Science based authentication of botanical ingredients

基于科学的植物成分认证

• 批准号: 9344290
• 负责人: Amar G. Chittiboyina
• 金额: $ 205.8万
• 依托单位: UNIVERSITY OF MISSISSIPPI
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-15 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9344290
• 关键词: Science; based; authentication; botanical; ingredients

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

摘要/摘要 根据DSHEA的规定21年，FDA一直负责确保 针对出现重大健康风险或承受的销售产品采取适当的监管行动 虚假或误导性标签主张。评估此类风险和索赔的基础是适当的 决策的科学基础。对于植物饮食中，这种科学基础的发展是 由于几个独特的功能，包括采购的可变性，缺乏制造 控制，宪法的复杂性，缺乏参考材料的可用性 由于草药或草药 - 药物相互作用而引起的市场和未知的不良影响。 2010年，FDA完全 实施了当前的良好制造实践（CGMP） 将“植物身份和真实性”的责任放在含有饮食补充剂的制造商上 各种植物学用途。但是，这些CGMP强调了什么 构成了确定身份真实性和安全性的“科学有效方法” 植物材料。解决围绕植物身份，真实性和安全性的复杂问题 在继续与FDA达成合作协议时，NCNPR已建立以下内容 具体目的旨在帮助FDA的研究需求： 1）协助识别和开发饮食草药补充剂和植物学清单 基于安全问题，趋势和知识的成分在美国销售 优先考虑进一步研究。 2）获取，验证和表征已验证的参考材料，包括原始和处理 植物材料和与FDA相关的纯天然产物，以评估其 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）与FDA科学家在共同感兴趣的研究领域合作。 5）协调有关BDS相关主题的科学研讨会和会议