FDA WARNING_LETTER - Healthy People Co - February 23, 2012

The FDA issued a Warning Letter to Healthy People Co. following inspections in late 2011 and early 2012 at their Irwindale and Huntington Park distribution centers, and a review of their websites. The letter addresses numerous products marketed as dietary supplements that are deemed unapproved new drugs and misbranded drugs.

Specifically, "Mince Belle Capsules," "EverSlim Capsules," "EverSlim Shake (Strawberry)," "EverSlim Shake (Chocolate)," and "EverLax Capsules" were found to contain undeclared sibutramine, a withdrawn prescription drug with serious cardiovascular risks. "Herbal Drink Acai-man mangosteen" and "Perfect Men" contained undeclared tadalafil, an active ingredient in an FDA-approved erectile dysfunction drug. These products are considered unapproved new drugs under 21 U.S.C. §§ 355(a) and 331(d) and misbranded under 21 U.S.C. §§ 352 due to undeclared ingredients, lack of adequate directions for use, false/misleading labeling, and being dangerous to health.

Additionally, "Prosvid," "Gojiman," "Healthy Coffee," "Rivere," "Ancestral," "Bevida," "Green Oxygen," "Max Clean Fiber," and "Nerval" are cited as unapproved new drugs (21 U.S.C. § 321