While dietary supplements are marketed as safe and all-natural, a recent study has found that many of them contain dangerous substances, including unapproved and unregulated pharmaceutically active ingredients. The authors of the study wrote that the substances represent “a serious public health concern.” The study was recently published in JAMA Network Open.
Researchers from the California Department of Public Health based their findings on an analysis of a Food and Drug Administration database that identifies “tainted” supplements. The products were marketed as dietary supplements from 2007 to 2016. Out of the products tested, 776 of them contained hidden active ingredients that are unstudied or considered unsafe.
An estimated 50 percent of Americans consume some type of dietary supplement, sustaining a $35 billion industry. They include vitamins, minerals and botanicals. The supplements aren’t classified by the FDA as drugs, but are considered foods. They are not intended to treat or prevent disease and are not subject to premarket safety and efficacy testing.
Being tainted or adulterated means that the product contains active ingredients not listed on the label. The FDA database tracked problems that emerged during “post-market surveillance,” which includes adverse-events reports and consumer complaints. Usually, the FDA handles these issues with warning letters and agency requests for voluntary recalls by the manufacturer.
Of the adulterated supplements analyzed during the study, about 46 percent were marketed for sexual performance, 41 percent were marketed for weight loss, and 12 percent were for building muscle. One of the substances found in the supplements was dapoxetine, an antidepressant that is not approved in the United States. Another was sibutramine, which was banned from the US market in 2010 due to cardiovascular risks. Sildenafil, the active drug in Viagra, and ephedrine, a stimulant banned since 2004, were also found in the supplements.
Having these undisclosed ingredients in the supplements exposes the public to serious health risks. The authors wrote, “Adulterated dietary supplements have the potential to cause adverse health effects both on their own and also in combination with other medications an individual may be taking.”