Abstract
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.
Statement of Significance
Innovations in the personalized nutrition (PN) field promise to improve opportunities to deliver tailored and effective programs but raise important questions regarding regulatory oversight since current products and services include components that are regulated by different offices in the FDA. The Personalized Nutrition Initiative at the University of Illinois, Urbana organized a workshop to address the regulatory implications of current PN products, future innovation within the current framework, and existing complexities of oversight.
Introduction
Nutrition recommendations and dietary guidelines can be effective when they are evidence-based, applicable to, and adopted by a specific population, subpopulation, or individual. The U.S. Department of Agriculture (USDA) and Health and Human Services Dietary Guidelines for Americans (DGA) provide population-based nutrition recommendations to meet nutrient needs, promote health, and prevent chronic disease [1]. The definitions of precision nutrition and personalized nutrition (PN) are not standardized and often overlap in this rapidly evolving field [2]; however, for the purposes of this report, the following definitions were utilized. Precision nutrition provides tailored dietary recommendations for specific subgroups within the general population. These groupings can be based on demographic factors (e.g., age, gender), biological markers (e.g., genetics, blood biomarkers), behavioral patterns, environmental factors, or risk for certain diseases (e.g., type 2 diabetes). The goal is to provide more targeted advice than general population guidelines but not as individualized as personalized nutrition. Information used for recommendations should be centered on evidence-based science and designed to promote dietary behavior change by considering unique goals and preferences. Personalized nutrition focuses on the individual level, considering unique genetic, phenotypic, medical, and lifestyle information to tailor dietary recommendations. The aim is to promote dietary behavior changes by aligning them with individual goals and preferences.
PN and precision nutrition often incorporate an interdisciplinary approach, relying on nutrition, systems biology, and behavioral sciences to develop tailored recommendations targeting a quantifiable improvement in health or function [3, 4]. Approaches should be structured within sound dietary guidance to help support individual needs while achieving public health recommendations. Indeed, emerging research suggests PN that combines systems biology with behavior sciences may help address an individual’s preferences, and unique health needs, and achieve public health recommendations more effectively than general guidelines [5-10]. As other findings, primarily focused on genetic-driven personalized interventions have been less effective, this area requires further research [11, 12].
The increasing consumer demand for tailored health interventions underscores the importance of developing scientifically robust, inclusive, and scalable PN programs [13, 14]. Furthermore, the field of PN is rapidly incorporating new tools to measure biomarkers and integrating artificial intelligence (AI) and machine learning (ML) models to support recommendations and lifestyle behavior change. These tools hold promise to improve our understanding of health requirements and scale the PN field by making it more accessible, but they also raise important questions regarding user safety, security, health, and privacy.
As the PN field grows, it is critical to consider the regulatory framework to establish and maintain credibility, build user trust and engagement, and prevent misinformation. Guidance areas for PN programs include ensuring the safety and accuracy of the tests and devices, having credentialed and skilled experts that develop and deliver the advice, responsible and clear communication of information and benefits, and scientific substantiation of claims [15]. Therefore, on March 6, 2024, the Personalized Nutrition Initiative at the University of Illinois Urbana-Champaign held a virtual workshop, “Challenges for Personalized Nutrition in the Current U.S. Regulatory Framework and Future Opportunities”. The workshop goals centered around the current regulatory framework for PN and included understanding: (i) the PN process and regulatory implications, (ii) the history, present status, applications, and limitations of the current U.S. regulatory framework when applied to PN, and (iii) the complexities of oversight of PN programs and the future horizon. The main purpose was to better understand current regulatory guidelines and how PN innovation fits within them to help guide responsible program development. Working with this framework will also benefit users by supporting safety, consistency, and credibility for PN programs. At the same time, rapidly developing technologies, such as AI consumer wearables and continuous biosensors are changing approaches to PN and health. Accordingly, this workshop also considered whether new regulations are needed to oversee this changing landscape.
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Perspective: Challenges for Personalized Nutrition in the Current U.S. Regulatory Framework and Future Opportunities. Donovan, Sharon M. et al. Advances in Nutrition, Volume 0, Issue 0,
DOI: 10.1016/j.advnut.2025.100382
