Science based authentication of botanical ingredients

概要/摘要 21年来，根据DSHEA的规定，FDA的主要责任是确保 对存在重大健康风险或存在以下风险的上市产品采取适当的监管行动： 虚假或误导性的标签声明。评估此类风险和索赔的基础是充分的 决策的科学基础。对于植物性膳食成分，开发这样的科学基础是 广泛的，因为几个独特的功能，包括采购的可变性，缺乏制造 控制，成分的复杂性，缺乏参考材料， 市场和未知的不良反应，由于草药，或草药药物相互作用。2010年，FDA 实施了植物膳食补充剂行业的现行良好生产规范（cGMP） 将“植物身份和真实性”的责任放在含有以下成分的膳食补充剂的制造商身上， 各种植物成分然而，这些cGMP的突出了究竟是什么的模糊性 构成了一种“科学有效的方法”，用于确定身份的真实性和安全性， 植物材料为了解决这些复杂的问题，围绕植物的身份，真实性和安全性 为了继续我们与FDA的合作协议，NCNPR已经建立了以下内容 具体目标是帮助满足FDA的研究需求： 1)协助确定和发展的膳食草药补充剂和植物 成分，基于安全问题，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比物质，包括原材料和经加工的参比物质 与FDA相关的植物材料和纯化天然产品，用于评估其 指纹、掺假、安全性和毒性。 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)协调关于与工商发展服务有关的专题的科学讲习班和会议，

PRJECT SUMMARY/ABSTRACT For 21 years under the provisions of DSHEA, the FDA has had 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 ingredients, development of such a science base is wide-ranging because of several unique features, including the variability of sourcing, lack of manufacturing controls, complexity of the constituents, lack of availability of reference materials widespread usage in the marketplace and unknown adverse effects due to herb-herb, or herb-drug interactions. 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 dietary supplements containing various botanical ingredients. However, these cGMP's have highlighted the ambiguity of exactly what constitutes a “scientifically valid method” for the determination of the identity authenticity and safety 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 dietary herbal supplements 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 the assessment of their fingerprinting, adulteration, safety and toxicity. 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