Published: Sun, October 14, 2018
Medicine | By Brett Sutton

Frequency of Unapproved Drug Ingredients in Supplements Indicates Need for Reform

Frequency of Unapproved Drug Ingredients in Supplements Indicates Need for Reform

Numerous adulterated muscle building products contained undeclared anabolic steroids, which, when abused, can lead to mental problems in the short term and kidney problems, liver damage and heart problems in the long term.

More than half of American adults say they use dietary supplements - which include vitamins, minerals, botanicals, amino acids, and enzymes not meant to treat or prevent disease - amounting to a $35 billion industry. Twenty percent contained at least two such drugs, and two of the supplements contained six unapproved drugs.

Some of these contained a cut-rate downgrade of the advertised ingredients, but of much more grave concern, numerous supplements that were marketed as 'natural, ' contained often-experimental versions of pharmaceutical drugs. Despite these contaminants, fewer thanhalf the products were recalled.

In the paper, written by officials in California public health agencies, the authors combed through data from FDA's Center for Drug Evaluation and Research for details about the offending products.

Controversy over adulterated supplements stretches back decades.

Cohen suggested that Congress reform the Dietary Supplement Health and Education Act of 1994 by requiring companies to register supplements with the FDA prior to sale and by providing the FDA with more effective enforcement tools such as immediately revoking an adulterated product's registration.

More than 50% of adults use dietary supplements, a $35 billion industry, notes the study.

About JAMA Network Open: JAMA Network Open is the new online-only open access general medical journal from the JAMA Network.


Sibutramine - an appetite suppressant taken off the market in 2010 due to cardiovascular risks - was cited in almost 85 percent of weight-loss supplements, according to the report.

'How we can have the premier public health agency not getting its job done is completely mystifying, ' he said. "This is someone spiking the product. It's not a supplement in any way, shape or form".

'There are actively experimental drugs in supplements that the FDA is aware of but they are not sharing that information with the public, ' says Dr Cohen.

But Pieter Cohen, who wrote an editorial that accompanied the new study, said many tainted supplements actually come from well-known manufacturers based in the United States.

The study goes on to explain that some of the supplements which received warnings from the FDA were found to still contain unapproved prescription drugs long after the discovery was made.

"This indicates that these products continue to be sold and are potentially unsafe even after FDA warnings", Kumar and co-authors wrote.

A spokesman for the FDA said the agency would comment later Friday.

As far as trends are concerned, the authors found that actions taken against steroid-tainted muscle building products had all but ceased after 2011. "If people choose to start taking supplements without medical advice, Cohen recommends 'single-ingredient" supplements rather than supplements with mixtures of ingredients, and to avoid supplement that promise health benefits like weight loss. Sibutramine for weight loss was also identified, even though it has the potential to increase blood pressure or pulse rate, especially in those with a history of heart disease or stroke. And Congress could require pre-market third-party testing of supplements-particularly of supplements advertised as weight loss, sex enhancement, or body building aids-to assure that they don't contain unsafe or unlabeled ingredients. But despite their recent popularity, a recent study shows that these supplements may not be what consumers think they are. 'There's just no way to interpret this other than the FDA is simply not doing its job, ' Cohen said.

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