Science based authentication of botanical ingredients

项目摘要/摘要 21年来，根据DSHEA的规定，FDA主要负责确保 对市场上存在重大健康风险的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适当的 为决策提供科学依据。对于植物性饮食成分，这样的科学基础的发展是 范围广泛，因为有几个独特的特点，包括来源的多样性，缺乏制造 控制、成分复杂、缺乏广泛使用的标准物质 由于草药-草药或草药-药物相互作用而产生的未知不良反应。在2010年，FDA完全 实施现行的植物性膳食补充剂行业良好生产规范(CGMP) 将“植物学身份和真实性”的责任推给含有以下成分的膳食补充剂制造商 各种植物成分。然而，这些cGMP突显了究竟什么是模棱两可的 构成一种确定身份真实性和安全性的“科学有效方法”。 植物材料。为了解决这些围绕植物学身份、真实性和安全性的复杂问题 为了继续我们与FDA的合作协议，NCNPR建立了以下协议 具体目的是帮助FDA的研究需求： 1)协助确定和制定草药膳食补充剂和植物学补充剂清单 成分，基于安全考虑、趋势和对在美国销售的植物药物的了解， 以确定进一步研究的优先顺序。 2)获取、验证和鉴定经过鉴定的参考材料，包括原材料和加工过的 与FDA相关的植物材料和纯化天然产品，用于评估其 指纹图谱、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)协调关于以下主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