Zencore Tabs maker issues voluntary recall
issued a voluntary nationwide recall of its product following
accusation it contains prescription drugs.
According to Bodee LLC, the US Food & Drug Administration (FDA) informed the manufacturer that the product Zencore Tabs contains aminotadalafil, an analog of tadalafil, the active ingredient of a drug used for erectile dysfunction (ED). The case highlights the issue of products masquerading as dietary supplements and how both industry and federal authorities should react to such cases. Bodee said it is conducting the recall following an FDA analysis of Zencore Tabs samples that were found to contain potentially harmful and undeclared ingredients. Zencore Tabs is sold in health food stores and by mail order nationwide and in Canada. According to Bodee, FDA maintains that aminotadalafil behaves in a similar manner to tadalafil and is expected to possess a similar pharmacological and adverse event profile. In addition, the federal agency found another lot of Zencore Tabs to contain sildenafil, another active ingredient for ED. These prescription drug ingredients are said to interact with the nitrates found in some other prescription drugs and in turn lower blood pressure to dangerous levels. As such, consumers with diabetes, high blood pressure, high cholesterol, or heart disease who are taking nitrates could be at risk of mixing a their medication with ingredients such as those allegedly found in some Zencore Tabs. In August, the Center for Science in the Public Interest (CSPI) asked both FDA and FTC (Federal Trade Commission) to investigate Zencore Tabs for the presence of drugs and to put a stop to sales and advertising for the product. CSPI also accused the marketer of misleading consumers through their advertising. "The marketing of Zencore Tabs appears to violate laws and regulations prohibiting the deceptive labeling and advertising of dietary supplements and the marketing of prescription drugs in non-prescription products," CSPI said in a letter to the agencies. CSPI requested that FDA, in collaboration with FTC: analyze the composition of Zencore Tabs; order the manufacturers not to sell the products until such a time as it is determined they are free of prescription drugs; stop the companies from marketing the benefits of these products until such a time as reliable clinical trials could back up such claims. Bodee now says it is reviewing the manufacturing companies it works with so as to resolve the issue of Zencore Tabs' composition. "The Company is working closely with the FDA in the recall process and is committed to the quality and integrity of its products," said Bodee in an official statement.
