FDA WARNING_LETTER - Schindele Enterprises dba Midwest Wholesale - November 05, 2013

The FDA inspected Schindele Enterprises, LLC DBA Midwest Wholesale's facilities from October 21 to November 5, 2013, identifying that "Xzone Gold," "MiracleZen," "Xzen Platinum," "New Extenze," "Magic for Men," "Sexy Monkey," and "Boost Ultra" are unapproved new drugs and misbranded drugs. Laboratory analyses confirmed these products contain undeclared sildenafil, tadalafil, and sulfosildenafil, active ingredients in FDA-approved prescription drugs like Viagra and Cialis. These products are deemed unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act [21 U.S.C. §§ 355(a) and 331(d)]. They are excluded from dietary supplement definition (201(ff)(3)(B)(i)) as their active ingredients were not pre-marketed as supplements. They are classified as drugs (201(g)(1)(C)) due to intended use and "new drugs" (201(p)) as they lack general recognition of safety and effectiveness. The products are also misbranded drugs under sections 502 and 301(a) of the FD&C Act [21 U.S.C. §§ 352 and 331(a)]. Violations include misbranding under 502(f)(1) for lacking adequate directions for use (as prescription drugs), under 502(a) for false/misleading labeling by failing to disclose serious health risks from PDE-5 inhibitors, and under 502(f)(2) for inadequate warnings. The firm is conducting a voluntary nationwide recall. Schindele Enterprises must respond within fifteen working days with corrective actions to prevent legal action, including seizure or injunction.