Prosecutors filed criminal and civil charges against 117 manufacturers and distributers of products being falsely marketed as dietary supplements. Recalls could also result for more than 100 dietary supplement products that received warnings from the U.S. Food and Drug Administration for concealed active ingredients.
All this is the result of a year-long investigation by the FDA. The IRS’s Criminal Investigation Division, U.S. Department of Justice, the Federal Trade Commission, U.S. Postal Inspection Service, U.S. Anti-Doping Agency and the Department of Defense have all joined the FDA in prosecuting the cases.
Estimates put U.S. sales of dietary supplements at $13 billion in 2013 and one study found that 49% of adults use dietary supplements. Weight-loss aids, body-building agents, and sexual enhancers make up the most common categories of supplements.
The term dietary supplement was defined by Congress in 1994 as “a product taken by mouth that contains a dietary ingredient intended to supplement the diet.” This put supplements in the regulatory category of foods, not drugs. Regulations, therefore, are not nearly as strict for supplements as for prescription medications. That opened the door for supplement manufacturers and distributers to inject into the market impure and mislabeled products.
For years the FDA made known to the supplement industry its concerns about deceptive marketing tactics and hidden ingredients in products. In an effort to achieve compliance to regulations, the FDA put the burden on manufacturers and distributors to self-police and self-report. Apparently, that did little to alleviate the FDA’s concerns.
These recent government actions and/or future recalls could result in class action or individual product liability lawsuits.
Meanwhile, consumers should check supplement labels for NSF certification. NSF certification confirms that the product is free from unsafe levels of heavy metals, herbicides, pesticides and other contaminants. Likewise athletes should be looking for products bearing the NSF Certified for Sport seal. Those products have been tested and contain no banned substances.
Source: Alexis Kellert. “Dietary supplement crackdown is certain to increase lawsuits,” lexology.com. 23 Nov. 2015.Posted By: Paul L. Owens
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