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New Study Totally Misrepresents Adverse Events Related to Dietary Supplements

New Study Totally Misrepresents Adverse Events  Related to Dietary Supplements
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Media outlets indulge in scaremongering, when the actual
study data presents a completely different story

October 15, 2015 — Yesterday, the New England Journal of Medicine released a statistical analysis of emergency room visits between 2004 and 2013. The study reported that just over 23,000 ER visits per year were linked to dietary supplements—prompting media outlets to run alarmist headlines about supplement safety and regulation. In point of fact, supplements have been proven time and time again to be incredibly safe, and the supplement industry is fully regulated.
“The conclusions this study draws are almost laughable,” said Gretchen DuBeau, Legal and Executive Director for the Alliance for Natural Health USA. “A closer look at the data shows that these cases were not caused by unsafe products. Twenty percent of the cases analyzed were the result of unsupervised children swallowing pills, forty percent of the cases in patients 65 and over had trouble swallowing uncrushed pills, and many cases were heart palpitations from ingesting too many diet pills, sexual enhancement pills, and energy drinks.”
Data from the Centers for Disease Control and Prevention show that there were actually only 3,249 adverse event reports submitted to the FDA related to supplements in 2012—a far cry from the 23,000 being claimed in the study. About 50% of Americans (150 million people) take supplements, so the ER visits represent about 0.015% of supplement users.
“I don’t know how the study authors can talk about product safety given these numbers,” continued DuBeau. “This study shows that people need to act responsibly and follow directions. And even though most of these cases were examples of irresponsible behavior, a miniscule percentage of people had adverse reactions. Yet many groups have called for vitamins and health-supporting herbs to be regulated as if they were dangerous drugs, in order to protect the public from a harm that does not actually exist.”
Most of the stories about supplements in the media claim that nutritional supplements are not regulated by the FDA, but this is simply untrue. The FDA is fully empowered to remove any product from the market that is unsafe, misbranded, or adulterated. Supplements must contain what is on the label or the FDA has the right and obligation to remove that product from store shelves. The agency is charged with enforcing the Dietary Supplement Health and Education Act, which holds supplement manufacturers to “good manufacturing practices” (industry standards for product quality); and it may take any necessary action based on adverse event reports. Both the FDA and the FTC also have to power to stop any fraudulent advertising.
“The FDA needs to do a better job of enforcing the law and punishing those who fail to properly make, label, and distribute their products. But even with the agency’s shortfalls, supplements are far, far safer to ingest than FDA-approved drugs, and statistically even safer than food. We all want to remove bad actors from the supplement industry, but exaggerating the risk posed by these isolated cases is not the way to do so. If we simply enforce the laws already in place, this demonstrably safe industry will become even more so, and consumers will continue to have access to this vital component of a naturally healthy lifestyle,” said DuBeau.

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