Classify One Chew Before Anyone Calls It a Supplement

When a pet owner carries an over-the-counter chew into an exam room, or when a veterinary clinic manager audits retail shelves, the product is often called a "pet supplement." The packaging often resembles a human nutraceutical, complete with a clean white bottle, an ingredient breakdown, and reassuring promises about mobility, skin radiance, or urinary wellness. Yet under United States federal law, that third box does not exist. For any labeled chew, topper, treat, or promotional claim, there are only two primary legal pathways under the Federal Food, Drug, and Cosmetic Act (FD&C Act): animal food or new animal drug. FDA does not recognize a dietary supplement category for animals.

This guide functions as a single-use intended-use classification worksheet. It addresses a specific, recurring regulatory question: For one labeled chew, topper, treat, or promotional claim, is the article still animal food because its intended use is derived mainly from nutrition, taste, or aroma; a new animal drug because its intended use is to diagnose, cure, mitigate, treat, or prevent disease, or to affect structure or function other than through nutrition, taste, or aroma; or a claimed dietary supplement that FDA treats as an invalid third category?

The Dietary Supplement Health and Education Act of 1994 (DSHEA) created a statutory carve-out exclusively for human products. In 1996, the Food and Drug Administration published a formal Federal Register notice confirming that DSHEA does not apply to products intended for animals. FDA's Center for Veterinary Medicine (CVM) reiterates across its current regulatory guidance that animal products marketed as dietary supplements are regulated either as animal food or as animal drugs, depending upon their composition and objective intended use. A human-style disclaimer stating that the statements have not been evaluated by the FDA does not create an animal dietary supplement category.

Establishing clear jurisdictional boundaries is vital before applying this worksheet. This article is not a recall reader (for evaluating contaminated or misbranded batches, see the guide to pet food recall notices and the veterinary recall trends analysis). It is not an encyclopedia of complete prescription or non-prescription urinary diets (see non-prescription cat food and urinary crystals). It is not an examination of extra-label drug use under the Animal Medicinal Drug Use Clarification Act (AMDUCA), which applies strictly to already-approved animal and human pharmaceuticals (see AMDUCA extra-label versus approved animal drugs versus bulk compounding). Nor does it review the New Animal Drug Application (NADA) approval architecture (see FDA veterinary drug approval process) or compounding pharmacy selection under CVM GFI #256 (see veterinary compounding pharmacy selection). Finally, this guide provides no dosing, diagnosis, or clinical treatment plans. Instead, it provides the precise regulatory criteria required to classify a single labeled article.

DSHEA Does Not Create an Animal Dietary-Supplement Box

To understand why pet supplements lack a dedicated legal category, one must trace the legislative architecture of the Dietary Supplement Health and Education Act of 1994 (Public Law 103-417). DSHEA amended the FD&C Act by creating 21 U.S.C. 321(ff), establishing a formal definition and regulatory framework for "dietary supplements." Crucially, Congress structured 21 U.S.C. 321(s)—the food additive definition—to explicitly exempt dietary ingredients intended for use in dietary supplements. In the human market, this statutory carve-out allows vitamins, minerals, amino acids, botanicals, and dietary substances to be marketed without pre-market food additive petitions or new drug approvals, provided they bear required disclaimers and avoid explicit disease-treatment claims.

Manufacturers then tried to apply this human framework to companion animals and livestock. On April 22, 1996, FDA issued a Federal Register notice titled Inapplicability of the Dietary Supplement Health and Education Act to Animal Products (61 FR 17706, docket number 95N-0308). After examining statutory language, intent, and legislative history, the agency determined that DSHEA does not apply to animal products.

The 1996 Federal Register notice grounded this determination in four distinct legal and structural realities:

1. Explicit Statutory Text Limiting Use to Man: Under 21 U.S.C. 321(ff)(1)(E), a dietary supplement is defined, in part, as an article that contains "a dietary substance for use by man to supplement the diet by increasing the total dietary intake." The statutory definition itself contains an express human limitation that does not encompass non-human species.

