Washington, D.C.—The Natural Products Association (NPA) has urged FDA to issue import alerts for supplements that fail to comply with NDI regulations, according to a press release. NPA submitted comments for the record to the Senate Finance Committee’s hearing COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection...
Washington, D.C.—Three trade associations representing the dietary supplements industry have sent a proposed framework for an NDI master file to Steven Tave, the Director of the Office of Dietary Supplement Programs. The goal with the proposed framework is to address the protection of innovation, according to the letter, which was...
Washington, D.C.— The Consumer Healthcare Products Association (CHPA) announced in a press release that it has submitted a citizen petition to the U.S. Food and Drug Administration (FDA) requesting that the agency establish a regulatory pathway for manufacturers to legally market dietary supplements containing cannabidiol (CBD). “Intense consumer demand and...
Carlsbad, CA—In his President's Address at The Conference: Council for Responsible Nutrition's Annual Symposium for the Dietary Supplement Industry, held in Carlsbad, CA, Steve Mister, President & CEO of CRN, outlined goals for the future. "We have a well-articulated vision for the next 25 years and clear set of goals...
Washington, DC--As part of its modernization efforts, the FDA has a new system for accepting and storing electronic submissions for new dietary ingredient notification (NDIN) and structure/function claim notification (SFCN). The new system, called the CFSAN Online Submission Module (COSM), has replaced the the FDA Unified Registration Listing System (FURLS).
Washington, D.C.—Scott Gottlieb, M.D., resident fellow at the American Enterprise Institute and former commissioner of FDA, wrote an op-ed in The Washington Post calling on FDA to act quickly and regulate cannabidiol (CBD). Dr. Gottlieb opened the op-ed by noting that CBD is everywhere, and that the market could surpass...
Washington, DC--The Natural Products Association (NPA) has filed comments with the Food and Drug Administration (FDA) regarding its review of “Responsible Innovation in Dietary Supplements.” NPA said these new comments reinforce points made during the Association's presentation at FDA’s May 16 meeting on the same topic. In the comments, NPA...
New York, NY — At the American Conference Institute’s 5th Annual Legal, Regulatory and Compliance Forum on Dietary Supplements, in partnership with the Council for Responsible Nutrition (CRN), Cara Welch, Ph.D., senior advisor for the Center for Food Safety and Applied Nutrition, Office of Dietary Supplement Programs, U.S. Food and...
Rockville, MD — Since the U.S. Food and Drug Administration (FDA) released its Revised Draft Guidance for New Dietary Ingredient (NDI) Notifications in August, industry has been working hard to understand how exactly it has changed since 2011, where it has improved and where further revisions should take place. It...
When it was announced that the U.S. Food and Drug Administration (FDA) was releasing its latest Draft Guidance of New Dietary Ingredient (NDI) Notifications, the industry held its breath. The original 2011 draft left much to be desired and naturally, there was a great deal of concern. Its release was...
