Evidence map›Paper›PMID 29626579›Full record

ReviewFood and chemical toxicology : an international journal published for the British Industrial Biological Research Association2018

Naturally complex: Perspectives and challenges associated with Botanical Dietary Supplement Safety assessment.

Kelly A Shipkowski, Joseph M Betz, Linda S Birnbaum, John R Bucher, Paul M Coates, D Craig Hopp, Duffy MacKay, Hellen Oketch-Rabah, Nigel J Walker, Cara Welch and 1 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing 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

32 citing papers in PubMed.

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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

11 authors.

Kelly A ShipkowskiDivision of the National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA; ICF International, Inc., Durham, NC, USA.
Joseph M BetzOffice of Dietary Supplements, National Institutes of Health, Bethesda, MD, USA.
Linda S BirnbaumNational Institute of Environmental Health Sciences, Research Triangle Park, NC, USA.
John R BucherDivision of the National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA.
Paul M CoatesOffice of Dietary Supplements, National Institutes of Health, Bethesda, MD, USA.
D Craig HoppNational Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, USA.
Duffy MacKayCouncil for Responsible Nutrition, Washington, DC, USA.
Hellen Oketch-RabahUS Pharmacopeial Convention, Rockville, MD, USA.
Nigel J WalkerDivision of the National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA.
Cara WelchUS Food and Drug Administration, Silver Spring, MD, USA.
Cynthia V RiderDivision of the National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA. Electronic address: cynthia.rider@nih.gov.

Funding

Toxicological Assessments for the National Toxicology ProgramZIAES103316 · NIEHS · NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES · PI WALKER, NIGEL J · 2016 to 2019
$31.9M
Studies of the fate of environmental contaminants in humans and animalsZIABC011476 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI BIRNBAUM, LINDA · 2013 to 2019
$5.8M
Intramural NIH HHS Z99 ES999999
6 · The paper itself

Abstract

Due to the extensive use of botanical dietary supplements by consumers in the United States, there is a need for appropriate research and data to support safety assessments. Complexity and variability, both natural and introduced, of botanical dietary supplements make research on these products difficult. Botanical dietary supplements are regulated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 1994 Dietary Supplement Health and Education Act (DSHEA). They are regulated as a category of food, which differs from the regulation of pharmaceutical products. Both manufacturers and the FDA are faced with the challenge of determining the best approaches for evaluating and monitoring the safety of botanical products. High quality botanicals research requires accurate identification and characterization of the material being studied. Inconsistent results in efficacy studies of botanical dietary supplements have led to efforts to improve the rigor and reproducibility of research in the field. Addressing the challenges associated with botanical dietary supplement safety is a global effort requiring coordination between numerous stakeholders, including researchers, suppliers, manufacturers, and regulators, all of whom play a role in ensuring that high quality products are available on the market.

Indexed as

Dietary SupplementsFood SafetyHumansPhytotherapyPlant ExtractsPlant Extracts

Identifiers

PMID29626579
PMCPMC6087675

What OpenQuestion holds

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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 OpenQuestion graph.