On April 7, 2014, the U.S. Food and Drug Administration (“FDA”) advised consumers to stop taking Zi Xiu Tang Bee Pollen products, which are promoted as body forming, weight loss dietary supplements. According to the FDA, the Company’s dietary supplements include at least one potentially dangerous pharmaceutical ingredient that is not declared on the product label. After testing a variety of different Zi Xiu Tang Bee Pollen dietary supplements, the FDA has discovered that each product contained at least one of the listed unnamed drug ingredients:
Phenolphthalein – A substance that is associated with cancer and is not a current ingredient in any accepted drug in the country.
Sibutramine – A controlled substance that has been deemed unsafe by the FDA and was removed from the market in October 2010. Sibutramine is a recognized substance that has been known to dramatically raise blood pressure levels in certain patients and has been known to introduce a powerful risk for people that have a history of congestive heart failure, stroke, coronary artery disease or arrhythmias. More information can be found here.
In the past, the FDA has issued statements to consumers and industry concerning the presence of undeclared active ingredients in dietary supplements. The Agency has found that although these products are often being marketed as dietary supplements, the presence of undeclared active ingredients causes them to be classified as unapproved new drugs under the Federal Food, Drug and Cosmetic Act (“FFDCA”).
Further, in alleging that these ingredients may be dangerous, the Agency noted it has received several serious adverse event reports that include extreme cardiac and other serious health issues. Some of the various negative health reports include suicidal thoughts, diarrhea, heart palpitations, tachycardia, chest pains, insomnia, seizures, anxiety and higher blood pressure levels. Additional information can be found here. These serious adverse event reports were collected as part of the industry’s regulatory burden and represent a part of the many responsibilities that industry must undertake in maintaining compliance with the laws and regulations enforced by the FDA. Under the FFDCA, manufacturers, packers and distributors of all dietary supplements are required to report serious adverse events to the FDA within fifteen (15) business days and to provide the FDA with updates as to any medical information for the entire year following the initial report.
For more information about the FDA’s regulation of dietary supplements and industry’s regulatory burden with respect to the marketing and sale of dietary supplements, including how you may satisfy your adverse event reporting requirements, please feel free to contact us at contact@sglawfl.com.
