Zencore in violation
This article was originally published in The Tan Sheet
Executive Summary
FDA says even after a March recall of the dietary supplement found to contain the active pharmaceutical ingredient benzamidenafil for erectile dysfunction, Century City, Calif.-based Bodee continued promoting Zencore Plus as a new and misbranded drug. FDA's July 27 warning letter notes Zencore Plus makes unauthorized structure/function claims, is not generally recognized as safe and effective, fails to declare the presence of benzamidenafil and neglects to warn users of potential side effects