• FDA Publishes Long-Awaited Draft Guidance Document on New Dietary Ingredients for use in Dietary Supplements
  • July 11, 2011 | Author: Frederick A. Stearns
  • Law Firm: Keller and Heckman LLP - Washington Office
  • On July 5, 2011, the Food and Drug Administration (FDA) announced the availability of a draft guidance document entitled "Dietary Supplements: New Dietary Ingredient Notifications and related Issues" (the Draft). This document (set up in "question and answer" format) is FDA's long-awaited effort to provide long-requested guidance to manufacturers and distributors of dietary supplements to clarify the Agency's view on (1) what substances may qualify as a "new dietary ingredient" (NDI); (2) when a "new dietary ingredient notification" (NDIN) is required to be submitted; and (3) what types of information should be included in an NDIN. The Draft is being published as required by Section 113(b) of the Food Safety Modernization Act (Pub. L. 111-353), which directed FDA to publish an NDI guidance document by approximately July 3, 2011.