119-hr597

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 597 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 597

To amend the Federal Food, Drug, and Cosmetic Act to clarify and update 
 the authority of the Food and Drug Administration to ensure national 
 uniformity in the regulation of the labels, labeling, and advertising 
 of companion animal pet food, and for other purposes.

_______________________________________________________________________

 IN THE HOUSE OF REPRESENTATIVES

 January 21, 2025

Mr. Womack (for himself, Mr. Valadao, Mr. Smith of Nebraska, Mr. Harder 
 of California, and Mr. Schmidt) introduced the following bill; which 
 was referred to the Committee on Energy and Commerce

_______________________________________________________________________

 A BILL

To amend the Federal Food, Drug, and Cosmetic Act to clarify and update 
 the authority of the Food and Drug Administration to ensure national 
 uniformity in the regulation of the labels, labeling, and advertising 
 of companion animal pet food, and for other purposes.

 Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Pet Food Uniform 
Regulatory Reform Act of 2025'' or the ``PURR Act of 2025''.

    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.

Sec. 2. Findings.

Sec. 3. Pet food regulation.

Sec. 4. Responsibilities.

Sec. 5. Regulations.

SEC. 2. FINDINGS.

 Congress finds the following:

    (1) The pet food industry is a growing sector in the United 
 States. Pet food exports have increased by double digits over 
 the last few years.

    (2) United States pet food manufacturers contribute to the 
 national economy by buying nearly $7,000,000,000 worth of 
 agricultural products from farmers, ranchers, and farm-product 
 processors every year.

    (3) Pet ownership has consistently grown in the United 
 States, resulting in an increase in pet food sales and an 
 accompanying increase in the interest by pet owners in how 
 their companion animals' food is regulated and produced.

    (4) Historically, pet food and livestock feed have been 
 regulated under the same framework. However, as pet owners' 
 relationships with their pets have changed, so too has their 
 understanding of pets' nutritional needs and preferences. Pet 
 food is specifically formulated to ensure complete nutrition 
 for the long and healthy lives of companion animals. Owning a 
 companion animal provides profound mental, social, and physical 
 health benefits for pet owners such as reduced blood pressure 
 and stress levels, and research indicates that companion 
 animals can play a role in managing depression. Before the 
 enactment of this Act, the regulatory framework that was 
 originally created for livestock feed no longer met the needs 
 of pets or their owners.

    (5) Before the enactment of this Act, the regulatory 
 framework governing pet food manufacture and sale, from 
 ingredient approvals to labeling requirements, was multifaceted 
 and wildly inconsistent. Regulatory regimes varied by State, 
 were developed in part by a combination of nongovernmental 
 entities and State government agencies, and were overseen by 
 the Food and Drug Administration's Center for Veterinary 
 Medicine.

    (6) Creating a more streamlined Federal regulatory process 
 for new pet food ingredients allows for expedited advances for 
 nutrition, greater innovation, and more functionality in a more 
 predictable regulatory environment.

    (7) Replacing the patchwork of regulation of pet food with 
 a uniform Federal regulatory framework improves marketplace 
 certainty, allows for more consistent and predictable 
 ingredient review and market introductions, and enhances 
 companion animal nutrition.

    (8) The nationwide availability of nutritious, safe, and 
 affordable pet food is substantially improved through a unified 
 comprehensive Federal system of oversight of the manufacture 
 and sale of pet food.

    (9) The manufacture of pet food and its marketing and sale 
 is undertaken throughout the United States and its territories 
 and is interstate commerce.

SEC. 3. PET FOOD REGULATION.

 Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
341 et seq.) is amended by adding at the end the following:

``

SEC. 425. PET FOOD.

 ``

    (a) 

=== Definitions. ===
-In this section:
 ``

    (1) The term `companion animal' means a domesticated 
 canine or feline.
 ``

    (2) The terms `generally recognized as safe' and `GRAS' 
 mean generally recognized as safe under 

section 201

    (s) .
 ``

    (3) The term `pet food' means any food manufactured and 
 distributed for consumption by companion animals, including 
 treats, nutritional supplements, and pet food ingredients.
 ``

    (4) The term `pet food ingredient' means an ingredient 
 intended for use in pet food.
 ``

    (5) The term `pet food ingredient submission' means a 
 submission to the Food and Drug Administration for a pet food 
 ingredient that is a petition under 

section 409 for any food 
 additive, a petition under 

section 721 for a color additive, or 
 a GRAS ingredient notification under subpart E of part 570 of 
 subchapter E of chapter I of title 21, Code of Federal 
 Regulations (or successor regulations).
 ``

    (b) Preemption.--
 ``

    (1) In general.--No State or a political subdivision of a 
 State may directly or indirectly establish, maintain, 
 implement, or enforce any authority or requirement relating to 
 the labels, labeling, and advertising of pet food.
 ``

