IGMPI India



FDA warns customers for the use of Zi Xiu Tang Bee Pollen

The US Food and Drug Administration (FDA) is warning customers to instantly stop using Zi Xiu Tang Bee Pollen, marketed as a product for weight loss and body reshaping. The product contains undeclared potentially harmful active pharmaceutical ingredient that is not mentioned on the product’s label. The FDA has conducted the tests for Zi Xiu Tang Bee Pollen products from various distributors in the United States and concluded that all the products that have been tested were found to contain one or both of the following undeclared drug ingredients:

•  Sibutramine: a substance that has been withdrawn from the US market in October 2010 for safety concerns. 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.

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 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. 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.