{{short description|Marketing term for supplement}} '''''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.<ref>{{Cite journal |last1=Puri |first1=Vivek |last2=Nagpal |first2=Manju |last3=Singh |first3=Inderbir |last4=Singh |first4=Manjinder |last5=Dhingra |first5=Gitika Arora |last6=Huanbutta |first6=Kampanart |last7=Dheer |first7=Divya |last8=Sharma |first8=Ameya |last9=Sangnim |first9=Tanikan |date=2022-11-03 |title=A Comprehensive Review on Nutraceuticals: Therapy Support and Formulation Challenges |journal=Nutrients |volume=14 |issue=21 |pages=4637 |doi=10.3390/nu14214637 |doi-access=free |issn=2072-6643 |pmc=9654660 |pmid=36364899}}</ref><ref>{{Cite news |last=Fernandes |first=Dr Edmond |title=Why nutraceuticals are crucial in protecting health beyond basic nutrition |url=https://timesofindia.indiatimes.com/blogs/global-health-focus/why-nutraceuticals-are-crucial-in-protecting-health-beyond-basic-nutrition/ |access-date=2025-06-13 |work=The Times of India |issn=0971-8257}}</ref><ref>{{Cite journal |last1=Vignesh |first1=Arumugam |last2=Amal |first2=Thomas Cheeran |last3=Sarvalingam |first3=Ariyan |last4=Vasanth |first4=Krishnan |date=2024-12-01 |title=A review on the influence of nutraceuticals and functional foods on health |journal=Food Chemistry Advances |volume=5 |article-number=100749 |doi=10.1016/j.focha.2024.100749 |issn=2772-753X|doi-access=free }}</ref>
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).<ref name="FDAHome17">{{cite web | title=Dietary Supplements | publisher=US Food and Drug Administration | date=12 December 2017 | url=https://www.fda.gov/consumers/consumer-updates/dietary-supplements | access-date=31 January 2019}}</ref><ref> {{cite web | title = The Nutrition Facts Label | date=13 March 2024 | publisher=The Food and Drug Administration, US Department of Health and Human Services | url = https://www.fda.gov/food/nutrition-education-resources-materials/nutrition-facts-label }}</ref> The same is widely accepted in Europe and parts of Asia and Africa.<ref>{{Cite journal |last1=Gulati |first1=Om P. |last2=Berry Ottaway |first2=Peter |date=2006-04-03 |title=Legislation relating to nutraceuticals in the European Union with a particular focus on botanical-sourced products |journal=Toxicology |volume=221 |issue=1 |pages=75–87 |doi=10.1016/j.tox.2006.01.014 |issn=0300-483X |pmid=16487647|bibcode=2006Toxgy.221...75G }}</ref><ref>{{Cite web |date=2025-03-04 |title=Food supplements {{!}} EFSA |url=https://www.efsa.europa.eu/en/topics/topic/food-supplements |access-date=2025-06-13 |website=www.efsa.europa.eu |language=en}}</ref>
==Regulation== Nutraceuticals are treated differently in different jurisdictions.
===Canada=== 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,<ref name="hc">{{cite web|url=https://www.hc-sc.gc.ca/fn-an/label-etiquet/claims-reclam/nutra-funct_foods-nutra-fonct_aliment-eng.php#1 |title=Nutraceuticals / Functional Foods and Health Claims on Foods: Policy Paper|publisher=Health Canada|date=June 24, 2013|access-date=January 30, 2014}}</ref> 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=== The term ''nutraceutical'' is not defined by the FDA.<ref name="fda19">{{cite web |title=How the FDA Regulates Nutraceuticals |work=FDA Reader |url=https://www.fdareader.com/blog/how-the-fda-regulates-nutraceuticals |publisher=US Food and Drug Administration |access-date=1 January 2024 |date=4 March 2019}}{{dead link|date=April 2026}}</ref> 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.<ref name=fda19/>
=== India === The nutraceutical segment in India is regulated by FSSAI and a license is mandatory for selling products under this segment.<ref>{{Cite web |title=FSSAI |url=https://fssai.gov.in/cms/health-supplements.php |access-date=2025-06-13 |website=fssai.gov.in}}</ref> Companies have been fined by courts in India for failure to comply with quality control regulations.<ref>{{Cite web |date=2016-04-07 |title=Ants in bottle of honey: Dabur told to give Rs 50,000 in legal aid account, pay Rs 35,000 to complainant |url=https://indianexpress.com/article/cities/chandigarh/ants-in-bottle-of-honey-dabur-told-to-give-rs-50000-in-legal-aid-account-pay-rs-35000-to-complainant/ |access-date=2025-06-13 |website=The Indian Express |language=en}}</ref>
===Other sources=== In the global market, there are significant product quality issues.<ref name="aron">{{cite journal |vauthors=Aronson JK |date=January 2017 |title=Defining 'nutraceuticals': neither nutritious nor pharmaceutical |journal=British Journal of Clinical Pharmacology |volume=83 |issue=1 |pages=8–19 |doi=10.1111/bcp.12935 |pmc=5338166 |pmid=26991455}}</ref><ref name="santini">{{Cite journal |last1=Santini |first1=Antonello |last2=Novellino |first2=Ettore |date=2018-06-03 |title=Nutraceuticals - shedding light on the grey area between pharmaceuticals and food |journal=Expert Review of Clinical Pharmacology |volume=11 |issue=6 |pages=545–547 |doi=10.1080/17512433.2018.1464911 |issn=1751-2433 |pmid=29667442 |doi-access=free}}</ref> 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== 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.<ref name=hc/>
