Amazon.com, Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

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.

Passage 2

“MANNERS Energy Boost,” “Round 2,” “WeFun,” “Genergy,” “Big Guys Male Energy Supplement,” and “Mens Maximum Energy Supplement” are not generally recognized as safe and effective for their above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).

Passage 3

The labeling for these products does not declare that they contain PDE-5 inhibitors. The use of PDE-5 inhibitors can be associated with significant safety issues and the risk of serious adverse events. The undeclared PDE-5 inhibitors in these products may pose serious health risks because consumers with underlying medical issues may take the products without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking.

Passage 4

“MANNERS Energy Boost,” “Round 2,” “WeFun,” “Genergy,” “Big Guys Male Energy Supplement,” and “Mens Maximum Energy Supplement” are also misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for their intended uses.

Passage 5

The undeclared sildenafil or tadalafil in “MANNERS Energy Boost,” “Round 2,” “WeFun,” “Genergy,” “Big Guys Male Energy Supplement,” and “Mens Maximum Energy Supplement” also causes the products to be misbranded under section 502(f)(2) of the FD&C Act, 21 U.S.C. 352(f)(2), because their labeling lacks adequate warnings against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users.

Passage 6

It is a prohibited act under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), to introduce or deliver for introduction into interstate commerce any food to which has been added a drug approved under section 505 of the FD&C Act or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. As noted above, FDA purchased “X Max Triple Shot Energy Honey” from www.amazon.com and confirmed through laboratory testing that the product contained undeclared tadalafil.