Severe medical events as a result of dietary supplement use – sold for weight loss, sexual function, muscle building and energy – are experienced by young people at a threefold higher rate than vitamin use. This is according to new Harvard T.H. Chan School of Public Health research, which cites the findings as “very concerning.” Although the study did not identify particular “risky” ingredients in the supplements, previous research has found that undeclared prescription pharmaceuticals, steroids, kava and germander are likely culprits, as they can lead to liver damage and other concerning health consequences. The team asserts that proactive enforcement of regulations is needed to reduce access and consumption among adolescents and young adults – the key demographic attracted to these kinds of supplements.
“The Food and Drug Administration (FDA) has issued countless warnings about supplements sold for weight loss, muscle building or sport performance, sexual function and energy, and we know these products are widely marketed to and used by young people. So what are the consequences for their health? That’s the question we wanted to answer,” says lead author Flora Or, Researcher with Harvard Chan School’s Strategic Training Initiative for the Prevention of Eating Disorders.
“These supplements are adulterated with toxic ingredients, based on prior research. We are only describing the tip of an iceberg because there is huge under-reporting both on the consumer and on the physician side [on adverse health impacts],” she tells.
The findings follow a recent FDA move to significantly “modernize” dietary supplement regulations and root out “bad actors” that distribute and sell dangerous products. It released a new Dietary Supplement Ingredient Advisory List containing warnings about unlawful ingredients in dietary supplements.
While many dietary supplements do meet the FDA’s standards, there are some companies who knowingly distribute and sell dangerous or otherwise illegal products that put consumers at risk, according to the regulatory agency.
This new Harvard study enforces concern over the efficacy and safety of some supplements, especially when they are targeted at vulnerable populations such as young people.
The supplements can be adulterated with toxic ingredients and are often marketed to young adults.
The researchers looked at adverse medical events that were reported between January 2004 and April 2015 in the FDA Adverse Event Reporting System on the food and dietary supplements database. They analyzed the relative risk for severe medical events such as death, disability and hospitalization in individuals aged 25 years and under that were linked with the use of dietary supplements sold for weight loss, muscle building, or energy – compared to vitamins.
They found that there were 977 single-supplement-related adverse event reports for the target age group. Of those, approximately 4 percent involved severe medical outcomes, including death and hospitalization.
Why are these supplements still on the market?
Despite FDA warnings on such supplements, many are still available for purchase.
This is due to two main reasons, Or tells. “First, dietary supplement manufacturers do not have to get the agency’s approval before producing or selling these products,” she notes.
“Second, the Dietary Supplement Health and Education Act prohibits the FDA from prescreening supplements for safety or efficacy and instead forces the agency to rely on an honor system in which manufacturers are expected by the government to ensure the safety of their products before launching them on the market.”
A further problem arises as, following consumer supplement use, it can be difficult to track the rates of dangerous outcomes as consumer and physician reporting tends to be low.
“Consumers are unlikely to link the symptoms to the supplements they consumed and report them unless the symptoms are very severe. There is also prior research suggesting that physicians under-report adverse events associated with dietary supplements,” she adds.
Moving forward, more research is needed to evaluate the effectiveness of different policy strategies to protect young people from dangerous dietary supplements.
Earlier this week, the FDA issued a warning to consumers about concerns regarding the safety of vinpocetine, an ingredient often marketed for cognitive sharpness. Specifically, the agency is voicing concerns about the use of this ingredient by women of childbearing age, following reports stating that vinpocetine may cause a miscarriage or harm fetal development.
In a similar vein, the FDA is seeking to provide “legal pathways” to the growing market of supplements and food and beverage products infused with cannabidiol (CBD). On May 31, the agency held a public hearing on products containing cannabis or cannabis-derived compounds, signaling its commitment to adequately respond to this growing industry opportunity and ensure consumer safety. More than 500 people attended the hearing and over 800 people registered to join the event remotely, while 100 speakers presented on the topic. “We encourage all stakeholders – presenters, attendees, and those unable to participate in today’s hearing – to submit comments to our docket on this topic, which is open until July 2, 2019,” noted Norman E. Sharpless, MD, USFDA Acting Commissioner of Food and Drugs.