Natural Wellness, LLC – FDA Warning Letter, Jun 30, 2010

The FDA issued a Warning Letter to Natural Wellness, LLC, on October 5, 2010, following an inspection from May 5 to June 30, 2010. The letter addresses the firm's distribution and marketing of "MasXtreme," "Passion Power for Men," and "Passion Power for Women" via websites and retail stores.

Laboratory analysis revealed these products, marketed as dietary supplements, contain undeclared active pharmaceutical ingredients. "MasXtreme," "Passion Power for Men," and "Passion Power for Women" contain phentolamine, an active ingredient in FDA-approved drugs for hypertensive episodes. Additionally, one lot of "MasXtreme" contained sildenafil, the active ingredient in Viagra, an FDA-approved drug for erectile dysfunction. Other lots of "MasXtreme" contained dimethylsildenafil, thiosildenafil, and ammotadfil.

These ingredients exclude the products from the dietary supplement definition because phentolamine and sildenafil were approved as new drugs before being marketed as dietary supplements or food. The products' labeling and website claims, such as "ENHANCE YOUR PERFORMANCE" and "improve your sexual performance," cause them to be unapproved new drugs under sections 505(a) and 301(d) of the Act, as they are not generally recognized as safe and effective.

Furthermore, these products are misbranded drugs under sections 502(f)