Market Updates

CRN: FDA’s Guidance on Master Files Lacks Necessary Enforcement Protocols

Without dedicated enforcement, the NDI program will remain as ineffectual as it is today, said Steve Mister, president and CEO of CRN.

Earlier this year, the U.S. Food and Drug Administration (FDA) created a list of priority guidance documents for 2023, one of which was called “Dietary Supplement Master Files: Draft Guidance for Industry.”
 
While guidance documents represent FDA’s current thinking on a specific topic or regulation, they don’t impose new legally enforceable requirements.
 
A Master File is a document which contains data deemed proprietary by a company, and is widely used in the drug industry in order to protect trade secrets.
 
This level of confidentiality, FDA proposes, would encourage more companies to submit New Dietary Ingredient Notifications (NDINs) to the agency as required, rather than simply declaring an ingredient as Generally Recognized as Safe (GRAS) through a self-affirmed process which provides the agency with no oversight. Many ingredients which the agency considers New Dietary Ingredients reach the marketplace today by going through the GRAS process, which it considers insufficient.
 
Proponents view the potential introduction of Master Files for dietary supplements not just as a tool to improve adherence to NDI framework, but also as a tool to add another layer of protection to intellectual property.
 
Bigger Fish to Fry
 
FDA intends to release the Master Files guidance as one of several parts in a final guidance on the NDIN process in the future, according to the Council for Responsible Nutrition.
 
Back in 2020, CRN endorsed a framework for NDI master files in a letter it submitted to FDA with two other trade associations, as a means of leveling the playing field for responsible companies that generate safety data pre-market. At the time, however, CRN stressed that an NDI master files protocol could only succeed if rigorously enforced.
 
Months before FDA issued its list of guidance priorities, the agency reportedly told CRN that it didn’t intend to devote any resources toward enforcing a master file program. If that remains the case, expect the NDI program to remain ineffectual, Steve Mister, president and CEO of CRN, warned.
 
“FDI’s enforcement of the NDI program thus far has been negligible, with only occasional warning letters issued to firms that have not filed the requisite NDI notifications for their new ingredients,” said Mister. “Without meaningful enforcement, FDA guidance on master files does little to support responsible companies desiring to innovate, to protect investment while doing so, and to fairly compete; and bad actors will continue to circumvent the law thereby posing risk to public safety. We strongly urge FDA to pair guidance on NDI master files with unwavering commitment to enforce its proper use. We urge FDA to clarify its intentions to advance dietary supplement oversight and innovation in new plans for the Human Foods Program.”
 
For this reason, and that there are more pressing issues at hand today, FDA should rethink whether now is the time for a master files guidance to be prioritized over other pressing issues, according to CRN.
 
“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,” said Mister.
 

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