December 30, 2014
The Natural Products Association (NPA) has responded to the the Food and Drug Administration (FDA) proposed collection of information that has been submitted regarding the procedure for a petition to request an exemption from 100 percent identity testing of dietary ingredients [Docket No. FDA-2013-N-1152].
The FDA would like to keep this information collection provision open to firms in the future to petition for an exemption from 100 percent identity testing of dietary ingredients. The FDA is willing to consider these petitions on a case-by-case basis, but the manufacturer must prove in the petition "that it has developed a system that it would implement as sound, consistent means of establishing, with no material diminution of assurance compared to the assurance provided by 100 percent identity testing, the identity of the dietary ingredient before use."
The FDA has not received any new petitions to request an exemption from 100 percent identity testing over the past three years and does not expect more than one petition will be submitted annually. The FDA estimates that a petition to request will take eight hours to complete.
In our comments to the agency, NPA made the following points:
NPA supports that this petition process to request an exemption from 100 percent identity testing of identity ingredients remain available. While the FDA has not received any new petitions to request an exemption from 100 percent identity testing of dietary ingredients, we expect the petition process to be used in the future. Therefore, NPA supports that these information collection provisions should be extended to provide for the future need of a firm in the dietary supplement industry to petition for an exemption from 100 percent identity testing of dietary ingredients.
NPA believes that a consistent definition and goal of identity testing is critical to any guidance written for this petition process. This will ensure that the burden required to use the petition is well understood.
NPA asks that any discussion in the guidance on identity include the minimum ingredient identity characteristics and parameters that must be addressed and monitored in the petition process, what degree of variability in these areas is acceptable, and what systems to determine the variability are viable.
NPA continues to believe Good Manufacturing Practices (GMP) are essential to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label.
NPA recognizes that it may be possible for a manufacturer to demonstrate, through various methods and processes in use over time for its particular operation, that a system of less than 100 percent identity testing would result in the comparable assurance provided by 100 percent identity testing, and per the intention of the rule, we believe that this exemption would have to be very specific to the dietary ingredient supplier/vendor, dietary supplement manufacturer and to the incoming raw dietary ingredient to uphold the integrity and intent of the final GMP rule.
NPA provides two broad categories where less than 100 percent identity testing may not be required to provide comparable assurance provided by 100 percent identity testing.
You can read NPA’s full comments here.
NPA will continue to keep members updated on this, as well as other regulatory matters, as more information becomes available. For more information, please visit the NPA website.
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