The Animal Health Legal Landscape:

The growth in this industry reflects broader structural trends, including rising pet ownership, increased spending on companion animal care, investment by private equity in veterinary practices and pet food companies, and heightened focus on livestock health, agriculture, and food security.

Today, the animal health industry faces an increasingly complex legal and regulatory environment. Companies operating in the sector should expect scrutiny from multiple federal and state regulators, increasing the importance of coordinated compliance across product development, manufacturing, marketing, distribution, and veterinary operations.

This Insight provides an introduction to the animal health legal landscape and the various legal agencies/authorities involved.

IMPORTANT ASPECTS OF THE INDUSTRY

Regulatory Framework

Animal health is regulated through an overlapping federal and state framework. The US Food and Drug Administration, Center for Veterinary Medicine (CMV) is the principal regulator of animal drugs and animal food, while the US Department of Agriculture (USDA), US Drug Enforcement Administration (DEA), US Environmental Protection Agency (EPA), US Centers for Disease Control and Prevention (CDC), Federal Trade Commission (FTC), US Department of Justice (DOJ), and state regulators exercise jurisdiction over specific products, activities, and risks.

Animal Drugs

FDA regulates the approval and use of animal drugs, including drugs incorporated into feed. Regulatory requirements will vary by product, intended use, species, and—in the feed context—the applicable drug and feed classification.

Animal Food & Feed

FDA regulates pet food and animal feed under the Federal Food, Drug, and Cosmetic Act (FFDCA) and Food Safety Modernization Act (FSMA) framework. Manufacturers may face federal facility-registration, food-safety, manufacturing, and preventive-control requirements, in addition to substantial state regulation.

Manufacturing & Food Safety

Animal food manufacturers generally operate under cGMP and FSMA preventive-control requirements, including hazard analysis, written food-safety plans, preventive controls, monitoring, corrective actions, verification, recall planning, and recordkeeping.

Labeling & Advertising

FDA generally has primary responsibility for product labeling, while FTC has primary responsibility for advertising. Animal food labeling is also heavily regulated at the state level, frequently using Association of American Feed Control Officials (AAFCO) models and standards.

Product Claims

Claims can affect a product’s regulatory classification. This is particularly significant for pet foods and animal supplements as animal products intended for ingestion generally do not have a separate federal “dietary supplement” category; disease-related or certain structure/function claims may cause a product to be regulated as a drug.

Controlled Substances

Veterinary controlled substances are subject to the federal Controlled Substances Act and DEA registration, prescribing, dispensing, recordkeeping, suspicious-order, and reporting requirements, supplemented by state controlled-substance laws.

Medicated Feed

Medicated feeds combine animal food with approved animal drugs and are subject to specialized FDA requirements. Depending on the product, veterinary feed directives and medicated-feed mill licensing requirements may apply.

Imports & Distribution

Imported animal foods and veterinary products are subject to FDA import requirements, including prior notice where applicable and FDA admissibility screening. Noncompliant products may be detained, placed on import alert, or refused admission.

Inspections & Enforcement

FDA enforcement ranges from informal regulatory actions and Warning Letters to detention, seizure, injunction, civil penalties, and criminal prosecution. FDA and state authorities also conduct facility inspections to assess compliance.

Recalls

Animal food and other FDA-regulated products may be subject to voluntary or FDA-mandated recalls. Recall obligations and regulatory response depend in part on the nature and severity of the health risk presented by the product.

Competition & Consumer Protection

FTC and DOJ authorities add antitrust and consumer-protection considerations, including merger review, competition enforcement, deceptive advertising, fraud, and other conduct affecting animal-health markets.

Veterinarian Services

Veterinary practice is primarily regulated at the state level through veterinary practice acts, licensing boards, and related regulations.

State requirements generally govern veterinarian and veterinary technician licensure, scope of practice and delegation, establishment of the veterinarian-client-patient relationship (VCPR), prescribing and dispensing, medical records, telemedicine, corporate ownership or operation of veterinary practices, facility standards, professional conduct, and disciplinary matters.

