CRN submits comments to FDA on ‘chemically altered’ definition for NDIs

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CRN submits comments to FDA on ‘chemically altered’ definition for NDIs

May 07
13:20 2013
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The Council for Responsible Nutrition (CRN) has submitted comments to the FDA via international law firm Steptoe & Johnson, LLP, to address when an ingredient is chemically altered such that it would require a separate NDI notification.

The submission, CRN’s fifth in relation to FDA’s New Dietary Ingredient (NDI) Draft Guidance, calls on the agency to “take into account not only whether the chemical structure of the dietary ingredient has been changed, but also whether any change in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All five of the dietary supplement trade associations have identified several issues with the FDA’s controversial NDI Draft Guidance, but the “chemically altered” issue is one which CRN believes would greatly – and unfairly – expand the category of ingredients that would constitute an NDI,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.


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