Nearly 800 nutritional supplements, from 2007 to 2016 over the counter were sold, contained unauthorized drug substances, a new analysis of the US Food and Drug Administration data found. More than one unauthorized pharmaceutical ingredient was found in 20% of these supplements, as revealed by the study published on Friday in JAMA Network Open.
The presence of prescription drugs, often in unknown concentrations, means that these supplements are essentially "unauthorized medicines" (19659004) "These products can have serious health consequences due to accidental misuse, overuse or interaction The same dietary supplements are due to other medicines, underlying health conditions, or other drugs in the US, "write the authors, led by Madhur Kumar of the California Department of Public Health, Food and Drug Administration.
More than 50% of adults use nutritional supplements, a $ 35 billion industry, the study notes
Kumar and his co-authors have contaminated the FDA's "Dietary Supplements_CDER" database for the years 2007-2016 Products checked. The database is managed on the agency The site of y as a resource for consumers and to increase transparency and public knowledge. The researchers performed the new analysis independently of the FDA.
The largest number of products containing hidden ingredients was reported in 2009 when two major callbacks together named 99 products. Otherwise, from 2012 to 2016, 443 of the total of 776 products were reported. In the vast majority of cases (97%), the unauthorized pharmaceutical ingredients were not declared on the supplements labels.
Most of the adulterated products, about 45%, were marketed for sexual enhancement, weight loss (about 41%), or muscle gain (12%). The drugs that are included in sexual enhancement products include sildenafil, tadalafil, and vardenafil, all prescription drugs used to treat erectile dysfunction that, if used too much, can cause serious damage to the blood vessels.
The most commonly reported pharmaceutical ingredients are weight gain loss products were sibutramine, which was taken off the US market in 2010 for cardiovascular risks, and the laxative phenolphthalein. Many of the adulterated muscle building products contained undeclared anabolic steroids, which in the short term can lead to mental health problems and kidney problems, liver damage and heart problems.
Other medications in adulterated nutritional supplements These include antidepressants and antihistamines, both of which have side effects and may interact with other medications.
"As the nutritional supplement industry continues to grow in the United States, it is important to continue to address this important public health issue," the authors concluded
. Pieter A. Cohen of the Massachusetts Cambridge Health Alliance said that although the FDA discovered 746 adulterated supplements, it has announced voluntary recalls for less than half of those products.
"Only 360 out of 746 (48%) were recalled from adulterated supplements, more than 350 products, available for sale," Cohen wrote in an editorial published with the study.
Although the FDA "has other enforcement tools available," the new study is in line with previous research, "" Cohen, who was not involved in this study.
Cohen, an associate professor of medicine at Harvard Medical School, believes that "more than FDA measures are needed to ensure that all adulterated nutritional supplements are taken effectively and quickly off the market."
FDA spokeswoman Lindsay Haake wrote in an e-mail that "the FDA recognizes the seriousness of this problem and it remains prepared to address this issue as well as possible within its resources and authorities." She noted that after discovering a fake booklet, the The primary objective of the Agency is to reduce risks to public health by informing consumers about potential dangers of working with the product and removing it from the market as soon as possible. "
Even after taking action against companies, the FDA faces" some challenges in deterring fraudulent commercialization of these types of products, "including product renaming To avoid detection, Haake wrote.
Cohen suggested Congress reformed the 1994 Diet Supplement Health and Education Act by requiring companies to register supplements with the FDA prior to sale and to provide FDA with more effective enforcement tools such as immediate deprivation of a misappropriated product
In In the meantime, the FDA has "not aggressively used all available aggressiveness tools to remove pharmaceutically adulterated supplements from the trade, jeopardizing consumer health," Cohen wrote.