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==Definition== In the United States, the [[Dietary Supplement Health and Education Act of 1994]] provides this description: "The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines the term "dietary supplement" to mean a product (other than [[tobacco]]) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, [[metabolite]], constituent, [[extract]], or combination of any of the aforementioned ingredients. Furthermore, a dietary supplement must be labeled as a dietary supplement and be intended for ingestion and must not be represented for use as conventional food or as a sole item of a meal or of the diet. In addition, a dietary supplement cannot be approved or authorized for investigation as a new [[drug]], [[antibiotic]], or biologic, unless it was marketed as a food or a dietary supplement before such approval or authorization. Under DSHEA, dietary supplements are deemed to be food, except for purposes of the drug definition."<ref name=DietSupplLabels>{{cite web | url = https://oig.hhs.gov/oei/reports/oei-01-01-00120.pdf | archive-url = https://web.archive.org/web/20041118061526/https://oig.hhs.gov/oei/reports/oei-01-01-00120.pdf | archive-date = 18 November 2004 | title =Dietary Supplement Labels: Key Elements | author = Office of Inspector General | publisher = U.S. Department of Health and Human Services | date = 2003 }}</ref> Per DSHEA, dietary supplements are consumed orally, and are mainly defined by what they are not: conventional foods (including [[meal replacement]]s), [[medical food]]s,<ref name = "FDA_FAQ_2016">{{cite web | url = https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM500094.pdf | title = Guidance for Industry: Frequently Asked Questions About Medical Foods | edition = Second | publisher = U.S. Food and Drug Administration | date = May 2016 }}</ref> [[preservative]]s or [[pharmaceutical drugs]]. Products intended for use as a [[nasal spray]], or [[Topical medication|topically]], as a lotion applied to the skin, do not qualify. FDA-approved drugs cannot be ingredients in dietary supplements. Supplement products are or contain [[vitamins]], [[Mineral (nutrient)|nutritionally essential minerals]], [[amino acid]]s, [[essential fatty acid]]s and non-nutrient substances extracted from [[plant]]s or [[animal]]s or [[Fungus|fungi]] or [[bacteria]], or in the instance of [[probiotic]]s, are live bacteria. Dietary supplement ingredients may also be synthetic copies of naturally occurring substances (for example: [[melatonin]]). All products with these ingredients are required to be labeled as dietary supplements.<ref name="DSHEA definition">{{cite book|author1=Committee on the Framework for Evaluating the Safety of Dietary Supplements, Food and Nutrition Board, Board on Life Sciences, Institute of Medicine and National Research Council of the National Academies|title=Dietary supplements a framework for evaluating safety|date=2004|publisher=National Academies Press|location=Washington, D.C.|isbn=978-0-309-09206-7|pages=ES-1–ES-3}}</ref> Like foods and unlike drugs, no government approval is required to make or sell dietary supplements; the manufacturer confirms the safety of dietary supplements but the government does not; and rather than requiring [[Risk–benefit ratio|risk–benefit analysis]] to prove that the product can be sold like a drug, such assessment is only used by the FDA to decide that a dietary supplement is unsafe and should be removed from market.<ref name="DSHEA definition" />
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