What happened
Original notice title
Amazon.com, Inc. MARCS-CMS 662503, December 20, 2023
From the archived source record
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. All of these products were introduced or delivered for introduction into interstate commerce by Amazon via your Fulfillment by Amazon service. 1 FDA confirmed through laboratory analyses that the “MANNERS Energy Boost,” “Round 2,” “Genergy,” and “X Max Triple Shot Energy Honey” products, purchased on www.amazon.com, contained the active pharmaceutical ingredient (API) tadalafil; and the “WeFun,” 2 “Big Guys Male Energy Supplement,” and “Mens Maximum Energy Supplement” products, also purchased on www.amazon.com, contained the API sildenafil. These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Unapproved New Drugs The “MANNERS Energy Boost,” “Round 2,” “WeFun,” “Genergy,” “Big Guys Male Energy Supplement,” and “Mens Maximum Energy Supplement” products that are marketed as dietary supplements are drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body. Misbranded Drugs Additionally, “MANNERS Energy Boost,” “Round 2,” “WeFun,” “Genergy,” “Big Guys Male Energy Supplement,” and “Mens Maximum Energy Supplement” are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 6844eccaf81c
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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