    (2) Rule of construction.--Nothing in this section shall 
 be construed to restrict State food safety oversight 
 activities, including any such activities relating to 
 implementation of the FDA Food Safety Modernization Act, 
 outbreak investigations, surveillance sampling, or 
 investigations of consumer complaints.
 ``
            (c) GRAS Ingredients.--
 ``

    (1) Ingredients deemed gras.--Ingredients that are 
 intended for use in pet food, and are not specifically 
 authorized for such use by the Food and Drug Administration as 
 a food additive, a color additive, or otherwise as of the date 
 of enactment of the PURR Act of 2025, are deemed to be GRAS 
 if--
 ``
        (A) such ingredients are identified in chapter 6 
 of the 2024 edition of the `AAFCO Official Publication' 
 (or any subsequent amendments thereto or editions 
 thereof) as acceptable for use in pet food (whether 
 specifically for use in dog or cat food, or for use in 
 animal food without restriction to species); and
 ``
        (B) there is no finding by the Food and Drug 
 Administration that such ingredients are not GRAS.
 ``

    (2) Voluntary notification.--A pet food manufacturer is 
 not required to notify the Food and Drug Administration of GRAS 
 ingredients used in pet food, but may voluntarily notify the 
 Food and Drug Administration of such GRAS ingredients that have 
 not previously been recognized by the Food and Drug 
 Administration as GRAS for use in pet food.
 ``
            (d) Timely Review.--Not later than 90 days after receipt of a pet 
food ingredient submission, the Secretary shall review such submission 
and issue an action letter that--
 ``

    (1) approves such submission or, in the case of a GRAS 
 ingredient notification, does not object to use; or
 ``

    (2) sets forth--
 ``
        (A) the specific deficiencies in such submission; 
 and
 ``
        (B) where appropriate, the actions necessary--
 ``
            (i) for such submission to be approved; 
 or
 ``
            (ii) in the case of a GRAS ingredient 
 notification, to resolve any concerns of the 
 Secretary.
 ``

    (e) Ingredients Sometimes Present.--
 ``

    (1) In general.--Pet food shall not be treated as 
 misbranded by reason of stating in the pet food ingredient list 
 on the product label that an ingredient of a type described in 
 paragraph

    (2) is sometimes, but not always, present in the pet 
 food.
 ``

    (2) Types of ingredients.--Paragraph

    (1) applies with 
 respect to the following types of ingredients:
 ``
        (A) Fat or oil ingredients.
 ``
        (B) Flavor ingredients.
 ``
            (C) Grain ingredients (including grain protein 
 ingredients).
 ``

    (3) Language to be used.--For an ingredient in pet food 
 to be labeled as sometimes present for purposes of paragraph

    (1) , such ingredient shall be identified by--
 ``
        (A) words such as `or', `and/or', or `contains 
 one or more of the following:'; or
 ``
        (B) other words indicating that the ingredient 
 may not be present.
 ``

    (f) Order of Ingredient Listing.--
 ``

    (1) In general.--Pet food shall be treated as misbranded 
 unless the ingredients required to be declared on the labeling 
 of a pet food are listed by common or usual name in descending 
 order of predominance by weight.
 ``

    (2) Exception.--If an ingredient in pet food is present 
 in amounts of 2 percent or less by weight, then instead of 
 identifying the ingredient in the order required by paragraph

    (1) , the ingredient may be placed at the end of the pet food 
 ingredient list following an appropriate quantifying statement, 
 such as `Contains __ percent or less of ______' or `Less than 
 __ percent of ______', with the blank percentage filled in with 
 a threshold level of 2 percent, or, if desired, 1.5 percent, 
 1.0 percent, or 0.5 percent, as applicable.
 ``

    (g) Permissible Marketing Claims.--Pet food shall not be treated 
as misbranded by reason of the following claims on labels and labeling 
and in advertising for pet food, without premarket approval of such 
claims by the Food and Drug Administration, if truthful, nonmisleading, 
and adequately substantiated:
 ``

    (1) Claims regarding hairball control.
 ``

    (2) Claims regarding tartar control, plaque removal, and 
 bad breath odor.
 ``

    (3) Claims regarding the ability of pet food to support 
 general urinary tract health.
 ``

    (4) `Human grade' claims for finished pet food (not for 
 individual ingredients) if all of the following circumstances 
 are met:
 ``
        (A) Every ingredient in the pet food and the 
 finished product is--
 ``
            (i) stored, handled, processed, and 
 transported in accordance with--
 ``
            (I) section 117 of title 21, Code 
 of Federal Regulations (or successor 
 regulations); and
 ``
            (II) the laws applicable to food 
 for human consumption, including such 
 laws relating to ingredients, process, 
 or facility type; and
 ``
            (ii) manufactured in accordance with 
 

section 507 of title 21, Code of Federal 
 Regulations (or successor regulations).
 ``
        (B) Each facility that manufactures the finished 
 pet food or an ingredient in the finished pet food is 
 registered pursuant to 

section 415 as a human food 
 facility.
 ``
            (C) The `human grade' claims clearly indicate 
 that the food is pet food, such as by stating `dog 
 food' or `cat treats'.
 ``

