Wikipedia

Nutraceutical

Nutraceutical is a term that evolved scientifically and also through marketing which is used to imply a pharmaceutical effect from plant extracts, compounds, food products which have efficacy and therapeutic influence on clinical outcomes and patient care largely through supplements.[1][2][3]

In the United States, nutraceuticals are considered and regulated as a subset of foods (such as dietary supplements) by the Food and Drug Administration (FDA).[4][5] The same is widely accepted in Europe and parts of Asia and Africa.[6][7]

Regulation

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Nutraceuticals are treated differently in different jurisdictions.

Canada

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Under Canadian law, a nutraceutical can be marketed as either a food or a drug; the terms nutraceutical and functional food have no legal distinction,[8] as both refer to "a product isolated or purified from foods that is generally sold in medicinal forms not usually associated with food [and] is demonstrated to have a physiological benefit or provide protection against chronic disease".

United States

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The term nutraceutical is not defined by the FDA.[9] Depending on its ingredients and the claims with which it is marketed, a product is regulated as a drug, dietary supplement, food ingredient, or food.[9]

India

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The nutraceutical segment in India is regulated by FSSAI and a license is mandatory for selling products under this segment.[10] Companies have been fined by courts in India for failure to comply with quality control regulations.[11]

Other sources

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In the global market, there are significant product quality issues.[12][13] Those marketing nutraceuticals internationally may claim their products contain certain ingredients, while the lack of regulation means there is no authority guaranteeing the accuracy of such claims, compromising the safety and effectiveness of such products. In the absence of regulation manufacturers and sellers can offer products of low quality or with ineffective or harmful ingredients.

Classification of nutraceuticals

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Nutraceuticals are products derived from food sources that are purported to provide extra health benefits, in addition to the basic nutritional value found in foods. Depending on the jurisdiction, manufacturers and sellers may claim their products prevent chronic diseases, improve health, delay the aging process, increase life expectancy, or support the structure or function of the body.[8]

Dietary supplements

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A vitamin B supplment
Dietary supplements, such as the vitamin B supplement shown above, are typically sold in pill form.

In the United States, the Dietary Supplement Health and Education Act (DSHEA) of 1994 defined the term "dietary supplement": "A dietary supplement is a product taken by mouth that contains a 'dietary ingredient' intended to supplement the diet. The 'dietary ingredients' in these products may include:[9] vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders."[14]

Dietary supplements do not have to be approved by the FDA before marketing, but companies must register their manufacturing facilities with the FDA and follow current good manufacturing practices (cGMPs).[9] With a few well-defined exceptions, manufacturers and sellers may only claim that a given dietary supplement supports the structure or function of the body, may not claim that it treats a disease or condition, and must include a label that says: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” The exceptions are when the FDA has reviewed and approved a health claim. In those situations the FDA also stipulates the exact wording allowed.[9]

Functional foods

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A sculpture of the father of Western medicine, Hippocrates.Hippocrates.
Considered a father of Western medicine, Hippocrates advocated the healing effects of food.

Functional foods are fortified or enriched during processing and then marketed as providing some benefit to consumers. Sometimes complementary nutrients are added, such as vitamin D to milk.

Health Canada defines functional food as "ordinary food that has components or ingredients added to give it a specific medical or physiological benefit, other than a purely nutritional effect".[15] In Japan, all functional foods must meet three requirements: foods must (1) be present in their naturally occurring form, rather than a capsule, tablet, or powder; (2) be consumed in the diet as often as daily; and (3) regulate a biological process in hopes of preventing or controlling disease.[16]

Market

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The modern nutraceutical market developed in Japan during the 1980s. In contrast to the natural herbs and spices used as folk medicine for centuries throughout Asia, the nutraceutical industry grew alongside the expansion of modern technology in the early 21st century.[17]

The market for nutraceuticals is projected to grow to about 614 billion euros per year (approx. US$675 billion; 2023) by 2027.[18]

Etymology

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The word nutraceutical is a portmanteau of nutrition and pharmaceutical, coined in 1989 by Stephen L. DeFelice.[19]

Criticism

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Because nutraceuticals are unregulated, these supplements are sold by marketing hype rather than being based on actual clinical evidence.[12][9][20] There is no compelling evidence for efficacy in nutraceuticals.[12][20] After scientists disputed the benefits of nutraceuticals, such as probiotics in yogurt, Danone was forced to pay a large financial penalty for falsely claiming its products Actimel and Activia boosted the immune system.[21]

Some scientists point out that there are no internationally defined properties of nutraceuticals.[13] Due to the vague, undiscriminating evidence for the biological effects of nutraceutical products, few experts have proposed abandoning the term.[12]

