Science based authentication, validation & safety of botanical ingredients

基于科学的认证、验证

• 批准号: 10670826
• 负责人: Ikhlas Ahmad Khan
• 金额: $ 238.3万
• 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 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10670826
• 关键词: Science; based; authentication; validation; safety

Abstract: As per the provisions of 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. The development and dissemination of research-based, scientifically valid information requires cooperation between academia, government, and industry. As a part of the FDA program to establish ‘Centers of Excellence (COE)’ in support of research relevant to their mission, in 2001 the office of dietary supplements at CFSAN, established an agreement with the National Center for Natural Products Research at the University of Mississippi. This agreement represents a cooperative effort to address critical research needs in the botany, chemistry, and biology aspects of dietary supplement ingredients, especially those of priority safety concern to CFSAN. Through two decades of the long-standing, successful inter-institutional cooperative research agreement, researchers at the COE addressed the ongoing quality and safety issues with botanical ingredients in dietary supplements and cosmetics. Specifically, several botanically-verified materials and chemical markers were established and utilized to address the quality and authenticity of more than 10,000 finished products. More than 200 independent analytical methods were designed, and the development of such tools was instrumental in addressing quality control issues with dietary supplement products. These findings allowed regulators to develop a critical scientific base to recall several thousands tainted botanical supplement products containing synthetic artifacts or others exogenous components. In addition to the state-of-the-art instrumentation available at the COE, in-house medicinal plant garden and collaborative research agreements with national and international botanical research partners allowed the COE to amass several thousand botanicals for both research and training purposes. As result of these cohesive scientific efforts, on average, the COE contributed more than 50 publications and generated about 1000 citations per year for the last 10 years, addressing various quality and safety issues with botanical ingredients integral to various dietary supplements and other products. The current proposal is a request for continued support to address critical quality and safety aspects of botanical ingredients’ in various finished products. This request aligns with CFSAN’s mission to assure public health. The COE will continue to augment the development of a prioritized list of botanicals of concern, implement reference materials, and develop suitable analytical methods for establishing the invaluable scientific base for requlatory compliance. The proposed diverse activities and resulting tools could provide an important arsenal to regulators to develop, implement and modify regulatory guidance to assure the quality and safety of botanical ingredients in dietary supplements, cosmetics, and other formulations.

摘要： 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带有虚假或误导标签的已上市产品采取行动 索赔开发和传播以研究为基础的、科学有效的信息需要 学术界、政府和工业界之间的合作。作为FDA建立“中心”计划的一部分， 为了支持与其使命相关的研究，2001年，膳食补充剂办公室 在CFSAN，与该大学的国家天然产品研究中心达成协议， 来自密西西比。该协议代表了一种合作努力，以解决植物学中的关键研究需求， 膳食补充剂成分的化学和生物学方面，特别是那些优先考虑安全性的成分， CFSAN。 通过二十年的长期、成功的机构间合作研究协议， COE的研究人员解决了膳食中植物成分的持续质量和安全问题， 补充剂和化妆品。具体来说，几种植物学验证的材料和化学标记物， 建立和使用的质量和真实性的成品超过10，000。超过 设计了200种独立的分析方法，这些工具的开发有助于 解决膳食补充剂产品的质量控制问题。这些发现使监管机构能够制定 一个关键的科学基础，召回数千种含有合成成分的受污染植物补充剂产品， 人工制品或其他外源成分。除了最先进的仪器外， COE，内部药用植物园以及与国家和国际合作研究协议 植物研究合作伙伴允许COE收集数千种植物用于研究， 培训目的。由于这些有凝聚力的科学努力，平均而言，COE贡献了50多个 出版物，并产生约1000引文，每年为过去10年，解决各种质量和 各种膳食补充剂和其他产品中不可或缺的植物成分的安全问题。 目前的建议是要求继续支持解决植物药的关键质量和安全问题， 各种成品中的成分。这一要求与CFSAN确保公众健康的使命一致。的 COE将继续加强关注植物的优先列表的开发， 材料，并开发合适的分析方法，为建立监管的宝贵的科学基础， 合规拟议的各种活动和由此产生的工具可以为监管机构提供一个重要的武器库 制定、实施和修改监管指南，以确保植物成分的质量和安全 用于膳食补充剂、化妆品和其他制剂。