Responsible dietary supplements companies invest in establishing the safety of their ingredients, the letter says, and a significant concern for these companies is that they must compete with companies that fail to generate and submit safety data specific to their NDIs and then claim that their ingredients are identical to NDIs that other firms properly notified the FDA of. The letter notes that in several cases, “product testing has demonstrated that their ingredients are indeed not identical, and in some cases, pose safety risks to consumers.” This creates an uneven playing field, while discouraging innovation: “The lack of deterrence for unscrupulous companies that bypass the notification requirement frustrates and discourages responsible companies.”
The NDI master file (NDI-MF), the letter says, is a tool to “streamline the collection and protection of data investments made by ingredient manufacturers. It provides a way to keep secured confidential information such as safety data related to an NDI and enables companies to authorize others to properly reference master file data. Without proof of authorization, a company cannot claim to have the same ingredient as another. With use of the NDI-MF, FDA would be able to identify and enforce against certain marketers of NDIs that fail to comply with the notification requirement.”
Related: Industry Associations Commend FDA for Taking Swift Action FDA Has New Portal for Submitting NDI and SFCN CRN, NAD End Self-Regulatory Program, Encourage Industry to Stay VigilantThe framework is modeled after the U.S. Drug Master File, the letter notes, with similar key elements regarding the submission and authorization process and protection of confidential information. The framework was developed by the members of CRN’s Master File Working Group and has been reviewed by CHPA and UNPA.
The letter emphasizes that the efficacy of the NDI-MF will depend on FDA’s support and a commitment to enforcement of its proper use. Without that commitment, establishing the program “only perpetuates continued indifference and leaves the intellectual property of responsible and innovative companies unprotected.”