Evidence map›Paper›PMID 30421981›Full record

ReviewCritical reviews in food science and nutrition2020

Current regulatory guidelines and resources to support research of dietary supplements in the United States.

Regan L Bailey

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Critical reviews in food science and nutrition, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 70 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
70citing papers in PubMed, 5 pooled it
–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

70 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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10 more citing papers are in PubMed but not listed here.

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

1 author.

Regan L BaileyDepartment of Nutrition Science, Purdue University, , West Lafayette, Indiana 47907, USA.

Funding

Development of a Total Nutrient IndexU01CA215834 · NCI · TEXAS A&M AGRILIFE RESEARCH · PI REGAN BAILEY, JANET A. TOOZE · 2017 to 2026
$2.2M
NCI NIH HHS U01 CA215834
6 · The paper itself

Abstract

The U.S. Dietary Supplement Health and Education Act (DSHEA) established the regulatory framework for dietary supplements as foods through the Food and Drug Administration (FDA). DSHEA outlined the legal definition, labeling requirements, and process for adverse event reporting for dietary supplements. FDA also issued formal guidance on current Good Manufacturing Practice to ensure that processes for preparation, packaging, labeling, and storage of supplements and ingredients are documented and meet specifications to ensure purity, composition, and strength. However, efficacy of dietary supplements is not required under U.S. law. Despite regulations to improve the marketplace, many challenges remain; as a result, the quality and safety of products available can be highly variable, especially for botanical and herbal products. The ability of regulators to successfully carry out their mission is hampered by the sheer number of products and manufacturing facilities and a lack of analytical methods for all ingredients and products in the marketplace, this is especially difficult for herbal and botanical dietary supplements. Safety issues continue to exist such as adulteration and contamination, especially with specific product types (i.e. body building, sexual enhancement). Thus, a need remains for continued efforts and improved techniques to assess the quality of dietary supplements, especially with regard to purity, bioavailability, and safety. This review will highlight the existing American regulatory framework for dietary supplements and will describe the remaining regulatory barriers to ensuring that safe and high-quality dietary supplements are offered in the marketplace.

Indexed as

Dietary SupplementsLegislation, FoodUnited StatesUnited States Food and Drug AdministrationDietary supplementsgood manufacturing practicesqualityregulationsafety

Identifiers

PMID30421981
PMCPMC6513729

What Socratic holds

Textmetadata
LicenceTDM
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.