2. Exclusively Human Congressional Findings: Section 2 of DSHEA sets forth the express findings of Congress. Every finding is anchored in human public health: improving human nutritional status, reducing human disease risk, empowering human consumers to manage their health, and mitigating expenditures within the human healthcare system. Nothing in the findings indicates a congressional intent to overhaul animal feed or veterinary medicine.

3. Animal Feed Safety and Human Food-Chain Integrity: Unlike adult humans who make autonomous, varied dietary choices, companion animals and livestock consume diets selected and controlled entirely by humans. Furthermore, animal feed and substances ingested by food-producing animals directly enter the human food supply, creating profound risks regarding tissue residues, environmental contamination, and multi-generational toxicity that the human supplement regime was never designed to manage.

4. Judicial Concurrence in Solid Gold: In 61 FR 17706, FDA cited as Ref. 1 the slip opinion in United States v. Solid Gold Holistic Animal Equine Nutrition Center et al., No. CV 88-0473-GT, slip op. at 7-8 (S.D. Cal. March 2, 1995). That citation is FDA's own 1996 reference that Congress's findings reflect an intent limited to humans; this article does not treat the slip opinion as independently retrieved. FDA's current pet-food literacy page adds that at least one court case has upheld the agency's thinking, without naming a later caption.

FDA's Center for Veterinary Medicine maintains this exact statutory position today. FDA's Animal Foods & Feeds page, content current as of 15 September 2025, and FDA's Regulation of Pet Food literacy page, content current as of 17 February 2022, state that DSHEA does not apply to animal products and that at least one court case has upheld the agency's thinking. Consequently, the dietary-ingredient exclusion from the food-additive definition in 21 U.S.C. 321(s) does not protect animal chews, powders, or toppers. If a substance is added to an animal food or water, it is subject to the food additive or Generally Recognized as Safe (GRAS) requirements of federal food law—unless its intended use pushes it across the statutory threshold into animal drug status.

Many commercial pet supplements feature the familiar human DSHEA box: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." On an animal product, this language is legally meaningless. It cannot shield an unapproved article from being deemed an adulterated animal drug if promotional claims establish a therapeutic intended use, nor does it exempt active botanicals or novel extracts from food-additive regulations if marketed as an animal food.

Read Intended Use from the Label, the Brochure, and the Website

Because there is no third category, determining whether an over-the-counter animal product is a food or a drug hinges entirely upon intended use. Under federal food and drug jurisprudence, intended use is an objective legal conclusion, not a manufacturer's subjective preference or marketing slogan.

The drug-labeling regulation at 21 CFR 201.128 supplies the meaning of intended uses. FDA's Animal Food Labeling and Pet Food Claims page, content current as of 2 March 2026, applies the same objective-intent method when asking whether a marketed food is actually a new animal drug. The regulation, current through 10 September 2026, states: "The words intended uses or words of similar import in §§ 201.5, 201.115, 201.117, 201.119, 201.120, 201.122, and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of an article (or their representatives). The intent may be shown by such persons' expressions, the design or composition of the article, or by the circumstances surrounding the distribution of the article."

The same section adds that objective intent may be shown by labeling claims, advertising, or oral or written statements. It is not confined to the physical container label. A firm is not regarded as intending an unapproved new use for an approved drug based solely on knowledge that health-care providers prescribe or use that drug for such a use. That proviso is about already-approved drugs; it does not convert a chew with disease claims into extra-label use. Channels that can establish intended use include:

• Direct Container Labeling: Product names, front-of-pack claims, ingredient listings, benefit icons, and packaging copy.

• Advertising and Collateral Materials: Point-of-sale brochures, clinic counter displays, catalog copy, print advertisements, and booth materials distributed at veterinary conferences.

