Nutraceutical is a marketing term used to imply a pharmaceutical effect from a compound or food product that has not been scientifically confirmed or approved to have clinical benefits.[1][2] In the United States, nutraceuticals are unregulated, existing in the same category as dietary supplements and food additives by the Food and Drug Administration (FDA), under the authority of the Federal Food, Drug, and Cosmetic Act.[3][4]

There are no internationally defined properties of nutraceuticals,[2] and, due to the vague, undiscriminating evidence for nutraceutical products having biological effects, experts have proposed abandoning the term.[1] The word "nutraceutical" is a portmanteau, blending the words "nutrition" and "pharmaceutical".[1]

Regulation

Nutraceuticals are treated differently in different jurisdictions.

Canada

Under Canadian law, a nutraceutical can either be marketed as a food or as a drug; the terms "nutraceutical" and "functional food" have no legal distinction,[5] referring 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

The term "nutraceutical" is not defined by the FDA.[6] 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.[6]

Other sources

In the global market, there are significant product quality issues.[1][2] Nutraceuticals from the international market may claim to use organic or exotic ingredients, yet the lack of regulation may compromise the safety and effectiveness of products. Companies looking to create a wide profit margin may create unregulated products overseas with low-quality or ineffective ingredients.

Classification of nutraceuticals

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, products may claim to prevent chronic diseases, improve health, delay the aging process, increase life expectancy, or support the structure or function of the body.[5]

Dietary supplements

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:[6] 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.”[7]

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).[6] With a few well-defined exceptions, dietary supplements may only be marketed to support the structure or function of the body, and may not claim to treat 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.[6]

Functional foods

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, additional complementary nutrients are added, such as vitamin D to milk.

Health Canada defines functional foods as “ordinary food that has components or ingredients added to give it a specific medical or physiological benefit, other than a purely nutritional effect.”[8] In Japan, all functional foods must meet three established requirements: foods should be (1) present in their naturally occurring form, rather than a capsule, tablet, or powder; (2) consumed in the diet as often as daily; and (3) should regulate a biological process in hopes of preventing or controlling disease.[9]

Possible clinical application

Nutraceuticals have been considered as possible adjuncts to therapies for clinical disorders.[10][11]

Market

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.[12]

The market for nutraceuticals is projected to grow to about 614 billion euros (approx. US$675 billion; 2023) by the year 2027.[13]

Etymology

The word "nutraceutical" is a portmanteau of the words "nutrition" and "pharmaceutical", coined in 1989 by Stephen L. DeFelice.[14]

Criticism

Because nutraceuticals are unregulated, these supplements are sold by marketing hype rather than being based on actual clinical evidence.[1][6][15] There is no compelling evidence for efficacy in nutraceuticals.[1][15] 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.[16]

See also

References

  1. 1 2 3 4 5 6 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.
  2. 1 2 3 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.
  3. ↑ "Supplement Makers Touting Cures for Alzheimer's and Other Diseases Get F.D.A. Warning". The New York Times. 11 February 2019. Retrieved 2019-05-11.
  4. ↑ "Labeling & Nutrition". The Food and Drug Administration, US Department of Health and Human Services. 5 October 2016. Retrieved 2016-10-11.
  5. 1 2 "Nutraceuticals / Functional Foods and Health Claims on Foods: Policy Paper". Health Canada. June 24, 2013. Retrieved January 30, 2014.
  6. 1 2 3 4 5 6 "How the FDA Regulates Nutraceuticals". US Food and Drug Administration. 4 March 2019. Retrieved 1 January 2024.
  7. ↑ "Overview of Dietary Supplements". Fda.gov. Retrieved 2011-06-03.
  8. ↑ "Glossary - Biotechnology". Health Canada. 2006-03-23. Retrieved 2011-06-03.
  9. ↑ 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.
  10. ↑ Sarris, Jerome; Murphy, Jenifer; Mischoulon, David; Papakostas, George I.; Fava, Maurizio; Berk, Michael; Ng, Chee H. (2016). "Adjunctive Nutraceuticals for Depression: A Systematic Review and Meta-Analyses". American Journal of Psychiatry. 173 (6): 575–587. doi:10.1176/appi.ajp.2016.15091228. hdl:10536/DRO/DU:30083400. ISSN 0002-953X. PMID 27113121.
  11. ↑ Banach, Maciej; Patti, Angelo Maria; Giglio, Rosaria Vincenza; et al. (2018). "The Role of Nutraceuticals in Statin Intolerant Patients". Journal of the American College of Cardiology. 72 (1): 96–118. doi:10.1016/j.jacc.2018.04.040. hdl:10447/433774. PMID 29957236.
  12. ↑ Shibamoto, Takayuki; Kanazawa, Kazuki; Shahidi, Fereidoon; et al., eds. (2008). Functional Food and Health. ACS Symposium. p. 993. ISBN 978-0-8412-6982-8.
  13. ↑ 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. PMID 34553208. S2CID 237608133.
  14. ↑ Kalra EK (2003). "Nutraceutical-definition and introduction". AAPS PharmSci. 5 (3): 27–28. doi:10.1208/ps050325. PMC 2750935. PMID 14621960.
  15. 1 2 Hayden, Thomas (1 August 2012). "Getting to know nutraceuticals". Scientific American. doi:10.1038/scientificamerican1207-38sp.
  16. ↑ "Dannon Pays Millions Over False Yogurt Claims". Canadian Broadcasting Corporation. 16 December 2010.

Further reading

  • 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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