FDA Extends Comment Period for New Dietary Ingredient Draft Guidance
On September 8, 2011, the U.S. Food and Drug Administration (FDA) announced that the comment period for its draft guidance, entitled Dietary Supplements: New Dietary Ingredient Notifications and Related Issues, will be extended until December 2, 2011. The draft guidance, issued on July 5, 2011, consists of more than 120 Q&As aimed at helping industry determine whether a dietary ingredient is a NDI, whether a notification is required, and what information should be included in the notification. Please see our previous report here for more information regarding NDIs.
Having been a controversial issue, various industry associations submitted requests for extension to the FDA, including the Natural Products Association (NPA), Council for Responsible Nutrition (CRN), United Natural Products Alliance (UNPA), American Herbal Products Association (AHPA), and Consumer Healthcare Products Association (CHPA). Additionally, the Alliance for Natural Health USA (ANH-USA) and other health advocacy groups claim that over 355,000 emails have been sent utilizing an online template to petition Congress regarding the draft guidance. Many activists view the draft guidance as a barrier to nutritional supplement access and claim the proposed regulations are beyond the scope of FDA authority. After receiving numerous requests to extend the comment period in order to provide a more comprehensive response, the FDA agreed to the extension.
Found here, the draft guidance is currently available for public comment. Fuerst Ittleman, PL will continue to monitor the progress of the draft guidance. For more information regarding the regulation of dietary supplements, please contact us at firstname.lastname@example.org.