FDA disease redefinition proposal marks "profound policy change," Israelsen maintains.
This article was originally published in The Tan Sheet
Executive Summary
FDA DISEASE REDEFINITION PROPOSAL A "PROFOUND" POLICY CHANGE, LDI Group President Loren Israelsen asserted at a nutraceuticals meeting in New York City May 20-21. The agency's April 29 proposed rule on allowable dietary supplement structure/function claims blurs the distinction between "disease" and "health condition," Israelsen maintained. The importance of the proposed redefinition of disease is being slighted by the industry, when, in fact, it "is a profound change of thinking and policy within FDA," he added. The meeting was sponsored by the Foundation for Innovation in Medicine.