FDA WARNING_LETTER - Zi Xiu Tang Success, LLC - October 24, 2012

On May 14, 2013, the FDA issued a Warning Letter to Zi Xiu Tang Success, LLC, following an inspection from October 18-24, 2012, at their Kutztown, PA distribution center. The letter addresses violations concerning "Ultimate Formula Bee Pollen Capsules" and "Zi Xiu Tang Bee Pollen Capsules."

FDA laboratory analysis confirmed both products contained undeclared sibutramine, a substance withdrawn from the U.S. market due to increased risks of heart attack and stroke. Sibutramine was authorized as a new drug for investigation in 1986 and was not marketed as a dietary supplement or food prior to this. Therefore, these products are excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(ii) of the Act.

The products are deemed unapproved new drugs under sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 355(a) and 331(d)] because they are intended for disease treatment/prevention or to affect body structure/function, and are not generally recognized as safe and effective. They are also classified as prescription drugs under section 503(b)(1)(A) due to the inherent dangers of sibutramine.

Furthermore