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{{short description|Class of nutritional product}} {{short description|Marketing term for supplement}}
{{globalise|2=United States|3=Canada|date=September 2024}}
] is grown commercially for its seeds rich in ].]]

⚫ A '''nutraceutical''' is a pharmaceutical alternative which ].<ref name="SarrisMurphy2016">{{cite journal|last1=Sarris|first1=Jerome|last2=Murphy|first2=Jenifer|last3=Mischoulon|first3=David|last4=Papakostas|first4=George I.|last5=Fava|first5=Maurizio|last6=Berk|first6=Michael|last7=Ng|first7=Chee H.|title=Adjunctive Nutraceuticals for Depression: A Systematic Review and Meta-Analyses|journal=American Journal of Psychiatry|volume=173|issue=6|year=2016|pages=575–587|issn=0002-953X|doi=10.1176/appi.ajp.2016.15091228|pmid=27113121|doi-access=free}}</ref><ref>{{cite journal|doi=10.1016/j.jacc.2018.04.040|pmid=29957236|title=The Role of Nutraceuticals in Statin Intolerant Patients|journal=Journal of the American College of Cardiology|volume=72|issue=1|pages=96–118|year=2018| last1=Banach|first1=Maciej|last2=Patti|first2=Angelo Maria|last3=Giglio|first3=Rosaria Vincenza|last4=Cicero|first4=Arrigo F.G.|last5=Atanasov|first5=Atanas G.|last6=Bajraktari|first6=Gani|last7=Bruckert|first7=Eric|last8=Descamps|first8=Olivier|last9=Djuric|first9=Dragan M.|last10=Ezhov|first10=Marat|last11=Fras|first11=Zlatko|last12=von Haehling|first12=Stephan|last13=Katsiki|first13=Niki|last14=Langlois|first14=Michel|last15=Latkovskis|first15=Gustavs|last16=Mancini|first16=G.B. John|last17=Mikhailidis|first17=Dimitri P.|last18=Mitchenko|first18=Olena|last19=Moriarty|first19=Patrick M.|last20=Muntner|first20=Paul|last21=Nikolic|first21=Dragana|last22=Panagiotakos|first22=Demosthenes B.|last23=Paragh|first23=Gyorgy|last24=Paulweber|first24=Bernhard|last25=Pella|first25=Daniel|last26=Pitsavos|first26=Christos|last27=Reiner|first27=Željko|last28=Rosano|first28=Giuseppe M.C.|last29=Rosenson|first29=Robert S.|last30=Rysz|first30=Jacek|display-authors=3|doi-access=free}}</ref> In the US, nutraceuticals are largely unregulated, as they exist in the same category as ]s and ] by the ], under the authority of the Federal Food, Drug, and Cosmetic Act.<ref>
'''Nutraceutical''' is a marketing term used to imply a ] effect from a compound or food product that has not been scientifically confirmed or approved to have ].<ref name="aron">{{cite journal |vauthors=Aronson JK |title=Defining 'nutraceuticals': neither nutritious nor pharmaceutical |journal=British Journal of Clinical Pharmacology |volume=83 |issue=1 |pages=8–19 |date=January 2017 |pmid=26991455 |pmc=5338166 |doi=10.1111/bcp.12935}}</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> In the United States, nutraceuticals are considered and regulated as a subset of foods (such as ]s) by the ] (FDA).<ref name="FDAHome17">{{cite web | title=Dietary Supplements | publisher=US Food and Drug Administration | date=12 December 2017 | url=https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm153239.htm | access-date=31 January 2019}}</ref><ref></ref><ref>
{{cite web {{cite web
| title = Supplement Makers Touting Cures for Alzheimer's and Other Diseases Get F.D.A. Warning | work=The New York Times | title = Supplement Makers Touting Cures for Alzheimer's and Other Diseases Get F.D.A. Warning | work=The New York Times
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| access-date = 2019-05-11 |date= 11 February 2019 }}</ref><ref> | access-date = 2019-05-11 |date= 11 February 2019 }}</ref><ref>
{{cite web {{cite web
| title = Labeling & Nutrition | publisher=The Food and Drug Administration, US Department of Health and Human Services | 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/IngredientsPackagingLabeling/LabelingNutrition/default.htm | url = https://www.fda.gov/food/nutrition-education-resources-materials/nutrition-facts-label }}</ref>

| access-date = 2016-10-11 |date= 5 October 2016 }}</ref> The word "nutraceutical" is a ] term, blending the words "nutrition" and "pharmaceutical".<ref>{{Cite journal |last=Santini |first=Antonello |last2=Novellino |first2=Ettore |date=2018-06-03 |title=Nutraceuticals - shedding light on the grey area between pharmaceuticals and food |url=https://doi.org/10.1080/17512433.2018.1464911 |journal=Expert Review of Clinical Pharmacology |volume=11 |issue=6 |pages=545–547 |doi=10.1080/17512433.2018.1464911 |issn=1751-2433 |pmid=29667442}}</ref>
There are no internationally defined properties of nutraceuticals.<ref name=santini/> Due to the vague, undiscriminating evidence for the biological effects of nutraceutical products, experts have proposed abandoning the term.<ref name=aron/> The word "nutraceutical" is a ], blending the words "nutrition" and "pharmaceutical."<ref name=aron/>


