Are Your Supplements Safe?

An Arivale Hot Topic

Niha Zubair, Arivale Clinical Research Scientist, PhD
Niha Zubair
Arivale Clinical Research Scientist, PhD

The supplement industry in the United States is booming, with roughly half of US adults consuming dietary supplements. But, a new study finds supplements with potentially hazardous hidden ingredients are still being sold despite warnings from the government.

The law defines dietary supplements as products taken orally that contain a “dietary ingredient.” This includes vitamins, minerals, amino acids, herbs/botanicals, and other substances that can be used to supplement the diet.

The FDA states dietary supplements are not intended to treat or prevent disease. And, unlike with pharmaceutical drugs, federal law doesn’t require dietary supplements to meet FDA safety standards prior to going on the market. In fact, the FDA only cares about supplements once they’ve entered the market. Reports of adverse effects, such as illness, injury, birth defects, or death; adulteration; or misbranding are recorded by the FDA. When a supplement has the potential to cause serious adverse health consequences, the FDA can take it off the market.

In terms of adulterated products, the FDA maintains a tainted supplements database on its website as a resource for the public. Each supplement in the database contains a potentially hazardous hidden ingredient and was issued a warning by the FDA. It’s important to note, however, that this database only displays a fraction of adulterated supplements, as the FDA claims it can’t test and identify all supplements with hidden ingredients.

The Study

In a study published earlier this month in JAMA Network Open – and covered by The Scientist – researchers analyzed data from the FDA’s tainted supplements database from 2007 through 2016.

During this time period, 776 adulterated dietary supplements – involving 146 different companies – were identified by the FDA. The greatest number of products containing hidden ingredients (173, or 22.3 percent of all adulterated supplements in the study) were reported in 2009 due to two large recalls that, in combination, identified 99 products. Of the 776 adulterated supplements, 157 (20.2 percent) contained more than one unapproved pharmaceutical.

Most adulterated products were marketed for sexual enhancement, weight loss, or muscle building. The most common adulterants for sexual enhancement, weight loss, and muscle building supplements were sildenafil (the active ingredient in Viagra), sibutramine (an appetite suppressant), and synthetic steroids/steroid-like ingredients, respectively.

Alarmingly, and despite an initial warning, there were 28 products with second or third warnings more than six months apart. Of these products, 19 were reported to contain new, unapproved ingredients in the second or third warning. This demonstrates that some potentially hazardous products continue to be sold even after warnings from the FDA.

Arivale’s Take

As the researchers note, adulteration of dietary supplements with active pharmaceutical ingredients is not accidental and “poses a serious public health risk as consumers unknowingly ingest these drugs.” Furthermore, the FDA is only able to test a portion of products available on the market, thus many more products than those recorded in the database are likely tainted.

As the dietary supplement industry is mostly unregulated and continues to grow, it’s essential to be a vigilant consumer. One way to avoid choosing potentially harmful supplements is to work with your primary health care provider or dietitian. Additionally, using supplements with a science backing and only when necessary is a prudent approach.

Finally, there’s a lesson in the most common types of adulterated supplements (sexual health, weight loss, and muscle building). These are areas where people are sometimes looking for a “magic bullet,” which unfortunately doesn’t exist.

Further Reading

[Arivale Hot Topics address health stories currently in the news. The Arivale Clinical Team’s commentary on these news articles is not a review of the scientific evidence, nor an endorsement of a specific study, and is not meant as official medical opinion.]