In a recent development, Amazon finds itself in hot water with the US Food and Drug Administration (FDA) due to the sale of several brands of eye drops that the agency has deemed “unapproved new drugs.” The FDA’s stern warning has prompted Amazon to take action by removing these products from its online marketplace.
FDA’s Warning to Amazon
On a Monday morning, the FDA issued a warning letter addressed to Amazon’s CEO, Andrew Jassy. The letter highlighted Amazon’s sale of seven brands of eye drops marketed as remedies for various eye conditions, such as pink eye, dry eyes, dust irritation, and cataracts. According to the FDA, these products qualify as “new drugs” being distributed by Amazon without the necessary FDA approval.
The brands mentioned 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.
Amazon, in response, has swiftly initiated the removal of these products from its vast online inventory. A spokesperson from Amazon emphasized the company’s commitment to safety, stating, “Safety is a top priority at Amazon. 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.”
The FDA contends that Amazon’s sale and distribution of these eye drops, which the agency deems as not “generally accepted as safe and effective,” violate the federal Food, Drug, and Cosmetic Act and United States Code.
Public Health Concerns
The FDA’s warning letter underscores the potential public health risks associated with these unapproved eye drops. Ophthalmic drug products, designed for administration into the eyes, carry an elevated risk of harm to users since this route bypasses some of the body’s natural defenses.
This recent warning follows previous FDA alerts regarding eye drops. In October, the agency cautioned the public about dozens of over-the-counter eye drop products, including those sold under store brands like CVS, Target, Walmart, and Rite Aid. These products were suspected of causing eye infections that could lead to vision loss or even blindness.
The FDA’s investigation revealed that the facility responsible for manufacturing these eye drops had “insanitary conditions” and had produced positive bacterial test results from environmental sampling of critical drug production areas. In response to the FDA’s alert, CVS, Rite Aid, Target, and Cardinal Health promptly removed the implicated products from their shelves and websites.
Furthermore, Mumbai-based Kilitch Healthcare India Ltd., which manufactured the affected eye drops from the October recall, issued a recall for all the eye drops on the FDA’s warning list. As of November 15, Kilitch Healthcare India Limited had not received any reports of adverse events related to the recall.
Past Contamination Warnings
This isn’t the first time the FDA has issued warnings related to eye drop products. Earlier this year, the FDA cautioned against the use of several other eye drop products due to contamination from bacteria or fungus.
In February, the US Centers for Disease Control and Prevention (CDC) advised healthcare providers and patients to avoid using EzriCare eye drops after an investigation into bacterial contamination. This contamination was linked to over 80 infections across 18 states. The infections involved a rare strain of drug-resistant bacteria known as Pseudomonas aeruginosa, which had never before been identified in the US. Tragically, four deaths were reported, along with 14 instances of vision loss and four cases in which eyeballs had to be surgically removed.
In light of the FDA’s warning and concerns regarding unapproved eye drop products, Amazon has taken steps to remove these items from its online marketplace. This incident serves as a reminder of the importance of rigorous oversight and quality control in the production and distribution of healthcare products, especially those intended for use in sensitive areas like the eyes.