Health Claim Substantiation and Submissions

Intertek provides scientific and regulatory support for substantiation of health claims for foods and dietary supplements in major jurisdictions worldwide.

Health claims on food labels and advertising are a representation that a relationship exists between consumption of a food and health. It is an effective way to communicate to consumers the health benefits of the food or dietary supplement.

Most countries have regulations and scientific standards in place to ensure that health claims are scientifically substantiated. The regulations and scientific requirements for substantiating health claims can differ based on the jurisdiction of interest, the type of claim, and the product of interest. Intertek’s health claim experts have in-depth knowledge of the hurdles to substantiating health claims and can assist you with the preparation of the necessary scientific evidence and claim substantiation applications to government agencies.

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, including reviewing claim statements on product labels, print ads, website material and consumer messaging
  • Comprehensive literature reviews to determine whether sufficient data exist to support a health claim
  • Systematic reviews and meta-analyses to support claims applications
  • For innovative products lacking scientific evidence of efficacy, assistance is available in the development, conduct, and management of clinical trials
  • Prepare and submit health claim applications
  • Provide stewardship and facilitate dialogue with regulatory agencies
  • Food Product Label Review Services

Jurisdictional Regulation Overview

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

 
We prepare Qualified Health Claim Petitions, Structure-Function Claim Notifications and substantiation files.
We are involved in the preparation of Product License Applications for Natural and Non-prescription Health Products (NNHPDs), and the substantiation of food health claims and function claims.
We are actively involved in the preparation of Article 13 and Article 14 substantiation dossiers.
We are involved in the preparation of Health/Functional Food registrations and Nutrient Supplement notifications.
We provide clients with scientific and regulatory support for health claims in India.
We are involved in notifying Food Standards Australia New Zealand (FSANZ) of self-substantiated food-health relationships.
We assess the appropriateness of claims on foods and Health Functional Foods (HFFs) and prepare HFF applications.
 
Need help or have a question? +1 905-542-2900
 

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+1 905-542-2900
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China
+86 10 5657 6600
Europe
+44 1252 392 464
Japan
+81-3-5639-9158