• Digital and Online Communications: Manufacturer websites, brand landing pages, web store product descriptions, video demonstrations, blog articles, and official social media posts.

• Oral and Written Statements: Statements made by company representatives, sales agents, detailing teams, sponsored webinars, and consumer service communications.

• Design, Composition, and Distribution Context: The pharmacological activity of ingredients, dosage formats (e.g., concentrated capsules versus bulk food), and whether distribution channels target disease management.

The regulation also states that if a packer, distributor, or seller intends different uses than the person from whom the article was received, that seller must supply adequate labeling for the new intended uses. Promoting a joint chew to manage canine hip dysplasia or osteoarthritis is a different intended use from a nutrition, taste, or aroma claim on the manufacturer's original labeling.

On FDA's page Animal Food Labeling and Pet Food Claims (content current as of March 2026), the agency explains that expressed or implied claims establishing an intent to cure, treat, prevent, or mitigate disease—or to affect the structure or function of the animal's body other than through nutritive value, aroma, or taste—indicate an intent to offer the product as a new animal drug. A manufacturer cannot insulate itself by printing a mild, non-specific phrase on the physical package while publishing explicit clinical claims, scientific disease white papers, or customer testimonials claiming disease relief on its website. Every promotional assertion forms part of the same objective evidentiary worksheet.

Still Food, or Already a New Animal Drug?

Once the complete evidentiary packet of label, brochure, and website claims is assembled, the article must be evaluated against the statutory definitions set forth in 21 U.S.C. 321.

The Statutory Definition of Food

Under 21 U.S.C. 321(f), food is defined as: "(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article." Decades of judicial interpretation have established that an article constitutes animal food when it is ingested primarily for nutrition, taste, or aroma. Any substance intended as an ingredient in an animal feed, treat, topper, or drinking water is legally food. While conventional animal food does not require pre-market FDA approval, it must be composed of safe ingredients (either approved food additives under 21 U.S.C. 348 or substances Generally Recognized as Safe under 21 U.S.C. 321(s)), produced under sanitary conditions, free from harmful contaminants, and truthfully labeled.

The Statutory Definition of Drug and New Animal Drug

Under 21 U.S.C. 321(g)(1), the FD&C Act defines drugs to include: "(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals."

FDA's Regulation of Pet Food literacy page gives concrete examples of how intended use triggers drug classification:

• Urinary Acidification: FDA's example is a product intended to make a cat's urine more acidic to maintain urinary tract health. That intended use is a drug because the structure/function effect is not derived mainly from nutrition, taste, or aroma. A separate food-claim path exists for certain complete adult-maintenance cat foods under GFI #55 and GFI #284; it is not this chew-or-topper identity.

• Arthritic Joint Function: FDA's example is a product intended to improve joint function in an arthritic dog. That intended use is a drug because the claimed effect is not derived mainly from nutrition, taste, or aroma and because it addresses an arthritic animal.

• Incompatibility of GRAS Status with Disease Claims: FDA states that a substance added to food cannot be GRAS if the intended use is to prevent or treat a disease. Its example is chondroitin sulfate, which cannot be GRAS when added to food to prevent or treat arthritis in pets; for that intended use it is an animal drug. FDA's GRAS sentence does not name glucosamine.

Once an article meets the definition of a drug under 21 U.S.C. 321(g), federal law applies a critical presumption: under 21 U.S.C. 321(v), it is evaluated as a new animal drug. A new animal drug is defined as any drug intended for use in animals whose composition is not generally recognized among qualified scientific experts as safe and effective (GRAS/GRAE) for the conditions prescribed, recommended, or suggested in its labeling.

