Food Health Claims Submissions and Substantiation Services
Intertek provides scientific and regulatory support for food health claims substantiation and submissions worldwide.
Health claims on food labels and advertising are a representation that a relationship exists between consumption of a food and health. Many countries, states, and other worldwide jurisdictions have regulations in place to ensure that health claims are scientifically substantiated.
Today, a global perspective is essential to gaining approval in multiple markets. Intertek’s scientific consultants understand the regulatory hurdles to health claims and can assist you with the documentation and submissions. Intertek has the expertise, resources and global reach to support its customers through its global network of laboratories and offices in more than 100 countries.
Our services include:
- Review of product formulations to determine whether any qualify for a health claim in a one or more jurisdictions
- Review of claims to ensure compliance with existing applicable regulations
- Comprehensive literature reviews to determine whether sufficient data exist to support a health claim
- For innovative products lacking scientific evidence of efficacy, assistance is available in the development, conduct, and management of clinical trial protocols
- Food Product Label Review Services
- Food Scientific and Regulatory Consulting
Intertek works closely with regulatory authorities worldwide in the submission of various health claim petitions:
- United States - we prepare Qualified Health Claim Petitions, Structure-Function Claim Notifications and substantiation files, and New Dietary Ingredient Notifications. We also assist clients in the regulatory approval of medical foods.
- Canada - we are involved in the preparation of Product License Applications for Natural Health Products
- European Union - we are actively involved in the preparation of Article 13 and Article 14 substantiation dossiers, as well as in the regulatory approval of Foods for Particular Nutrition Uses (PARNUTS)
- Japan - we assist with the regulatory approval of Foods for Specified Health Uses (FOSHU)
- Australia/New Zealand - we are engaged in the regulatory approval of Special Purpose Foods
Related Food Services:
Request more information to see how Intertek can help your organization with Food Health Claims Submissions and Substantiation Services.