Food product claims substantiation, Food Product Claims

Claims Consulting and Substantiation for Food and Dietary Supplements

Claims consulting and substantiation involve the development, evaluation, and validation of product claims to ensure they are scientifically supported and compliant with applicable regulatory requirements. This process includes defining, recommending, or creating new claims for both new product developments (NPDs) and existing products being introduced into new markets. It also encompasses providing strategic guidance on the scientific evidence required to support and substantiate such claims.

Health claims for food and dietary supplements are statements that establish a relationship between a food, nutrient, or ingredient and a specific health benefit or physiological function. In contrast, food product claims (or food labeling claims) describe a product’s characteristics, performance, intended use, composition, or application and are typically communicated through product labels, packaging, advertising, or promotional materials. Both types of claims play a critical role in informing consumers about a product’s benefits and differentiating products in the marketplace.

To ensure regulatory compliance and consumer trust, all claims must be accurate, clearly communicated, and supported by appropriate scientific evidence. The substantiation requirements vary depending on several factors, including:

• Type of claim (e.g., health claims, nutrient content claims, functional claims, structure/function claims, or non-addition claims)

• Product category and classification

• Ingredient composition and formulation

• Specific declarations such as sugar-free, gluten-free, low-fat, or other nutritional claims

• Country-specific regulations and regulatory expectations

In many jurisdictions, certain health claims and other regulated claims require prior authorization from the relevant Health Authority (HA). Companies may need to submit a formal application supported by scientific studies, clinical data, published literature, and other evidence demonstrating the validity of the claim. The Health Authority reviews the submitted documentation to determine whether the claim can be approved for use on product labels and marketing materials.

Freyr provides comprehensive consulting services for the development, evaluation, and substantiation of food and dietary supplement claims. Our experts assist clients in defining compliant product label claims based on formulation, ingredient profiles, product classification, applicable regulations, and the availability of scientific evidence. With extensive knowledge of global regulatory frameworks and claim approval procedures, Freyr supports the preparation of scientific dossiers, evidence packages, and health claim applications to facilitate successful regulatory review and market access.