Science Based Authentication of Dietary Supplements

摘要/总结 根据 DSHEA 的规定，FDA 的主要责任是确保适当的监管 针对存在重大健康风险或带有虚假或误导性的已上市产品采取行动 标签声明。评估此类风险和索赔的基础是充分的科学基础 决策。对于植物膳食补充剂来说，建立这样的科学基础尤其重要 由于一些独特的特征，包括成分的复杂性、 采购、缺乏参考材料、缺乏制造控制以及快速扩大使用 市场。 2010年，FDA全面实施现行良好生产规范（cGMP） 植物膳食补充剂行业将“植物身份和真实性”的责任置于 植物膳食补充剂制造商。然而，这些 cGMP 在很多方面都增加了 确定身份的“科学有效方法”的复杂性以及 植物材料的真实性。为了解决围绕植物身份的这些复杂问题， 真实性和安全性，为了延续我们与 FDA 的合作协议，NCNPR 已 制定了以下具体目标来帮助满足 FDA 的研究需求： 1. 以安全为基础，协助鉴定和制定BDS和植物成分清单 对在美国销售的植物药的担忧、趋势和知识，以便优先进行进一步研究。 2. 获取、验证和表征经过验证的参考材料，包括原材料和加工植物 与 FDA 相关的材料和纯化天然产品，用于评估其安全性。 3.与FDA交换技术和科学信息、分析方法和参考资料 科学家和其他利益相关者。 4. 与 FDA 科学家在共同感兴趣的研究领域进行合作。 5. 协调有关北斗系统相关公共卫生主题的科学研讨会和会议 满足高优先级的科学和研究需求。 该提案扩大了现有协议下有关北斗系统潜在安全问题的研究，并且 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.