[ad_1]
NEW YORK (CNN) – Nearly 800 non-prescription food supplements from 2007 to 2016 contained unapproved pharmaceutical ingredients, according to a new data analysis by the US Food and Drug Administration. 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 can have serious adverse health effects due to accidental misuse, misuse or interaction with other drugs, health problems under or the presence of drugs contained in the same dietary supplement, "wrote the authors, led by Madhur Kumar, of California. Department of Public Health, Food and Drugs Directorate.
The study indicates that more than 50% of adults use dietary supplements, a $ 35 billion industry.
Kumar and his co-authors reviewed the FDA's database on contaminated products marketed under the name of Dietary Supplements_CDER from 2007 to 2016. The database is maintained on the agency's website as 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most commonly detected pharmaceutical ingredients in adulterated weight loss products were sibutramine, which had been withdrawn from the US market in 2010 due to cardiovascular risks, and laxative phenolphthalein.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 among 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 gaps in FDA regulation over supplements," wrote Cohen, who did not participated in this study.
Cohen, an associate professor of medicine at Harvard Medical School, believes that "more than FDA measures will be needed to ensure that all adulterated supplements are effectively and quickly removed from the market."
FDA spokeswoman 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 this problem as best as possible. that he can ". She noted that once a adulterated supplement is discovered, "the main goal of the agency is to mitigate any risk to public health by informing consumers about the dangers associated with the product and work to remove it 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 Dietary Supplements Act of 1994 by requiring companies to register supplements with the FDA prior to sale and by providing the FDA with more effective tools for enforce the law, such as the immediate revocation of the registration of an altered product.
In the meantime, the fact that the FDA "is not aggressively using all the tools available to remove the falsified pharmaceutical supplements from trade is putting the health of consumers at risk," wrote Cohen.
Related stories
Source link
