FDA Notifies Amazon Over Sale of Certain Harmful Sexual Enhancement Products

By Reuters Staff

July 30, 2021

(Reuters) - The U.S Food and Drug Administration (FDA) notified Amazon.com Inc over the sale of sexual enhancement and weight-loss products that had potentially harmful drug ingredients, in a letter addressed to the company's new boss Andy Jassy.

The FDA had already warned consumers in December https://www.fda.gov/news-events/press-announcements/fda-warns-consumers-avoid-certain-male-enhancement-and-weight-loss-products-sold-through-amazon-ebay to avoid male enhancement and weight-loss products sold through Amazon, eBay and other retailers, citing hidden dangerous drug ingredients.

In a letter https://www.fda.gov/media/151096/download dated July 26, the FDA said it tested dozens of products it bought from December 2019 to February 2020 and found they contained one or more of the drug ingredients sildenafil, tadalafil and vardenafil.

None of these ingredients were named in the products' labeling, the health regulator said.

Sildenafil, tadalafil and vardenafil are active ingredients in FDA-approved prescription drugs Viagra, Cialis and Levitra, which are used to treat erectile dysfunction.

Those ingredients could interact with some prescription drugs and may lower blood pressure to dangerous levels, the FDA said.

"We continue to find potentially dangerous products available for purchase and urge stores, websites and online marketplaces, including Amazon, to do more to protect consumers by not selling or facilitating the sale of potentially dangerous and illegal FDA-regulated products," the health regulator said on Twitter on Thursday.

In one instance, the FDA said it had purchased a product from the Amazon website which the company had previously said it had restricted, adding it was concerned the e-commerce website's filters were inadequate.

The FDA has asked Amazon to submit a written response within 15 working days on steps it has taken to address such violations.

Amazon was not immediately available for a comment.

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