| Most countries place dietary supplements in a special category under the general umbrella of foods, not drugs. This necessitates that the manufacturer, and not the government, be responsible for 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.[52] In addition, the Food and Drug Administration uses the Adverse Event Reporting System to monitor adverse events that occur with supplements.[53] In 2007, the US Code of Federal Regulations (CFR) Title 21, part III took effect, regulating GMP practices 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.[54] In the European Union, the Food Supplements Directive requires that only those supplements that have been proven safe can be sold without a prescription.[55] For most vitamins, 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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