Washington D.C.—The Council for Responsible Nutrition (CRN) submitted a letter to the FDA in response to FDA's inclusion of "Dietary Supplement Master Files: Draft Guidance for Industry" in its list of priority guidance documents for 2023 as one part of the agency's New Dietary Ingredient (NDI) Notification final guidance to be released in several parts in the future. 

CRN is urging FDA to either:

  • Allocate resources for enforcing the dietary supplement master file framework alongside the guidance release, or;
  • Redirect resources to more impactful topics for consumer benefit, as guidance without enforcement might not benefit the industry or consumers.

"On July 6th, amid the recently announced plans to reimagine the Human Foods Program, including its new organization structure and resource allocation for the oversight of foods, including dietary supplements, FDA added among its list of priority guidance documents for 2023 'Dietary Supplement Master Files: Draft Guidance for Industry,'" CRN President and CEO Steve Mister wrote in a letter to Cara Welch, Ph.D., Director, Office of Dietary Supplement Programs Center for Food Safety and Applied Nutrition. "CRN understands FDA anticipates releasing the long-awaited New Dietary Ingredient (NDI) Notification final guidance in parts later this year, but we were surprised, however, to see a separate guidance on dietary supplement master files as being one part. 

Mister added, "We were disappointed when FDA informed CRN that it did not intend to devote resources for enforcement of a master file program for dietary supplements three years ago and surprised last month when the agency announced it is moving forward with a guidance on master files. Unless resources are allocated to the regulation of dietary supplements, including enforcement of NDI notification requirements, FDA should rethink prioritizing a master files guidance. Other pressing dietary supplement issues are awaiting the agency's action, including issuing other parts of the NDI guidance to address major concerns related to the agency's revised NDI draft guidance issued in August 2016, as well as a response to industry's citizen petition on the application of section 201(ff)(3)(B) of the federal Food, Drug and Cosmetic Act--the drug preclusion provision. FDA's attentions would be better spent on these endeavors."

Related: FDA Rejects Congressional Request for Public Hearing on NMN

FDA Proposes Reorg; Industry Reacts to Impact on Dietary Supplements