On February 15, 2024, the Pet Food Uniform Regulatory Reform Act of 2024 (PURR Act of 2024 or, herein, PURR Act) was introduced in the United States House of Representatives by a bipartisan group of five members, and has been referred to the House Committee on Energy and Commerce. If the PURR Act becomes law in its current form, it will change the traditional regulatory scheme for pet food ingredients and claims in which the Food and Drug Administration (FDA) and the states share jurisdiction. At present and for a number of decades, many states’ laws provide that pet food manufacturers must submit their pet food labels to states for review and approval. If the state did not approve the label, the pet food could not be sold into that state. The bill’s “findings” refer to the benefits of “[c]reating a more streamlined Federal regulatory process for new pet food ingredients” and “[r]eplacing the patchwork of regulation of pet food with a uniform Federal regulatory framework.” The PURR Act would add new section 425 to the Federal Food, Drug, and Cosmetic Act (FDCA), which defines “pet food” as “any food manufactured and distributed for consumption by companion animals, including treats, nutritional supplements, and pet food ingredients,” and would broadly preempt states from directly or indirectly establishing, maintaining, implementing, or enforcing any authority or requirement relating to the marketing or labeling of pet food. The PURR Act defines “companion animal” to mean “a domesticated canine or feline” and therefore would not extend to other animals.
The PURR Act defines “pet food ingredient submission” as a submission to FDA for a pet food ingredient, which can either be a food additive petition under FDCA section 409, a color additive petition under FDCA section 721, or a Generally Recognized as Safe (GRAS) ingredient notification under 21 C.F.R. part 570. The PURR Act states that not later than 90 days following such submission, FDA must 1) approve the submission or, 2) if the submission is a GRAS notification, affirmatively fail to object, or 3) must identify the specific deficiencies in the submission and, where appropriate, the actions necessary for approval or, for a GRAS notification, to resolve FDA’s concerns. Ingredients that have not specifically been approved as food additives, color additives, or otherwise, but are currently eligible for use in pet food pursuant to listing as feed ingredient definitions in chapter 6 of the 2024 Association of American Feed Control Officials (AAFCO) Official Publication, will be deemed GRAS unless FDA has found that such ingredients are not GRAS.
The PURR Act prescribes language to list fat or oil ingredients, flavor ingredients, and/or grain ingredients that may sometimes be present in a pet food, and allows ingredients present in amounts of 2 percent or less by weight to be listed in the ingredient declaration in other than descending order by weight if accompanied by an appropriate quantifying statement (e.g., “less than __ percent”).
Regarding claims, the PURR Act would allow hairball control, tartar control, plaque removal, bad breath odor, and general urinary tract health support claims without FDA premarket approval provided the claims are truthful, nonmisleading and adequately substantiated. It would also codify both AAFCO’s “natural” definition and requirements for human grade claims currently captured in AAFCO’s “Guidelines for ‘Human Grade’ Pet and Specialty Pet Food Claims.”
The PURR Act would require FDA to issue guidance within 18 months based on the AAFCO guidance in the 2024 AAFCO Official Publication regarding substantiating nutritional adequacy claims, metabolizable energy protocols, affidavits for pet food testing protocols, data to support a calorie content claim, analytical variations and the use of menadione sodium bisulfate complex (MSBC) in animal feed. Also, FDA must issue proposed regulations within one year of enactment and final regulations within two years. The initial regulations must include the AAFCO model pet food rules.
If enacted, the PURR Act would also place on the FDA Center for Veterinary Medicine responsibility for conducting science based reviews of pet food ingredients, submitting an annual report to Congress on performance metrics, educating pet owners, veterinarians and the companion animal industry about pet food, educating pet owners on pet food safety and conducting research to support and improve pet food policies and regulatory decisions.
On its website, the Pet Food Institute announced its support for the PURR Act, and provided an analysis of the new legislation. Certain other pet food industry groups, such as Pet Food Association of Canada and the Pet Industry Distributors Association, also have expressed support for the legislation. Notably, Petfood Industry News reported yesterday that Austin Therrell, Executive Director of AAFCO said, “AAFCO was not consulted or invited to be involved in the drafting of H.R.7380,” but AAFCO told Petfood Industry News that it was given a draft of the bill shortly before the bill was introduced. Mr. Therrell also said, “As a result of AAFCO’s limited input, we do have many concerns related the proposed legislation. At this time AAFCO is collaborating with numerous trade organizations with insight into the feed industry to review our concerns and determine the best next steps." In the same edition, Petfood Industry News also reported that the American Feed Industry Association (AFIA) had told it that AFIA is considering any unintended consequences this bill could introduce and therefore, does not currently have a position on H.R. 7380.
What should you do?
Pet food companies and manufacturers of ingredients used in pet foods who are in favor of the proposed changes or who have concerns and questions should reach out to your trade association or congressional representatives.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Animal Food and Drug practice.
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