Federal Regulation of Probiotics: An Analysis of Existing Regulatory Framework

描述（由申请人提供）：益生菌的联邦法规：现有监管框架的分析和替代框架的建议。该提案要求提供资金，以支持对现有监管框架及其对市场上可用或不久的将来可用的新益生菌产品监管的适当性进行评估。该项目将包括文献综述，现有相关法规和条例的审查，以及为期三天的会议，每次会议将邀请来自监管，科学，生物技术，政府和学术界的15-20名受邀参与者，讨论现有的食品，膳食补充剂，及药物的资料，足以确保益生菌的安全性及销售商就含有益生菌成分的产品所作与健康有关的声称的准确性。该提案的重点是对消费者可以或将可以在没有处方的情况下使用的益生菌产品以及在临床环境中可以或将可以用于人类患者的益生菌产品进行监管。此外，研究的重点将仅限于那些宣传自己具有益生菌特性或基于益生菌特性提出健康相关声明的商业和临床产品。第一次会议将集中在益生菌的科学-包括益生菌研究的现状，益生菌的当前和未来的临床应用，益生菌的当前和未来的商业用途，以及消费或使用益生菌的益处和风险的讨论。第二次会议将重点关注目前含有益生菌成分的消费品的监管框架是否充分。第三次会议将重点关注制定益生菌监管的适当框架，并提出监管政策建议。在最终会议后，研究者将在与会者的帮助下准备一篇论文或一系列论文，其中将包括以下主题：a）益生菌的当前监管; B）记录益生菌使用的获益和风险; c）益生菌监管的当前监管框架的充分性;以及d）如适用，建议益生菌监管的替代监管模式。公共卫生相关性：益生菌领域是一个新的领域，可能适合也可能不适合美国目前的监管框架，以规范人类使用的食品和药物。与所有新技术一样，至关重要的是，在新技术的采用使对新技术强加新的监管结构变得过于繁琐或不切实际之前，就可能的产品风险和适当的监管进行跨学科讨论。该项目将探讨益生菌研究的现状，并确定益生菌在消费品和临床应用中的当前和潜在用途。研究人员将汇集卫生政策，人类微生物组科学以及食品和药物监管领域的专家，讨论当前监管框架的充分性和任何潜在的替代方案，以便为政策制定者提供旨在保护公众的监管选择误导性声明或可能来自使用益生菌产品的任何潜在风险。

DESCRIPTION (provided by applicant): Federal Regulation of Probiotics: An Analysis of the Existing Regulatory Framework and Recommendations for Alternative Frameworks. This proposal requests funding to support an evaluation of existing regulatory frameworks and their appropriateness for the regulation of new probiotic products that are available in the market or will be available in the near future. The project will include a literature review, review of existing relevant statutes and regulations, and three day-long meetings that will each bring together 15-20 invited participants from the regulatory, scientific, biotechnology, government and academic communities to discuss whether the existing regulatory framework of foods, dietary supplements, and drugs is sufficient to ensure the safety of probiotics and accuracy of health-related claims made by sellers of products with probiotic components. The focus of the proposal is the regulation of probiotic products that are or will be available to consumers for human use without a prescription and probiotic products that are or will be available to human patients in the clinical setting. Additionally, the focus of the study will be only those commercial and clinical products that promote themselves as having, or make health-related claims based on, probiotic properties. The first meeting will focus on the science of probiotics - including the current state of probiotic research, current and future clinical applications of probiotics, current and future commercial uses of probiotics, and a discussion of the benefits and risks of consuming or using probiotics. The second meeting will focus on the adequacy of the current regulatory framework for consumer products that contain probiotics components. The third meeting will focus on developing an appropriate framework for the regulation of probiotics and making regulatory policy recommendations. Following the final meeting, the Investigators will prepare a paper or series of papers, with the help of meeting participants, that will include the following topics: a) current regulation of probiotics; b) documented benefits and risks of probiotics use; c) the adequacy of the current regulatory frameworks for the regulation of probiotics; and d) if appropriate, suggested alternative regulatory models for the regulation of probiotics. PUBLIC HEALTH RELEVANCE: The field of probiotics is a new field that may or may not fit into the current regulatory framework in the United States that is in place to regulate food and drugs for human use. As with all new technologies, it is critical that an interdisciplinary discussion of possible product risks and appropriate regulation take place before uptake of the new technology makes it too burdensome or unrealistic to impose a new regulatory structure on the new technology. This project will explore the current state of probiotics research and identify current and potential uses of probiotics in consumer products and clinical applications. The Investigators will bring together experts in the area of health policy, human microbiome science, and food and drug regulation to discuss the adequacy of the current regulatory frameworks and any potential alternatives in order to provide policy makers with regulatory options designed to protect the public from misleading claims or any potential risks that might derive from the use of probiotic products.