==Regulation== ==Regulation==
Line 15: Line 18:


===Canada=== ===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=http://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 is demonstrated to have a physiological benefit or provide protection against chronic disease."

⚫ 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,<ref>{{cite web|url=http://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> referring to "a product isolated or purified from foods that is generally sold in medicinal forms not usually associated with food is demonstrated to have a physiological benefit or provide protection against chronic disease."


===United States=== ===United States===
The term "nutraceutical" is not defined by ].<ref>Staff, FDA. Last updated March 29, 2013. .</ref> Depending on its ingredients and the claims with which it is marketed, a product is regulated as a ], ], food ], or ].<ref>Staff, FDA. Last Updated March 27, 2013. </ref><ref>{{Cite book |author=Committee on the Framework for Evaluating the Safety of the Dietary Supplements |year=2005 |chapter=Committee Change |chapter-url=http://books.nap.edu/openbook.php?record_id=10882&page=21 |title=Dietary Supplements: A Framework for Evaluating Safety |publisher=Institute of Medicine |page= |isbn=978-0-309-09110-7 |doi=10.17226/10882 |pmid=25009855 |url=https://archive.org/details/dietarysupplemen0000unse/page/21 }}</ref> The term "nutraceutical" is not defined by the FDA.<ref name="fda19">{{cite web |title=How the FDA Regulates Nutraceuticals |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}}</ref> Depending on its ingredients and the claims with which it is marketed, a product is regulated as a drug, ], food ingredient, or food.<ref name=fda19/>


===Other sources=== ===Other sources===
In the global market, there are significant product quality issues.<ref name="regulation">{{Cite book|title=Regulation of Functional Foods and Nutraceuticals: A Global Perspective |first=Clare M. |last=Hasler |publisher=IFT Press and Blackwell Publishing |year=2005 |isbn=978-0-8138-1177-2}}{{Page needed|date=September 2010}}</ref> Nutraceuticals from the international market may claim to use ] or ] ingredients, yet the lack of regulation may compromise the safety and effectiveness of products. Companies looking to create a wide ] may create unregulated products overseas with low-quality or ineffective ingredients. In the global market, there are significant product quality issues.<ref name=aron/><ref name=santini/> Nutraceuticals from the international market may claim to use ] or ] ingredients, yet the lack of regulation may compromise the safety and effectiveness of products. Companies looking to create a wide ] may create unregulated products overseas with low-quality or ineffective ingredients.


==Classification of nutraceuticals== ==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 ], improve health, delay the ] process, increase ], or support the structure or function of the body.<ref name="hc1"></ref> 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 ], improve health, delay the ] process, increase ], or support the structure or function of the body.<ref name=hc/>


===Dietary supplements=== ===Dietary supplements===
], such as the vitamin B supplement shown above, are typically sold in pill form.]] ], 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 ] is a product taken by mouth that contains a 'dietary ingredient' intended to supplement the diet. The 'dietary ingredients' in these products may include: ], ], ] or other botanicals, ], and substances such as ], organ tissues, glandulars, and ]. Dietary supplements can also be ] or concentrates, and may be found in many forms such as ], ]s, softgels, ], ], or ]s.”<ref name="fda1">{{cite web|url=https://www.fda.gov/Food/DietarySupplements/ConsumerInformation/ucm110417.htm |title=Overview of Dietary Supplements |publisher=Fda.gov |access-date=2011-06-03}}</ref> In the United States, the Dietary Supplement Health and Education Act (DSHEA) of 1994 defined the term "dietary supplement": "A ] 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/> ], ], ] or other botanicals, ], and substances such as ], organ tissues, glandulars, and ]. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as ], capsules, softgels, ], liquids, or powders."<ref name="fda1">{{cite web|url=https://www.fda.gov/Food/DietarySupplements/ConsumerInformation/ucm110417.htm |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). 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. 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, 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.<ref name=fda19/>


===Functional foods=== ===Functional foods===
] advocated the healing effects of food.]] ] advocated the healing effects of food.]]
]s are ] or enriched during ] and then marketed as providing some benefit to consumers. Sometimes, additional complementary nutrients are added, such as ] to ]. ]s are ] or enriched during ] and then marketed as providing some benefit to consumers. Sometimes, additional complementary nutrients are added, such as ] to milk.


