The Utah Natural Products Alliance (UNPA) has filed comments with the US Food and Drug Administration, responding to that agency's request for comments on the premarket notification program for new dietary ingredients. (NDI's)
Specifically, the association questions the intent of the introduction by the FDA of the term 'chemical composition' in regards to a dietary supplement as it seeks a response to the question "what changes in chemical composition to a dietary ingreident would cause it to become a substance that is not a dietary ingredient?". This term appears again as FDA asks what changes in chemical composition of an 'old dietary ingredient' would cause it to become a 'new dietary ingredient', and UNPA suggests rewording of this question so that it deals with the concept of a safety risk as a result of change or modification.
FDA's question about what changes of use would trigger the need for a separate NDI notification was noted to be extremely problematic for both the agency as well as for industry, suggesting that "the agency would need to establish an underlying rationale that there is a problem that needs to be solved by requiring the filing of NDI notices for ordinary changes in conditions of use."
The alliance also notes several unapproved lists of 'old dietary ingredients' suggesting that arguments in the past had deduced that such lists might beocme obsolete, inflexible and possibly create an undue burden to add forgotten ingredients. At the same time, as part of its reponse, UNPA indicated willingness to participate, if a refreshed list beacme desirable.
UNPA also supports, in their comments, alignment of the NDI process with the GRAS affirmation process, "insofar as the type and nature of the information required to demonstrate that an NDI is reasonablyexpected to be safe."
Other specific comments include the ability to withdraw NDI submissions without prejudice, a provision for generic NDI submissions, differentiated from proprietary and unique product submissions, and the creation of a moratorium period for the submission of NDI filings for products now on the market, arguing that such a period would allow companies to assess whether some products might require NDI's and submit these NDI's without jeopardizing current commercial viability.