FDA states that, by virtue of Supreme Court interpretations of the necessary basis for general recognition, for all practical purposes there are no animal drugs that are not also new animal drugs. Under 21 U.S.C. 360b(a)(1), a new animal drug is deemed unsafe for purposes of 21 U.S.C. 351(a)(5) unless there is in effect an approval, a conditional approval, an index listing, or another authorization such as emergency use. FDA's current animal-drug pages describe the usual legal-marketing-status pathways as:

1. New Animal Drug Application (NADA): Full pre-market FDA approval demonstrating safety and effectiveness through substantial evidence (see the FDA veterinary drug approval process guide).

2. Abbreviated New Animal Drug Application (ANADA): FDA approval for generic bioequivalent veterinary pharmaceuticals.

3. Conditional Approval (CNADA): FDA conditional approval under 21 U.S.C. 360ccc. FDA's current pages state that conditional approval is only available for some animal drugs for use in a minor species or in a major species under special circumstances, and that the drug is safe with a reasonable expectation of effectiveness when used according to the label.

4. Index Listing: Listing on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species under 21 U.S.C. 360ccc-1.

5. Other authorization, including emergency use: 21 U.S.C. 360b(a)(1)(D) also treats an authorization under 21 U.S.C. 360bbb-3 as a legal-marketing-status pathway. FDA's animal-drug pages describe Emergency Use Authorization as a public-health-emergency pathway, not a chew-label identity.

The following three-lane matrix summarizes how federal regulators evaluate an ingested animal product:

Reviewed Food Claims Under GFI #55 and GFI #284 Are Not This Chew's Escape Hatch

Manufacturers of animal chews and toppers frequently attempt to defend structure/function marketing by pointing to complete cat food bags that bear claims such as "maintains urinary tract health" or "hairball control." They argue that if a commercial kibble can claim to maintain urinary tract health, an over-the-counter cranberry chew or acidifying paste should be allowed to make the same claim without being classified as a drug. This argument misconstrues FDA's pet food claim review architecture.

FDA reviews specific pet-food claims such as maintains urinary tract health, low magnesium, and hairball control. Those reviews are not NADA approval. Data guidance for urinary-tract-health-related cat-food claims is in CVM GFI #55 and GFI #284:

• CVM GFI #55 (June 1994): Supportive Data for Cat Food Labels Bearing Reduces Urinary pH Claims: Protocol Development. GFI #55 is protocol-development guidance for cat-food labels bearing reduces urinary pH claims. It is data guidance for that food-claim path, not NADA approval and not a crystal-treatment protocol.

• CVM GFI #284 (Finalized October 2024): Using Relative Supersaturation to Support Urinary Tract Health Claims for Adult Maintenance Cat Food. GFI #284 recommends how manufacturers of adult-maintenance cat food can use relative supersaturation (RSS) methodology to substantiate labeling that the food supports urinary tract health by promoting a healthy mineral content in the urinary tract. FDA describes RSS as a measurement that estimates the potential for crystal formation and bladder-stone (urolith) growth.

Crucially, GFI #284 and GFI #55 do not provide an escape hatch for standalone chews, toppers, or claimed supplements. Several fundamental boundaries prevent a chew from invoking these pathways:

1. Limited Strictly to Complete Diets: GFI #284 applies to adult-maintenance cat food using RSS methodology. It is not a protocol for chews, toppers, or products marketed as dietary supplements. A standalone chew cannot rely on that food-claim path.

2. Specific Mechanism-of-Action Language: To remain within the food structure/function lane, CVM recommends that foods substantiated under GFI #284 include an explicit mechanism statement: "Promotes a healthy mineral content in the urinary tract." This language ties the claim directly to the nutritional and mineral composition of the diet, rather than an active pharmacological effect.

3. Food Substantiation Is Not NADA Approval: Substantiating a food claim under GFI #284 or GFI #55 does not grant New Animal Drug Application approval, nor does it allow a manufacturer to claim that the food treats, cures, or dissolves urinary stones. A reviewed food claim is not a diagnosis of crystals, stones, or feline idiopathic cystitis (see non-prescription cat food for urinary crystals, bladder stones in cats, and feline idiopathic cystitis).

