U.S. Regulatory Structure Can Support Personalized Nutrition
As personalized nutrition (PN) continues to gain traction, it can be challenging to navigate the regulatory environment as no single framework explicitly addresses PN. PN programs require several components that may need to be regulated differently depending on the application. Companies may not be aware that many, if not all, pieces of a product or service can fit within the existing U.S. regulatory framework.
Following a workshop led by the Personalized Nutrition Initiative (PNI) at the University of Illinois, we collaborated on a paper published in Advances in Nutrition that explores how PN fits within the current U.S. regulatory structure and identifies areas where policies should evolve. Here, we break down the insights and what they mean for your business.
Pillars of Current Regulatory Oversight
Regulatory oversight in the U.S. is fragmented across multiple agencies, covering the components of PN rather than the entire service. This patchwork approach provides a benefit as it allows multiple services with distinct elements to exist simultaneously. This is important because different PN program solutions will be required to meet individuals' unique needs. This creates opportunities for new market entries but also complexity for companies navigating multiple regulatory categories.
Where Regulation Needs to Evolve
While the existing framework provides structure, innovation in AI-driven personalization, biomarker testing, and digital health integration is outpacing regulations. The goal is to ensure PN regulations are protective and adaptable, allowing innovation while maintaining consumer trust.
Defining Core Elements of PN: A standardized approach is needed to clarify what defines a PN service. Once defined, applying existing regulations and identifying where new regulations are needed is easier. The paper outlines four core elements:
Applying a Tiered Approach: Just as medical devices have different classifications, PN services should also be evaluated based on their application and implications for user health and safety. For example, AI-generated dietary recommendations may require different oversight than diagnostics used to measure and make recommendations based on biomarkers. A tiered approach will allow regulations to evolve with emerging technology.
Global Regulatory Collaboration: Interdisciplinary collaboration will be essential depending on the application. Aligning U.S. regulations with international bodies, like the EU Data Protection Board and the International Medical Device Regulators Forum, can help create consistent privacy, transparency, and AI governance. This can also provide the blueprint needed for the industry to scale across borders.
Opportunities for Industry
While the regulatory landscape presents some challenges, there are opportunities for companies in the PN space to use the regulatory framework to their advantage.
Innovative Offerings: A company may combine multiple elements—like GPT, testing, wearables, recommendations, supplements, or other nutrition products—to create a highly personalized ecosystem. Along with these inputs comes a responsibility to follow applicable regulations to protect your consumers.
Guidance: Many companies avoid direct collaboration with regulatory bodies, yet doing so could be a strategic advantage. In fact, the FDA encourages communication. For example, the Q-submission program can provide presubmission feedback on medical device development to ensure clarity on regulatory expectations.
Competitive Advantage: As AI and digital health platforms grow, clear substantiation, privacy protection, and transparency will build trust. In an industry that blends food, ingredients, technology, and healthcare, embracing regulatory clarity isn't just about compliance – it's a pathway to credibility and scale.
Personalized nutrition is at a critical point of growth, and current regulations can serve as a blueprint for responsible innovation. At Nlumn, we are committed to helping businesses navigate this evolving space with evidence-based, regulatory-aligned strategies. Ready to discuss how these regulations may impact your business?