A C-HIT analysis of data has revealed that the U.S. Food and Drug Administration (FDA) has identified an average of two dietary supplements, every week for the past 7½ years, as "tainted" and "potentially hazardous".
The FDA has reported that the supplements contained prescription drug ingredients, controlled substances, or untested pharmaceutical ingredients that are prohibited by federal law and “can pose considerable dangers to consumers,” including stroke, liver damage, kidney failure, and death. Since 1st January 2008, the C-HIT’s analysis of FDA data has revealed 615 dietary supplements that were identified as tainted. In the first half of the year 2015, 59 tainted dietary supplements were posted on the FDA’s website.
The U.S. Department of Justice took court action against two supplement companies in Montana and Iowa in July this year for illegally selling or distributing prohibited or misbranded products. Regulators acknowledge they are overmatched in their ability to monitor the supplements though there are cases in which some violations have prompted immediate legal action.
U.S. Sen. Richard Blumenthal, D-Conn., is working with U.S. Sen. Dick Durbin, D-Ill., to reintroduce the Dietary Supplement Labeling Act to call a crackdown on the dietary supplements industry. Blumenthal said the Act would help consumers differentiate between supplements that are safe and those that may have severe side effects or drug interactions. The Dietary Supplement Labeling Act would require manufacturers to provide more information on product labels and the Act would give more authority to the Food and Drug Administration to require manufacturers to register their products and ingredients and provide proof of any health-benefit claims. Blumenthal added the dietary supplement market is a dangerous Wild West of inadequate regulation” that deprives consumers “of basic health and safety information” and results “in serious injuries and deaths.”
The dietary supplement industry has explored in popularity during the past 15 years to push annual sales to $35 billion, according to the Council for Responsible Nutrition, a trade group that represents supplement manufacturers. The organization reveals that about 150 million adults nationally, or 7 out of every 10, ingest dietary supplements that are sold in various forms, tablets, capsules, powders, energy bars, and liquids.
Previously, the FDA had stated that some supplements are useful in reducing the risk of certain diseases. For example, folic acid supplements could make a claim about minimizing the risk of birth defects of the brain and spinal cord but the FDA also commented that dietary supplements are not intended to treat, diagnose, cure, or alleviate the effects of diseases.
Steve Mister, president and CEO of the Council for Responsible Nutrition, said some small companies, particularly many that sell their products on the Internet, are giving a bad reputation to the industry.
C-HIT’s analysis of another FDA database disclosed many warning letters were sent in the recent past to manufacturers of dietary supplements, including four in Connecticut. The FDA issued a warning letter to Klein Laboratories in July 2014 after its manufacturing facility in North Haven was inspected. The FDA revealed the label for the company’s bodybuilding product, Osteojuv, “revealed serious violations” of federal regulations by claiming it targets pain and inflammation.
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