Washington DC-The Council for Responsible Nutrition (CRN) submitted comments in response to the FDA’s draft guidance on new food ingredient (NDI) filings and enforcement discretion. (Background: CRN responds to FDA’s proposed NDI enforcement discretion guidance.)

As CRN has noted, the paradox of NDI filing and enforcement discretion has been a burning issue affecting the natural products industry. Ingredients like cannabidiol (CBD), N-acetyl cysteine ​​(NAC), and others fall into the drug exclusion trap.

“While well-intentioned, the FDA must address the uncertainties and enforcement shortcomings described by CRN before it can expect full compliance with NDI notifications,” said Steve Mister, President and CEO. of CRN. “Industry has repeatedly implored the FDA to address key concerns related to its draft revised NDI guidance issued in August 2016. CRN submitted these comments to urge the FDA, once again, to stop putting the NDI cart before the horse.”

1. The FDA should remove portions of its 2016 draft NDI guidelines that are inconsistent with the intent of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
2. Few companies will benefit from enforcement discretion as the FDA’s draft 2016 NDI guidelines stand and industry concerns remain.
3. Industry needs an authoritative list of pre-DSHEA food ingredients.
4. An NDI master file system established to protect intellectual property would encourage NDI submissions.
5. The FDA estimate of 4,600 NDI notifications that should have been submitted is not supported by evidence.
6. If the FDA goes ahead with its enforcement discretion, the 180-day grace period should be extended.

the CRN’s full comments, which were signed and submitted by Andrea Wong, Ph.D., Senior Vice President, Scientific and Regulatory Affairs; Megan Olsen, Senior Vice President and General Counsel; and Haiuyen Nguyen, Vice President, Regulatory and Nutrition Policy, can be consulted here.