CRN submitted comments to the US Food and Drug concerning the enforcement hiatus, which was announced by FDA in mid May. When the Agency announced the policy, it stated the purpose was to make clear “our intent to exercise enforcement discretion, for a limited time and in limited circumstances, to encourage firms to correct past failures to submit an NDI notification.”
As part of the announcement, FDA stated that it estimated that 4,600 NDI Notifications should be on file, based on its surveillance of the market. But in the 15 years or so the NDI docket has been open, only about 1,200 notifications have come in.
CRN: Without fixes, amnesty is dead in water
CRN said that gap is no surprise, given the many issues industry stakeholders have with the language of the NDI Draft Guidance which would govern any NDI Notification. If FDA does not move forward to work with industry to address some of these issues, CRN said it’s doubtful many companies will take the Agency up on its offer to submit notifications under the amnesty policy.
“We think there are still a lot of issues with the NDI Draft Guidance,” Haiuyen Nguyen, CRN’s vice president of regulatory and nutrition policy.
CRN’s comments, which were penned by Nguyen along with Andrea Wong, PhD, CRN's senior vice president for scientific and regulatory affairs, and chief counsel Megan Olsen, lay out a number of sticking points with the guidance, many of which have hung fire since FDA released the first version more than 10 years ago.
CRN’s top concerns are:
- FDA should withdraw parts of its 2016 NDI draft guidance that are inconsistent with the intent of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
- Few companies will take advantage of enforcement discretion while FDA’s 2016 NDI draft guidance stands and industry concerns remain.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.
"While well-intentioned, FDA needs to address the uncertainties and enforcement gaps CRN has outlined before it can expect full compliance with NDI notifications. Industry has repeatedly implored FDA to address major concerns related to its revised NDI draft guidance issued in August 2016.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,” said Steve Mister, CRN’s president and CEO.