FDA Breaks Up With AAFCO

Charlie Elrod, Ph.D., Vice-President, NEAFA

In just a month from now, the eighteen year-old Memorandum of Understanding (MOU) between the Food and Drug Administration (FDA) and the Association of American Feed Control Officials (AAFCO) will be coming to an end.  Since 2006, this MOU has provided the framework under which the FDA provided scientific and technical assistance to AAFCO in the process for feed ingredients to either be accepted through the animal food additive petition or to be generally recognized as safe for use in livestock feed or pet food.  This breakup does not affect any ingredients which are already defined in the annually published AAFCO Official Publication but will certainly slow down the process for any new ingredients to be approved.  

This seems a bit ironic after AFIA successfully lobbied, in two different federal budget years, for the addition of significant funding to increase technical staffing within FDA to accelerate the process of feed ingredient reviews.  However, the need to revamp the food ingredient approval process is driven by activist activity, potential litigation and a lack of transparency in the process.  We witnessed this pressure last year when a bill was introduced in New York State which would have charged NYS Department of Ag & Markets with developing its own food/feed ingredient approval process.  This would have been a difficult mandate for Ag & Markets to fulfill.  NEAFA lobbied effectively against this bill and it eventually died in committee.  

The FDA has established a comment period for the public to register their thoughts on changes needed to promote the efficiency of the feed ingredient process.  If interested, you can submit comments here.  Comments will be accepted until midnight on December 9, 2024.

The process of approving GRAS feed ingredients was changed several years ago to a system whereby firms or individuals can notify FDA of their own determination that a substance is GRAS based on their own data.  However, FDA must still review the application’s merits and will issue a “no questions” letter if they believe the data to be consistent with a GRAS designation.  Effective September 1st, FDA will stop accepting new Food Additive Petitions and GRAS applications in order to give them one month to clear pending applications before the October 1st end of the MOU.

FDA has published a draft for a new Animal Food Ingredient Consultation process which outlines the ways in which companies developing animal food ingredients can consult with FDA following the demise of the MOU with AAFCO.  They are accepting comments on this process as well.  

As you know, NEAFA collaborates very closely with AFIA. Louise Calderwood and Leah Wilkinson are seeking input from AFIA members and will be providing talking points and a letter template for AFIA members to use.  While making our individual comments to FDA via the link above will be useful, it will also be very worthwhile to provide comments to AFIA where they can summarize them and effectively lobby as the voice of the feed industry.  Comments to AFIA can be submitted here.

This is a very important issue for our industry and one that we will stay closely attuned to.  As more information becomes available, we’ll be sure to share it in the NEAFA newletter or in email blasts to members.