Functional Foods Regulation System: Proposed Regulatory Paradigm by Functional Food Center

Summary

This policy paper articulates the Functional Food Center's proposed regulatory paradigm for functional foods, addressing the current gap in FDA-specific guidance that creates uncertainty for manufacturers and consumers. The authors outline a 17-step scientific validation and approval process, and propose a third-party certification system modelled on kosher labeling to expedite market entry whilst maintaining safety and credibility. The model aims to balance innovation, consumer protection, and transparent communication in an evolving functional food market.

Regional applicability

This paper proposes a United States-centric regulatory model addressing FDA gaps; however, the certification approach and principles of transparent, third-party validation may inform discussion of functional food regulation in the United Kingdom, where the FSA and EFSA currently manage health claims and novel foods under EU-retained frameworks and emerging domestic policy.

Key measures

Proposed regulatory process steps; certification framework design; comparison with existing FDA approval timelines and kosher labeling model

Outcomes reported

The paper proposes a 17-step regulatory approval process for functional foods and outlines a certification model inspired by kosher labeling systems to streamline market approval and ensure consumer safety.

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