Health Canada defines functional foods as “ordinary food that has components or ingredients added to give it a specific medical or ] benefit, other than a purely nutritional effect.”<ref name="hcgloss">{{cite web|url=http://www.hc-sc.gc.ca/sr-sr/biotech/about-apropos/gloss-eng.php |title=Glossary - Biotechnology |publisher=Hc-sc.gc.ca |date= 2006-03-23|access-date=2011-06-03}}</ref> In ], 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.<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> Health Canada defines functional foods as "ordinary food that has components or ingredients added to give it a specific medical or ] benefit, other than a purely nutritional effect."<ref name="hcgloss">{{cite web|url=http://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 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.<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>


==Possible clinical application==
==History==
⚫ Nutraceuticals have been considered as possible adjuncts to therapies for clinical disorders.<ref name="SarrisMurphy2016">{{cite journal|last1=Sarris|first1=Jerome|last2=Murphy|first2=Jenifer|last3=Mischoulon|first3=David|last4=Papakostas|first4=George I.|last5=Fava|first5=Maurizio|last6=Berk|first6=Michael|last7=Ng|first7=Chee H.|title=Adjunctive Nutraceuticals for Depression: A Systematic Review and Meta-Analyses|journal=American Journal of Psychiatry|volume=173|issue=6|year=2016|pages=575–587|issn=0002-953X|doi=10.1176/appi.ajp.2016.15091228|pmid=27113121|doi-access=free|hdl=10536/DRO/DU:30083400|hdl-access=free}}</ref><ref>{{cite journal|doi=10.1016/j.jacc.2018.04.040|pmid=29957236|title=The Role of Nutraceuticals in Statin Intolerant Patients|journal=Journal of the American College of Cardiology|volume=72|issue=1|pages=96–118|year=2018|display-authors=3| last1=Banach|first1=Maciej|last2=Patti|first2=Angelo Maria|last3=Giglio|first3=Rosaria Vincenza|last4=Cicero|first4=Arrigo F.G.|last5=Atanasov|first5=Atanas G.|last6=Bajraktari|first6=Gani|last7=Bruckert|first7=Eric|last8=Descamps|first8=Olivier|last9=Djuric|first9=Dragan M.|last10=Ezhov|first10=Marat|last11=Fras|first11=Zlatko|last12=von Haehling|first12=Stephan|last13=Katsiki|first13=Niki|last14=Langlois|first14=Michel|last15=Latkovskis|first15=Gustavs|last16=Mancini|first16=G.B. John|last17=Mikhailidis|first17=Dimitri P.|last18=Mitchenko|first18=Olena|last19=Moriarty|first19=Patrick M.|last20=Muntner|first20=Paul|last21=Nikolic|first21=Dragana|last22=Panagiotakos|first22=Demosthenes B.|last23=Paragh|first23=Gyorgy|last24=Paulweber|first24=Bernhard|last25=Pella|first25=Daniel|last26=Pitsavos|first26=Christos|last27=Reiner|first27=Željko|last28=Rosano|first28=Giuseppe M.C.|last29=Rosenson|first29=Robert S.|last30=Rysz|first30=Jacek|doi-access=free|hdl=10447/433774|hdl-access=free}}</ref>
⚫ The word "nutraceutical" is a blend of the words "]" and "]", coined in 1989 by ], founder and chairman of the Foundation of Innovation Medicine.<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>
]ns, ]ians, ], and ] are just a few civilizations that have used food as ].<ref name="hndbk">{{Cite book|title=Handbook of Nutraceuticals and Functional Foods |edition=1st |editor1-first=Robert E. C. |editor1-last=Wildman |publisher=CRC Series in Modern Nutrition |year=2001 |isbn=978-0-8493-8734-0}}{{Page needed|date=September 2010}}</ref> "Let food be thy medicine." is a common misquotation<ref>{{cite news|last=Cardenas|first=Diana|url=https://www.researchgate.net/publication/258099432|title=Let not thy food be confused with thy medicine: The Hippocratic misquotation|year=2013|publisher=e-SPEN Journal}}</ref> attributed to ], who is considered by some{{who?|date=July 2021}} to be the father of ].


