Recorded: Sept. 27, 2018
Duration: 2 hours
Members - $199
Non-Members - $399
Access to NDI Database
AHPA NDI Guidance
Learn to successfully traverse the New Dietary Ingredient (NDI) notification process and avoid common pitfalls that can result in FDA objections.
Dr. Ali Abdel-Raman, Supervisory Toxicologist at CFSAN / FDA, will discuss FDA’s views on the procedures for submitting an NDI notification, the types of data and information that manufacturers and distributors should consider when evaluating the safety of a dietary supplement containing an NDI, and what should be included in an NDI notification.
Merle Zimmermann, Ph.D., AHPA’s Chief Information Analyst, will provide a tour and demonstration of AHPA’s NDI Database to illustrate recent trends in NDI notifications and FDA responses.
Dr. John Endres, Chief Scientific Officer, AIBMR Life Sciences, Inc., will discuss the benefits of getting GRAS status as an alternative for ingredient suppliers who want to market their ingredients for use in both dietary supplements and foods.
Section 413 of the Federal Food, Drug and Cosmetic Act (FD&C Act) requires the manufacturer or distributor of a NDI, or of a dietary supplement containing the NDI, to submit a pre-market notification to the Food and Drug Administration (FDA) at least 75 days before introducing the NDI or dietary supplement into interstate commerce, unless the NDI and any other ingredients in the dietary supplement have been present in the food supply as an article used for food in a form in which the food has not been chemically altered. The notification must contain in the information, including any citation to published articles, which is the manufacturer or distributor’s basis for concluding that a dietary supplement containing the NDI will reasonably be expected to be safe. In August 2016, FDA announced the availability of a revised draft guidance for NDIs that superseded the July 2011 draft guidance. The dietary supplement industry and FDA share the goal of ensuring that NDI notifications, when required, are clearly presented and thorough in providing safety information to FDA as required by law.
AHPA has created the AHPA NDI Database, a searchable online resource that documents more than 950 NDI notifications that have been submitted to FDA. This database provides indispensable access to and understanding of notifications submitted to FDA for new NDIs that are used in dietary supplements. It is the only up-to-date compilation of NDI notifications available. This subscriber-based database also provides a concise “outcome statement” for each NDI file that quickly summarizes how FDA has responded to every notification, and the problems—if any—that the agency identified for each.
- Ali Abdel-Rahman, Ph.D., Supervisory Toxicologist, Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA)
- John Endres, ND, Chief Scientific Officer, AIBMR Life Sciences, Inc.
- Will Woodlee, Esq., Partner, Kleinfeld, Kaplan and Becker, LLP (Q&A Only)
- Merle Zimmermann, Ph.D., Chief Information Analyst, American Herbal Products Association (AHPA)