FDA ends partnership with feed organization, will handle review process internally

The Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM) is changing its approach to its 17-year partnership with the Association of American Feed Control Officials (AAFCO). In the past, the FDA has provided scientific and technical support for reviews of new animal food ingredients to AAFCO. Now the FDA is implementing its own internal review processes.

The nonprofit animal food organization announced August 2 it had been notified by the FDA CVM that the agency would not be renewing its memorandum of understanding (MOU) with AAFCO concerning new animal food ingredient definitions when the agreement expires October 1.

"AAFCO has been communicating openly with the FDA during this review time, and although we are disappointed that CVM leadership decided not to renew the longstanding MOU, we respect that this is the direction they feel is best as they continue to grow and evolve their programs," AAFCO Executive Director Austin Therrell told AVMA News.

Starting this October, the Food and Drug Administration will no longer provide scientific support of reviews of new animal food ingredients to the Association of American Feed Control Officials.

"AAFCO is in the process of evaluating our programs and practices as well, and we will continue to pursue opportunities that meet the needs of the state members across the United States," Therrell added.

AAFCO does not approve, certify, or endorse any animal food products. Rather, it advises state, federal, and international feed regulators on animal feed and pet foods by developing ingredient definitions, label standards, and laboratory standards. This information is used to support state and federal laws regulating the manufacture, sale, and distribution of animal food and food ingredients.

Ultimate authority for regulating substances used in animal foods lies with the FDA, including food additives and substances generally recognized as safe (GRAS) for their intended uses.

Since 1920, AAFCO has maintained the AAFCO Official Publication, containing a comprehensive list of animal food ingredients, including FDA-approved animal food additives, substances that are GRAS for their intended use, and animal food ingredient definitions established through the AAFCO Ingredient Definition Request Process.

The FDA CVM entered into an MOU with AAFCO in 2007 outlining how the agency would provide its scientific and technical expertise to the FDA in reviewing ingredient definitions requested by industry or AAFCO. The agreement was previously renewed several times.

Charlotte Conway, deputy director of the FDA CVM's Office of Foods, explained the FDA had determined that with the upcoming expiration of the MOU, the time was right for the agency to step back as scientific and technical reviewers for AAFCO ingredients and to focus resources on FDA-driven programs.

"The agency had already begun an evaluation of its existing animal food ingredient review programs, which most recently has included a request for public comments," Conway said. "Although the MOU will expire, the FDA intends to continue participating in AAFCO committees and meetings and to work closely with AAFCO and states to help ensure the safety of the animal food supply."

Once the MOU ends, the FDA plans to review its processes for approving and recognizing new animal food ingredients to determine whether improvements are needed.

During this evaluation, the FDA will implement the Animal Food Ingredient Consultation (AFIC) process. This process is meant to keep the FDA informed about new ingredients entering the market, address safety concerns before they are marketed, and involve the public in discussions about these ingredients. The AFIC process will also establish a baseline of safety information, according to the FDA, making it easier to monitor these ingredients once they are on the market.

Additionally, the FDA will outline its enforcement policies for ingredients assessed through the AFIC process.

The FDA is confident that the agency will move expeditiously to finalize its plans-draft guidances #293 and #294-before the MOU expires, Conway said, adding that there are many variables outside of the FDA's control that could affect the timing.

"Whether or not the two draft guidances are finalized by October 1, the initial steps for consulting with the FDA on an animal food ingredient are similar," she said. "Firms with questions or concerns about how the upcoming transition affects their animal food ingredients are encouraged to email animalfood-premarketfda.hhs.gov(animalfood-premarket[at]fda[dot]hhs[dot]gov)and seek assistance."

Public link

Please use the above public link if you want to share this noodl on another website.