===Dietary supplements=== [[File:B vitamin supplement tablets.jpg|thumb|upright|alt=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:<ref name=fda19/> 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."<ref name="fda1">{{cite web|url=https://www.fda.gov/Food/DietarySupplements/ConsumerInformation/ucm110417.htm |archive-url=https://web.archive.org/web/20090603045226/http://www.fda.gov/Food/DietarySupplements/ConsumerInformation/ucm110417.htm |url-status=dead |archive-date=June 3, 2009 |title=Overview of Dietary Supplements |publisher=Fda.gov |access-date=2011-06-03}}</ref>
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).<ref name=fda19/> 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.<ref name=fda19/>
===Functional foods=== [[Image:Hippocrates rubens.jpg|thumb|upright|alt= 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".<ref name="hcgloss">{{cite web|url=https://www.hc-sc.gc.ca/sr-sr/biotech/about-apropos/gloss-eng.php |title=Glossary – Biotechnology |publisher=Health Canada |date= 2006-03-23|access-date=2011-06-03}}</ref> 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.<ref name="scidir">{{Cite journal|doi=10.1016/S0899-9007(00)00332-4 |title=Nutraceuticals and functional foods: introduction and meaning |year=2000 |last1=Hardy |first1=G |journal=Nutrition |volume=16 |pmid=10906598 |issue=7–8|pages=688–9}}</ref>
==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.<ref name="fctfd">{{Cite book|title=Functional Food and Health |editor1-first=Takayuki |editor1-last=Shibamoto |editor2-first=Kazuki |editor2-last=Kanazawa |editor3-first=Fereidoon |editor3-last=Shahidi |editor4-first=Chi-Tang |display-editors = 3 |editor4-last=Ho |publisher=ACS Symposium |page=993 |year=2008 |isbn=978-0-8412-6982-8}}</ref>
The market for nutraceuticals is projected to grow to about 614 billion euros per year (approx. US$675 billion; 2023) by 2027.<ref>{{cite journal |doi=10.1039/D1CS00524C |title=Sustainable production of pharmaceutical, nutraceutical and bioactive compounds from biomass and waste |date=2021 |last1=Espro |first1=Claudia |last2=Paone |first2=Emilia |last3=Mauriello |first3=Francesco |last4=Gotti |first4=Roberto |last5=Uliassi |first5=Elisa |last6=Bolognesi |first6=Maria Laura |last7=Rodríguez-Padrón |first7=Daily |last8=Luque |first8=Rafael|display-authors=3 |journal=Chemical Society Reviews |volume=50 |issue=20 |pages=11191–11207 |pmid=34553208 |s2cid=237608133 |hdl=11585/843405 |hdl-access=free }}</ref>
==Etymology== The word ''nutraceutical'' is a portmanteau of ''nutrition'' and ''pharmaceutical'', coined in 1989 by Stephen L. DeFelice.<ref name="aapsj">{{Cite journal|author=Kalra EK |title=Nutraceutical-definition and introduction | journal=AAPS PharmSci |volume=5 |issue=3 |pages=27–28 |year=2003 |pmid=14621960 |pmc=2750935 |doi=10.1208/ps050325}}</ref>
==Criticism== Because nutraceuticals are unregulated, these supplements are sold by marketing hype rather than being based on actual clinical evidence.<ref name=aron/><ref name=fda19/><ref name="hayden">{{cite journal|url=https://www.scientificamerican.com/article/getting-to-know-nutraceut/|title=Getting to know nutraceuticals|last=Hayden|first=Thomas|date=1 August 2012|journal=Scientific American|volume=17 |issue=4 |pages=38–43 |doi=10.1038/scientificamerican1207-38sp|url-access=subscription}}</ref> There is no compelling evidence for efficacy in nutraceuticals.<ref name=aron/><ref name=hayden/> 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.<ref>{{cite web|url=https://www.cbc.ca/news/dannon-pays-millions-over-false-yogurt-claims-1.881099|title=Dannon Pays Millions Over False Yogurt Claims|date=16 December 2010|publisher=Canadian Broadcasting Corporation}}</ref>
Some scientists point out that there are no internationally defined properties of nutraceuticals.<ref name="santini" /> Due to the vague, undiscriminating evidence for the biological effects of nutraceutical products, few experts have proposed abandoning the term.<ref name="aron" />
==See also== * Functional beverage * Medical food * Health claims on food labels * ''Cosmeceutical'' for cosmetic products with quasi-medicinal claims * Probiotic
==References== {{reflist}}
==Further reading== * Pathak, Y.V. (editor, 2010). ''Handbook of Nutraceuticals (vol. 1): Ingredients, Formulations, and Applications''. CRC Press. {{ISBN|978-1-4200-8221-0}}
==External links== *[https://web.archive.org/web/19990117021247/http://www.cfsan.fda.gov/%7Edms/supplmnt.html US FDA/CFSAN – Dietary Supplements]
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Category:Food science Category:Nutrition Category:Pharmacy Category:Marketing