Supplement Product Development & Compliance

Supplement product developers must understand market and target requirements early in the development stage to avoid rework. FoodChain ID offers Supplements R&D Insight software that evaluates ingredient regulatory status, usage and health claims. Organizations may also benefit from supplements consulting services when evaluating formulation strategies and regulatory requirements.

In the European Union (EU), a novel food (NF) is defined as any food that was not consumed to a significant degree by humans within the EU before May 15, 1997. The regulation of NFs, primarily under Regulation (EU) 2015/2283, aims to ensure the safety of new food products before they enter the market. The novel foods application process requires technical expertise. FoodChain ID provides novel food application support to ensure applications meet all the EFSA and European Commission regulatory requirements. Companies preparing submissions for European markets can benefit from early regulatory planning and assessment.

In the United States, supplement claims include structure/function claims, general well-being claims and nutrient-deficiency claims. The European Commission determines permitted nutrition claims and authorized and non-authorized health claims. FoodChain ID experts work in the United States, Europe and Asia to guide clients when evaluating the market complexity of claim regulations. Organizations can also leverage regulatory and scientific affairs consulting to help assess claim substantiation and compliance requirements across markets, including the United States.

FoodChain ID is a member of the American Herbal Products Association, the Council for Responsible Nutrition and the United Natural Products Alliance.

Supplements development is the process of researching, formulating, validating, and preparing supplements for market launch. It is important because it helps companies create compliant, effective, and market-ready products while reducing development risks and delays. Organizations can accelerate this process through tools such as Supplements R&D Insight and specialized supplements consulting services that support formulation, regulatory evaluation and market readiness.

Yes. Nutraveris, the leading European regulatory consultancy for food supplements, joined FoodChain ID in 2020. Its regulatory scientists and formulation expertise are now part of FoodChain ID’s Supplements R&D Insight and Supplements Compliance solutions, giving supplement brands a single, trusted partner for regulatory and scientific support.

Registering a novel food ingredient requires a formal novel food application under Regulation (EU) 2015/2283, supported by a scientific dossier that EFSA reviews before granting authorization. See our Novel Food page for step-by-step support with novel food ingredient registration, applications and dossier preparation, or our Scientific and Regulatory Consulting for related GRAS/NDI guidance.

FoodChain ID’s Regulatory Limits product includes an EU food additives database covering authorized uses, limits and E-number status, so you can confirm compliance before finalizing a label. Pair it with our Supplements Compliance service for full label review.

Dietary supplement testing verifies that a product’s ingredients, potency and purity match label claims, covering microbiological safety, contaminant screening and stability testing across US and EU requirements – see our Testing for USA and Testing for Europe services. A dietary supplement formulation consultant helps balance dosage, stability and label claims early in development through our Supplements R&D Insight platform, reducing the risk of costly reformulation later.