As CRN noted, the NDI filing and enforcement discretion paradox has been a hot-button issue affecting the natural products industry. Ingredients like cannabidiol (CBD), N-acetyl cysteine (NAC), and others are falling into the drug preclusion trap.
"While well-intentioned, FDA needs to address the uncertainties and enforcement gaps CRN has outlined before it can expect full compliance with NDI notifications," said CRN President & CEO Steve Mister. "Industry has repeatedly implored FDA to address major concerns related to its revised NDI draft guidance issued in August 2016. CRN submitted these comments to ask FDA, once again, to stop putting the NDI cart before the horse.”
CRN's outlined its six issues with the NDI Draft Guidance
- FDA should withdraw parts of its 2016 NDI draft guidance that are inconsistent with the intent of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
- Few companies will take advantage of enforcement discretion while FDA’s 2016 NDI draft guidance stands and industry concerns remain.
- Industry needs an authoritative list of pre-DSHEA dietary ingredients.
- An NDI master file system established to protect IP would encourage NDI submissions.
- FDA's estimate of 4,600 NDI notifications that should have been submitted is not supported by evidence.
- If FDA moves forward with enforcement discretion, the 180-day grace period should be extended.