Tuesday, December 16 , 2014
The Association of American Feed Control Officials (AAFCO) ingredient approval process, used by 49 states, has an unclear future with the U.S. Food and Drug Administration. Despite a 35-year cooperative relationship, the American Feed Industry Association (AFIA) has learned that FDA feels specifically "the AAFCO process ultimately falls short" and "the majority of ingredients that are included in the AAFCO 'official publication' are neither approved food additives nor are they generally recognized as safe (GRAS)."
The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires FDA to establish petfood processing and ingredient "standards." Initially, this caused FDA confusion over the legal differences in interpreting "definition"-the term used in the AAFCO OP-and FDAAA's use of the word "standard," a term of legal art found nowhere in the federal Food, Drug and Cosmetic Act (fFDCA). It now appears FDA is trying to harmonize the AAFCO process with the requirements in the fFDCA. FDA is working to complete a GRAS analysis for ingredients listed in the OP and are exploring the options to address the other ingredients in the OP that are not GRAS nor approved food additives.
After several situations where FDA agreed to either a legislative fix or an administrative remedy-only to back out at the 11th hour-AFIA turned to Congress for help. AFIA has recently met with congressional offices to put pressure on FDA to stop complicating the issues surrounding ingredient approvals. Instead, AFIA is pushing FDA to administratively remedy a situation that is discouraging ingredient development.
Last fall, with strong AFIA membership support, 38 members of Congress wrote letters to FDA asking for a solution and clarifying that it was never the intent of Congress to interfere with the AAFCO ingredient approval process.
AFIA met with Rep. Collin Peterson (D-Minn.) and his staff again recently. They have not decided how they will respond to FDA but remain willing to help. The staffs in other offices continue to demonstrate their willingness to assist AFIA.
AFIA equipped several dozen state grain-feed/agribusiness leaders who flew to Washington, D.C., recently with a one-pager and briefed them on the issue. What AFIA is looking for now is the industry's help. The organization would like to hear from member companies about their experiences with ingredient approvals so AFIA can share them with congressional offices and with FDA.
Please think about recent ingredient approval processes your company has experienced-FDA has told Capitol Hill this agency confusion has not held up pending approvals-and let AFIA know what an ideal process would be moving forward. Also please think about how regulatory uncertainly has affected your business, especially in terms of investment/innovation, revenue and jobs. AFIA will soon send out a form to collect such information.
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