See also

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References

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  1. ↑ Puri, Vivek; Nagpal, Manju; Singh, Inderbir; Singh, Manjinder; Dhingra, Gitika Arora; Huanbutta, Kampanart; Dheer, Divya; Sharma, Ameya; Sangnim, Tanikan (2022-11-03). "A Comprehensive Review on Nutraceuticals: Therapy Support and Formulation Challenges". Nutrients. 14 (21): 4637. doi:10.3390/nu14214637. ISSN 2072-6643. PMC 9654660. PMID 36364899.
  2. ↑ Fernandes, Dr Edmond. "Why nutraceuticals are crucial in protecting health beyond basic nutrition". The Times of India. ISSN 0971-8257. Retrieved 2025-06-13.
  3. ↑ Vignesh, Arumugam; Amal, Thomas Cheeran; Sarvalingam, Ariyan; Vasanth, Krishnan (2024-12-01). "A review on the influence of nutraceuticals and functional foods on health". Food Chemistry Advances. 5 100749. doi:10.1016/j.focha.2024.100749. ISSN 2772-753X.
  4. ↑ "Dietary Supplements". US Food and Drug Administration. 12 December 2017. Retrieved 31 January 2019.
  5. ↑ "The Nutrition Facts Label". The Food and Drug Administration, US Department of Health and Human Services. 13 March 2024.
  6. ↑ Gulati, Om P.; Berry Ottaway, Peter (2006-04-03). "Legislation relating to nutraceuticals in the European Union with a particular focus on botanical-sourced products". Toxicology. 221 (1): 75–87. Bibcode:2006Toxgy.221...75G. doi:10.1016/j.tox.2006.01.014. ISSN 0300-483X. PMID 16487647.
  7. ↑ "Food supplements | EFSA". www.efsa.europa.eu. 2025-03-04. Retrieved 2025-06-13.
  8. 1 2 "Nutraceuticals / Functional Foods and Health Claims on Foods: Policy Paper". Health Canada. June 24, 2013. Retrieved January 30, 2014.
  9. 1 2 3 4 5 6 "How the FDA Regulates Nutraceuticals". FDA Reader. US Food and Drug Administration. 4 March 2019. Retrieved 1 January 2024.[dead link]
  10. ↑ "FSSAI". fssai.gov.in. Retrieved 2025-06-13.
  11. ↑ "Ants in bottle of honey: Dabur told to give Rs 50,000 in legal aid account, pay Rs 35,000 to complainant". The Indian Express. 2016-04-07. Retrieved 2025-06-13.
  12. 1 2 3 4 Aronson JK (January 2017). "Defining 'nutraceuticals': neither nutritious nor pharmaceutical". British Journal of Clinical Pharmacology. 83 (1): 8–19. doi:10.1111/bcp.12935. PMC 5338166. PMID 26991455.
  13. 1 2 Santini, Antonello; Novellino, Ettore (2018-06-03). "Nutraceuticals - shedding light on the grey area between pharmaceuticals and food". Expert Review of Clinical Pharmacology. 11 (6): 545–547. doi:10.1080/17512433.2018.1464911. ISSN 1751-2433. PMID 29667442.
  14. ↑ "Overview of Dietary Supplements". Fda.gov. Archived from the original on June 3, 2009. Retrieved 2011-06-03.
  15. ↑ "Glossary – Biotechnology". Health Canada. 2006-03-23. Retrieved 2011-06-03.
  16. ↑ Hardy, G (2000). "Nutraceuticals and functional foods: introduction and meaning". Nutrition. 16 (7–8): 688–9. doi:10.1016/S0899-9007(00)00332-4. PMID 10906598.
  17. ↑ Shibamoto, Takayuki; Kanazawa, Kazuki; Shahidi, Fereidoon; et al., eds. (2008). Functional Food and Health. ACS Symposium. p. 993. ISBN 978-0-8412-6982-8.
  18. ↑ Espro, Claudia; Paone, Emilia; Mauriello, Francesco; et al. (2021). "Sustainable production of pharmaceutical, nutraceutical and bioactive compounds from biomass and waste". Chemical Society Reviews. 50 (20): 11191–11207. doi:10.1039/D1CS00524C. hdl:11585/843405. PMID 34553208. S2CID 237608133.
  19. ↑ Kalra EK (2003). "Nutraceutical-definition and introduction". AAPS PharmSci. 5 (3): 27–28. doi:10.1208/ps050325. PMC 2750935. PMID 14621960.
  20. 1 2 Hayden, Thomas (1 August 2012). "Getting to know nutraceuticals". Scientific American. 17 (4): 38–43. doi:10.1038/scientificamerican1207-38sp.
  21. ↑ "Dannon Pays Millions Over False Yogurt Claims". Canadian Broadcasting Corporation. 16 December 2010.

Further reading

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  • Pathak, Y.V. (editor, 2010). Handbook of Nutraceuticals (vol. 1): Ingredients, Formulations, and Applications. CRC Press. ISBN 978-1-4200-8221-0
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