FDA Finalizes New Dietary Ingredient Guidance, but Questions Remain
The U.S. Food and Drug Administration (FDA) has issued final guidance for industry on New Dietary Ingredient (NDI) Notifications and Related Issues, specifically the Identity and Safety Information About the NDI (Final Identity Guidance). This guidance finalizes certain portions of the agency's 2016 revised draft guidance, while leaving critical questions unanswered.
The Final Identity Guidance provides updated recommendations on the identity and safety information that the FDA expects in a New Dietary Ingredient Notification (NDIN). While not establishing new requirements, the guidance offers more detailed recommendations on the evidence that could support a history of safe use, including the use of new approach methodologies (NAMs), in vitro assays, and in silico modeling to reduce or replace animal testing. The guidance also updates safety recommendations for nonviable microbial ingredients and ingredients involving nanotechnology.
However, the FDA has left critical sections of the 2016 Draft Guidance in draft form, including the type and extent of safety evidence required to establish a reasonable expectation of safety. The agency has indicated that it intends to prioritize finalizing these remaining portions, but the timing remains unclear.
The NDI requirement was added to the Federal Food, Drug, and Cosmetic Act by the Dietary Supplement Health and Education Act of 1994, which requires a safety notification for dietary ingredients that are new to the market. The FDA has been working on finalizing its guidance on NDI notifications since 2011, with the latest draft issued in 2016.
The FDA's approach to finalizing the guidance has been unusual, with the agency issuing revised draft and final portions in an incremental fashion. The Final Identity Guidance notes that stakeholders may submit comments at any time, and the agency will consider them in determining whether further revisions are warranted.
