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SILVER SPRING, MD- Nearly 800 dietary supplements sold by the United States. More than one unapproved pharmaceutical ingredient was found in 20% of these supplements, the study published Friday in JAMA Network Open showed.
The presence of prescription drugs, often at unknown concentrations, means that they 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 effects" accidental misuse, "overuse," or "interaction with other medications," or "other diseases", "wrote the authors," 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 independent analysis of the FDA.
The greatest number of products were reported in 2009, when two large recalls together named 99 products. Otherwise, 443 of the total 776 products were reported in 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 in anabolic steroids, which, when abused, can lead to mental problems in the long term.
Other drugs include antidepressants and antihistamines, and both interact with other medications.
"As the dietary supplement industry continues to grow in the United States, it is essential to further address this significant public health issue," the authors concluded.
Dr. Pieter A. Cohen of Cambridge Health Alliance in Massachusetts said that the FDA discovered 746 adulterated supplements.
"Only 360 of 746 (48%) were reviewed, leaving the majority of adulterated supplements, more than 350 products," Cohen wrote in an editorial published with the study.
Though the FDA "has other enforcement tools at its disposal," the FDA's "major deficiencies in the FDA's regulation of supplements," wrote Cohen, who was not involved in this study.
Cohen, an associate professor of medicine at Harvard Medical School, believes that "more than FDA action will be required to ensure that all adulterated supplements are effectively removed from the market."
FDA spokeswoman Lindsay Haake wrote in an email that said, "the FDA recognizes the seriousness of this problem and continues to report it." primary objective is to mitigate any risk posed to the public by consumers as to any risks associated with the product and to work to remove it from the market as soon as possible. "
Even after taking action against companies, the FDA sometimes "faces several challenges in deterring fraudulent marketing of these types of products," including relabeling of products to evade detection, Haake wrote.
Cohen suggests that Congress reform the Dietary Supplement Health and Education Act of 1994 by providing additional information to the FDA and providing the FDA with more effective enforcement tools.
In the meantime, the FDA's "failure to aggressively use drugs at risk," Cohen wrote.
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