FDA WARNING_LETTER - Gadget Island, Inc. - July 21, 2023

The FDA issued a Warning Letter to Naeem Azizian regarding products sold on www.gearisle.com, www.smokewrap.com, and www.ultimamax.com. Between January and July 2023, the FDA reviewed www.gearisle.com, where "NUX Male Enhancement," "DYNAMITE Male Sexual Enhancement," and "ProPower Knight Plus 2550mg" were sold. Laboratory analyses confirmed these products contain undeclared tadalafil and sildenafil, active ingredients in FDA-approved prescription drugs Cialis and Viagra, respectively.

These products are unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)). They are also misbranded drugs under section 502 and 301(a) of the FD&C Act (21 U.S.C. 352 and 331(a)) because their labeling fails to bear adequate directions for use, is false or misleading due to undeclared ingredients, and lacks adequate warnings. Tadalafil and sildenafil were not marketed as dietary supplements before their drug approval, excluding these products from the dietary supplement definition.

The undeclared PDE-5 inhibitors pose serious health risks, especially for individuals taking nitrates,