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.

This 3-year R01 based at the University of Minnesota and Vanderbilt University will convene a national Working Group of top legal and scientific experts to analyze current U.S. federal and state law, regulation, and guidance on translational genomics, and to generate consensus recommendations on what the law should be, to optimize successful translation of genomics into clinical use. The law underlying genomics is currently unclear, poorly understood, and contested.