Therefore, FDA's drug example of a product intended to make a cat's urine more acidic remains the baseline rule for this worksheet: if a chew, powder, or paste is intended to acidify urine to maintain urinary tract health, and it is not an adult-maintenance cat food on the GFI #55 or GFI #284 food-claim path, that intended use makes it a new animal drug. Without approval, conditional approval, indexing, or other authorization, it does not have legal marketing status.

What This Page Does Not Decide: Complete Diets, Recalls, Extra-Label Use, and Withdrawn Staff Matrices

To maintain analytical rigor, this intended-use worksheet excludes several adjacent regulatory frameworks and historical policies that industry discussions often conflate with pet supplement classification.

Complete Therapeutic Diets and CPG Sec. 690.150

Compliance Policy Guide (CPG) Sec. 690.150, issued in April 2016, addresses dog and cat food diets that are labeled or marketed to diagnose, cure, mitigate, treat, or prevent disease and that also provide all or most nutrients as the pet's sole diet. Section IV of CPG 690.150 sets forth specific factors FDA staff consider when deciding whether to exercise enforcement discretion regarding animal-drug approval requirements for these veterinary therapeutic diets (such as kidney support or gastrointestinal diets).

Crucially, CPG 690.150 contains an express, non-negotiable exclusion: "This guidance does not apply to products intended for nutritional supplementation of foods for animals and/or products marketed as dietary supplements for animals." Manufacturers of joint chews or digestive toppers cannot invoke CPG 690.150 enforcement discretion. Furthermore, enforcement discretion is an administrative enforcement priority, not a grant of legal marketing status, and does not create a dietary supplement category.

Withdrawn Staff Guidance Is Not Current Policy

A major source of confusion in online veterinary articles and consultant white papers is the continued citation of obsolete, withdrawn FDA staff documents:

• CPG Sec. 690.100 Withdrawn in 2020: CPG Sec. 690.100, titled Nutritional Supplements for Companion Animals (originally issued in 1980 and revised in 1995), outlined historical enforcement discretion for certain over-the-counter animal nutrient supplements. FDA formally withdrew CPG 690.100 on February 20, 2020, confirming that it was obsolete and no longer reflected agency thinking. Citing CPG 690.100 today as legal justification for marketing animal supplements is invalid.

• CVM PPM 1240.3605 Withdrawn in May 2024: For decades, industry analysts relied on CVM Program Policy and Procedures Manual (PPM) Guide 1240.3605, a 1998 internal staff manual titled Regulating Animal Foods with Drug Claims. That document contained a classification matrix that occasionally permitted structure/function claims on animal foods. On May 20, 2024, FDA published a notice in the Federal Register (89 FR 43852) formally withdrawing PPM 1240.3605, declaring that it no longer reflects current agency policy. In an accompanying May 21, 2024 letter to industry, FDA encouraged firms developing animal food substances with structure/function intended uses to contact CVM early at animalfood-premarket@fda.hhs.gov and stated its intent to issue successor guidance. Until that new guidance is finalized, classification rests strictly on the statutory text of 21 U.S.C. 321.

Food Ingredient Identity vs Claim Conversion

If an article is evaluated as animal food, its ingredients must comply with animal feed laws. Under 21 CFR 501.4(a), ingredients must be listed by their common or usual names in descending order of predominance by weight. FDA states that names defined by the Association of American Feed Control Officials (AAFCO) and listed in its Official Publication may be common usage names. CVM GFI #293, finalized 23 October 2024, describes FDA's policy that it generally does not intend to initiate enforcement action for food-additive approval requirements for ingredients listed in chapter six of the 2024 AAFCO Official Publication. AAFCO definitions are not federal regulations.

An AAFCO-defined ingredient name does not convert a disease or non-food structure/function claim into food. Listing an ingredient by an AAFCO name does not authorize osteoarthritis-treatment or other disease claims. If the label or website promotes those endpoints, the product is an unapproved new animal drug regardless of ingredient nomenclature.

