On May 19, FDA announced in draft guidance the agency’s intent to exercise enforcement discretion, for a limited time and in limited circumstances, to encourage manufacturers and distributors to correct any past failures to submit a required NDI notification. Council for Responsible Nutrition (CRN) President and CEO Steve Mister expressed the following thoughts on the announcement.
“CRN applauds FDA’s announcement today of an amnesty period for companies to file an NDI notification with the agency if they have previously failed to do so,” said Mister. “We encourage companies who have products in the market that are using clearly defined new ingredients to take advantage of this opportunity and submit to the agency their data demonstrating the safety of these products.
“Unfortunately, the concerns the agency expressed are partially of its own making by failing to provide a clear direction for when an NDI notification is required and failing to enforce the existing requirements. FDA has refused to develop an authoritative list of grandfathered ingredients—or to accept as authoritative—the well-documented lists developed by the industry. Eleven years after FDA first proposed a draft guidance to clarify when an ingredient qualifies as ‘new,’ consumers and industry alike are still waiting for the agency to finalize that guidance.
“Three years ago, CRN proposed a master file system to the agency to protect ingredient innovation and incentivize firms to submit NDI notifications with the assurance that their intellectual property would be protected—but FDA declined to provide the enforcement required to make the system work. Much uncertainty still exists as to when an ingredient is ‘new’ and subject to the notification requirement.
“FDA cannot expect firms to submit their safety dossiers and manufacturing processes for possible objection when it provides neither meaningful consequences for the failure to file nor a clear roadmap for when an NDI notification is necessary.
“Enforcement discretion would be better enacted after the above issues are resolved.”
For more information, visit www.crnusa.org.
