CRN submits comments to FDA on ‘chemically altered’ definition for NDIs
The submission, CRN’s fifth in relation to FDA’s New Dietary Ingredient (NDI) Draft Guidance, calls on the agency to “take into account not only whether the chemical structure of the dietary ingredient has been changed, but also whether any change in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.”
All five of the dietary supplement trade associations have identified several issues with the FDA’s controversial NDI Draft Guidance, but the “chemically altered” issue is one which CRN believes would greatly – and unfairly – expand the category of ingredients that would constitute an NDI, thereby inappropriately placing unnecessary and burdensome requirements on the industry.
The association is calling on FDA to 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.
CRN also urges 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.
The full submission can be read here: http://www.crnusa.org/pdfs/CRN-FDA-Comments050713.pdf
In the comments, Steptoe & Johnson stated: “The key factor in the FDA guidance with respect to all of these types of food and food-contact substances is that a submission to FDA is recommended only for manufacturing changes which alter the chemical structure of a product in a way which has the potential to create an issue concerning the safety of the product for its intended conditions of use.
“This precedent supports the proposition that ‘chemically altered’ under DSHEA should not be defined by a list of processing methods.”
According to CRN’s Duffy MacKay, N.D., vice president, scientific & regulatory affairs, “This guidance is a very important one for our industry, and we are working hard to help ensure the agency hears the concerns of industry, and that it will respond with a more reasonable final guidance.”
