This is part of CRN’s Associate Member Spotlight series and reflects the views, opinions, and expertise of the featured member company, FoodChain ID. The content is provided for informational purposes only and does not represent the views, positions, or policies of CRN.
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Bringing an innovative ingredient to market takes more than promising science. Understanding the regulatory requirements of your target markets early in development can help avoid unnecessary studies, costly revisions and delays to commercialization.
The FoodChain ID team offers five practical considerations when developing innovative ingredients for dietary supplements and functional foods:
- Start with regulatory strategy. Assess the ingredient's status, intended uses and applicable regulatory pathways before commissioning studies or finalizing manufacturing processes.
- Understand market-specific requirements. The European Union's Novel Food framework differs significantly from U.S. pathways for Generally Recognized as Safe (GRAS) substances and New Dietary Ingredients (NDIs). Identifying the appropriate pathway early helps determine the evidence needed.
- Build an ingredient-specific evidence package. Safety assessments should reflect the ingredient's identity, composition, manufacturing process and intended uses. Changes in manufacturing can affect whether previously generated data remain applicable.
- Think globally when planning studies. Companies considering multiple markets should evaluate how evidence developed for one jurisdiction may support submissions in another, reducing duplication where requirements overlap.
- Account for realistic costs and timelines. Regulatory planning should consider not only submission requirements but also the time and investment needed for safety studies, data generation and responses to regulatory questions.
Explore FoodChain ID's full article on five key takeaways for innovative ingredient development for additional guidance on building an effective regulatory strategy.
Go deeper: FoodChain ID experts will also present a complimentary webinar on Nov. 11, examining ingredient eligibility, authorization requirements and permitted claims for supplements in the EU, U.S. and Canada.
Questions? Contact Leah Johnston (Leah.johnston@foodchainid.com).