Organic & Natural Health Association files Citizen Petition to request application of dietary supplement GMPs to ingredient suppliers.

  • As previously covered on this blog, the Organic & Natural Health Association (ONHA) has indicated its interest in seeing FDA extend the application of current Good Manufacturing Practice (GMP) regulations in 21 CFR Part 111 (which apply to finished dietary supplements) to dietary ingredients themselves.
  • ONHA has now filed a Citizen Petition with FDA, requesting that the Agency expand the scope of 21 CFR Part 111 accordingly.  Specifically, the Citizen Petition asks FDA to amend Part 111 to (1) include dietary ingredient suppliers within the scope of the requirements; and (2) clarify the regulatory obligations imposed on private label distributors of finished dietary supplements.
  • ONHA has acknowledged that the dietary supplement industry’s response to its request will be “mixed,” which is understandable in light of the additional regulatory burdens on ingredient suppliers that ONHA proposes.  FDA typically takes a very long time to respond to Citizen Petitions, so we do not expect Agency action on this matter anytime soon.  Still, the filing of the Citizen Petition itself marks a bold public step for ONHA.  Particularly in light of recent supplement controversies, one wonders whether de facto “ingredient supplier” GMPs could become a voluntary industry standard, even in the absence of formal Agency action.