The following is a summary of the  Pet Food Institute's  (PFI) recommendations on self-affirmed generally recognized as safe ingredients (SA-GRAS). Geoffery Wong of the Food and Drug Administration (FDA) will present on this topic October 15 at the PFI Annual Industry Meeting.

  1. FDA's Center for Veterinary Medicine (CVM) does not have the resources to review ingredients under both SA-GRAS and the Association of American Feed Control Official's (AAFCO) Ingredient Definition Committee (IDC). The firm seeking the approval should determine which way they want to submit.
  2. A firm can make a determination that a particular use of a substance is GRAS and go to market. Or, notify FDA of its notification.
  3. The scientific standard for a determination of GRAS requires the same quality and quantity of information in a food additive petition.
  4. Proceeding with the AAFCO process has a lower data hurdle, in part because these ingredients are ones for which FDA does not have safety concerns.
  5. If they notify FDA the result will be:
    Letter of no questions
    Letter stating insufficient basis
    CVM does not support listing an ingredient that goes through the FDA-SA-GRAS process in the OP.
    If a state takes action against an ingredient that is the subject of a no questions letter and is listed on the Web site, FDA will not support the state challenge.
  6. An ingredient the firm wants listed in the OP must go through the AAFCO-IDC process.

At the PFI Annual Industry Meeting, The Update Session, October 15, at 2 p.m., will feature:

  • Ricky Schroeder, manager, Feed & Fertilizer Reg., Texas A&M University (AAFCO Perspectives)
  • Bill Burkholder, petfood specialist, FDA, CVM (Current state of petfood regulations)
  • Geoffery Wong, supervisor, Ingredient Safety Team, FDA, CVM (More information on Self-Affirmed GRAS)
  • Kim Young, deputy director, Division of Compliance, FDA, CVM (Reportable Food Registry)
  • Kristin Schmitz, senior staff veterinarian, USDA, APHIS, VA, NCIE (Canadian Export Issues)