BETHESDA, MD—If you’re wondering what to tell parents about dietary supplements for their children, don’t expect too much help from the government or from medical academia any time soon.

“No data,” was the frequent refrain at a recent two-day National Institutes of Health (NIH) conference on dietary supplement use in children. Government agencies and nutrition researchers have barely begun to explore the issue of nutritional supplements and herbal medicines in children, despite widespread public use of these products.

It seems that the more common and accepted supplement use becomes, the further researchers retrench, calling for the most basic science and fretting over the lack of adequate methodology. In short, when it comes to experimenting with supplements, the nation’s parents are way ahead of researchers.

The bulk of the dialogue at the conference focused on use of common multivitamins and minerals—products most of us have come to believe are at least harmless, if not beneficial. But experts don’t always agree.

Much of the controversy revolves around the 1994 Dietary Supplements Health Education Act (DSHEA), which opened the door for dietary supplements to be marketed without advance approval from the FDA. The burden is on the FDA to prove a product unsafe based on reports of adverse events or other information. In the words of FDA Nutrition Scientist Beth Yetley, PhD, in passing DSHEA, “Congress assumed we had a long history of supplement use and that these products were safe,” thus begging the question, are supplements “innocent until proven guilty,” or vice versa?

In general, the public sees vitamins, minerals, herbs, and botanicals as safe alternatives to prescription medicines and useful products for prevention and wellness. As government researchers and conventional medical practitioners wave red flags, wring their hands, and lament the lack of data, parents around the country continue to experiment.

The American Academy of Pediatrics recently acknowledged the widespread use of supplements in a policy statement on “complementary and alternative” medicine, urging clinicians to recognize parents’ interest in these subjects, educate themselves about potential benefits and risks, and develop better lines of communication with the families (Pediatrics 2001; 107(3) 598–601). The policy statement notes that, “Pediatric use of CAM is especially likely in children with chronic illness or disability (see related story).”

Some researchers are concerned that even a daily multivitamin could push kids into “dangerous” levels of nutrient intakes. But Sanford Miller, PhD, of Georgetown University’s Center for Food and Nutrition Policy pointed out the U.S. Department of Agriculture’s new guidelines on upper limits of nutrient intake are mostly theoretical, because there is little dose-response data. Dr. Miller believes researchers have yet to establish “criteria we all accept to define biological substances essential to life.”

FDA’s Dr. Yetley pointed out there are few preclinical studies on supplements that focus specifically on their biological action and dose responses; assumptions about efficacy—and safety—are all based on observational studies.

The NIH’s National Center for Complementary and Alternative Medicine (NCCAM) has taken up the gauntlet to fund both basic research and clinical trials, but its resources are limited. And to date, the supplement industry has not filled the void. Supplement manufacturers do not have the same incentive to conduct studies as pharmaceutical makers do—first because they are not legally required, and second because they believe they do not benefit in the unregulated marketplace if they do.

In terms of research on children, there is a particular paucity of data. Even with conventional pharmaceuticals, it was only recently that drug companies began studying top prescription medicines in children. It took a huge government “carrot” to get them to do so.

Sumner Yaffe, MD, special assistant to the director of the NIH’s National Institute of Child Health and Human Development, pointed to the 1997 FDA Modernization Act, which gave drug companies an extension on their patents in exchange for studying products in children. “Economic incentives play a role,” said Dr. Yaffe. “We should use this model if we feel that we should study dietary supplements in infants and children before they’re recommended for use.”

But, Dr. Yaffe conceded, companies have made minimal efforts to conduct pediatric studies with prescription drugs no longer under patent protection, because they stand to gain little. So how does this model apply to the supplement industry, whose products are not protected by patents at all? It doesn’t. Dr. Yaffe could only recommend more government funded research.

Adriane Fugh-Berman, MD, assistant clinical professor at George Washington University’s School of Medicine and Health Sciences, pointed to the available evidence as well as the historic use of botanicals, saying “I think there’s a lot of safe use of herbal remedies in the home. What we really need to watch out for are unscrupulous manufacturers or practitioners pushing inappropriate herb use on parents or kids.”

Dr. Fugh-Berman contends that naturopathic physicians (NDs) and others trained in prescribing botanicals generally understand which plant sources are safe, which manufacturers have good production standards, and which supplements should not be used in combination with other drugs. It is mainstream medical practitioners, eager to please patients, who may not be aware of subtle distinctions between botanicals or the lesser-known contraindications.

The conference offered little direction for the clinician seeking answers about specific supplements or the future of government regulation of them. For now, health care providers and consumers must continue to sift through the claims and the limited data for themselves; currently the scientific community offers no consensus or clear guidance.