On April 7, 2014, the U.S. Food and Drug Administration (“FDA”) released an advisory, warning consumers not to use bee pollen capsule marketed under the name Zi Xiu Tang Bee Pollen. The purpose for the advisory, previously reported here, was to alert the public that the product contained potentially harmful active pharmaceutical ingredients, which had not been listed on the label for the product and was the subject of a FDA warning letter.
The undeclared substances, Sibutramine Hydrochloride (sibutramine), an active ingredient in the obesity drug Meridia (pulled from the United States market in December 2010 based on increased risk for stroke and heart attack in users), and Phenolphthalein, an inactive ingredient linked to cancer risk, were found in multiple test samples from various distributors. The FDA warning letter was issued to manufacturers of Zi Xiu Tang Bee Pollen, threatening that seizure of product and criminal prosecution measures would be taken should they refuse to comply with proper labeling under FDA guidelines. Despite this warning, manufacturers and distributors of Zi Xiu Tang Bee Pollen continued its marketing and labeling practices, resulting in the FDA issuing an Import Alert to ban the product’s entry into the US market. Further action, if warranted by the FDA, may include the issuance of additional warning letters to the company and heightened enforcement action, including product seizures, injunctions and possible criminal charges.
The problem of undeclared ingredients in weight loss supplements and other products, drug ingredients or otherwise, is taken very seriously by the FDA. As evidenced by the February 14, 2013 raid of Globe All Wellness, LLC by U.S. Marshals acting on behalf of the FDA, the measures taken to uphold the requirements of the Federal Food, Drug and Cosmetic Act (FFDCA) can be severe. FDA warning letters, product recalls and seizures, and ultimately criminal prosecution can occur where noncompliance with these requirements is found. Companies, including manufacturers, or distributors of products that have received a warning letters from the FDA should take these issues seriously and take steps towards achieving compliance in order to avoid heightened scrutiny and enforcement by the FDA.
If you have any questions about the FDA warning letters and how you can maintain compliance with regulations pertaining to the labeling and marketing of these products, please contact us at email@example.com.