FDA Alerts Amazon On Supplements Tied to Male Impotency

Amazon has been alerted by the US Food and Drug Administration (FDA) to take action regarding men's health and energy supplements that contain the active pharmaceutical ingredients (API) sildenafil and tadalafil from the medications Viagra and Cialis, which are used to treat erectile dysfunction (ED) (1^✔ ✔Trusted Source
U.S. FDA WARNING LETTER Amazon.com, Inc.

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FDA Notifies Men’s Health Supplements Using Viagra Ingredients

In a letter to Amazon CEO Andy Jassy, the agency listed seven different products available on the e-commerce platform with ingredients found in Viagra and Cialis. "This letter concerns your firm's distribution of products that violate the Federal Food, Drug, and Cosmetic Act. The FDA purchased on your website products that are labeled as energy-enhancing supplements or food, but laboratory analyses confirmed that they contained undeclared and potentially harmful active pharmaceutical ingredients," the agency said.

An Amazon spokesperson told The Verge that the products were removed from the website before the FDA letter. FDA purchased "MANNERS Energy Boost", "Round 2", "WeFun", "Genergy", "Big Guys Male Energy Supplement", "Mens Maximum Energy Supplement", and "X Max Triple Shot Energy Honey" on Amazon.

The FDA confirmed through laboratory analyses that the products contained the active pharmaceutical ingredient (API) tadalafil and sildenafil. These ingredients are not declared on the product's labeling.

These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.

Information on the labels demonstrates that these products are marketed as dietary supplements. "However, these products do not meet the definition of 'dietary supplement'," said the FDA.

The FDA asked Amazon to investigate and determine the causes of any "violations and to prevent their recurrence or the occurrence of other violations". "It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations," the agency said.

Reference:

1. U.S. FDA WARNING LETTER Amazon.com, Inc. - (https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amazoncom-inc-662503-12202023)

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