FDA WARNING_LETTER - Amazon.com, Inc. - December 20, 2023

The FDA issued a Warning Letter to Amazon concerning the distribution of products containing undeclared active pharmaceutical ingredients (APIs) through its website and Fulfillment by Amazon service. Laboratory analyses confirmed that several products, including “MANNERS Energy Boost,” “Round 2,” “WeFun,” “Genergy,” “Big Guys Male Energy Supplement,” and “Mens Maximum Energy Supplement,” marketed as dietary supplements, contained sildenafil or tadalafil. These APIs are active ingredients in FDA-approved erectile dysfunction drugs and were not marketed as supplements or foods before their drug approval, thus excluding them from the dietary supplement definition. Consequently, these products are deemed unapproved new drugs under sections 201(p), 301(d), and 505(a) of the FD&C Act. Furthermore, they are misbranded under sections 502(a), 502(f)(1), and 502(f)(2) of the FD&C Act due to false/misleading labeling, failure to bear adequate directions for use, and lack of adequate warnings, respectively. The undeclared APIs pose serious health risks, particularly interactions with nitrates. Additionally, “X Max Triple Shot Energy Honey,” a food product, was found to contain undeclared tadalafil, constituting a prohibited act under section 301(ll) of the FD&C Act. Amazon is responsible for these violations and must respond within fifteen working days, detailing corrective actions to prevent recurrence and ensure compliance, or face potential legal action, including seizure or injunction.