Claims that rendered the firms' products unapproved new drugs and were listed in FDA warning letters include "It’s basically an oral sunscreen … This would be especially useful for people who have had skin cancer, are at risk for skin cancer.” The firms FDA warned are Isocell North America Inc., Sunergized LLC, Pharmacy Direct Inc. and Napa Valley Bioscience LLC.
Four dietary supplement firms that recently received FDA warning letters not only marketed their products with claims intended for sunscreen drug ingredients, they also made claims that would get sunscreen products in a regulatory jam.
Claims that rendered the firms' products unapproved new drugs and were listed in warning letters FDA published May 22 include...