The US Food and Drug Administration has issued a warning to Amazon for selling several brands of eye drops that the agency considers “unapproved new drugs.”
On Monday, the FDA released a warning letter addressed to Amazon CEO Andrew Jassy noting that the e-commerce website was selling seven brands of eye drops marketed as treatments for conditions like pink eye, dry eyes, dust irritation and cataracts.
As a result, the agency says, the products can be classified as “new drugs” that Amazon is distributing without FDA approval.
The brands included 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 a top priority at Amazon,” a spokesperson said in a statement. “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.”
Amazon’s sale and distribution of the eye drops – which the FDA says are not “generally accepted as safe and effective” – without prior agency approval constitutes a violation of the federal Food, Drug, and Cosmetic Act and United States Code, according to the letter.
“These products are especially concerning from a public health perspective,” the FDA’s letter says. “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.”
Manufacturer recalls other eyedrops
Monday’s warning letter follows others from the FDA raising the alarm about eye drops.
In October, the agency warned that dozens of over-the-counter eye drop products, including those sold under store brands including CVS, Target, Walmart and Rite Aid, could lead to eye infections resulting in vision loss or blindness.
Although eye drops are supposed to be sterile, the agency reported that the facility where the drops were manufactured had “insanitary conditions” and “positive bacterial test results from environmental sampling of critical drug production areas” in the facility.
CVS, Rite Aid and Target removed the products from store shelves and websites. Cardinal Health, which had six of its Leader brand eye drops on the FDA’s list, issued a recall for the products in early November.
On Wednesday, Mumbai-based Kilitch Healthcare India Ltd., which manufactured the affected eye drops from the October recall, also issued a recall for all the eye drops on the FDA’s warning list. Kilitch Healthcare India Limited said it had not received any reports of adverse events related to the recall as of November 15.
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Earlier this year, the FDA warned against using several other eye drop products due to contamination from bacteria or fungus.
In February, the US Centers for Disease Control and Prevention urged health care providers and patients to avoid using EzriCare eye drops after an investigation into bacterial contamination linked with over 80 infections across 18 states.
The infections involved a rare strain of the drug-resistant bacteria Pseudomonas aeruginosa that had never before been identified in the US. Four deaths were reported, along with 14 instances of vision loss and four cases in which eyeballs had to be surgically removed.