A team of researchers, led by Madhur Kumar of the California Department of Public Health Food and Drug Branch, recently uncovered that 776 supplements sold over the counter - from 146 companies - from 2007 through 2016 contained unapproved pharmaceutical ingredients.
More than 50% of adults use dietary supplements, a $35 billion industry, notes the study. Despite these contaminants, fewer thanhalf the products were recalled.
What's more, although the Food and Drug Administration (FDA) identified these tainted supplements, less than half of these products were recalled.
Though the FDA "has other enforcement tools at its disposal", the new study is consistent with previous research showing "major deficiencies in the FDA's regulation of supplements", wrote Cohen, who was not involved in this study.
Overall, almost 80 percent of all the supplements contained one unapproved drug ingredient, while over 20 percent contained more than one.
Results: Unapproved pharmaceutical ingredients were identified in 776 dietary supplements, a lot of them marketed for sexual enhancement, weight loss or muscle building; 20 percent of the products had more than one unapproved ingredient; and 28 products were named in two or three warnings.
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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.
The study focused on various warnings and alerts put forth by the FDA from 2007 through 2016 regarding tainted supplements.
Plus, 'the recalls aren't completely effective, but the FDA isn't even bothering to recall many of these products, ' he says.
When a company refuses to voluntarily recall its products, the FDA has a number of tools it can use to get the product off the market: the agency can send a warning letter to the company, visit the factory for an inspection or issue a mandatory recall. He cited a 2014 study that he and others conducted that found 20 of 27 supplements were still adulterated with drugs and available for purchase between eight and 52 months after they were recalled by the FDA. Others may choose them because they are less expensive or because they are readily available at gas stations and convenience stores, Cohen said. Additionally, patients who take prescription medications already and then add a supplement without their doctor's knowledge could be at risk of drug interactions without even knowing it. For example, sibutramine can increase blood pressure or heart rate, which could be risky for people with a history of stroke or heart disease.
According to the paper, previous research has found that dietary supplement use was associated with 23,000 trips to the emergency room and 2,000 hospitalizations in the US annually. If a supplement is deemed a health risk, then the agency can issue a class action recall; however, this is hard to prove and often goes underreported. That way, each supplement would have a registration code to identify it, which would allow the FDA to know exactly what supplements are being sold in the country. She noted that once an adulterated supplement is discovered, "the agency's primary objective is to mitigate any risk posed to public health by informing consumers about any dangers associated with the product and to work to remove it from the market as soon as possible".
Men precluded from taking erectile dysfunction drugs may turn to these supplements, not realizing that they are getting the very same pharmaceuticals, they said.
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