FDA to create definitions and standards for animal food ingredients.

  • For years, animal feed and pet food ingredients have been marketed in the U.S. with the blessing of FDA and/or the Association of American Feed Control Officials (AAFCO) (a voluntary membership organization including both federal and state regulatory officials).  Currently, the lawful marketing of an animal food ingredient is based on an FDA regulation (food additive regulation or GRAS regulation), a GRAS Notification that receives a “no questions” letter, or an ingredient definition in the AAFCO manual.  FDA and AAFCO have worked together under a longstanding memorandum of understanding (MOU) to regulate animal food ingredients.
  • FDA has now announced a new strategy to establish ingredient definitions and standards for animal food.  As part of its plan, FDA will be reviewing all AAFCO listings and formally confirming those ingredients that are recognized as GRAS or approved by the Agency as food additives.  For the remaining AAFCO-listed ingredients, FDA will determine whether the existing scientific literature supports a GRAS determination or a food additive approval and will formally confirm the applicable regulatory status of the ingredients.  In cases where FDA cannot find sufficient information to make a GRAS determination or to issue a food additive approval, the Agency will require the manufacturer to submit a food additive petition to allow continued legal use of the product in animal food.
  • On the one hand, FDA’s strategy ultimately may better harmonize the field of animal food regulation across the federal and state levels.  But on the other hand, the strategy poses the potential for industry upheaval if the Agency re-evaluates certain ingredients and finds no support for GRAS status or food additive approval.  Particularly if an ingredient has a long history of safe use in the animal food supply, an FDA determination that the manufacturer must now submit a food additive petition to justify continued use is likely to incite significant industry protest.