06.03.13
The five associations representing the dietary supplement industry have requested that FDA issue revised guidance on new dietary ingredient (NDI) notifications, with a specific focus on the information to be included to identify the new dietary ingredient.
The request, made by the American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN), the Consumer Healthcare Products Association (CHPA), the Natural Products Association (NPA) and the United Natural Products Alliance (UNPA), was made in the form of comments submitted by AHPA to FDA in April, and joined by CRN, CHPA, NPA and UNPA in separate submissions.
The groups noted that FDA’s rule on NDI notifications, as codified in 21 CFR 190.6, does not specifically state what information should be provided to the agency on the identity of the ingredient that is the subject of an NDI notification. Yet the most common objection communicated by FDA in its responses to NDI notifications is that the agency “is unable to establish the identity” of the dietary ingredient that is the subject of the notification.
Earlier comments submitted by each of the trade associations to FDA’s June 2011 draft guidance, “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,” were generally critical. In June 2012, FDA informed the associations that the agency was planning to promulgate revised draft NDI guidance and would permit additional input from the industry on these topics.
Meanwhile, CRN recently provided its fifth substantive submission to FDA in response to the agency’s NDI Draft Guidance, this time through comments submitted by international law firm Steptoe & Johnson, LLP. This document specifically addresses when an ingredient is chemically altered such that it would require a separate NDI notification to FDA.
On behalf of CRN, the Steptoe & Johnson comments call on the agency to “take into account not only whether the chemical structure of the dietary ingredient has been changed, but also whether any change in structure is sufficiently significant to potentially cause dietary supplements containing the dietary ingredient to be unsafe for consumers.” In other words, FDA should examine not just the manufacturing process to determine what is chemically altered, but compare the starting and ending substances with an eye to whether those changes affected the safety of the end product.
The comments also urge FDA to consider the efficiency and effectiveness to be gained were the agency to focus on the chemical identity and safety of the dietary ingredient, as opposed to establishing an exhaustive list of manufacturing processes that do not chemically alter a dietary ingredient. Further, the comments suggest FDA look favorably to its own precedent in how it has previously approached the “chemically altered” definition as a model for NDIs, which focuses on whether the change in the method of production alters the chemical structure of the dietary ingredient in a way which has the potential to be significant for its safety. That standard of evaluation for chemical changes should be equally applicable under DSHEA as compared to other FDA-regulated food products.
The request, made by the American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN), the Consumer Healthcare Products Association (CHPA), the Natural Products Association (NPA) and the United Natural Products Alliance (UNPA), was made in the form of comments submitted by AHPA to FDA in April, and joined by CRN, CHPA, NPA and UNPA in separate submissions.
The groups noted that FDA’s rule on NDI notifications, as codified in 21 CFR 190.6, does not specifically state what information should be provided to the agency on the identity of the ingredient that is the subject of an NDI notification. Yet the most common objection communicated by FDA in its responses to NDI notifications is that the agency “is unable to establish the identity” of the dietary ingredient that is the subject of the notification.
Earlier comments submitted by each of the trade associations to FDA’s June 2011 draft guidance, “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,” were generally critical. In June 2012, FDA informed the associations that the agency was planning to promulgate revised draft NDI guidance and would permit additional input from the industry on these topics.
Meanwhile, CRN recently provided its fifth substantive submission to FDA in response to the agency’s NDI Draft Guidance, this time through comments submitted by international law firm Steptoe & Johnson, LLP. This document specifically addresses when an ingredient is chemically altered such that it would require a separate NDI notification to FDA.
On behalf of CRN, the Steptoe & Johnson comments call on the agency to “take into account not only whether the chemical structure of the dietary ingredient has been changed, but also whether any change in structure is sufficiently significant to potentially cause dietary supplements containing the dietary ingredient to be unsafe for consumers.” In other words, FDA should examine not just the manufacturing process to determine what is chemically altered, but compare the starting and ending substances with an eye to whether those changes affected the safety of the end product.
The comments also urge FDA to consider the efficiency and effectiveness to be gained were the agency to focus on the chemical identity and safety of the dietary ingredient, as opposed to establishing an exhaustive list of manufacturing processes that do not chemically alter a dietary ingredient. Further, the comments suggest FDA look favorably to its own precedent in how it has previously approached the “chemically altered” definition as a model for NDIs, which focuses on whether the change in the method of production alters the chemical structure of the dietary ingredient in a way which has the potential to be significant for its safety. That standard of evaluation for chemical changes should be equally applicable under DSHEA as compared to other FDA-regulated food products.
