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.
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.
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| Hoffmann, D E; Fraser, C M; Palumbo, F B et al. (2013) Science and regulation. Probiotics: finding the right regulatory balance. Science 342:314-5 |
| Human Microbiome Project Consortium (2012) Structure, function and diversity of the healthy human microbiome. Nature 486:207-14 |
| Human Microbiome Project Consortium (2012) A framework for human microbiome research. Nature 486:215-21 |
