Perspective: Challenges for Personalized Nutrition in the Current U.S. Regulatory Framework and Future Opportunities.

Personalized Nutrition (PN) aims to provide tailored dietary recommendations to improve a person's health outcomes by integrating a multitude of individual-level information and support desired behavior changes. The field is rapidly evolving with technological advances. As new biomarkers are discovered, wearables and other devices can now provide up-to-the-minute insights, and artificial intelligence (AI) and machine learning (ML) models support recommendations and lifestyle behavior change. Advancements in the field enhance the potential for tailored and effective programs but raises important questions regarding user safety, security, health, transparency, and privacy. The Personalized Nutrition Initiative at the University of Illinois held the workshop, "Challenges for Personalized Nutrition in the Current U.S. Regulatory Framework and Future Opportunities," to address regulatory implications of current PN programs, future innovation within the current framework, and existing complexities of oversight. A majority of PN programs combine multiple components and these components may need to be regulated differently. The areas of food, supplements, in vitro diagnostics, and medical and wellness devices were described and discussed as they apply to PN programs. The speakers and discussants concluded that regulatory guidance for PN programs should focus on ensuring (i) safety and accuracy of the tests and devices, (ii) credentialed and skilled experts develop the advice, (iii) responsible and clear communication of information and benefits, (iv) substantiation of scientific claims, and (v) procedures are implemented to protect user privacy. Furthermore, as this field incorporates new devices, biomarkers, behavior-based tools, and the integration of AI and ML, the need to adapt the existing regulatory framework was also considered. Working closely with regulatory bodies is required and should be an opportunity to provide users with transparency, build trust, and create a source of differentiation for PN innovators.