    (5) `Natural' claims if all of the following 
 circumstances are met:
 ``
        (A) Subject to subparagraph
            (C) , the term 
 `natural' refers to a food or ingredient derived solely 
 from plant, animal, or mined sources--
 ``
            (i) in its unprocessed state; or
 ``
            (ii) having been subject to physical 
 processing, heat processing, rendering, 
 purification, extraction, hydrolysis, 
 enzymolysis, or fermentation, but not having 
 been produced by or subject to a chemically 
 synthetic process and not containing any 
 additives or processing aids that are 
 chemically synthetic except in amounts as might 
 occur unavoidably in good manufacturing 
 practices.
 ``
        (B) The term `natural' is only used to reference 
 the product as a whole when all of the ingredients and 
 components of ingredients meet the description in 
 subparagraph
        (A) .
 ``
            (C) If the food or ingredient contains chemically 
 synthesized vitamins, minerals, or other trace 
 nutrients used as ingredients in pet food, a 
 disclaimer--
 ``
            (i) discloses the addition of such 
 vitamins, minerals, and other trace nutrients 
 by name or category;
 ``
            (ii) is juxtaposed with the term 
 `natural'; and
 ``
            (iii) appears with the largest or most 
 prominent use of the term `natural' on each 
 panel of the label on which the term appears, 
 in the same style and color print and at least 
 one-half the size of the term natural.
 ``
            (D) A disclaimer under subparagraph
            (C) is not 
 required when the term `natural' is used in reference 
 to one ingredient and is not referring to the whole 
 product.
 ``

    (h) Guidance on Certain Topics.--
 ``

    (1) In general.--The Secretary shall issue guidance with 
 respect to pet food addressing each of the following topics:
 ``
        (A) Methods for substantiating nutritional 
 adequacy of pet foods.
 ``
        (B) Pet food metabolizable energy protocols.
 ``
            (C) Affidavits for pet food testing protocol 
 completion.
 ``
            (D) Data to support a calorie content claim.
 ``
        (E) Analytical variations

    (Avs) .
 ``
        (F) Recommendations for use of menadione sodium 
 bisulfite complex

    (MSBC) in animal feed.
 ``

    (2) Initial guidance.--
 ``
        (A) Timing.--Not later than 18 months after the 
 date of enactment of the PURR Act of 2025, the 
 Secretary shall issue initial guidance under this 
 subsection.
 ``
        (B) Basis.--The initial guidance under 
 subparagraph
        (A) shall be based on the guidance 
 contained in the 2024 edition of the `AAFCO Official 
 Publication'.''.

SEC. 4. RESPONSIBILITIES.

 Title X of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 
et seq.) is amended by adding at the end the following:

``

SEC. 1015. RESPONSIBILITIES FOR PET FOOD REGULATION.

 ``

    (a) Delegation of Responsibility.--The Secretary shall delegate 
to the Director of the Center for Veterinary Medicine responsibility 
for carrying out 

section 425 and, as appropriate, other 
responsibilities and authorities of the Food and Drug Administration 
with respect to pet food.
 ``

    (b) Duties.--The responsibilities of the Director of the Center 
for Veterinary Medicine shall include--
 ``

    (1) conducting and coordinating science-based reviews of 
 pet food ingredient submissions;
 ``

    (2) submitting an annual report to the Congress on 
 performance metrics, including performance on--
 ``
        (A) the review of submissions and issuance of 
 action letters under 

section 425
            (d) ;
 ``
        (B) the issuance of initial guidance under 
 

section 425

    (h) and any subsequent revisions to such 
 guidance; and
 ``
            (C) the proposal and finalization of initial 
 regulations under 

section 5 of the PURR Act of 2025 and 
 any subsequent revisions to such regulations;
 ``

    (3) educating pet owners, veterinarians, and the 
 companion animal industry about pet food;
 ``

    (4) communicating and educating consumers on the safety 
 of pet food; and
 ``

    (5) carrying out research to support and improve policies 
 and regulatory decisions regarding pet food.
 ``
            (c) === Definitions. ===
-In this section, the terms `companion animal', 
`pet food', and `pet food ingredient submission' have the meanings 
given to those terms in 

section 425.''.

SEC. 5. REGULATIONS.

    (a) In General.--The Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall--

    (1) not later than one year after the date of enactment of 
 this Act, issue proposed regulations to implement the 
 amendments made by this Act; and

    (2) not later than two years after the date of enactment of 
 this Act, finalize such regulations.

    (b) Contents.--The initial regulations promulgated to implement the 
amendments made by this Act shall include PF 1 through PF 12 of the 
``Model Regulations for Pet Food and Specialty Pet Food Under the Model 
Bill'' in chapter 4 of the 2024 edition of the ``AAFCO Official 
Publication''.
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