Experts Share Data on Safety of Plant-Derived Supplements
As sales of herbal supplements in the U.S. rise, the National Institute of Environmental Health Sciences (NIEHS) and its partners are working to gather data and advance testing methods to assess the safety of these products.
“Throughout history, almost every human civilization has used botanicals for different purposes,” said Dr. Heather Patisaul, scientific director of the NIEHS Division of Translational Toxicology (DTT) at a recent NIEHS summit. “The mission of DTT is to improve public health through data and knowledge development that’s translatable, predictive and timely. And that is the goal in partnering and working on botanicals.”
NIEHS, together with the U.S. Food and Drug Administration (FDA) and the nonprofit Health and Environmental Sciences Institute (HESI), formed the Botanical Safety Consortium in 2019. The mission of this public-private partnership—which includes government agencies, academic and research institutes, private industry groups and consulting organizations—is to evaluate “new approach methods” (NAM) for use with complex botanical mixtures. The NAMs aim to use methods other than vertebrate animals in safety testing.
“Since the 1990s, NIEHS and National Toxicology Program researchers have characterized hazards associated with botanicals, such as aloe vera, ginseng and kava, using in vivo models,” explained Dr. Cynthia Rider, a toxicologist in the NIEHS Systems Toxicology Branch. “Through the consortium and annual summit, we are working to expand the in vitro and in silico toolbox available for evaluating a botanical’s toxicity and adverse effects on various biological systems.”
Active ingredients in plants have been used in pesticides, pharmaceuticals and many consumer products, according to Dr. Hellen Oketch-Rabah, deputy director of the FDA Office of Dietary Supplement Programs.
The goal, she said, is to determine whether the NAM testing data yields results similar to data gathered through vertebrate animal testing.
“Once we have well-developed and validated tests,” Oketch-Rabah said, “they will provide an opportunity for others to screen data-poor botanicals.”
During the last few years, nine consortium working groups have evaluated a handful of botanicals, including aconite, ginseng, milk thistle and oleander. The groups gathered active ingredient and toxicity information, created extracts to learn the chemical profile of each botanical and performed tests to determine methods that could be used to evaluate safety.
Photo: Steve McCaw/NIEHS
At the summit, the working groups presented snapshots of their findings, such as whether certain botanicals resulted in toxic effects. The information will be available in the Chemical Effects in Biological Systems (CEBS) database (https://cebs.niehs.nih.gov/cebs/) for all to review and cite in publications.
As the data-gathering phase ends, the Botanical Safety Consortium plans to facilitate robust evaluation of botanical ingredients, as well as to test and predict outcomes on human health.
“What we want to do is enhance our battery of tests,” said Connie Mitchell, senior scientific program manager at HESI who helps manage the consortium. “That might be adding tools to assess absorption, distribution, metabolism and excretion, adding testing methods or looking at various other preparations of botanicals.”
Botanical safety resources
To learn more about botanical safety, see the Botanical Safety Consortium’s site: https://bit.ly/3Ct5Fem.
Also see:
NIH’s Office of Dietary Supplements botanicals fact sheets: https://go.nih.gov/zFu2oFX
The FDA’s dietary supplements page with information for consumers, industry and the media: https://bit.ly/3Q1Hs1C
The National Toxicology Program Botanical Dietary Supplements Program fact sheet: https://go.nih.gov/vVFVUs0.