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Claims Review, Substantiation, and Notification Support
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.
Food Product Claims Substantiation - Overview
Claims consulting and substantiation involve defining and supporting product claims with the necessary scientific evidence, whether for new product development or market entry. Food and supplement claims—such as health, nutrient content, functional, or labeling claims (e.g., sugar-free, gluten-free)—must be accurately expressed and scientifically validated in line with country-specific regulations. In many markets, health claims require submission to the Health Authority for approval. Pharma Wizard offers expert consultation to help manufacturers design compliant claims, prepare supporting evidence, and navigate claim substantiation applications efficiently.
Food Product Claims Substantiation
- Expertise
- Advantages
- 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.
