Most of the adulterated products were marketed for sexual enhancement, analysis finds
The supplements could harm the health of those who take them, authors said
Nearly 800 dietary supplements sold over the counter from 2007 through 2016 contained unapproved drug ingredients, a new analysis of US Food and Drug Administration data found. More than one unapproved pharmaceutical ingredient was found in 20% of those supplements, the study published Friday in JAMA Network Open showed.
The presence of prescription medicines, often at unknown concentrations, means these supplements are essentially “unapproved drugs” that could be harmful to users’ health, according to the study authors.
“These products have the potential to cause severe adverse health effects owing to accidental misuse, overuse, or interaction with other medications, underlying health conditions, or other drugs within the same dietary supplement,” wrote the authors, led by Madhur Kumar of the California Department of Public Health Food and Drug Branch.
More than 50% of adults use dietary supplements, a $35 billion industry, notes the study.
Kumar and his co-authors reviewed the FDA’s Tainted Products Marketed as Dietary Supplements_CDER database for 2007 through 2016. The database is maintained on the agency’s website as a resource for consumers and to increase transparency and public knowledge. The researchers performed the new analysis independent of the FDA.
The greatest number of products found to contain hidden ingredients were reported in 2009, when two large recalls together named 99 products. Otherwise, 443 of the total 776 products were reported from 2012 to 2016. In the overwhelming majority of cases (97%), the unapproved pharmaceutical ingredients were not declared on the labels of the supplements.
Most of the adulterated products, about 45%, were marketed for sexual enhancement, weight loss (about 41%) or muscle-building (12%). Drugs found in sexual enhancement products included sildenafil, tadalafil and vardenafil, all active ingredients in prescription medications intended for erectile dysfunction, which, when overused, can cause serious damage to the blood vessels.
The most common pharmaceutical ingredients detected in adulterated weight loss products were sibutramine, which was removed from the US market in 2010 due to cardiovascular risks, and the laxative phenolphthalein. Many of the adulterated muscle building products contained undeclared anabolic steroids, which, when abused, can lead to mental problems in the short term and kidney problems, liver damage and