Urgent Drug Recall Issued for Weight Loss Supplement Due to Harmful Undeclared Ingredients
The US Food and Drug Administration (FDA) has issued an urgent drug recall, warning consumers to immediately stop using Zi Xiu Tang Bee Pollen, a weight loss and “body shaping” supplement manufactured in China.
The FDA warns that the Bee Pollen supplement contains Sibutramine and Phenolphthalein, which are not declared on the label, making the supplement a drug.
Sibutramine is a controlled substance, per FDA regulations, that was removed from the market in 2010 because it can substantially increase blood pressure or pulse rate, which can be harmful in patients with heart disease, congestive failures, arrhythmia, or stroke.
Phenolphthalein is not an active ingredient in any approved drugs in the US, according to the FDA, and studies indicate that it can increase cancer risk.
“Products that contain hidden drugs pose a real danger to consumers,” Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research said. “This is especially true when the products have names that mislead consumers into believing they are safe and natural.”
The FDA is currently investigating distribution of the supplement as part of the drug recall, and “may issue warning letters or take enforcement action, such as seizures, injunctions, and, or criminal charges.” Preliminary reports indicate that the product was sold through online and retail stores across the US, including spas and fitness centers, and has been promoted as safe and effective by licensed health care professionals.
The FDA and Failure to Regulate Dangerous Drug Recalls
Mitchell Katz, MD, said in an editor’s note that the number of dangerous drug recalls ”grossly underestimates the number of products on sale with unapproved ingredients.”
“Dietary supplements should be treated with the same rigor as pharmaceutical drugs and with the same goal: to protect consumer health,” Katz wrote.
A 2011 study conducted by Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School, found that even supplements that had fallen under Class I dangerous drug recalls could still be purchased. According to Cohen, although the FDA issued the serious recall, it was still voluntary because the FDA has no oversight specifically over supplements. For example, the weight loss supplement Pai You Guo, recalled in 2009 because it contained a banned dangerous drug, could still be bought in 2011.
In March 2013, the FDA issued a notice to consumers that many sexual enhancement drugs contained unreported pharmaceuticals, including Viagra.
Cohen suggested that consumers who want to buy supplements should stick to those with only one ingredient, or just vitamins and minerals. Consumers could also look for supplements that have been certified by the US Pharmacopeial Convention or NSF International, which can provide assurance that the supplements do not contain illegal or unregulated pharmaceuticals.
The Strom Law Firm Can Help with Dangerous Drug Recall Cases
Strom Law Firm, L.L.C. is a leader in the consumer protection battle against dangerous drug recalls and defective devices. We represent individuals who have been killed or injured by dangerous or defective pharmaceuticals. If you or a family member have been injured or killed after using a dangerous drugs such as dietary or weight loss supplements with undeclared ingredients, contact our dangerous drug lawyers as soon as possible so that we can begin taking steps to preserve evidence and your claim immediately. We offer free consultations to discuss the facts of your case. 803.252.4800