FDA makes health claim notification estimates
This follows a notice published in May this year (73 FR 25749), which had called for comment on the collection of information on the health claim notification process.
The process relates specifically to the submission of notifications of health claims or nutrient content claims based on authoritative statements of scientific bodies of the US Government, and needs to be observed by any company wishing to make these claims on their products.
FDA said it had received only one comment further to the publication of this notice, and it was not related to the information collection. The agency is now submitting its proposed collection of information to the Office of Management and Budget (MOB) for review and clearance.
Health claim estimates
Based on FDA’s experience, it said it expects to receive one nutrient content claim notification and two health claim notifications per year.
These would require 1,150 hours of agency time to process – 250 hours for the nutrient content claim, and 450 hours for each health claim.
Food manufacturers wishing to market foods with label claims based on an authoritative statement of a scientific body of the US Government or the National Academy of Sciences need to notify FDA of the use of these claims 120 days before marketing their products.
As set out in the Federal Food, Drug and Cosmetic Act (section 403[r][C] and 403[r][C]), a notification must include:
· The exact wording of the claim
· A copy of the authoritative statement
· A description of the basis upon which this is considered an authoritative statement
· Balanced scientific literature relating to the relationship between a nutrient and a disease or health-related condition to which the claim refers
· Information on analytical methodology for the nutrient
To view the full FDA notice, click here.