These hundreds of supplements include unapproved pharmaceuticals

Henrietta Strickland
October 14, 2018

The review of a Food and Drug Administration database of contaminated supplements for the years 2007 to 2016 most commonly turned up sildenafil - the drug sold as Viagra - and other erectile dysfunction drugs in sex enhancement products; sibutramine and the laxative phenolphthalein, both banned by the FDA, in weight loss supplements; and steroids or their analogues in muscle-building products.

Overall, almost 80 percent of all the supplements contained one unapproved drug ingredient, while over 20 percent contained more than one.

Sibutramine, a potentially unsafe weight-loss drug was found in 85 percent of the adulterated slimming supplements and steroids or steroid synthetics were in almost 90 percent of muscle building supplements.

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. Pop a pill that contains a drug that lowers your blood pressure, and if you happen to suffer from low blood pressure already, the consequences of this lack of oversight could be dire.

The greatest number of products found to contain hidden ingredients were reported in 2009, when two large recalls together named 99 products.

The drugs found in the supplements have "the potential to cause serious adverse health effects owing to accidental misuse, overuse or interaction with other medications, underlying health conditions or other pharmaceuticals", the researchers wrote.

Thanks to the 1994 Dietary Supplement Health and Education Act, dietary supplements are classified as food rather than drugs, and are thus not subjected to the same stringent standards for premarket safety and effectiveness. The $35 billion supplement market includes multivitamins, minerals, botanicals and other products.

During this period, 776 dietary supplements were found to contain drugs.

"Active pharmaceuticals continue to be identified in dietary supplements, especially those marketed for sexual enhancement or weight loss, even after FDA warnings".

'The law permits supplements to be sold as if they work in humans, and that creates a perverse incentive for [manufacturers] to sneak something in there so it will actually work'.

"The FDA didn't even bother to recall more than half of the potentially hazardous supplements", writes Dr. Pieter Cohen, a Harvard Medical School professor and an internist with Cambridge Health Alliance in Boston, in an accompanying editorial comment to the paper.

"While the FDA does not assess the safety of supplements prior to market, the agency is tasked with identifying and removing adulterated and hazardous supplements from the marketplace", he wrote.

Plus, 'the recalls aren't completely effective, but the FDA isn't even bothering to recall many of these products, ' he says. But the study found that the FDA rarely employed such tools; out of the 146 companies involved in the making of the tainted supplements, the FDA issued just seven warning letters; and did not issue any mandatory recalls. Others may choose them because they are less expensive or because they are readily available at gas stations and convenience stores, Cohen said. Sibutramine, widely found in the weight loss products, can substantially increase blood pressure and pulse rate. Cohen advises consumers to speak with their doctor before they start taking a supplement.

"As the dietary supplement industry continues to grow in the United States, it is essential to further address this significant public health issue", the researchers wrote.

Other reports by Click Lancashire

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