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US FDA warns Amazon on sale of unapproved eye drops on global e-commerce platform

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The U.S. Food and Drug Administration (FDA) has issued a stern warning to e-commerce giant Amazon.com (AMZN.O) concerning the sale of seven unapproved eye drops on its global platform.  

In a letter dated November 13, the FDA raised concerns about Amazon’s offering of eye drops that have not undergone the necessary scrutiny to be recognised as safe and effective for providing temporary relief from various eye symptoms, including excessive watery discharge, redness, burning, and pink eye. 

This cautionary move by the FDA follows its recent advisory to consumers, urging them to avoid using 26 over-the-counter eye drop products due to potential risks of infection and, in some instances, possible vision loss.  

The regulatory agency emphasized that eye products, in general, pose a heightened risk to consumers as they circumvent some of the body’s natural defences. 

What you should know  

The FDA’s warning specifically targets seven products available on Amazon’s platform, including Similasan Pink Eye Relief, Can-C Eye Drops, Optique 1 Eye Drops, and OcluMed Eye Drops, among others.  

This development comes on the heels of a similar FDA alert in September, where eight companies, including major pharmacy players CVS Health (CVS.N) and Walgreens Boots Alliance (WBA.O), were cautioned against manufacturing or marketing certain unapproved eye products. 

Swiss drugmaker Similasan, a privately held company, has previously been under the FDA’s scrutiny, with requests to adhere to safety limits for diethylene glycol or ethylene glycol levels. 

These contaminants, found in some medicines, could pose severe health risks, including lethal poisoning at elevated concentrations.  

The FDA’s actions underscore the importance of stringent oversight in ensuring the safety of products available to consumers, particularly those involving sensitive areas like the eyes. 


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