FDA WARNING_LETTER - Healthy Body Forero - October 31, 2009

The FDA issued a Warning Letter to Healthy Body Forero Inc. following a September-October 2009 inspection, concerning their "YI SHOU Ultimate Fat Burner 400mg capsules" and "YI SHOU Ultimate Fat Burner Extra Strength 650mg capsules." Laboratory analysis revealed both products contain undeclared sibutramine, the active pharmaceutical ingredient in the FDA-approved prescription obesity drug Meridia. Consequently, the products are deemed not dietary supplements per 21 U.S.C. § 321(ff)(3)(B), but unapproved new drugs under 21 U.S.C. § 321(g)(1)(C) and § 321(p), as they are intended to affect body function and are not generally recognized as safe and effective. Their introduction into interstate commerce without an FDA-approved application violates 21 U.S.C. §§ 331(d) and 355(a). Furthermore, the products are misbranded under 21 U.S.C. §§ 352(a) and 321(n) due to the failure to declare sibutramine, rendering labeling false and misleading. As unapproved prescription drugs (21 U.S.C. § 353(b)(1)(A)), they lack adequate directions for use, causing further misbranding under 21 U.S.C. § 352(o)(1), violating 21 U.S.C. § 331(a). The firm initiated a recall but failed to inform distributors of sibutramine's presence or potential harm. The products have since been embargoed by Puerto Rico authorities. Healthy Body Forero must respond within fifteen working days, detailing corrective actions, recurrence prevention, and providing documentation, including the status of embargoed products, to avoid further legal action.