Executive Summary

FDA seizes 376 cases of Opti-Cran and other herbals valued at $500,999 from Hillestad Pharmaceuticals, the agency announces July 18. FDA had classified the items as "unapproved new drugs represented as dietary" supplements that "fail to bear adequate directions for use." The Woodruff, Wisc.-based firm received a warning letter in 1997 charging its products, including Opti-Cran, were not GRAS/E for their intended uses. FDA also seizes 927 bottles of Metabolite dietary supplement, valued at $32,400, from One World Fulfillment Distribution in Mobridge, S.D. (1see FDA Recalls & Court Actions, p. 18)