FDA WARNING_LETTER - Akron Bee Pollen

The FDA issued a Warning Letter to Tiffany R. Smith, owner of Akron ZXT Bee Pollen, regarding products distributed via her website and other retail outlets. The FDA's laboratory analysis confirmed that "Zi Xiu Tang Bee Pollen Capsule" and "Bee Thin" contain undeclared sibutramine, a drug withdrawn from the market due to increased risks of heart attack and stroke. "Zi Xiu Tang Bee Pollen Capsule" also contained undeclared phenolphthalein, a chemical with cancer-causing risks.

These products, marketed as dietary supplements, are deemed unapproved new drugs because sibutramine was authorized for investigation as a new drug before being marketed as a dietary supplement or food. The products are also considered drugs due to their intended uses, including weight loss, fat reduction, and appetite suppression. They are new drugs as they are not generally recognized as safe and effective.

The products are misbranded because their labeling lacks adequate directions for use, which is impossible to provide given sibutramine's prescription-only status and withdrawal due to safety concerns. The labeling is also false and misleading, failing to reveal material facts about the serious health risks posed by the undeclared ingredients. Furthermore, the products lack adequate warnings and are dangerous to health when used as recommended.

These violations contravene sections 505(a), 301(d), 502, and 301(a) of the FD&C Act