MONDAY, Oct. 15, 2018 — Dietary supplements often include active pharmaceuticals, even after warnings from the U.S. Food and Drug Administration, according to a study published online Oct. 12 in JAMA Network Open.
Jenna Tucker, M.P.H., from the California Department of Food and Agriculture in Sacramento, and colleagues extracted data from the FDA’s Center for Drug Evaluation and Research Tainted Products Marketed as Dietary Supplements database from 2007 to 2016. Trends across adulterated dietary supplements associated with an FDA warning were summarized.
The researchers found 776 FDA-identified adulterated dietary supplements, with 146 companies implicated. Most of the products were marketed for sexual enhancement, weight loss, or muscle building (45.5, 40.9, and 11.9 percent, respectively); 20.2 percent of adulterated products contained more than one unapproved ingredient. Twenty-eight products were named in two or three warnings more than six months apart; at the second or third warning, 67.9 percent of these products were reported to contain new unapproved ingredients. In 2014 to 2016, 38.6 percent of adulterated samples were identified through online sampling and 34.3 percent were identified through examination of international mail shipments.
“The active pharmaceutical ingredients identified in dietary supplements are present at unknown concentrations and have not been characterized as safe and effective by the FDA, making them unapproved drugs,” the authors write. “These products have the potential to cause severe adverse health effects.”
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Posted: October 2018