FDA Requests Public Comment on Notification of a Health Claim or Nutrient Content Claim

Aug 05, 2011   

Companies seeking to use health claims or nutrient content claims on food labeling must submit notification to the FDA prior to marketing. Pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act), such claims must be based on current, published, authoritative statements from certain federal scientific bodies. On August 3, 2011, the U.S. Food and Drug Administration (FDA) announced in the Federal Register that the Agency is seeking public comment concerning the collection of information associated with the submission of notifications of health claims or nutrient content claims.

In 1998, the FDA released guidance regarding the submission of health claims and nutrient content claims. At the time, the Agency stated that the notification must contain the exact wording of the claim, description of the basis relied upon, a copy of the statement referred to, a balanced representation of literature in a bibliography, and information on analytical methodology. The Agency estimates that review of the information collection will take 250-450 hours per notification depending upon the nature of the claim. Currently, the notification must be submitted to the FDA via regular mail.

The FDA invites public comment until October 3, 2011, regarding:

  • Whether the proposed collection of information is necessary for the proper performance of FDAs functions, including whether the information will have practical utility
  • The accuracy of FDAs estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used
  • Ways to enhance the quality, utility, and clarity of the information to be collected
  • Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques

Fuerst Ittleman will continue to monitor the FDA for changes to submission requirements for notifications of health claims or nutrient content claims. For more information regarding submission of notifications, contact us at contact@fidjlaw.com.