The Food and Drug Administration has released a Final Guidance for Industry to address some ongoing issues with procedures and timing for submitting New Dietary Ingredient Notifications (NDINs). Since 1994, a manufacturer wishing to market a New Dietary Ingredient has needed to file a dossier (Notification) to document the manufacturer’s reasonable expectation of the ingredient’s safety. In 2011, FDA issued a draft NDI guidance, which was met with resistance on a number of fronts; FDA issued a revised draft 5 years later. Further work since then has focused on specific topics in the Guidance, with this release of Section V (“NDI Notification Procedures and Timeframes”) addressing who must submit an NIDN, what it should contain, and the schedule for submission and processing by FDA.
Scientists in ToxStrategies’ Foods and Consumer Products practice continue to monitor developments and stand ready to help clients navigate the regulatory framework for bringing new ingredients to market. Please contact Rayetta Henderson or Candace Doepker for additional information.