FDA WARNING_LETTER - Descor LLC - August 19, 2014

On August 19, 2014, the FDA issued a Warning Letter to Descor, LLC, regarding their product "Asset Bee Pollen," distributed via www.assetcapsules4u.com. An FDA laboratory analysis confirmed the product contained undeclared sibutramine, an active pharmaceutical ingredient previously withdrawn from the U.S. market due to increased risks of heart attack and stroke. Previous Descor products ("Asset Extreme," "Asset Extreme Plus," "Asset Bold") also contained sibutramine.

The FDA determined "Asset Bee Pollen" is an unapproved new drug and a misbranded drug. Sibutramine is excluded from the definition of a dietary supplement because it was authorized for investigation as a new drug before being marketed as a dietary supplement or food. The product is considered a drug due to its intended use for weight loss, increased energy, and metabolism speed. It is an unapproved new drug under sections 505(a) and 301(d) of the FD&C Act because it is not generally recognized as safe and effective and lacks an FDA-approved application.

Furthermore, "Asset Bee Pollen" is misbranded under section 502 of the FD&C Act because it lacks adequate directions for use, which are impossible to provide given sibutramine's prescription-only status (prior to withdrawal) and serious safety risks. The labeling is also false and misleading under section 50