FDA WARNING_LETTER - Novacare, LLC - March 22, 2010

The FDA conducted an inspection of NovaCare, LLC (TSN Labs, Inc.) from March 8-22, 2010. The inspection revealed that the firm's ingredient (b)(4) and several products marketed as dietary supplements, including "Aziffa," "MONSTER EXCYTE," and "Stiff Nights," contained sulfoaildenafil, an analogue of sildenafil (Viagra's active ingredient).

These products are deemed unapproved new drugs under section 505(a) of the Act [21 U.S.C. § 355(a)] because they are not generally recognized as safe and effective. They are also misbranded drugs under sections 502(f)(1), 502(f)(2), and 502(a) [21 U.S.C. §§ 352(f)(1), 352(f)(2), 352(a)]. The ingredient (b)(4) is also classified as a misbranded drug.

The products' labeling claims, such as "Male Sexual Stimulant" and "INCREASED SEX DRIVE," indicate they are drugs intended to affect body structure/function. Since sulfoaildenafil is a synthetic pharmaceutical ingredient, not a dietary ingredient, these claims do not conform to dietary supplement regulations. Furthermore, the products are considered prescription drugs due to potential harmful