Nutraceutical
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,
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.
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
Dietary supplements
In the United States, the Dietary Supplement Health and Education Act (DSHEA) of 1994 defined the term "dietary supplement": "A
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
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
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
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 "
Criticism
Because nutraceuticals are unregulated, these supplements are sold by
See also
- Medical food
- Health claims on food labels
- Cosmeceutical for cosmetic products with quasi-medicinal claims
- Probiotic
References
- ^ PMID 26991455.
- ^ PMID 29667442.
- ^ "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.
- ^ "Labeling & Nutrition". The Food and Drug Administration, US Department of Health and Human Services. 5 October 2016. Retrieved 2016-10-11.
- ^ a b "Nutraceuticals / Functional Foods and Health Claims on Foods: Policy Paper". Health Canada. June 24, 2013. Retrieved January 30, 2014.
- ^ a b c d e f "How the FDA Regulates Nutraceuticals". US Food and Drug Administration. 4 March 2019. Retrieved 1 January 2024.
- ^ "Overview of Dietary Supplements". Fda.gov. Retrieved 2011-06-03.
- ^ "Glossary – Biotechnology". Health Canada. 2006-03-23. Retrieved 2011-06-03.
- PMID 10906598.
- PMID 27113121.
- PMID 29957236.
- ISBN 978-0-8412-6982-8.
- S2CID 237608133.
- PMID 14621960.
- ^ .
- ^ "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