safety is our top priority,” the company said in an emailed statement Wednesday.
“We require that all products offered in our stores comply with applicable laws and regulations,” the statement said. “The product in question has been investigated and is currently being removed.”
FDA will notify Amazon within 15 business days of receiving the letter what steps it has taken to address this violation and will prevent Amazon from selling unapproved new drugs for ophthalmology in the future. He said he would notify them.
Dozens of eye drops were pulled from shelves this year out of caution after regulators raised concerns about their manufacturing and consumers reported adverse health effects from the products.
In late October, the FDA advised consumers to stop using more than 20 over-the-counter eye drop products due to the potential risk of eye infections that can lead to partial vision loss or blindness. Recommended.
In January and February, two brands of eye drops It was recalled after it was found to be linked to a drug-resistant strain of bacteria that was found to have caused at least four deaths and serious health problems for several others.
Unapproved eye drops sold on Amazon were not included in any of these recalls or warnings.
Approximately 117 million Americans used eye drops and eyewashes in 2020. According to the Bureau of Statisticsa market research company.
Experts say eye drops are generally safe and recommend seeing your eye doctor to recommend safe products.