Current regulatory guidelines and resources to support research of dietary supplements in the United States.
Current regulatory guidelines and resources to support research of dietary supplements in the United States.
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DOI：
10.1080/10408398.2018.1524364
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发表时间：
2020
影响因子：
10.2
通讯作者：
Bailey RL
中科院分区：
文献类型：
--
作者：
Bailey RL
美国膳食补充剂健康和教育法案（DSHEA）通过食品和药物管理局（FDA）建立了膳食补充剂作为食品的监管框架。DSHEA概述了膳食补充剂的法律的定义、标签要求和不良事件报告流程。FDA还发布了关于现行药品生产质量管理规范的正式指南，以确保补充剂和成分的制备、包装、贴标和储存过程得到记录，并符合质量标准，以确保纯度、成分和强度。然而，美国法律并不要求膳食补充剂的功效。尽管有改善市场的法规，但仍存在许多挑战;因此，现有产品的质量和安全性可能存在很大差异，特别是植物和草药产品。监管机构成功执行其使命的能力受到产品和生产设施数量庞大以及市场上所有成分和产品缺乏分析方法的阻碍，这对于草药和植物膳食补充剂来说尤其困难。安全问题继续存在，如掺假和污染，特别是特定产品类型（即健身，性增强）。因此，仍然需要持续的努力和改进的技术来评估膳食补充剂的质量，特别是关于纯度、生物利用度和安全性。本综述将重点介绍美国现有的膳食补充剂监管框架，并将描述剩余的监管障碍，以确保市场上提供安全和高质量的膳食补充剂。
The U.S. Dietary Supplement Health and Education Act (DSHEA) established the regulatory framework for dietary supplements as foods through the Food and Drug Administration (FDA). DSHEA outlined the legal definition, labeling requirements, and process for adverse event reporting for dietary supplements. FDA also issued formal guidance on current Good Manufacturing Practice to ensure that processes for preparation, packaging, labeling, and storage of supplements and ingredients are documented and meet specifications to ensure purity, composition, and strength. However, efficacy of dietary supplements is not required under U.S. law. Despite regulations to improve the marketplace, many challenges remain; as a result, the quality and safety of products available can be highly variable, especially for botanical and herbal products. The ability of regulators to successfully carry out their mission is hampered by the sheer number of products and manufacturing facilities and a lack of analytical methods for all ingredients and products in the marketplace, this is especially difficult for herbal and botanical dietary supplements. Safety issues continue to exist such as adulteration and contamination, especially with specific product types (i.e. body building, sexual enhancement). Thus, a need remains for continued efforts and improved techniques to assess the quality of dietary supplements, especially with regard to purity, bioavailability, and safety. This review will highlight the existing American regulatory framework for dietary supplements and will describe the remaining regulatory barriers to ensuring that safe and high-quality dietary supplements are offered in the marketplace.
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影响因子：
3.6
作者：
Benkhedda, Karima;L'Abbe, Mary R.;Cockell, Kevin A.
通讯作者：
Cockell, Kevin A.
影响因子：
2.9
作者：
Austin, Krista G.;Farina, Emily K.;Lieberman, Harris R.
通讯作者：
Lieberman, Harris R.
影响因子：
4.6
作者：
Coghlan ML;Maker G;Crighton E;Haile J;Murray DC;White NE;Byard RW;Bellgard MI;Mullaney I;Trengove R;Allcock RJ;Nash C;Hoban C;Jarrett K;Edwards R;Musgrave IF;Bunce M
通讯作者：
Bunce M
影响因子：
4.2
作者：
Bailey, Regan L.;Gahche, Jaime J.;Picciano, Mary Frances
通讯作者：
Picciano, Mary Frances
影响因子：
4.3
作者：
Dwyer, Johanna T.;Picciano, Mary Frances;Perry, Charles R.
通讯作者：
Perry, Charles R.