==Market==
The modern nutraceutical market began to develop in ] during the 1980s. In contrast to the natural ] and ] used as ] for centuries throughout ], the nutraceutical industry has grown alongside the expansion and exploration of modern ].<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 modern nutraceutical market developed in Japan during the 1980s. In contrast to the natural ] and ] used as ] 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&nbsp;billion ]s (approx. US$675&nbsp;billion; 2023) by the year 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 }}</ref>
One example is a traditional Japanese drug called 'Kampo' which is derived from many medicinal plants. This test was done to investigate the pharmacological effects of functional foods and Kampo medicine. The experiments were performed using disease models. When extracts were taken from Kampo and functional foods and were administered there was a lowered pro-inflammatory rate.<ref>{{Cite journal|last=Nishizawa|first=Mikio|last2=Okumura|first2=Tadayoshi|last3=Ikeya|first3=Yukinobu|date=2019-03-01|title=Assessment of anti-inflammatory effects of Japanese Kampo medicine versus functional foods|url=https://www.ffhdj.com/index.php/ffhd/article/view/566|journal=Functional Foods in Health and Disease|language=en|volume=9|issue=2|pages=79–91|doi=10.31989/ffhd.v9i2.566|issn=2160-3855|doi-access=free}}</ref>

==Etymology==
⚫ The word "nutraceutical" is a portmanteau of the words "nutrition" and "]", 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== ==Criticism==
Because nutraceuticals are unregulated, these supplements are sold by ] rather than being based on actual ].<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|doi=10.1038/scientificamerican1207-38sp}}</ref> There is no compelling evidence for efficacy in nutraceuticals.<ref name=hayden/> After scientists disputed the benefits of nutraceuticals like ] in yogurt, ] was forced to pay millions for falsely claiming its products ] and Activia boosted the ].<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> Because nutraceuticals are unregulated, these supplements are sold by ] rather than being based on actual ].<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}}</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 ]s in yogurt, ] was forced to pay a large financial penalty for falsely claiming its products ] and Activia boosted the ].<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>
{{Further|topic=the immune and digestive health nutritional supplement|Serovera}}


==See also== ==See also==
* ]
* ] * ]
* ] * ]
* ] for cosmetic products with quasi-medicinal claims * ] for cosmetic products with quasi-medicinal claims
*] * ]


==References== ==References==
Line 64: Line 71:


==External links== ==External links==
⚫ *
*

⚫ *
{{Authority control}}


] ]
] ]
] ]
]

Latest revision as of 09:15, 1 October 2024

Marketing term for supplement
Globe icon.The examples and perspective in this article deal primarily with the United States and Canada and do not represent a worldwide view of the subject. You may improve this article, discuss the issue on the talk page, or create a new article, as appropriate. (September 2024) (Learn how and when to remove this message)

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. 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).

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

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, as both refer to "a product isolated or purified from foods that is generally sold in medicinal forms not usually associated with food is demonstrated to have a physiological benefit or provide protection against chronic disease."

United States

The term "nutraceutical" is not defined by the FDA. 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.

Other sources

In the global market, there are significant product quality issues. 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.

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: 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."

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). 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.

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." 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.

Possible clinical application

Nutraceuticals have been considered as possible adjuncts to therapies for clinical disorders.

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.

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

Etymology

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

Criticism

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

Further information on the immune and digestive health nutritional supplement: Serovera

See also

References

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  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.
  3. "Dietary Supplements". US Food and Drug Administration. 12 December 2017. Retrieved 31 January 2019.
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  6. "The Nutrition Facts Label". The Food and Drug Administration, US Department of Health and Human Services. 13 March 2024.
  7. ^ "Nutraceuticals / Functional Foods and Health Claims on Foods: Policy Paper". Health Canada. June 24, 2013. Retrieved January 30, 2014.
  8. ^ "How the FDA Regulates Nutraceuticals". US Food and Drug Administration. 4 March 2019. Retrieved 1 January 2024.
  9. "Overview of Dietary Supplements". Fda.gov. Retrieved 2011-06-03.
  10. "Glossary – Biotechnology". Health Canada. 2006-03-23. Retrieved 2011-06-03.
  11. 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.
  12. 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.
  13. 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.
  14. Shibamoto, Takayuki; Kanazawa, Kazuki; Shahidi, Fereidoon; et al., eds. (2008). Functional Food and Health. ACS Symposium. p. 993. ISBN 978-0-8412-6982-8.
  15. 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.
  16. Kalra EK (2003). "Nutraceutical-definition and introduction". AAPS PharmSci. 5 (3): 27–28. doi:10.1208/ps050325. PMC 2750935. PMID 14621960.
  17. ^ Hayden, Thomas (1 August 2012). "Getting to know nutraceuticals". Scientific American. 17 (4): 38–43. doi:10.1038/scientificamerican1207-38sp.
  18. "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

External links

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