Regulatory Comments to Docket No. FDA-2013-N-1152; Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (OMB Control Number 0910-0608)—Reinstatement
Date: December 29, 2014
Background:
FDA submitted a notice in the Federal Register asking for stakeholder comment on whether to do away with the option for companies to file an exemption from 100 percent identity testing because no company to date has ever filed for such an exemption.
Issue:
NPA supports that this petition process to request an exemption from 100 percent identity testing of identity ingredients remain available. While the agency 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 has long recognized that misidentification of dietary ingredients used in dietary supplements can present significant public health as well as economic concerns. In that spirit, we support the following from the original Interim Final Rule (IFR): “proposed alternative testing that will demonstrate that there is no material diminution of assurance, compared to the assurance provided by 100 percent identity testing, of the identity of the dietary ingredient before use when the dietary ingredient is obtained from one or more suppliers identified in the petition.” While we are supportive of the agency’s position offered in the IFR and we too recognize 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, 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. We do not believe submitting a petition to request an exemption from 100 percent identity testing of a dietary ingredient is something that should be taken lightly, nor should such exemption be granted without exhaustive demonstration of both the supplier’s/vendor’s and manufacturer’s quality systems, specifically that knowledge of a given firm’s operating procedures could be used to provide such assurances comparable to 100 percent identity testing.
Action:
NPA requested that FDA keep this exemption open and available to firms who may have the historical data to demonstrate an alternative sampling plan that would not result in material diminution of assurance provided by 100 percent identity testing.
