FDA WARNING_LETTER - Shaping Beauty, Inc. / H & S GMP Factory - January 28, 2011

On July 14, 2011, the FDA issued a Warning Letter to Shaping Beauty, Inc. / H & S GMP Factory, following an inspection from January 12-28, 2011. The letter identified multiple products as unapproved new drugs and misbranded drugs.

**Violations and Deficiencies:**

* **Celerite Slimming Capsules and Celerite Slimming Tea:** These products were found to contain undeclared sibutramine, an active pharmaceutical ingredient withdrawn from the market due to increased risks of heart attack and stroke. Despite being marketed as dietary supplements, they are excluded from the dietary supplement definition under 21 U.S.C. § 321(ff)(3)(B)(ii) because sibutramine was authorized for investigation as a new drug before being marketed as a dietary supplement or food. They are considered unapproved new drugs (21 U.S.C. § 355(a)) and misbranded (21 U.S.C. § 352(f)(1), § 352(a), § 352(j)) due to lack of adequate directions for use, false/misleading safety claims, failure to reveal material facts, and being dangerous when used as recommended. * **moraz galilee medical herbs TEENAGE Polygonum Teenage Facial Cream:** Marketed with acne treatment claims,