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Cited by 494Complementary and Alternative Medicine StudiesNutrition and Health StudiesBiomedical Ethics and Regulation

Dietary Supplements: Regulatory Challenges and Research Resources

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Dwyer, Johanna, Coates, Paul, Smith, Michael·2018·Nutrients
DOI 10.3390/nu10010041PMC PMC5793269
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Abstract

Many of the scientific and regulatory challenges that exist in research on the safety, quality and efficacy of dietary supplements are common to all countries as the marketplace for them becomes increasingly global. This article summarizes some of the challenges in supplement science and provides a case study of research at the Office of Dietary Supplements at the National Institutes of Health, USA, along with some resources it has developed that are available to all scientists. It includes examples of some of the regulatory challenges faced and some resources for those who wish to learn more about them.

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  • As of this writing, creatine monohydrate is the only form of creatine that is listed on the FDA's inventory of GRAS notices.

    “As of this writing, CrM is the only form of creatine that is listed on the FDA’s inventory of GRAS notices [239] (see Table 5).”

    From Bioavailability, Efficacy, Safety, and Regulatory Status of Creatine and Related Compounds: A Critical Review (2022) · cites this paper as [239]

    Section 2.2 discusses FDA regulation of dietary supplements and new dietary ingredient notifications, but not the FDA’s inventory of GRAS notices. Searches for creatine, creatine monohydrate, and GRAS found no passage addressing whether creatine monohydrate is the only creatine form listed. (LLM, conf=0.76)

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Sorted by citations

Authors
Dwyer, J., Coates, P., & Smith, M.
Affiliations
  • National Institutes of Health (US)
  • University of Mississippi (US)
Corresponding author
Dwyer, Johanna
ORCID
Venue
Nutrients
Publisher
MDPI AG
Published
2018-01-04
Volume
10
Issue
1
Pages
41
ISSN
2072-6643 (ISSN-L)
DOI
10.3390/nu10010041
PMC
PMC5793269
OpenAlex
W2781506010
Cited by
494
References
7
Citations by year
2026: 46 · 2025: 69 · 2024: 74 · 2023: 66 · 2022: 82 · 2021: 62 · 2020: 48 · 2019: 30 · 2018: 17
FWCI
9.17
Type
journal article
Language
en
Open access
Licence
Locations
  • Nutrients (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
Office of Dietary Supplements, National Institutes of Health USA
Topics
  • Health Sciences › Medicine › Complementary and alternative medicine › Complementary and Alternative Medicine Studies
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Nutrition and Health Studies
  • Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
Keywords
dietary supplements, supplement regulation, supplement safety, supplement quality, supplement efficacy, National Institutes of Health, research resources
MeSH terms
Animals, Consumer Product Safety, Health Policy, Humans, Terminology as Topic, Policy Making, Quality Control, Risk Assessment, Dietary Supplements, Government Regulation, Biomedical Research

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