Federal Regulation of Probiotics: An Analysis of Existing Regulatory Framework

描述(由申请人提供)：益生菌的联邦监管：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已有或将在不久的将来上市的新益生菌产品进行监管的适当性进行评估。该项目将包括文献综述、对现有相关法规和法规的审查，以及为期三天的会议，每次会议将召集来自监管、科学、生物技术、政府和学术界的15-20名应邀与会者，讨论现有的食品、膳食补充剂和药品监管框架是否足以确保益生菌的安全性，并确保含有益生菌成分的产品销售商提出的与健康有关的声明的准确性。该提案的重点是监管消费者在没有处方的情况下可以或将可供人使用的益生菌产品，以及在临床环境中可以或将可供人类患者使用的益生菌产品。此外，研究的重点将只是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。第一次会议将集中讨论益生菌的科学--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，以及关于消费或使用益生菌的好处和风险的讨论。第二次会议将集中讨论目前对含有益生菌成分的消费品的监管框架的充分性。第三次会议将集中讨论制定适当的益生菌监管框架，并提出监管政策建议。在最后一次会议之后，调查人员将在与会者的帮助下编写一篇或一系列论文，其中将包括以下专题：a)目前对益生菌的监管；b)有据可查的益生菌使用的好处和风险；c)目前监管益生菌的监管框架是否充分；以及d)如果适当，建议监管益生菌的替代监管模式。与公共健康相关：益生菌领域是一个新领域，可能适合也可能不适合美国目前的监管框架，该框架旨在监管人类使用的食品和药物。与所有新技术一样，至关重要的是，在采用新技术之前对可能的产品风险和适当的监管进行跨学科的讨论，这使得对新技术实施新的监管结构过于繁重或不切实际。该项目将探索益生菌研究的现状，并确定益生菌在消费品和临床应用中的当前和潜在用途。调查人员将召集卫生政策、人类微生物组科学以及食品和药品监管领域的专家，讨论当前监管框架和任何潜在替代方案的充分性，以便为政策制定者提供旨在保护公众免受误导性声明或使用益生菌产品可能产生的任何潜在风险的监管选择。

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.