FDA Announces Plan to Streamline Animal Food Regulation

On March 27, 2015, FDA announced a strategy to establish ingredient definitions and standards for animal food.  The goal of FDA’s strategy is to promote consistency in the Agency’s regulatory review and clearance of animal food ingredients.  

Currently, ingredients used in animal feed and pet food (collectively, “animal food”) are subject to overlapping regulation and review by FDA, individual states, and the Association of American Feed Control Officials (AAFCO), a voluntary membership organization including regulatory officials from the federal and state governments).  For many years, FDA and AAFCO have worked together under a memorandum of understanding (MOU) to regulate animal food ingredients.  To be lawfully marketed, an animal food ingredient must have an appropriate FDA regulatory status (food additive regulation, Generally Recognized as Safe (GRAS) regulation, or “no questions” letter in response to a GRAS Notification) or must be the subject of an ingredient definition in the AAFCO manual. 

Under the Food and Drug Administration Amendments Act of 2007 (FDAAA), Congress required FDA to work AAFCO and other stakeholders to take regulatory action to establish ingredient standards and definitions with respect to pet food.  Despite being several years overdue, FDA’s new proposed strategy is intended to implement the FDAAA mandate. 

In order to align AAFCO ingredient listings with FDA’s official regulatory process, FDA plans to take the following steps:

• Confirm and codify (via rulemaking) those AAFCO-listed food ingredients that are recognized as GRAS or approved by the Agency as food additives;
• Evaluate the remaining AAFCO-listed food ingredients and;
  • Where the scientific literature supports a GRAS determination → affirm the ingredients as GRAS (permitting public comment on the supporting information);
  • Where the existing data and information are sufficient to meet the food additive approval standard → issue a food additive approval for the substance.
  • Where FDA does not have data to make a GRAS determination or to approve the ingredient as a food additive → require the manufacturer of the ingredient to submit a food additive petition to permit continued legal use of the substance in animal food.

Although FDA’s strategy ultimately may increase transparency and consistency in the regulation of animal food additives, the Agency’s actions potentially could disrupt the animal food supply. Presumably it will take some time for FDA to work through the AAFCO list, which will create a period of uncertainty about the future regulatory status of widely-marketed ingredients. The industry certainly will experience upheaval in cases where FDA re-evaluates 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 its continued use is likely to be met with industry resistance.

For many years, the animal food industry has been subject to a patchwork of federal and state regulation and oversight, at times roughly united under the AAFCO process.  FDA’s current initiative may mark the beginning of a significant shift in historical practice, bringing the regulation of animal food squarely under federal regulatory control.