Gadget Island, Inc.

Selected passages from the FDA letter

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

Passage 1

FDA confirmed through laboratory analyses that samples of your “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” products each contain the undeclared pharmaceutical ingredients tadalafil and sildenafil.

Passage 2

Given that tadalafil and sildenafil were not marketed as dietary supplements or as food before Cialis and Viagra were approved, your “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” products are excluded from the definition of dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i).

Passage 3

There is no FDA-approved application in effect for “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” or “ProPower Knight Plus 2550mg.” Introduction or delivery of these products into interstate commerce without an approved application violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).

Passage 4

Your “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” products 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 use.

Passage 5

The labeling for your “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” products do not declare that the products contain PDE-5 inhibitors.

Passage 6

The undeclared active pharmaceutical ingredients in your products also cause these 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 for the protection of users.