The role of quality assurance and standardization in the safety of botanical dietary supplements
The role of quality assurance and standardization in the safety of botanical dietary supplements
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DOI：
10.1021/tx7000493
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发表时间：
2007-04-01
影响因子：
4.1
通讯作者：
Farnsworth, Norman R.
中科院分区：
文献类型：
--
作者：
van Breemen, Richard B.;Fong, Harry H. S.;Farnsworth, Norman R.
补充和替代疗法的重要性，如植物膳食补充剂，在世界各地继续增加（1）。世界卫生组织（WHO）估计，发展中国家的大多数人依赖传统和草药作为他们的主要医疗保健来源。在美国，42%的人口报告使用补充和替代药物，特别是植物膳食补充剂（3），估计每年花费51亿美元（4）。膳食补充剂的营销和使用在1994年通过“膳食补充剂和健康教育法案”后在美国迅速增长，该法案免除了膳食补充剂作为药物的监管，前提是它们不用于诊断，治疗，治愈或预防疾病（5）。尽管植物膳食补充剂的使用在过去二十年中大幅增加，其有效性和安全性的证据尚未得到充分记载。例如，在美国，植物性膳食补充剂目前不受良好生产规范的约束，不需要功效证明，也不需要FDA的上市前批准，除非提出类似药物的声明。植物膳食补充剂的安全性是制造商的责任，FDA在安全保证方面的作用仅限于对不良反应的上市后监测。由于膳食补充剂没有疾病治疗或预防益处，因此它们不受FDA监管，并且这些产品的功效研究相对较少。
The importance of complementary and alternative therapies such as botanical dietary supplements continues to increase throughout the world (1). The World Health Organization (WHO) has estimated that the majority of people in developing countries depend on traditional and herbal medicines as their primary source of health care (2). In the United States, 42% of the population have reported using complementary and alternative medicines, especially botanical dietary supplements (3), costing an estimated $5.1 billion per year (4). The marketing and use of dietary supplements has grown rapidly in the United States following the passage of the ‘Dietary Supplement and Health Education Act’in 1994, which exempts dietary supplements from regulation as drugs providing that they are not marketed for the diagnosis, treatment, cure, or prevention of disease (5).Although the use of botanical dietary supplements has increased substantially during the last two decades, evidence for their efficacy and safety has not been well documented. In the United States for example, botanical dietary supplements are currently exempt from good manufacturing practice, do not require proof of efficacy, and do not require pre-marketing approval by the FDA unless drug-like claims are made. The safety of botanical dietary supplements is the responsibility of the manufacturers, and the role of the FDA in safety assurance is limited to post-marketing monitoring of adverse effects. Since no disease treatment or prevention benefits may be claimed for dietary supplements, they are exempt from FDA regulation, and efficacy studies for these products are relatively rare.