Claim substantiation burden

Executive Summary

FDA estimates it will take 44 hours - not one hour as the agency previously estimated - for a firm to gather substantiation for a dietary supplement claim for which there is "adequate publicly available and widely established evidence supporting the claim," a June 7 Federal Register notice says. FDA increased the estimate after it received several comments challenging the original. Assembling supporting scientific information "when the claim is novel or when the claim is pre-existing but the scientific underpinnings of the claims are not widely established" is estimated to take around 120 hours per claim, FDA says. The agency disagreed with one comment challenging FDA's determination that there are no capital, operating or maintenance costs associated with the collection of the substantiation. Comments are due by July 9...