Evidence map›Paper›PMID 41208233›Full record

ReviewPharmaceutical biology2025

From Vision to Reality: Five Years of the Botanical Safety Consortium.

Constance A Mitchell, Amy L Roe, Scott Auerbach, Cécile Bascoul, Michelle Embry, Stephen Ferguson, Stefan Gafner, Matthias Gossmann, Bill J Gurley, Holly Johnson and 13 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Pharmaceutical biology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors.

Constance A MitchellHealth and Environment Sciences Institute, Washington, District of Columbia, USA.
Amy L RoeProcter & Gamble Healthcare, Cincinnati, Ohio, USA.
Scott AuerbachDivision of Translational Toxicology, National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina, USA.
Cécile BascoulProduct Safety, dōTERRA International, Pleasant Grove, Utah, USA.
Michelle EmbryHealth and Environment Sciences Institute, Washington, District of Columbia, USA.
Stephen FergusonDivision of Translational Toxicology, National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina, USA.
Stefan GafnerAmerican Botanical Council, Austin, Texas, USA.
Matthias GossmanninnoVitro GmbH, Juelich, Germany.
Bill J GurleyNational Center for Natural Products Research, School of Pharmacy, University of Mississippi, University, Mississippi, USA.
Holly JohnsonAmerican Herbal Products Association, Silver Spring, Maryland, USA.
Olaf KelberBayer Consumer Health, Steigerwald Arzneimittelwerk GmbH, Darmstadt, Germany.
Julie KrzykwaHealth and Environment Sciences Institute, Washington, District of Columbia, USA.
Jacob LarsonHerbalife International of America Inc, Torrance, California, USA.
Yitong LiuDivision of Toxicology, Office of Chemistry and Toxicology, Office of Laboratory Operations and Applied Science, Human Foods Program, U.S. Food and Drug Administration, Laurel, Maryland, USA.
Catherine MahonyThe Procter & Gamble Company, Mason, Ohio, USA.
Andre Monteiro da RochaFrankel Cardiovascular Center Cell Regeneration Core/Internal Medicine-Cardiology, University of Michigan, Ann Arbor, Michigan, USA.
Stefan PfuhlerThe Procter & Gamble Company, Mason, Ohio, USA.
Vincent SicaThe Procter & Gamble Company, Mason, Ohio, USA.
Suramya WaidyanathaDivision of Translational Toxicology, National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina, USA.
Remco H S WesterinkNeurotoxicology Research Group, Division of Toxicology, Institute for Risk Assessment Sciences (IRAS), Faculty of Veterinary Medicine, Utrecht University, Utrecht, The Netherlands.
Kristine WittRetired, Formerly Division of Translational Toxicology, National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina, USA.
Hellen Oketch-RabahOffice of Dietary Supplement Programs, Office of Dietary Supplements Program (OFCSDSI), Human Foods Program (HFP) (formerly CFSAN), College Park, Maryland, USA.
Cynthia RiderDivision of Translational Toxicology, National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina, USA.

Funding

Combined Exposures and Mixtures Research ProgramZIAES103373 · NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES · 2025 to 2025
$967k
Intramural NIH HHS ZIA ES103373
6 · The paper itself

Abstract

contextBotanicals, including products derived from plants, fungi, and algae, are increasingly consumed worldwide. Their complex compositions and variable phytochemical profiles present significant challenges for safety assessment. Traditional toxicology methods are time and resource intensive, and the variability of botanicals makes it difficult to test one lot as representative.

objectiveThe Botanical Safety Consortium (BSC), launched in 2019, was established to advance fit-for-purpose toxicity testing strategies for botanicals. This manuscript summarizes the progress of the BSC, with emphasis on the activities of its Working Groups.

methodsThe BSC Working Groups evaluate established new approach methodologies (NAMs), including

resultsThe evaluations address toxicological endpoints such as hepatotoxicity, genotoxicity, developmental and reproductive toxicity, neurotoxicity, cardiotoxicity, and dermal toxicity. Early findings have identified fit-for-purpose screening tools that can generally be applied to botanical testing, with some nuances and considerations.

conclusionFuture work will focus on refining and enhancing the tool-kit through assay refinement, filling endpoint gaps with additional assays, and incorporating ADME data and in silico modeling approaches. This collaborative, science-driven framework aims to modernize botanical safety evaluation, address regulatory needs, and ultimately protect public health while supporting the global demand for botanical-based dietary supplements, cosmetics, and other products.

Indexed as

Plant PreparationsToxicity TestsAnimalsHumansRisk AssessmentPlant PreparationsBotanicaldietary supplementsNAMsnatural productssafetytoxicology

Identifiers

PMID41208233
PMCPMC12604121

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.