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===Governmental regulation=== Most countries place dietary supplements in a special category under the general umbrella of ''foods'', not drugs. As a result, the manufacturer, and not the government, has the responsibility of ensuring that its dietary supplement products are safe before they are marketed. Regulation of supplements varies widely by country. In the [[United States]], a dietary supplement is defined under the [[Dietary Supplement Health and Education Act]] of 1994.<ref>[https://www.fda.gov/opacom/laws/dshea.html Legislation]. Fda.gov (15 September 2009). Retrieved on 12 November 2010.</ref> There is no FDA approval process for dietary supplements, and no requirement that manufacturers prove the safety or efficacy of supplements introduced before 1994.<ref name="Wendt" /><ref name="Price" /> The [[Food and Drug Administration]] must rely on its Adverse Event Reporting System to monitor adverse events that occur with supplements.<ref>{{cite web| title = Adverse Event Reporting System (AERS) | url = https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm | work = [[FDA]] | date = 20 August 2009 | access-date = 12 November 2010}}</ref> In 2007, the US [[Code of Federal Regulations]] (CFR) Title 21, part III took effect, regulating Good Manufacturing Practices (GMPs) in the manufacturing, packaging, labeling, or holding operations for dietary supplements. Even though product registration is not required, these regulations mandate production and quality control standards (including testing for identity, purity and adulterations) for dietary supplements.<ref>U.S. Food and Drug Administration. [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=111 CFR β Code of Federal Regulations Title 21]. Retrieved 16 February 2014.</ref> In the European Union, the [[Food Supplements Directive]] requires that only those supplements that have been proven safe can be sold without a prescription.<ref>{{CELEX|32002L0046|text=Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements}}</ref> For most vitamins, [[pharmacopoeia|pharmacopoeial standards]] have been established. In the United States, the [[United States Pharmacopeia]] (USP) sets standards for the most commonly used vitamins and preparations thereof. Likewise, monographs of the [[European Pharmacopoeia]] (Ph.Eur.) regulate aspects of identity and purity for vitamins on the European market.
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