CNN –
The U.S. Food and Drug Administration has issued a warning to Amazon for selling several brands of eye drops that the agency classifies as “unapproved new drugs.”
On Monday, the FDA released a warning letter to Amazon CEO Andrew Jassy, noting that the e-commerce site sells seven brands of eye drops used to treat conditions such as conjunctivitis, dry eyes, dust irritation and cataracts be marketed.
As a result, according to the authority, the products should be classified as “new medications” that Amazon sells without FDA approval.
The brands 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 Sophia Chamomile Herbal Eye Drops.
Amazon says it has begun removing the products from its online marketplace.
“Safety is Amazon’s top priority,” a spokesperson said in a statement. “We require that all products offered in our store comply with applicable laws and regulations. The products in question have been investigated and are currently being removed.”
Amazon’s sale and distribution of the eye drops – which the FDA says are not “generally recognized as safe and effective” – without prior regulatory approval is a violation of the Federal Food, Drug and Cosmetic Act and the U.S. Code, it says the writing.
“These products are of particular concern from a public health perspective,” the FDA letter said. “Ophthalmic drugs intended for administration into the eyes generally pose a higher risk of harm to the user because the route of administration of these products bypasses some of the body’s natural defenses.”
Monday’s warning letter follows others from the FDA sounding the alarm about eye drops.
In October, the agency warned that 26 over-the-counter eye drop products, including those sold under store brands such as CVS, Target, Walmart and Rite Aid, could cause eye infections that could lead to vision loss or blindness.
Although eye drops are supposed to be sterile, the agency reported that there were “unhygienic conditions” at the facility where the drops were manufactured and there were “positive bacterial test results from environmental samples in critical drug production areas.”
CVS, Rite Aid and Target have removed the products from shelves and websites. Cardinal Health, which had six of its Leader brand eye drops on the FDA’s list, recalled the products in early November.
On Wednesday, Mumbai-based Kilitch Healthcare India Ltd., which manufactured the affected eye drops in the October recall, also issued a recall for all eye drops that are on the FDA’s warning list.
Earlier this year, the FDA warned against the use of several other eye drop products due to bacterial or fungal contamination.
In February, the U.S. Centers for Disease Control and Prevention urged health care providers and patients to avoid using EzriCare eye drops following an investigation into bacterial contamination linked to over 80 infections in 18 states.
The infections involved a rare strain of the drug-resistant bacterium Pseudomonas aeruginosa that had never before been identified in the United States. Four deaths were reported, as well as 14 cases of vision loss and four cases in which eyeballs had to be surgically removed.