Science Based Authentication of Dietary Supplements

摘要/概要 根据DSHEA的规定，FDA主要负责确保适当的监管 对存在重大健康风险或虚假或误导的上市产品采取行动 标签声明。评估此类风险和索赔的基础是充分的科学依据， 决策的对于植物性膳食补充剂来说，发展这样一个科学基础尤其重要。 由于几个独特的特征，包括成分的复杂性， 采购、缺乏参考材料、缺乏制造控制以及在 市场。2010年，FDA全面实施了现行的药品生产质量管理规范（cGMP）， 植物膳食补充剂行业将“植物身份和真实性”的责任放在 植物性膳食补充剂的生产商。然而，这些cGMP在许多方面增加了 关于什么构成确定身份的“科学有效方法”的复杂性， 植物材料的真实性。为了解决这些围绕植物身份的复杂问题， 真实性和安全性，并继续我们与FDA的合作协议，NCNPR已 制定了以下具体目标，以帮助满足FDA的研究需求： 1.基于安全性，协助确定和开发BDS和植物成分清单 关注、趋势和在美国销售的植物药的知识，以便于进一步研究。 2.获取、验证和表征经认证的参考物质，包括原材料和加工过的植物 与FDA相关的材料和纯化的天然产品，以评估其安全性。 3.与FDA交换技术和科学信息、分析方法和参考材料 科学家和其他利益相关者。 4.在共同感兴趣的研究领域与FDA科学家合作。 5.协调关于与公共卫生有关的生物多样性和发展服务相关专题的科学讲习班和会议， 满足高度优先的科学和研究需求。 该提案扩大了现有关于存在潜在安全问题的BDS协议下的研究， 将努力扩展到其他新出现的问题植物。

Abstract/Summary Under the provisions of the DSHEA, the FDA has primary responsibility for ensuring that appropriate regulatory actions are taken against marketed products that present significant health risks or bear false or misleading label claims. Foundational to the evaluation of such risks and claims is an adequate scientific base for decision-making. For botanical dietary supplements, development of such a science base is especially problematic because of several unique features, including the complexity of the constituents, variability of sourcing, lack of availability of reference materials, lack of manufacturing controls and rapidly expanding use in the marketplace. In 2010 the FDA fully implemented the current good manufacturing practices (cGMP) for the botanical dietary supplement industry placing the onus of "botanical identity and authenticity" on the manufacturers of botanical dietary supplements. However, these cGMP's have in many ways increased the complexity as to what constitutes a "scientifically valid method" for the determination of the identity and authenticity of botanical materials. To address these complex issues surrounding botanical identity, authenticity, and safety and in continuation of our cooperative agreement with the FDA, the NCNPR has established the following specific aims to aid in the research needs of the FDA: 1. Assist in the identification and development of a list of BDS and botanical ingredients, based on safety concerns, trends, and knowledge of botanicals being marketed in the U.S., to prioritize for further research. 2. Acquire, validate, and characterize authenticated reference materials, including raw and processed plant materials and purified natural products of relevance to FDA, for evaluation of their safety. 3. Exchange technical and scientific information, analytical methods, and reference material with FDA scientists and other stakeholders. 4. Collaborate with FDA scientists in research areas of mutual interest. 5. Coordinate scientific workshops and conferences on BDS-related topics of public health relevance to address high priority science and research needs. This proposal expands the research under the current agreement on BDS with potential safety issues, and extends the effort to additional emerging problem botanicals.