Recent Op-Ed calls for separate adverse event reporting system just for military personnel

A recent Op-Ed published in Air Force Times expressed concern about the impact dietary supplement usage in the armed forces could have on military readiness. Specifically, the authors noted the lack of a system to track adverse events experienced by service members taking dietary supplements, citing research that estimates less than 2% of adverse events are even reported to the U.S. Food and Drug Administration (FDA). This research¹ also showed that many healthcare practitioners did not know how to report adverse events to the agency.

In the study, out of 270 Department of Defense nonphysician healthcare professionals (HCPs), such as dietitians, physician assistants or occupational therapists, and 68 emergency medicine physicians (EMPs), only 40% of HCPs knew where to report adverse events and only 38% knew how to report them. Only 38% of EMPs asked their patients about dietary supplements, however, 78% of them reported encountering an adverse event. Of those EMPs, only 12% confirmed reporting the adverse event, however none of these were reported to FDA, but rather another specialist (12%), poison control (9%), or hospital database (7%). Clearly, this indicates that greater education is needed to educate healthcare practitioners about dietary supplements and adverse event reporting. In fact, at least 39% of HCPs and 59% of EMPs reported never receiving formal training on dietary supplements.

When it comes to adverse events, the majority are due to adulterated products. Adulterants such as steroids, stimulants and prescription drugs can be dangerous on their own, but interaction with other prescribed drugs or over-the-counter medicine can also pose a substantial risk. That is why the Department of Defense established Operation Supplement Safety (OPSS), which is a critical resource for service members and their healthcare providers, so that they can make informed decisions about the products they take. The program allows service members to ask experts questions, and maintains a continuously updated list of prohibited ingredients on its website. Offering resources to service members is important because research shows that dietary supplement usage is higher among service members than the general population. This higher usage is also where much of the military’s concerns stem from.

The authors of the article cite a study² from 2018 which found that out of 39,977 service members, 69% reported taking dietary supplements more than once a week, most commonly: multivitamin or multiminerals (50%), antioxidants (34%), individual vitamins or minerals (33%), bodybuilding supplements (27%), fish oils (26%), herbals (16%), and weight-loss supplements (16%). Usage was higher among women, those with higher education levels, Marine Corps. Service members, officers, those with higher body mass index, and those engaged in greater physical activity, weight training, and weight control programs. Because sports nutrition products are more prone to adulteration, and therefore adverse events, the authors of the paper advocate for discouraging of dietary supplements through peer groups and leadership action to reduce their usage, and prevent adverse events.

Despite the access service members have to valuable educational resources, the authors of the Air Force Times article view dietary supplements usage as a liability, and advocate for a centralized adverse event reporting system just for the military to better track and mitigate adverse events in the future. In fact, legislation recently signed into law by President Biden, called The National Defense Authorization Act of 2022, includes reporting language from both the Senate and House committees urging the Department of Defense to address the gap in reporting of dietary supplement related adverse events.

“The reporting language from both committees is a huge step forward in the effort to have an internal Department of Defense reporting system that has not been realized to date, despite a recommendation by the Institute of Medicine in 2008. Adverse event reporting on dietary supplements in the Department of Defense would inform both the military health system and the FDA about potential health risks, which would have a beneficial impact on patient care, public safety, and mission readiness,” the authors conclude.

In response to the article, president and CEO of the Council for Responsible Nutrition (CRN) expressed how important the safety of service members is, but did not agree that a centralized adverse event reporting system for the military was necessary.

“The current federal adverse event reporting system (AER) administered by FDA works. Creating additional federal bureaucracy to duplicate this effort inside the military is counterproductive and wasteful,” said Mister. “CRN supports mandatory product listing, which will allow FDA to see all supplement labels and identify potential problems. Our members share our commitment to transparency and are required to submit information on all the products they manufacture and market in the Supplement OWL. Adding a redundant regulatory mechanism likely won’t address the underlying problem of spiked products, and would be a disservice to our military.”

Reference

1. Rittenhouse M et al. “Dietary supplements: knowledge and adverse event reporting practices of department of defense healthcare providers.” Military Medicine, vol. 185, no. 11-12 (2020): 2076-2081
2. Knapik JJ et al. “Dietary supplement use in large representative sample of the U.S. Armed Forces.” Journal of Academy of Nutrition and Dietetics, vol. 118, no. 8 (2018): 1370-1388