Do Your Supplements Contain Unapproved Pharmaceuticals?


Kumar and his co-authors reviewed the FDA's Tainted Products Marketed as Dietary Supplements_CDER database for 2007 through 2016.

There may be a good reason why that miracle herbal supplement is working so well - it may be getting some help from the big guys - active pharmaceuticals - according to a new analysis of a US Food and Drug Administration database.

Cohen is the author an editorial that accompanies the new analysis, which was published online October 12 in JAMA Network Open.

Almost 800 dietary supplements sold in the United States were found to be contaminated with unapproved ingredients - in some cases, drugs that have been banned by the Food and Drug Administration - in an industry analysis by California public health scientists.

An estimated 50 percent of Americans consume some type of dietary supplement, sustaining a $35 billion industry.

Dietary supplements include vitamins, minerals, botanicals, amino acids, and enzymes that according to the US Food and Drug Administration (FDA) are not meant to treat or prevent disease. The most common adulterants were sildenafil for sexual enhancement supplements, sibutramine for weight loss supplements, and synthetic steroids or steroid-like ingredients for muscle building supplements, with 157 products (20.2%) containing more than 1 unapproved ingredient.

The most common pharmaceutical ingredients detected in adulterated weight loss products were sibutramine, which was removed from the U.S. market in 2010 due to cardiovascular risks, and the laxative phenolphthalein.

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Results From 2007 through 2016, 776 adulterated dietary supplements were identified by the FDA and 146 different dietary supplement companies were implicated.

The study, published in JAMA Network Open, revealed that more than one unapproved pharmaceutical ingredient was found in 25 per cent of those supplements. Worst of all, the FDA had failed to issue a product recall for more than half of them.

Other drugs found in the adulterated supplements include antidepressants and antihistamines, both of which may have side effects and interact with other medications.

The FDA's Dietary Supplement Health and Education Act of 1994 essentially places the burden for evaluating supplement safety, content and labeling primarily on the shoulders of the manufacturers. Discounting a number of multiple warning for some products, the researchers identified a total of 776 dietary supplements. The appetite suppressant, previously sold as Meridia, has been pulled from the market in the United States over concerns about an increased risk for cardiovascular events.

"There's many problems with the law [regulating supplements], so the ideal situation would be to revise the law so the FDA could do this much more efficiently", Pieter Cohen, an assistant professor at Harvard Medical School who has studied the dangers of supplements, told Gizmodo.

However, less than half of these products were recalled after the FDA learned of their contents, which has left the federal agency facing criticism for failing to pursue companies that are selling the misleading supplements. "Because there is a clear set of steps you can take". Cohen advises consumers to speak with their doctor before they start taking a supplement. Nearly all the muscle building supplements, 82 out of 92 products, contained synthetic steroids or steroid-like ingredients.