FDA WARNING_LETTER - Globe All Wellness, LLC - July 08, 2011

The FDA issued a Warning Letter to Globe All Wellness, LLC, following an inspection from May 18 to July 8, 2011. The letter addresses violations concerning SlimXtreme™ Herbal Slimming Capsule and ViaXtreme™ Ultimate Sexual Enhancer Dietary Supplement for Men, marketed on www.viaxtreme.com and www.diet66.com.

Laboratory analysis confirmed SlimXtreme contained undeclared sibutramine, a withdrawn prescription drug with serious health risks. ViaXtreme contained undeclared sildenafil, sulfoaildenafil, aildenafil, and thiosildenafil, all PDE-5 inhibitors and analogues of sildenafil (Viagra's active ingredient).

These products are deemed unapproved new drugs under 21 U.S.C. § 355(a) and misbranded drugs under 21 U.S.C. §§ 352 and 353. They are excluded from dietary supplement definitions because their active pharmaceutical ingredients were authorized as new drugs or approved as new drugs before being marketed as dietary supplements or foods.

Both products are considered prescription drugs due to their potential for harmful effects and require professional supervision. They are misbranded because they lack adequate directions for lay use (21 U.S.C. § 352(f)(1)), contain false/misleading safety statements and fail to reveal material facts about risks (21 U.S.C.