FDA Warns Amazon Over Supplements With Undeclared and Potentially Harmful Ingredients

FDA, in a letter to Amazon CEO: This letter concerns your firm's distribution of products that violate the Federal Food, Drug, and Cosmetic Act (the 'FD&C Act'). The United States Food and Drug Administration (FDA) purchased on your website, www.amazon.com, products that are labeled as energy enhancing supplements or food, but laboratory analyses confirmed that they contained undeclared and potentially harmful active pharmaceutical ingredients. As discussed further below, your firm is responsible for introducing or delivering for introduction into interstate commerce products that are unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a).

Furthermore, the products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. 352. As explained further below, 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). Your firm is also responsible for introducing or delivering for introduction into interstate commerce a food that is prohibited under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll).

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