Adjacent Clinical and Manufacturing Hubs

For issues outside the scope of this one-use classification worksheet, readers should consult VetMedGuide's dedicated clinical and regulatory resources:

• Adverse Events and Recalls: For assessing foreign material contamination, nutrient toxicities, or manufacturing defects, see our guide to reading pet food recall notices and the multi-year veterinary recall analysis.

• Veterinary Drug Compounding: For legal custom preparations under CVM GFI #256 when FDA-approved formulations are unavailable, see veterinary compounding pharmacy selection.

• Prescription Drug Classifications: Approved joint drugs such as Adequan or Librela have legal marketing status as animal drugs; a chew sold next to them is classified by its own intended use. See Adequan versus Librela, dog arthritis treatment, and cat arthritis treatment. A recognized nutritional-deficiency feeding question, such as guinea pig vitamin C deficiency, is not this chew identity.

One Labeled Fictional Worksheet

To apply these principles in clinical and operational practice, this section works through a single, labeled fictional product. This case study is explicitly stamped as a fictional regulatory example. It does not depict an actual commercial brand, does not evaluate a commercial product line, and does not provide clinical purchasing or treatment advice.

Case Scenario: Canine Mobility Nibbles

A veterinary clinic is approached by a distributor offering a new over-the-counter dog product labeled "Canine Mobility Nibbles." The product arrives in a plastic jar containing 60 soft chews. The clinic's inventory manager conducts a three-part evidentiary audit across the physical label, the product sales brochure, and the manufacturer's e-commerce website:

• Container Label Expressions: The front label reads: "Canine Mobility Nibbles — Advanced Hip & Joint Support Soft Chews for Dogs." The subhead states: "Delicious natural chicken flavor. Helps ease joint stiffness from daily exercise and supports joint mobility." The back panel lists glucosamine hydrochloride, chondroitin sulfate, and methylsulfonylmethane as "active ingredients," with no milligram amounts, NADA, ANADA, conditional-approval, or index identity, followed by: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

• Sales Brochure Expressions: A promotional glossy brochure distributed with the product states: "Formulated by veterinary experts to halt the progression of degenerative joint disease and protect aging hips."

• Manufacturer Website Expressions: On the manufacturer's retail website, the product description claims: "Clinically shown to rebuild damaged joint cartilage, reduce joint inflammation, and provide natural relief for arthritic dogs without the side effects of NSAIDs." The page includes customer testimonials claiming the chews cured canine limp within two weeks.

The clinic manager systematically audits each dimension against federal statutory criteria:

Final Classification Verdict

Based on this objective audit, the final regulatory determination is clear: Canine Mobility Nibbles is an unapproved new animal drug. Although its front label uses milder "joint support" wording, the brochure and website establish objective intent to treat, mitigate, and prevent canine osteoarthritis. Because the product lacks an approved application, conditional approval, index listing, or other authorization, 21 U.S.C. 360b(a)(1) deems it unsafe for purposes of 21 U.S.C. 351(a)(5), and 21 U.S.C. 331(a) prohibits introducing that adulterated article into interstate commerce. This fictional packet is not a recommendation to buy or avoid a named commercial brand, and it is not a dose or treatment plan.

When conducting this audit in a clinic or practice setting, clinicians and practice managers must always mark unknown promotional statements, distributor claims, or state licensing records as unknown. Under no circumstances should veterinary teams extrapolate human dietary supplement rules, fabricate compliance, or provide treatment dosing based on unapproved animal drug packaging.

Sources

The regulatory conclusions, statutory interpretations, and procedural frameworks detailed in this guide are derived from the following official primary sources and regulatory notices:

• U.S. Food and Drug Administration, Center for Veterinary Medicine: FDA's Regulation of Pet Food. Comprehensive guidance on statutory definitions of animal food versus animal drugs, the inapplicability of DSHEA, and examples of drug claims on pet products.

