Donovan Sharon M, Abrahams Mariette, Anthony Joshua C, Bergia Robert, Blander Gil, Brisbois Tristin D, Keck Anna-Sigrid, Moore Edwin G, Morck Timothy A, Nieman Kristin M, Ordovas Jose M, Steiber Alison, Winters Barbara L, Wu Thuyvan
Department of Food Science and Human Nutrition, and Personalized Nutrition Initiative, Carl R. Woese Institute for Genomic Biology, University of Illinois Urbana-Champaign, Urbana, IL, United States.
Qina, Ltd, Olhao, Portugal.
Adv Nutr. 2025 Mar;16(3):100382. doi: 10.1016/j.advnut.2025.100382. Epub 2025 Jan 25.
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 supporting 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 and machine learning models support recommendations and lifestyle behavior change. Advancements in the field enhance the potential for tailored and effective programs but raise 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 United States 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 1) safety and accuracy of the tests and devices, 2) credentialed and skilled experts develop the advice, 3) responsible and clear communication of information and benefits, 4) substantiation of scientific claims, and 5) procedures are implemented to protect user privacy. Furthermore, as this field incorporates new devices, biomarkers, behavior-based tools, and the integration of artificial intelligence and machine learning, 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.
个性化营养（PN）旨在通过整合大量个人层面的信息并支持期望的行为改变，提供量身定制的饮食建议，以改善个人的健康状况。随着技术进步，该领域正在迅速发展。随着新生物标志物的发现，可穿戴设备和其他设备现在可以提供即时洞察，人工智能和机器学习模型支持建议和生活方式行为改变。该领域的进步增强了制定量身定制且有效的计划的潜力，但也引发了有关用户安全、安保、健康、透明度和隐私的重要问题。伊利诺伊大学的个性化营养倡议举办了“当前美国监管框架下个性化营养面临的挑战及未来机遇”研讨会，以探讨当前PN计划的监管影响、当前框架内的未来创新以及现有监管复杂性。大多数PN计划结合了多个组成部分，这些组成部分可能需要不同的监管方式。描述并讨论了食品、补充剂、体外诊断以及医疗和健康设备等领域在PN计划中的应用。发言者和讨论者得出结论，PN计划的监管指南应侧重于确保：1）测试和设备的安全性和准确性；2）由具备资质和技能的专家提供建议；3）负责且清晰地传达信息和益处；4）科学声明的证实；5）实施保护用户隐私的程序。此外，由于该领域纳入了新设备、生物标志物、基于行为的工具以及人工智能和机器学习的整合，还考虑了调整现有监管框架的必要性。需要与监管机构密切合作，这应该是一个为用户提供透明度、建立信任并为PN创新者创造差异化来源的机会。
