Ivan Wasserman Quoted in “FDA’s Take Down of NMN Raises Fairness, Transparency Concerns”
Ivan Wasserman discussed the FDA’s recent decision that NMN is not a lawful dietary ingredient with Nutraingredients-USA. As reported, the development further complicates the decision to develop an NDI dossier and is part of an increasingly hard line stance by the Agency on the drug exclusion question.
“First CBD, then NAC, and now NMN. What’s next? Is FDA’s 2022 interpretation of this and many provisions of DSHEA consistent with Congress’ intent in 1994? Without any legislative history to guide it is very difficult to know. Should companies go through the time and expense of submitting NDI notifications when there will always be a risk that some drug study will at some point be uncovered?”
To read more of what Ivan had to say, click here.