FDA NEWS RELEASE
For Immediate Release: April 7, 2014
Media Inquiries: Tara Goodin, 240-402-3157, email@example.com
Consumer Inquiries: 888-INFO-FDA
FDA warns consumers not to use Zi Xiu Tang Bee Pollen capsules
Tainted product contains undeclared drug ingredients with health risks
The U.S. Food and Drug Administration is warning consumers to immediately stop using Zi Xiu Tang Bee Pollen, marketed as a product for weight loss and body reshaping. The product contains at least one potentially harmful active pharmaceutical ingredient that is not listed on the product’s label.
The FDA has tested multiple Zi Xiu Tang Bee Pollen products from various distributors in the United States. 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 following undeclared drug ingredients:
- Sibutramine – a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
- Phenolphthalein – 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.
The 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, tachycardia (increased heart rate), suicidal thoughts, chest pain, diarrhea, anxiety, insomnia, increased blood pressure and seizure. Consumers who have experienced any negative side effects while taking this product should consult a health care professional.
“Products that contain hidden drugs pose a real danger to consumers," said Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “This is especially true when the products have names that mislead consumers into believing they are safe and natural.”
Zi Xiu Tang Bee Pollen is manufactured by Guangzhou Zi Xiu Tang Biotechnology Co., Ltd. in Guangdong Province, China. 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.
The FDA is investigating the distribution of Zi Xiu Tang Bee Pollen products in the United States and may issue warning letters or take enforcement action, such as seizures, injunctions and/or criminal charges.
Health care professionals and consumers should report any adverse events related to Zi Xiu Tang Bee Pollen or other weight loss products to the FDA’s MedWatch program by:
- completing and submitting the report online at www.fda.gov/medwatch/report.htm; or
- downloading the form, completing it and then faxing it to 1-800-FDA-0178.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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