The US Food and Drug Administration (FDA) has recently issued a stern warning to Amazon, resulting in the e-commerce giant removing seven different brands of eye drops from its platform. These products were flagged by the FDA as “unapproved new drugs” due to their marketing claims.
The FDA’s warning letter to Amazon CEO Andrew Jassy highlighted that the site was offering eye drops claiming to treat various conditions like pink eye, dry eyes, and cataracts. According to the FDA, this qualifies these products as “new drugs” that require approval before distribution, which Amazon had not obtained.
The affected brands identified in the FDA’s letter include 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. In response, Amazon has initiated the process of removing these products from its online marketplace.
Amazon, emphasizing safety as a top priority, stated through a spokesperson that they ensure all products on their platform comply with relevant laws and regulations. The removal process for the implicated products is already underway.
This action by Amazon comes in the wake of the FDA’s determination that the sale of these eye drops without prior approval violates the federal Food, Drug, and Cosmetic Act. The FDA expressed particular concern due to the inherent risks of ophthalmic drug products, which are applied directly into the eyes and thus bypass some of the body’s natural defenses.
This situation follows closely on the heels of other FDA warnings regarding eye drops. In October, the FDA cautioned against numerous over-the-counter eye drop products, including those under store brands from CVS, Target, Walmart, and Rite Aid, due to potential infection risks leading to vision loss or blindness. This warning stemmed from the discovery of unsanitary conditions and positive bacterial tests in the manufacturing facility.
As a result, CVS, Rite Aid, Target, and Cardinal Health (which had several of its Leader brand eye drops listed) responded by removing these products and issuing recalls where necessary.
Additionally, Mumbai-based Kilitch Healthcare India Ltd., the manufacturer behind the October recall, also issued a recall for all the eye drops listed in the FDA’s warning. As of mid-November, Kilitch Healthcare India Limited reported no adverse events related to the recall.
Earlier this year, the FDA had issued warnings against several other eye drop products due to contamination issues, including bacteria and fungus. In one notable case, the CDC advised against using EzriCare eye drops following an investigation into bacterial contamination that resulted in over 80 infections across 18 states, including cases of vision loss, surgical removal of eyeballs, and even four fatalities.
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