• U.S. Food and Drug Administration, Center for Veterinary Medicine: Animal Foods & Feeds. Agency hub explaining federal regulation of animal food, feed ingredients, and the absence of a dietary supplement classification for animals.

• U.S. Food and Drug Administration, Center for Veterinary Medicine: Animal Food Labeling and Pet Food Claims. Regulatory framework governing expressed and implied claims, common ingredient nomenclature under 21 CFR 501.4(a), and CVM claim review protocols.

• U.S. Food and Drug Administration, Center for Veterinary Medicine: FDA Regulation of Animal Drugs. Foundational overview of animal drug statutory definitions under 21 U.S.C. 321(g), the new animal drug standard under 21 U.S.C. 321(v), and pre-market approval pathways.

• Federal Register / U.S. Food and Drug Administration: Inapplicability of the Dietary Supplement Health and Education Act to Animal Products, 61 FR 17706 (April 22, 1996). Definitive FDA notice determining that DSHEA does not apply to animal feeds, pet food, or companion animal products (docket number 95N-0308).

• United States Congress: 21 U.S.C. § 321 — Definitions; generally. Federal statutory definitions including food (subsection f), drug (subsection g), food additive (subsection s), new animal drug (subsection v), and human dietary supplement (subsection ff).

• U.S. National Archives (eCFR) / Food and Drug Administration: 21 CFR 201.128 — Meaning of intended uses. Federal regulation defining objective intent through labeling, advertising, oral or written claims, and distribution circumstances.

• U.S. Food and Drug Administration, Center for Veterinary Medicine: Unapproved Animal Drugs. Compliance guidance defining the legal marketing status of animal drugs and the prohibition against marketing unapproved new animal drugs in interstate commerce.

• U.S. Food and Drug Administration, Center for Veterinary Medicine: CVM GFI #55 Supportive Data for Cat Food Labels Bearing Reduces Urinary pH Claims: Protocol Development. June 1994 data guidance for complete cat food labels bearing urinary pH reduction claims.

• U.S. Food and Drug Administration, Center for Veterinary Medicine: CVM GFI #284 Using Relative Supersaturation to Support Urinary Tract Health Claims for Adult Maintenance Cat Food. October 2024 guidance detailing relative supersaturation methodology and recommended mechanism-of-action statements for adult maintenance cat foods.

• U.S. Food and Drug Administration, Center for Veterinary Medicine: CPG Sec. 690.150 Labeling and Marketing of Dog and Cat Food Diets Intended to Diagnose, Cure, Mitigate, Treat, or Prevent Diseases. April 2016 compliance policy guide outlining enforcement discretion criteria for complete therapeutic pet diets, expressly excluding products marketed as dietary supplements.

• U.S. Food and Drug Administration, Center for Veterinary Medicine: CPG Sec. 690.100 Nutritional Supplements for Companion Animals (Withdrawn 2/20/2020). Notice of formal withdrawal of obsolete 1995 staff guidance regarding companion animal nutritional supplements.

• Federal Register / U.S. Food and Drug Administration: Program Policy and Procedures Manual Guide 1240.3605 Regulating Animal Foods With Drug Claims; Withdrawal, 89 FR 43852 (May 20, 2024). Formal withdrawal notice for the 1998 staff guidance matrix on animal foods with drug claims.

• U.S. Food and Drug Administration, Center for Veterinary Medicine: FDA Letter to Industry: Industry Encouraged to Contact FDA Regarding Novel Animal Foods with Drug Claims. May 21, 2024 notice encouraging manufacturers of animal food substances with structure/function intended uses to contact CVM early.

• U.S. Food and Drug Administration, Center for Veterinary Medicine: CVM GFI #293 FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients. October 2024 guidance outlining FDA enforcement discretion for common and usual feed ingredient names listed in the 2024 AAFCO Official Publication.