Last Wednesday, I received a very upbeat email from AAFCO celebrating CVM having issued its final guidance (GFI 293) [allowing] animal feed and pet food manufacturers to continue using ingredients published in the 2024 Official Publication (OP) for products sold in interstate commerce. The letter was one which although an announcement, also solicited comments.
Overall, I found that AAFCO is mistaken to assume that GFI 293 comes anywhere close to conferring absolution or amnesty for ingredients presently listed in the OP or items that may be listed in the OP in the future; on page 2 of the guidance, it specifically states that “The definitions adopted through the AAFCO ingredient definition request process are not Federal regulations and they do not bind FDA or animal food manufacturers under Federal law.” However, I believe the biggest error is not reading the entire page of the guidance, as illustrated by the notice at the top of all the pages (except the cover page) i.e., “Contains Nonbinding Recommendations”.
In any event, what follows is my revised and slightly expanded response to the AAFCO letter.
Dear Mr. Therrell:
People fail to read "between the lines" on documents issued by CVM. For example, the original 2007 MOU was hailed by industry as a new era of transparency when CVM disclosed the arrangement between CVM and AAFCO, believing that the new era of transparency was equivalent to legitimizing the process. However, the real message of the MOU was that the process had an expiration date.
The same is true for CVM's GFI 293. First, GFI 293 does not change the law (the Federal Food Drug and Cosmetic Act or FFDCA), which plainly states an ingredient added to food must be (1) safe and (2) shown to be safe according to specific criteria - either as a food additive or GRAS and via the latter process, by specific, credentialed individuals described in the regulation or the ingredient having been present in food (feed) prior to January 1, 1958:
First, the “safe” is described as:
Section 201(u) "The term ‘‘safe,’’ ... has reference to the health of man or animal."
Second, the criteria or process by which the methods for obtaining compliance for ingredients is described below:
Section 201(s) "The term ‘‘food additive’’ means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food ... if [that] substance is not [already] generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use...”
Further, GFI 293 does not legitimize non-compliant food additives or non-GRAS ingredients in the OP, even though many ingredients may be eligible for compliance via simple measures available in the law. However, because the ingredients are not compliant, they have no protection provided by the Administrative Procedures Act (APA); that is, the ingredient and any product containing the non-compliant ingredient may be condemned as being adulterated on the basis that it contains a non-compliant ingredient. While the APA requires that the producer be given notice of a violative action of (a compliant ingredient, such as a food additive, prior sanctioned ingredient or a GRAS ingredient) via a notice in the Federal Register and allowed a time to reply, a non-compliant ingredient may be seized immediately.
Secondly, GFI 293 does not confer immunity to class action lawsuits, demanding that CVM "clean up" the animal feed industry, nor is immunity conferred to state law, such as California’s Legal Remedies Act, Unfair Competition Law or False Advertising Law. Under the Unfair Competition Law, it may be possible for a manufacturer of a new ingredient, as a replacement for one already in the OP, to sue, demanding that while he must show his new ingredient is safe, but the one in the OP has never been required to show its safety. The False Advertising Law might be implemented because the label describing contents of a package (for example, on a bag of dog food), implies that all the contents are safe and compliant with federal law - which they are not.
Thirdly, CVM takes a pass on ingredients in the 2024 AAFCO-OP if "FDA has no questions or concerns about the safety of an ingredient." What happens when a researcher or competitor conducts an animal study at a very high dose, which shows toxicity in the test animals and then the competitor complains to CVM that because the competing additive has shown to be toxic, but a safe level of use has not been established? According to its own rules, CVM would be obligated to take action on the substance, requiring that it be removed from the OP and possibly demanding the ingredient be seized.
Regarding AAFCO's program at KSU. While the process being initiated at KSU is well-intentioned, it is woefully incomplete and lacking the rigor required for a substantive finding. I have some expertise in this area (1) and my review of the description shows some very large gaps. AAFCO should be aware that several organizations have written unfavorable descriptions of the GRAS process, including the General Accounting Office (GAO)(2), the Environmental Working Group (3) and Consumer Reports (4), all of whom would be anxious to write another scathing account of GRAS being used to cheat, if not endanger, the public.
Further, regarding GRAS determinations by AAFCO, if AAFCO is willing to accept GRAS determinations by the KSU group, AAFCO must be willing to level the playing field and accept GRAS determinations by other groups as well. In the past, we have submitted GRAS determinations to various states who have declined to accept them on the basis that the state "did not have the expertise to review the GRAS".
In reality, any GRAS must meet Federal requirements and there are many guidances at FDA on the subject of GRAS; therefore, the new paradigm of acceptance must be that if the Ingredient Committee has questions on a GRAS, clarification may be requested of the submitter and if the GRAS otherwise meets the criteria of the Federal guidances, then it is submitted to the Board, which recommends it for approval by the General Membership, indicating acceptance by AAFCO and all parties as members of AAFCO and; whereupon, it is incorporated into the Official Publication.
Mr. Therrell, thank you for this opportunity to comment on the suggested remedies to the recently terminated MOU. Should you have any questions or comments, please feel free to contact me. Thank you and best regards,
George A. Burdock, PhD
Diplomate, American Board of Toxicology
Fellow, Academy of Toxicological Sciences
Fellow, American College of Nutrition
President, Burdock Group
859 Outer Road
Orlando, FL 32814
PH 407.802.1400 x168
FX 407.802.1405
REFERENCES
(1) George A. Burdock and Ioana G. Carabin (2004). Generally recognized as safe (GRAS): history and description. Toxicology Letters 150:3-18. (available on request)
(2) Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS) GAO-10-226 (https://www.gao.gov/products/gao-10-246).
(3) What is GRAS? https://www.ewg.org/news-insights/news/2024/03/what-gras
(4) GRAS: The Hidden Substances in Your Food Critics say the FDA's newest rule on ingredients 'generally recognized as safe' leaves consumers at risk (https://www.consumerreports.org/food-safety/gras-hidden-ingredients-in-your-food/)
Burdock Group services include our opinions or beliefs as we have determined them, based on facts obtained, as well as various suggested courses of action and the results that might be anticipated. Any statements are intended to be an expression of opinion only, based on information available to us at the time, and should not be construed as a promise, guarantee, or legal advice as we are not lawyers. Further, this opinion is limited to relevant United States federal regulations and does not include tribal, state, local or municipal laws, statutes, ordinances or regulations, unless otherwise specified.