Health Claim Substantiation

The science in support of a role for nutrition in the maintenance of health and in the prevention of disease continues to evolve. Worldwide, regulations are in place to ensure that health claims are scientifically substantiated; that is, they are based on evidence from well-designed human experimental studies.

Our scientific consultants understand the complex regulatory hurdles to health claims and can assist you with documentation and submissions. Our services include:

• Review of product formulations to determine whether any qualify for a health claim in a given jurisdiction.
• 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 for which scientific evidence of efficacy is lacking, assistance is available in the development, conduct, and management of clinical trial protocols.

NutriSciences works closely with regulatory authorities worldwide in the submission of various health claim petitions:

• In the US, 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.
• In Canada, we are involved in the preparation of Product License Applications for Natural Health Products.
• In the EU, 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).
• In Japan, we assist with the regulatory approval of Foods for Specified Health Uses (FOSHU).
• In Australia/New Zealand, we are engaged in the regulatory approval of Special Purpose Foods.

With representation in North America, the EU, and Asia, we are certain we can address your specific international marketing needs.

Click here for our "Health Claim Substantiation" portfolio.