ISSUE: FDA has tested multiple Zi Xiu Tang Bee Pollen products from various distributors in the United States (US). All products that have been tested, including those that claim to be “genuine” and “anti-counterfeit,” have been found to contain one or both of the undeclared drug ingredients sibutramine and Phenolphthalein. FDA has received dozens of adverse event reports, including many serious cardiac issues, associated with the use of Zi Xiu Tang Bee Pollen. Reports have included heart palpitations, increased heart rate, suicidal thoughts, chest pain, diarrhea, anxiety, insomnia, increased blood pressure and seizure.
FDA is investigating the distribution of Zi Xiu Tang Bee Pollen products in the US and may issue warning letters or take enforcement action, such as seizures, injunctions and/or criminal charges.
BACKGROUND: Zi Xiu Tang Bee Pollen is marketed as a product for weight loss and body reshaping. It is offered for sale on the Internet, and it can be found in various retail stores, spas and fitness centers. In addition, licensed health care professionals have promoted the product. See the Press Release for product photos.
Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons and is known to substantially increase blood pressure and/or pulse rate in some patients.
Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it presents a cancer-causing risk.
RECOMMENDATION: FDA is warning consumers to immediately stop using Zi Xiu Tang Bee Pollen. Consumers who have experienced any negative side effects while taking this product should consult a health care professional.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[04/07/2014 - Press Release - FDA]