DENVER — Use of herbs and supplements to treat various conditions has been increasing in pediatric patients, making it essential that providers ask about supplement use and review safety of supplements with families, according to a session presented at the annual meeting of the American Academy of Pediatrics.
“We must approach herbs and supplements with an open mind and consider [their use] through multiple lenses, including both potential health benefits and morbidity, safety and efficacy, affordability, and equity of access,” Cora Breuner, MD, MPH, a professor of pediatrics and adolescent medicine at Seattle Children’s Hospital and the University of Washington, told attendees.
Sales keep increasing in the supplement industry, which is estimated to generate over $124 billion by 2033 in the US. More than half of American adults and more than a third of American children report taking at least one type of dietary supplement, including multivitamins, in a 2023 review. Non-Hispanic White populations and those with a higher family income, greater food security, private health insurance, and higher levels of education report higher use.
Among children, the age group with the highest prevalence of use was aged 2-5 (43%), followed by 6- to 11-year-olds (37.5%), 12- to 19-year-olds (30%), and those under 2 years old (22%). Though multivitamins were the most common type of supplement taken, a study in 2020 found that use of non-vitamin, non-mineral supplements is increasing, particularly among adolescents. The most common ones are omega-3 fatty acids, probiotics, fiber, and melatonin.
Despite high rates of use and the fact that most people use traditional, complementary, or alternative medicine (TCAM) alongside conventional medicine, research has also found low rates of disclosure of TCAM use to healthcare providers, primarily because of fear about the provider’s judgment. There is a place for use of herbs and supplements in pediatric practice, but pediatricians and patients need to be aware of how much less regulated the industry is compared to prescription and over-the-counter drugs that undergo evaluation by the FDA.
“We just need to be very careful about this particular industry, and we need to also be careful about documentation,” Breuner said. “I want to make sure that you leave here remembering to ask about dietary supplements at every healthcare visit and make sure that you are documenting it in an EMR so that we can track if there’s any side effects.” She recommended reviewing the safety of dietary supplements at every healthcare visit.
Breuner noted the limitation of federal legislative oversight for supplements by the Dietary Supplement Health and Education Act of 1994. This law refers to vitamins, minerals, herbs and other botanicals, amino acids, and dietary supplements, and it made three major changes to the industry:
- It exempted dietary supplements from premarket review, allowing products to enter the market without efficacy testing. Products also do not need FDA approval for marketing claims.
- It allows companies to offer only “reasonable assurance” of their products’ safety without proving their safety.
- It does not require any manufacturing standards for supplements, though reputable manufacturers are in favor of standards.
Breuner highlighted two examples of safety concerns that have emerged in this landscape. One is the discrepancy between quantities on the label of supplements and the actual amounts in the product. A 2023 study of melatonin gummies revealed 88% of products were inaccurately labeled, with the actual amount of melatonin ranging from 74% to 347% of what the label claimed.
Another was a 2021 CDC case report of a 2-year-old child with exceptionally high blood levels of lead (48 μg/dL) despite no known exposures. The child’s 9-month-old cousin, in a different household, had similarly high levels, and further investigation revealed that the families were using turmeric that had lead levels of 2000 mg/kg.
Both of these reports are cautionary tales about the need to ask families about supplement use and discuss their safety. A 2019 study of adverse events from supplements in youth identified 977 adverse event reports from January 2004 to April 2015 that included 166 hospitalizations, 39 life-threatening events, and 22 deaths. The highest-risk supplements were those marketed for weight loss, muscle building, and energy.
Breuner and her co-presenter, Jillian Hagerman, DO, a pediatric and adolescent medicine specialist at Kaiser Permanente, Bellevue, Washington, provided several resources pediatricians can use to research the most up-to-date evidence on herbs and supplements. They include the following:
- NatMed Pro can be accessed through many institution libraries
- Dietary supplement fact sheets from the National Institutes of Health
- FDA Office of Dietary Supplement Programs has an Ingredient Directory with links to FDA actions and communications and has consumer resources, including recalls, safety alerts, and scams
- FDA Health Fraud Product Database has lists of products with FDA health fraud violations.
- The use of third party verification labeling, including National Science Foundation International, United States Pharmacopeia Dietary Supplement Verification Program, and ConsumerLab
- Operation Supplement Safety scorecard is a checklist for assessing whether a supplement seems safe
Questions pediatricians can consider in reviewing evidence include:
- Was there standardization of the dietary supplement product used by all participants in the study?
- Did the product contain a single ingredient? Did the product also contain a pharmaceutical compound (which can lead to false claims about the clinical benefit of the supplement)?
- Was the product in the study verified by an independent third party for purity and potency?
Leslie Pelinka, MD, a pediatrician at PeaceHealth Medical Group, Eugene, Oregon, who attended the session, was particularly grateful to learn about third-party verification. “For families that are really motivated to use supplements and food as alternative medicine and really want to do their research, now I can tell them" to look for that third-party verification, she told Medscape Medical News. Pelinka also appreciated the consistent message to be cautious about long-term use but to try a supplement for a couple of weeks and see if it works.
The presentation did not use external funding. Breuner, Hagerman, and Pelinka had no disclosures.
Tara Haelle is a science/health journalist based in Dallas.
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