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According to a new analysis of data from the US Food and Drug Administration, nearly 800 non-prescription food supplements from 2007 to 2016 contained unapproved pharmaceutical ingredients.
According to a new analysis of data from the US Food and Drug Administration, nearly 800 non-prescription food supplements from 2007 to 2016 contained unapproved pharmaceutical ingredients. The study published Friday in the JAMA Network Open revealed that more than one unapproved pharmaceutical ingredient was found in 20% of these supplements.
The presence of prescription drugs, often at unknown concentrations, means that these supplements are essentially "unapproved drugs" that could harm the health of users, according to the authors of the study.
"These products may have serious adverse health effects due to accidental misuse, overuse or interaction with other drugs, underlying health problems, or the presence of medicines contained in the same dietary supplement, "wrote the authors, led by Madhur Kumar, of California. Department of Food and Drugs, Department of Public Health.
The study indicates that more than 50% of adults use dietary supplements, a $ 35 billion industry.
Kumar and his co-authors reviewed the FDA Contaminated Product Database marketed as Dietary Supplements_CDER from 2007 to 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 independently of the FDA.
The largest number of products containing hidden ingredients was reported in 2009, when two large boosters together named 99 products. In addition, 443 of the 776 products in total were reported from 2012 to 2016. In the vast majority of cases (97%), unapproved pharmaceutical ingredients were not reported on the supplement labels.
Most adulterated products, about 45%, were marketed to improve sexual performance, lose weight (about 41%) or develop muscle (12%). Sildenafil, tadalafil and vardenafil are drugs in prescription drugs for the treatment of erectile dysfunction that, if overused, can cause serious damage to the blood vessels.
The most commonly detected pharmaceutical ingredients in adulterated weight loss products were sibutramine, which had been withdrawn from the US market in 2010 due to cardiovascular risks, and laxative phenolphthalein. Many adulterated bodybuilding products contained undeclared anabolic steroids which, if abused, can lead to short-term mental problems and kidney problems, liver damage and long-term heart problems.
Antidepressants and antihistamines, which can have side effects and interact with other medications, are some of the other medications that are found in adulterated supplements.
"As the dietary supplement industry continues to grow in the United States, it is critical to further address this important public health issue," the authors concluded.
Dr. Pieter A. Cohen of the Cambridge Health Alliance, Mass., Said that although the FDA has discovered 746 adulterated supplements, it has announced voluntary recalls for less than half of these products.
"Only 360 out of 746 (48%) have been recalled, leaving the majority of falsified supplements, more than 350 products, available for sale," wrote Cohen in an editorial published with the study.
Although the FDA "has other application tools," the new study is consistent with previous research showing "major shortcomings in the regulation of FDA supplements," wrote Cohen, who did not participate in this study.
Cohen, an associate professor of medicine at Harvard Medical School, believes that "the FDA must not act to ensure that all adulterated supplements are effectively and quickly removed from the market."
FDA spokesperson Lindsay Haake wrote in an e-mail that "the FDA recognizes the seriousness of this problem and continues to act within the limits of its resources and authorities to resolve it as best it can. ". She stated that once an adulterated supplement was discovered, "The primary goal is to mitigate public health risks by informing consumers of the hazards associated with the product and striving to withdraw from the market as quickly as possible. "
Even after taking action against companies, the FDA "sometimes has a hard time discouraging the fraudulent commercialization of such products," including relabeling products to avoid detection, writes Haake.
Cohen suggested to Congress to reform the Health and Education Supplements Act of 1994 by requiring companies to register supplements with the FDA before sale and by providing the FDA with more effective tools to enforce the rules, such as the immediate revocation of the registration of an altered product.
In the meantime, the fact that the FDA "has not aggressively used all the tools available to remove falsified pharmaceutical supplements from trade is putting consumer health at risk," wrote Cohen.
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