If you think that only natural ingredients are in your dietary supplement, take a look at this study published in JAMA Network Open on October 12, 2018. Can you really trust what’s on that label? During the last decade, over 700 warnings have been issued by U.S. health officials in regards to the sale of dietary supplements that contain unapproved and dangerous drug ingredients. In 98% of those cases, these ingredients were not noted anywhere on the labeling.
Between 2007 and 2016, 46% of the more than 700 warnings were for supplements that were proclaimed to be for sexual pleasure, 41% for weight-loss products, and 12% for supplements marketed as muscle-builders.
“In the United States, more than 50% of adults consume dietary supplements, fueling a $35 billion industry.” (Jama Network Open) Vitamins, minerals, botanicals, amino acids, and enzymes are not a replacement for over-the-counter or prescription medications, and are not intended to prevent or treat disease, per warnings from the US Food and Drug Administration (FDA). The FDA classifies dietary supplements as food, rather than drugs.
Over-the-counter drugs and prescriptions are carefully vetted by the FDA, supplements are not. “The FDA’s Dietary Supplement Health and Education Act of 1994 essentially places the burden for evaluating supplement safety, content and labeling primarily on the shoulders of the manufacturers,” said Dr. Peter Cohen, general internist with the Cambridge Health Alliance. (US News)
This arrangements means that although the FDA can remove any supplement reported to cause harm from the market, it is done only after the fact. This raises the risk for tainted supplements to cause “serious adverse events” such as kidney failure, stroke, liver injuries, blood clots, and even death.
Each year in the United States, dietary supplements are associated with 23,000 emergency room visits and 2,000 hospitalizations. There are many more instances where adverse events were not reported, possibly because the consumer didn’t attribute their symptoms to the use of a dietary supplement, or the consumer did not know to report. Also, reports received don’t always initiate “consumer protection actions like inspections or warning letters.”
Cohen says that since he started tracking the problem a decade ago, “I have only seen the number of supplements adulterated [containing unapproved ingredients] with drugs increase rapidly.
Back in 2009, it appeared that there might be less than 150 brands of supplements that contain drugs. Now it’s clear that there are well over 1,000 brands of supplements that contain active drugs.”
The Tainted Products Marketed as Dietary Supplements_CDER database, maintained by the FDA’s Center for Drug Evaluation and Research on its website, will hopefully increase transparency and public knowledge. This database shows dietary supplements associated with an FDA warning starting in 2007.
A change in the laws that govern the way supplements are monitored by the FDA is required before there is any solution to this problem. Until then, Cohen says always ask your doctor about any supplements. He also advises his patients who want to use supplements to purchase those that have only one ingredient on the label, and avoid any that have health claims on the label.
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