CHICAGO—Industry experts discussed successfully submitting a New Dietary Ingredient (NDI) notification, while keeping FDA’s recently released NDI Draft Guidance in mind, at the American Herbal Products Association’s (AHPA) one-day Congress on New Dietary Ingredients in Chicago. The seminar also helped dietary supplement makers and ingredient suppliers developed comments in response to the Draft Guidance.
Clif McLellan, M.S., director of toxicology services, NSF International, discussed the components of an NDI submission. He went into detail about the general requirements, which include a description of the NDI, identity Information, specifications, manufacturing process and conditions of use. His talk also covered substance-specific requirements and case studies. For a single chemical, such as a vitamin, mineral or amino acid, FDA requires common name, molecular formula, structural formula and CAS registry number. He used a case study of salt to describe filing an NDI for a single chemical. He also outlined what would be required in an NDI for chemical mixtures, botanicals and botanical derivatives, fermented ingredients, enzymes and microbial dietary ingredients.
Andrea Wong, Ph.D., senior scientific and regulatory consultant, Cantox Health Sciences International, an Intertek Company, discussed using history of use to help fulfill the safety requirements of NDI notifications. History of safe use, clinical data or a combination of both are required to support an NDI notification, Wong said. Evidence beyond history of use is required when the supplement uses a higher serving than historically consumed, is intended to be used for a longer duration than historically reported or if there are changes in the target population. She recommended seeking expert advice if a company is unsure of its history of safe use data.
Claire Kruger, Ph.D., D.A.B.T., CEO and COO, director of health sciences, Spherix, took the stage to discuss choosing toxicology studies to support the safety requirement for NDI notifications. Toxicology, she said, determines how an organism is affected by exposure to a substance. Toxicology studies are needed for an NDI notification when a company can’t bridge the safety of the NDI for its intended use to a historically used ingredient due to a change in chemical composition, dose, duration or frequency of use. For more about Kruger’s take on toxicology studies for NDI notifications, check out INSIDER’s artice on her presentation at the United Natural Products Alliance’s (UNPA) conference.
In the second half of the seminar, AHPA presented its “Interim Guidance for New Dietary Ingredient Notifications," a document created to assist companies in the dietary supplement trade when they file an NDI notification with FDA. The document was original published in May 2006, but was revised after FDA issued its Draft Guidance in July 2011. AHPA said it expects the FDA to revise the guidance when it is issued in its final form, so the trade association will again revise its guidance.
