Evidence map›Paper›PMID 36673519›Full record

ReviewFoods (Basel, Switzerland)2023

Investigating the Regulatory Process, Safety, Efficacy and Product Transparency for Nutraceuticals in the USA, Europe and Australia.

Muralikrishna Gangadharan Komala, Ser Gin Ong, Muhammad Uzair Qadri, Lamees M Elshafie, Carol A Pollock, Sonia Saad

Abstract readReview
In one paragraph

Review in Foods (Basel, Switzerland), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing 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

19 citing papers in PubMed.

  1. Review
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  11. Article
  12. Nutraceuticals: a promising, yet unregulated Frontier in Healthcare.European journal of clinical nutrition · 2025
    Review
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  18. Therapeutic Potential ofPharmaceuticals (Basel, Switzerland) · 2023
    Review
  19. Article
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

6 authors.

Muralikrishna Gangadharan KomalaRenal Medicine, Kolling Institute of Medical Research, University of Sydney, St. Leonards, NSW 2065, Australia.ORCID 0000-0003-0534-0584
Ser Gin OngRenal Medicine, Kolling Institute of Medical Research, University of Sydney, St. Leonards, NSW 2065, Australia.
Muhammad Uzair QadriRenal Medicine, Kolling Institute of Medical Research, University of Sydney, St. Leonards, NSW 2065, Australia.
Lamees M ElshafieRenal Medicine, Kolling Institute of Medical Research, University of Sydney, St. Leonards, NSW 2065, Australia.
Carol A PollockRenal Medicine, Kolling Institute of Medical Research, University of Sydney, St. Leonards, NSW 2065, Australia.
Sonia SaadRenal Medicine, Kolling Institute of Medical Research, University of Sydney, St. Leonards, NSW 2065, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Increased numbers of patients with chronic conditions use nutraceuticals or food-based therapeutics. However, to date, there is no global consensus on the regulatory processes for nutraceuticals. With the increased use, issues of quality and safety have also arisen. This review summarises the current regulations held for nutraceuticals in the USA, European and Australian jurisdictions using regulatory authority sites and databases. The efficacy and safety concerns, product development, gaps in regulation and challenges in ensuring product authenticity are also summarised. The data highlight the complexity that the globalisation of nutraceuticals brings with respect to challenges in regulation and associated claims regarding efficacy and safety. The development of an effective system with integrity is needed to increase vertical collaboration between consumers, healthcare practitioners, and government agencies and the development of international risk assessment criteria and botanical compendia. This will help in greater transparency and improved trust in the process and products. Emerging technologies could play a role in improving systems engineering by information sharing and leveraging the strengths of different countries. In conclusion, nutraceuticals have been poorly regulated leading to spurious claims based on little or no real evidence. This makes it difficult to separate meaningful results from poor data. More stringent regulation and an effective system of integrity are required to ensure efficacy and safety and enable the adequate monitoring and increase consumer and healthcare professionals' confidence.

Indexed as

food-based therapeuticsregulationsserialisation technology

Identifiers

PMID36673519
PMCPMC9857896

What OpenQuestion 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 OpenQuestion graph.