Supplement aisles are lined with a combination of legitimate vitamins and loosely regulated products that make big claims about enhancing sexual performance, boosting energy, building muscle, and losing weight. But those flashy claims may come with some serious health risks, according to new research out of Harvard University’s T.H. Chan School of Public Health.
The FDA maintains a database where consumers can register any harm that may have come to them as a result of a supplement. An analysis of 11 years of these “adverse event” reports published in The Journal of Adolescent Health showed that dietary supplements for weight loss, energy, sexual function, and muscle building had especially poor track records.
"By severe medical outcomes, I mean hospitalization, disability, emergency room visits and even death."
Forty percent of reports on those supplement types were tales of “severe medical outcomes,” study author Flora Or, Sc.D., a research fellow at the Chan School’s Strategic Training Initiative for the Prevention of Eating Disorders, tells Inverse.
“By severe medical outcomes, I mean hospitalization, disability, emergency room visits and even death,” Or says. “The most important takeaway is that relative to vitamins, supplements sold for weight loss, energy, and muscle building are almost three times the risk for severe medical events.”
Or conducted her analysis of FDA reports alongside S. Bryn Austin, Ph.D., a social epidemiologist and behavioral scientist at Harvard and the paper’s senior author. Together, they found that that muscle building supplements, weight loss supplements, and energy supplements had roughly three times greater risk of an adverse event than traditional vitamins. Sexual enhancement supplements showed 2.4 times greater risk than traditional vitamin supplements.
How common is it to actually pick up a supplement that makes a flashy claim? Fifty-two percent of Americans report taking dietary supplements in general, and other research has pointed to the idea that significant numbers of teens are also drawn to use supplements, particularly to increase muscle mass — one of the three in Or’s risky bunch. The 2016 Growing Up Today Survey published in Pediatrics noted that 12 percent of teenage boys reported using a muscle-building product in the past year.
In this analysis, 18- to 25-year-olds experienced the highest rates of these adverse events, but they also made up the greatest percentage of the dietary supplement user base. Of the 977 reports that involved only one supplement, 578 came from 18- to 25-year-olds.
“People should definitely stay away from supplements sold for weight loss, muscle building, sexual function, weight loss, and energy,” says Or.
But her results are just part of a bigger picture. Earlier work suggests that these supplements are risky because they contain ingredients that aren’t listed on the labels — including drugs like sildenafil, more commonly known as Viagra.
In other words, it’s not always clear what ingredients are in these types of dietary supplements, which points to issues with how these products are regulated.
Due to the 1994 Dietary Supplement Health and Education Act (DSHEA), manufacturers and distributors of supplements are responsible for showing that they’re safe and effective. Then, once the product hits shelves, the FDA can take action and issue warnings or recalls if adverse event reports arise.
However, in light of the severity of these events, Or and her co-authors urge a repeal of DSHEA, since it only addresses safety issues after something has gone wrong. They call the regulatory landscape “utterly insufficient” in light of the risks they expose.
“This act prohibits the FDA from pre-screening products for safety and efficacy, and instead, forces the FDA to rely on an honor system by which manufacturers are expected to ensure the safety of their products on the market,” she says. “As you can tell, that can be problematic.”
That system places the burden on the consumer to report these sometimes severe effects, which these authors used to illuminate which types supplements seem to present the greatest risks. But it also means that we’re likely only getting part of the story. Or says that these findings “are really just showing the tip of an iceberg, because there are huge underreporting of these adverse events.”
People may not report their adverse event to physicians — not many people will admit to taking massive amounts of Cobra Sexual Energy, for instance. And additionally, some physicians may not register these cases with the FDA, she explains.
But despite the underreporting of these adverse events, Or notes that there is some movement toward limiting the sale of certain types of weight loss supplements to minors. For example, there’s proposed legislation in New York City that would ban the sale of some weight loss supplements, like “flat tummy teas” (which are technically dietary supplements) to teens.
But the safest thing for right now is to keep an eye on any supplement that claims to have a flashy effect. Or’s research shows that weight loss, sexual function, and muscle building supplements certainly have an impact, but it may not be the one consumers are hoping for.
Purpose: The aim of the study was to evaluate the relationship between supplement categories and adverse events in children, adolescents, and young adults.
Methods: This is a retrospective observational study using adverse event reports between January 2004 and April 2015 in the U.S. Food and Drug Administration Adverse Event Reporting System on food and dietary supplements database. We quantified the relative risks for severe medical events of dietary supplements sold for various functions relative to vitamins among individuals aged between 0 and 25 years. Severe medical events include death, disability, life-threatening events, hospitalization, emergency room visit, and/or required intervention to prevent permanent disability.
Results: There were 977 single-supplement erelated adverse event reports affecting individuals aged between 0 and 25 years over 11 years (50.6% female; age: mean 1⁄4 16.5 years, standard deviation 1⁄4 7.5 years). Supplements sold for muscle building (risk ratio [RR] 1⁄4 2.7; 95% confidence interval [CI] 1⁄4 1.9e4.0), energy (RR 1⁄4 2.6; 95% CI 1⁄4 1.9e3.6), and weight loss (RR 1⁄4 2.6; 95% CI 1⁄4 1.9e3.4) were associated with almost three times the risk for severe medical events compared with vitamins.
Conclusions: Consumption of dietary supplements sold for weight loss, muscle building, and energy involved increased risks for severe medical events compared with vitamins. Proactive enforcement of regulations is needed to reduce access and consumption among children, adolescents, and young adults.