WASHINGTON — 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.”
About CRN:
The Council for Responsible Nutrition (CRN), founded in 1973 and based in Washington, D.C., is the leading trade association representing the dietary supplement and functional food industry. Bringing together manufacturers, ingredient suppliers, and service providers, CRN unites its member companies around a shared commitment to science, transparency, and responsible business practices—advancing a strong, credible marketplace that supports consumer health and industry growth.
In an increasingly complex regulatory and media environment, CRN serves as the industry’s front line—shaping science-based policy, defending market access, and countering misinformation. Through strategic advocacy, self-regulatory leadership, voluntary guidelines, and evidence-based communications, CRN ensures that responsible companies are recognized, protected, and positioned to innovate and compete. Learn more at crnusa.org and follow @CRN_Supplements on X and LinkedIn.