Association of American Feed Control Officials (AAFCO) is facing an uncertain future with the U.S. Food and Drug Administration. FDA’s general advisors have told the Agency that AAFCO’s process for approving ingredient definitions “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).”
If AAFCO’s ingredient definition and approval process does not meet federal requirements, all ingredients must be subject to a formal review and acceptance procedure.
A new, terrifying, paradigm
Panic-stricken, the animal feed and pet food industry are scrambling as it would mean ingredients already defined by AAFCO, would be subject to be reevaluation under this new FDA paradigm.
Terrified at the possibiltiy of AAFCO coming to an end, the feed industry has launched an all out campaign to put pressure on FDA “to stop complicating the issues surrounding ingredient approvals and recognize AAFCO’s ingredient definitions” by attempting a legislative initiative to amend existing federal law. Their goal is to get Congress to embed formal recognition of AAFCO feed ingredient definitions directly into the Federal Food, Drug and Cosmetic Act (FD&C Act).
Accusing the FDA of interfering with the AAFCO ingredient approval process and of discouraging ingredient development, industry pressured members of Congress to write letters to FDA asking for a solution, presumptuously assuming “it was never the intent of Congress” to interfere with their business.
You say “standards” and I say “definitions”
Industry complained that problems arose over the Agency’s interpretation of the terms “standards” and “definitions,” asserting because the term “standards” is nowhere to be found in the FD&C Act the FDA has no business using a term that cannot be referenced to in law and they should just stick to AAFCO’s ingredient “definition” term instead.
The feed industry is unlikely to succeed in persuading Congress to insert AAFCO into the FD&C Act when it was the melamine tragedy that spurred Congress to pass the Food and Drug Administration Amendments Act of 2007, which mandated regulations addressing pet food ingredient standards and definitions, processing standards and updated standards for labeling.
Unlike ingredients approved by AAFCO for animal feed and pet food, the FDA uses the GRAS list: A lists food additives (ingredients) that are generally regarded as safe, is used by manufacturers to choose additives to use when they are developing products.
Back in the good ol’ days
In the early days, back in 1958 when Congress passed the law requiring the FDA to conduct rigorous pre-market reviews of food additives and approve or reject them based on scientific evidence, most additives on the GRAS list were included because they had been in circulation for a long time with no detectable harm to humans. Therefore, common ingredients such as sugar and gelatin were exempted from review, since they had been safely used for years. Manufacturers had to formally petition FDA to approve a new food additive as GRAS was based on scientific studies published in peer-reviewed journals.
Those days are long gone, now all ingredient manufacturers have to do is submit GRAS designations as determined by their own company or consulting firms they have hired. The consulting firms selected by manufacturers to make GRAS determinations often have conflicts of interests between their obligations to ensure that the use of the additive is safe and their financial relationships to the company.
It all went to Hell in a handbasket
Everything, GRAS wise, began to go downhill in 1997 when the FDA phased out the step of formally approving the manufacturer’s decision, replacing the traditional petitioning process for a manufacturer seeking GRAS status with a procedure that lets corporations determine if a substance is GRAS or not; and when a manufacturer determined that an additive should be added to the GRAS list, they were not required to notify the FDA.
Currently, companies may determine a substance is GRAS without FDA’s approval or knowledge.
The FDA does not independently evaluate data supporting a GRAS determination, but instead reviews the corporation’s summary. And this information about the proposed additive is not readily available to the public.
In the 15 years since this rule was proposed, more than 250 food additives have entered the food supply based solely on manufacturer safety claims. The lack of independent review in GRAS determinations raises concerns about the integrity of the process and whether it ensures the safety of the food supply, particularly in instances where the manufacturer does not notify the FDA of the determination.
Just as the FDA handed authority to determine GRAS status over to the corporations it is meant to regulate, similarly, the FDA handed the process of approving pet food and animal feed ingredients over to AAFCO: a voluntary organization whose model bills and regulations are not required to be adopted in every state.
The end of an era
It’s unclear whose usefulness has come to an end, whether it be the FDA whose obligation it is to provide the regulatory scrutiny the public deserves or AAFCO, whose authority the pet food and animal feed industry has come to depend on in a unhealthy way.
One thing is clear, that the relationship between the FDA and AAFCO, which is due to expire next year, should not be renewed if we are to see any substantive and meaningful reform of the feed industries and the feed industry has no business in regulating how pet food ingredients are defined, approved and labeled.