Sean Moloughney, Editor10.03.16
Five years after releasing its initial draft guidance on New Dietary Ingredient (NDI) Notification procedures, FDA issued revisions in August, hoping to clarify some points of confusion and better communicate what the agency expects, and when.
Under the Dietary Supplement Health and Education Act (DSHEA), manufacturers must notify the agency at least 75 days before marketing a dietary supplement that contains an NDI not marketed in the U.S. before Oct. 15, 1994 (unless the NDI is used in the food supply without “chemical alteration”). Additionally, if an ingredient is Generally Recognized As Safe (GRAS), an NDI notification is not required.
Ultimately, FDA believes NDIs are underreported, noted Cara Welch, PhD, senior advisor for FDA’s Office of Dietary Supplement Programs, who covered some major points of the draft guidance during a recent presentation to industry. The agency has estimated there are more than 55,000 dietary supplements on the market today and about 5,500 new products are launched each year. However, over the past 20 years, since DSHEA passed in 1994, the agency has received fewer than 1,000 NDI notifications.
Dr. Welch noted that in 2011 the agency heard companies argue that almost every manufacturing change would require an NDI notification. The revised guidance seeks to adjust that misunderstanding, clarifying that only when a manufacturing change alters “physiochemical purity or biological properties,” will a notification be required.
FDA is also prepared to develop an authoritative list of “grandfathered” dietary ingredients based on independent, verifiable data from industry, she said. In terms of stakeholder input, Dr. Welch said the agency would like to hear more about how best to develop that list of “grandfathered” ingredients, as well as processes and manufacturing methods that alter ingredient identity, and those methods that do not (along with the scientific information to back it up).
The revised guidance emphasizes FDA’s view that an NDI notification must be specific to the finished dietary supplement, not just the ingredient. However, notifications may cover multiple supplements using the same ingredient, and companies may submit a confidential “NDI master file,” which can be referenced in subsequent notifications.
The draft guidance isn’t perfect, and there are many questions your company will need to answer before determining if and when you must submit an NDI notification. At the end of the day though, these notifications are a requirement under the law. It would serve the industry’s best interest to put aside any anger, resentment, or denial, and work with the agency and industry experts in order to gain further clarity and reach consensus.
Under the Dietary Supplement Health and Education Act (DSHEA), manufacturers must notify the agency at least 75 days before marketing a dietary supplement that contains an NDI not marketed in the U.S. before Oct. 15, 1994 (unless the NDI is used in the food supply without “chemical alteration”). Additionally, if an ingredient is Generally Recognized As Safe (GRAS), an NDI notification is not required.
Ultimately, FDA believes NDIs are underreported, noted Cara Welch, PhD, senior advisor for FDA’s Office of Dietary Supplement Programs, who covered some major points of the draft guidance during a recent presentation to industry. The agency has estimated there are more than 55,000 dietary supplements on the market today and about 5,500 new products are launched each year. However, over the past 20 years, since DSHEA passed in 1994, the agency has received fewer than 1,000 NDI notifications.
Dr. Welch noted that in 2011 the agency heard companies argue that almost every manufacturing change would require an NDI notification. The revised guidance seeks to adjust that misunderstanding, clarifying that only when a manufacturing change alters “physiochemical purity or biological properties,” will a notification be required.
FDA is also prepared to develop an authoritative list of “grandfathered” dietary ingredients based on independent, verifiable data from industry, she said. In terms of stakeholder input, Dr. Welch said the agency would like to hear more about how best to develop that list of “grandfathered” ingredients, as well as processes and manufacturing methods that alter ingredient identity, and those methods that do not (along with the scientific information to back it up).
The revised guidance emphasizes FDA’s view that an NDI notification must be specific to the finished dietary supplement, not just the ingredient. However, notifications may cover multiple supplements using the same ingredient, and companies may submit a confidential “NDI master file,” which can be referenced in subsequent notifications.
The draft guidance isn’t perfect, and there are many questions your company will need to answer before determining if and when you must submit an NDI notification. At the end of the day though, these notifications are a requirement under the law. It would serve the industry’s best interest to put aside any anger, resentment, or denial, and work with the agency and industry experts in order to gain further clarity and reach consensus.
