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The FDA has issued a warning letter to Amazon.com (NASDAQ:AMZN) for the distribution of products that violate federal laws set forth by the Food, Drug, and Cosmetic Act.
An investigation by the FDA revealed that products labeled as energy-enhancing supplements or dietary supplements on Amazon’s site contained undisclosed and potentially dangerous active pharmaceutical ingredients, including sildenafil and tadalafil, as confirmed by laboratory analyses.
The FDA said in the letter that, “Surprisingly, the labeling for these products does not include some important ingredients. Specifically, sildenafil and tadalafil, powerful phosphodiesterase type-5 inhibitors, are the active ingredients in widely prescribed drugs for erectile dysfunction—Viagra and Cialis.”
“The danger of these undisclosed ingredients lies in their potential interaction with nitrates commonly found in medications like nitroglycerin. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. This combination can lead to highly dangerous drops in blood pressure. The failure to disclose these ingredients in the products’ labeling renders them misbranded under Section 502(a) of the FD&C Act,” the FDA stated in the letter.
Further introducing or delivering these products for introduction into interstate commerce is prohibited under sections 301(a), 301(d), and 505(a) of the FD&C Act, 21 U.S.C. 331(a), 331(d), and 355(a) and introducing or delivering for introduction into interstate commerce a food that is prohibited under section 301(ll) of the FD&C Act, the FDA added.
In a letter addressed to CEO Andrew Jassy dated December 20th, the FDA has requested a response within fifteen working days from the date of receipt of this letter.
