FDA WARNING_LETTER - Atlas Operations, Inc. - November 16, 2009

On June 4, 2010, the FDA issued a Warning Letter to Atlas Operations, Inc. following an inspection from October 28 to November 16, 2009. The inspection and subsequent laboratory analyses revealed significant violations.

The company was found to be marketing unapproved and misbranded drugs. Products like "ROCK HARD WEEKEND," "72 HOURS," "STAMIN IT," "Finally On DEMAND," "STAMINIL," and "VIERECT," labeled as dietary supplements, contained sulfoaildenafil, an analogue of sildenafil (Viagra's active ingredient), making them unapproved new drugs and misbranded due to undeclared active ingredients and lack of adequate directions/warnings. "On Cycle II Hardcore" contained a synthetic anabolic steroid, also rendering it an unapproved new drug. Additionally, thin strip and topical products such as "Sleep Quick Strips," "Sleep Once Again," "Sleep Ease," "Insomnix," "Musclextreme Pump Extreme," "Derma-Tropin," and "GH.X Growth Hormone Extreme" were deemed unapproved new drugs because their intended use (affecting body structure/function) and non-ingestible forms classify them as drugs, not dietary supplements. "Derma-Tropin" was also misbranded for misleading labeling regarding hGH content.

The inspection also uncovered serious Current Good Manufacturing Practice (cGMP) deficiencies (21 CFR Part