Executive Summary

FDA will collect information on the preparation of health and nutrient content claims pending the Office of Management and Budget's approval of the agency's request, according to a Sept. 25 Federal Register notice. Firms wishing to make nutrient content claims or health claims based on an authoritative statement of a scientific body should notify FDA of the claim 120 days before it markets the claim, the agency says. The notification should include the exact words of the claim, a copy of the authoritative statement, scientific literature and other elements, according to the agency. FDA estimates it will take 250 hours to collect the information required by the nutrient content claim notification and 450 hours to collect the information required by the health claim notification statute. The agency estimates it will receive one nutrient claim notification and two health claim notifications annually