Food Product Claims Substantiation

Food and dietary supplement health claims associate food components with desired health outcomes, while food product claims (also referred to as food labeling claims) are statements written on product labels, advertisements, or promotional materials that convey the product's performance, usage, indication, or application. Food product claims substantiation is essential to ensure that consumers receive accurate and reliable information about the health benefits and performance of food and food supplement products.

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Food Product Claims Substantiation - Overview

Claims consulting and substantiation encompasses the process of defining, recommending, or creating new claims for products, offering comprehensive guidance on the necessary scientific data to support these claims. This includes both new product developments (NPD) and existing products entering new markets.

While food and food supplement health claims are the statements that link food components to a desired state of health, food product claims (food labeling claims) are statements made on a product label or advertising/promotional material to express the product performance, usage, indication and application. Both claims convey the health benefits of a product to consumers. These claims should be expressed correctly and are to be substantiated scientifically, according to the supporting data. These scientific requirements and substantiation can differ, based on various factors like the type of claims, health claims, nutrient content claims, functional claims, non-additional claims, declarations (like sugar-free, gluten-free, and low-fat) for the product of interest, and country-specific requirements.

In some countries, to get a health claim or any other claim approved, you need to submit your health claim application to the respective Health Authority (HA). The HA then verifies the application and supporting documents/literature to authorize the claim on the product label.

Freyr provides consultation on new claims/health claims or defining product label claims based on the formulation, type/list of ingredients, product classification, regulations, and the number of studies/papers available in scientific literature to food product claims substantiation. Freyr health claim experts, have an in-depth knowledge of Regulatory procedures and can assist you with the preparation of the necessary scientific evidence and food supplement claims substantiation applications.

Food Product Claims Substantiation

  • Review product formulas or ingredients to determine whether they qualify for a food health claim, dietary supplement claim, nutrient claim, or functional claim.
  • Review food label claims to determine if it qualifies for a health claim or any other type of claim.
  • Review claim statements to ensure compliance with existing regulations.
  • Literature reviews and preparation & submission of food health claims applications.
  • Guidance on claims substantiation data and references.
  • Food supplement claims substantiation guidance as per Regulatory requirements.
  • Cost-effective consultation services.
  • End-to-end claims/functional food product claims Regulatory consultation.
  • Qualified team of experts with hands-on experience across all categories of health foods like health supplements, dietary supplements, nutraceuticals, health functional foods, health functional beverages, foods for special dietary use, etc.
  • Support for region-specific Regulatory complexities.
  • Claims supporting data consultation and advice.
  • Extensive partner network across the globe.
  • A strong relationship with global Health Authorities (HAs).
  • A structured approach to ensure quick market access.