Structure/function filings
This article was originally published in The Tan Sheet
Executive Summary
Industry burden for filing dietary supplement structure/function claims estimated at 1,875 hours annually, FDA says in July 8 Federal Register notice. Burden is significantly higher than previous estimate of 350-700 hours "due to an increase in the number of notifications being received by the agency," which FDA now estimates at 2,500 per year. Industry's estimated annual cost also has increased from $8,750-$17,500 to $31,250-$62,500...