Do Your Supplements Contain Unapproved Pharmaceuticals?

Viagra, steroids, and appetite suppressant drugs may be helping your supplements do their job – here’s where to see the list.

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. The database contains supplements that the FDA has purchased, tested and found to be adulterated.

In a report published on JAMA Network Open, the authors explain that potentially harmful active drugs continue to be identified by the FDA in over-the-counter dietary supplements. The authors write: 

“In this quality improvement study, analysis of the US Food and Drug Administration warnings from 2007 through 2016 showed that unapproved pharmaceutical ingredients were identified in 776 dietary supplements, and these products were commonly marketed for sexual enhancement, weight loss, or muscle building. The most common adulterants were sildenafil [Viagra] for sexual enhancement supplements, sibutramine [Meridia] 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.”

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. Instead, the FDA only gets involved after a supplement has been shown to be harmful, at which point the agency can issue a recall.

But then there’s this: “Even after FDA tests proved the supplements contained unapproved or recalled medications,” reports NPR, “many of the products continued to be marketed and sold, the analysis finds.”

“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. “How could it be that our premier public health agency spends the time and money to detect these hidden ingredients and then doesn’t take the next obvious step, which is to ensure that they are removed from the marketplace?”

Meanwhile, over half of American adults say they take dietary supplements. And while we all believe that supplements must be doing good things for us, they can cause a lot of harm.

According to the paper, previous research has found that dietary supplement use was associated with 23,000 trips to the emergency room and 2,000 hospitalizations in the U.S. annually. They list adverse events due to the use of dietary supplements as stroke, acute liver injury, kidney failure, pulmonary embolisms, and death.

You can read about the methodology and specifics of the report here, Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated With US Food and Drug Administration Warnings. But we’ll just cut to the chase with the report’s conclusion:

“Active pharmaceuticals continue to be identified in dietary supplements, especially those marketed for sexual enhancement or weight loss, even after FDA warnings. The drug ingredients in these dietary 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 within the supplement.”

And here’s the database where you can see which supplements are on the FDA’s naughty list – but be warned, the list only includes a small fraction of the potentially hazardous products with hidden ingredients marketed to consumers on the internet and in retail establishments, notes the FDA. Still, it’s a start: Tainted Products Marketed as Dietary Supplements_CDER.