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.
- 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.
- 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.
- The scientific standard for a determination of GRAS requires the same quality and quantity of information in a food additive petition.
- 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.
- 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.
- 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)