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WASHINGTON — In regard to FDA issuing draft guidance on NDI notification master files for supplements today, CRN president and CEO Steve Mister offered the following comments on the development:
“It’s a positive development to see the FDA moving ahead with this draft guidance. In 2020, CRN developed an NDI master file framework for dietary supplements to protect our members’ investments and intellectual property, and this is clearly a step in the right direction, incorporating many of the elements we put forward.
“But as we have previously stated, meaningful enforcement alongside guidance is crucial in supporting responsible companies desiring to innovate, to protect investment while doing so, and to fairly compete. FDA must deter bad actors who circumvent the law thereby posing risk to public safety.
“So, while we welcome this draft guidance, we, at the same time, strongly urge FDA to publicly announce its resolve to enforce the proper use of master files.”
