FDA raps Amazon over products containing undeclared drugs

Online retailer Amazon has been taken to task by the FDA for allowing products such as nutritional supplements that contain pharmaceutical ingredients to be sold to the public, even though they could be harmful.

The letter to Amazon chief executive Andy Jassy says that the FDA made test purchases of "dozens of products" intended for sexual enhancement and weight loss and conducted laboratory analysis on them, confirming the presence of "undeclared and potentially harmful drug ingredients."

It says Amazon is marketing unapproved new drugs as well as misbranding drugs, and indicates this is not the first time that it has taken the company to task over this kind of activity.

In 2018, for example, the FDA alerted Amazon about sexual enhancement products featuring the brand name Rhino which were found to be laced with undeclared drug ingredients, and warned of another case the following about male enhancement products featuring the brand name Man Fuel.

The supplement products were found on testing to contain sildenafil and tadalafil, pharma ingredient used in erectile dysfunction medicines Viagra and Cialis.

In at last one instance the retailer seems to have ignored the FDA's advice, according to the letter from Donald Ashley, director of the FDA's Office of Compliance.

Amazon continued to distribute one offending products – called Kopi Jantan Tradisional Natural Herbs Coffee – even after it was specifically advised by the FDA that it contained sildenafil.

"Amazon has acknowledged that your systems sometimes fail to detect specific products Amazon attempts to restrict. Based on this information, FDA is concerned that your filters are inadequate," writes Ashley.

"In addition, we are concerned that after Amazon has informed us that it removed products similar to those identified by FDA to contain undeclared drug ingredients, FDA has continued to find products nearly identical to those products offered for sale by the same third-party sellers on your platform, fulfilled by Amazon."

The letter orders Amazon to submit a written response to the FDA within 15 days explaining the specific steps it has taken to address the violations.

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