These were questions addressed by personalized nutrition experts in a recent paper published in the journal Advances in Nutrition.
The article is an extension of a workshop held last March at the University of Illinois Urbana-Champaign titled “Challenges for Personalized Nutrition in the Current U.S. Regulatory Framework and Future Opportunities.”
Amway, Archer Daniels Midland Co., General Mills, Givaudan, Mars Wrigley, National Dairy Council, PepsiCo and Pharmavite provided financial support for the workshop.
Commenting on the report, Joshua Anthony, an author on the paper and founder and CEO at personalized nutrition consultancy Nlumn, told NutraIngredients-USA that the experts agreed that policymakers should align with the core elements of the field. These include data collection, analyses, recommendations and delivery, and benefits and feedback.
He added that this approach will also allow flexibility for policymakers and companies to apply technology differently depending on its use.
“I think that evolving regulations to address the different components of personalized nutrition makes sense,” Anthony said. “For example, AI or machine learning models used for providing user feedback may be subject to different regulations than that for biomarker analysis.”
The Office of Science and Technology Policy, part of the Executive Office of the President, provides a roadmap for an AI Bill of Rights, although it does not offer specific guidelines regarding nutrition.
The workshop participants concluded that regulatory guidance for personalized nutrition programs should also focus on the following:
- safety and accuracy of the tests and devices,
- credentialed and skilled experts develop the advice,
- responsible and clear communication of information and benefits,
- substantiation of scientific claims, and
- procedures are implemented to protect user privacy
“People worry the personalized nutrition programs aren’t regulated or don’t fit within regulatory frameworks,” Anthony said. “In fact, regulations help provide a blueprint for the responsible practice of personalized nutrition. It may be confusing because regulations aren’t written to cover personalized nutrition per se outside of special conditions, such as medical foods.”
Instead, regulations target the component parts of a product or service, such as devices, nutrition products, packaging and claims. Anthony said when examining each of these areas, there is detailed guidance to support innovation.
Rapid tech changes
The researchers defined personalized nutrition as a discipline focused on the individual to consider unique genetic, phenotypic, medical and lifestyle information to tailor dietary recommendations. The goal is to promote dietary behavior change alongside the individual’s goals and preferences.
Personalized nutrition can be an interdisciplinary field, relying on nutrition, systems biology and behavioral sciences to devise tailored recommendations that can measurably improve an individual’s health or function.
The discipline is also moving quickly to embrace swift changes in technology.
“The field of personalized nutrition is rapidly incorporating new tools to measure biomarkers and integrating artificial intelligence and machine learning models to support recommendations and lifestyle behavior change,” the researchers wrote. “These tools hold promise to improve our understanding of health requirements and scale the personalized nutrition field by making it more accessible, but they also raise important questions regarding user safety, security, health and privacy.”
Global coordination
Personalized nutrition does not always deliver a health or functional benefit, especially when programs can sometimes be marketed without prior research to determine their effectiveness. This argues for the enforcement and expansion of regulatory policies, the researchers noted.
Expansion might include offering a pathway for personalized nutrition provider to communicate about disease prevention. The experts suggested that this is critical given that chronic disease-related deaths are on the rise.
They added that the rapidly changing field also requires international coordination.
“Global collaboration with regulatory bodies such as the European Union Data Protection Board and the IMDRF, can help bolster and harmonize standards and facilitate global adoption of innovations while ensuring safety, oversight and efficacy of personalized nutrition programs, including factual and transparent communication of benefits,” the paper noted.
Coordination also includes setting up a network of personalized nutrition and regulatory experts to provide support for the increasing number of companies entering the market. The researchers suggested that a certification process could communicate quality to consumers.
“This would provide innovative start-ups as well as larger companies interested in participating in [personalized nutrition] programs access to learn which regulations apply, what they should have in place and what they are allowed to claim,” the researchers wrote. “This network would support companies’ understanding of implications for data security relative to partnerships, developing application programming interfaces, and data sharing.”
Source: Advances in Nutrition. doi: 10.1016/j.advnut.2025.100382. “Perspective: Challenges for Personalized Nutrition in the Current U.S. Regulatory Framework and Future Opportunities”. Author: Sharon M. Donovan et al.
