Diane B. McColl, Principal, Hyman, Phelps & McNamara P.C.
Michael Landa, Deputy Director, Regulatory Affairs, FDA
Dr. Ashley Roberts, Cantox Health Sciences International

Issues to be discussed: Congress has put in place a little known prohibition in the Food and Drug Administration Amendment Act of 2007 that represents a shift in the dividing line between foods and drugs. The provision, known as Section 912, is now in effect and prohibits the addition to a food of an approved drug. It also prohibits the addition of a drug for which substantial clinical trials have been executed and made public. The potential widespread ramifications of Section 912 make it impossible to ignore, particularly with respect to research and development.