WASHINGTON, D.C. — The Council for Responsible Nutrition (CRN) issued the following statement regarding the U.S. Food and Drug Administration's final guidance on identity and safety information in new dietary ingredient (NDI) notifications:
“CRN welcomes FDA’s final guidance on identity and safety information in new dietary ingredient notifications, which provides greater flexibility in demonstrating safety, recognizes the value of historical use and existing scientific evidence, and offers clearer expectations for manufacturers. Several of these improvements reflect recommendations CRN previously submitted to the agency.
“However, we are disappointed that FDA retained its generally recommended 25-year benchmark for establishing a history of safe use, although the agency clarified that shorter periods may be supported by additional evidence. The guidance also continues to recommend that notifications include safety information about other dietary and non-dietary ingredients in finished supplements, an approach CRN has previously urged FDA to reconsider.
“More broadly, important regulatory questions remain unresolved, particularly regarding what qualifies as a dietary ingredient, when an ingredient is considered new, and when a notification is required. CRN urges FDA to prioritize addressing these fundamental issues to provide the regulatory certainty necessary to support responsible innovation and consumer access to safe dietary supplements.”
