CRN Weighs in Further on NDIs

WASHINGTONThe Council for Responsible Nutrition (CRN) has proposed FDA consider the impact on safety for consumers when deciding whether a chemically-altered ingredient is subject to certain notification requirements under federal dietary supplement law.

Through an outside law firm, Steptoe & Johnson, LLP, the comments were filed Tuesday as FDA works on crafting revised draft guidance governing "new dietary ingredients" (NDIs). As mandated under federal law, manufacturers and distributors seeking to market dietary supplements containing NDIs must first notify FDA.

CRN, the Washington, D.C.-based trade association representing dietary supplement manufacturers and ingredient suppliers, has asked FDA to consider potential safety concerns when determining whether an ingredient has been chemically altered.

FDA should 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," CRN recommended in the comments through its counsel.

In 2011, the agency released draft guidance on NDIs. But industry has been critical of it and FDA has revealed plans to issue revised guidance. The comments filed represent CRN's fifth submission since the draft guidance was released.

Trade groups are seeking clarity on a number of other issues, including what information supplement firms must include to identify new ingredients.