ANIMAL HEALTH REGULATORY AGENCIES

• US Food and Drug Administration, Center for Veterinary Medicine – Covers both animal drug and animal food regulation.
  • Office of New Animal Product Evaluation – Reviews safety and effectiveness for animal drugs, feed additives, and manufacturing methods.
  • Office of Generic Animal Drugs – Reviews bioequivalence of generic new animal drugs in pharmaceutical dosage forms and for use in animal feed.
• US Department of Agriculture
  • USDA, National Veterinary Services Laboratories – Ensures timely and accurate laboratory support for nationwide animal health diagnostic system.
  • USDA, Food Safety and Inspection Service – Public Health Veterinarians are tasked with inspecting meat, poultry, and egg products, surveilling foreign animal disease, and enforcing animal welfare laws.
  • USDA, Animal and Plant Health Inspection Service (APHIS) – Prevents foreign animals from entering the United States and protects the welfare of animals under such laws as the Animal Welfare Act.
    • APHIS, Veterinary Services – Serves as the primary national veterinary authority, conducting disease surveillance, managing health emergencies, and facilitating safe international trade.
    • APHIS, Center for Veterinary Biologics – Implements the Virus-Serum-Toxin Act to ensure that veterinary biologics are pure, safe, potent, and effective.
• US Drug Enforcement Administration – Regulates the manufacture, import, export, distribution, and dispensing of controlled substances, including animal drugs.
• US Environmental Protection Agency, Office of Pesticide Programs – Regulates the manufacture, sale, and use of pesticides to protect public health and the environment.
• US Centers for Disease Control and Prevention, One Health Office – Advances a collaborative, cross-sector approach to preventing and responding to health threats at the intersection of people, animals, plants, and the environment.
• US Department of Justice – Investigates and prosecutes criminal and civil violations involving the meat industry, including antitrust offenses, fraud, and serious violations of federal food safety laws, often in coordination with USDA and other federal agencies.
• Federal Trade Commission – Protects competition and consumers in the animal health products market by enforcing antitrust laws, reviewing mergers and acquisitions, and taking action against unfair or deceptive marketing, advertising, and business practices.
• Better Business Bureau, National Advertising Division – Recommends modifications or discontinuation of unsupported advertising claims for animal health products based on consumer complaints.
• State Boards of Veterinary Medicine – Primary regulators of veterinary professionals and the practice of veterinary medicine, administering state veterinary practice acts and related regulations.
• State Boards of Pharmacy – Regulate the practice of pharmacy and the distribution and dispensing of prescription drugs, including drugs prescribed for animal patients.

ANIMAL HEALTH LAWS

• Federal Food, Drug, and Cosmetic Act, 21 USC §§ 301 et seq. – The principal federal statute governing animal drugs, animal food/feed, and certain veterinary products; provides FDA with authority over product approval, adulteration and misbranding, labeling, manufacturing, inspections, imports, and enforcement.
• Food Safety Modernization Act, Pub. L. No. 111-353 – Establishes preventive-control requirements for most animal food manufacturers, including hazard analysis, written food safety plans, preventive controls, monitoring, corrective actions, verification, recall planning, and recordkeeping.
• Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Pub. L. No. 107-188 – Requires registration of most animal-food manufacturing facilities and prior notice to FDA for animal food imported or offered for import into the United States.
• Virus-Serum-Toxin Act, 21 USC §§ 151–159 – Governs veterinary biologics; administered by USDA APHIS’s Center for Veterinary Biologics to ensure covered products are pure, safe, potent, and effective.
• Animal Welfare Act, 7 USC §§ 2131 et seq. – Federal animal-welfare law administered by USDA APHIS for animals and activities within its statutory jurisdiction.
• Controlled Substances Act, 21 USC §§ 801 et seq. – Establishes the federal closed distribution system for controlled substances, including controlled drugs used in veterinary medicine. DEA requirements address registration, prescribing and dispensing, recordkeeping, suspicious orders, theft/loss reporting, and certain distribution reporting.
• Federal Trade Commission Act/Federal Antitrust Laws, 15 USC §§ 41 et seq. – FTC regulates unfair or deceptive advertising and business practices affecting animal-health products and, together with DOJ, enforces federal competition laws, including review of mergers and acquisitions.
• Federal Insecticide, Fungicide, and Rodenticide Act, 7 USC §§ 136 et seq. – Authorizes EPA to regulate the registration, labeling, distribution, sale, and use of pesticides, including certain flea, tick, and other pest-control products used on or around animals. Covered products generally must be EPA-registered before distribution or sale and must be marketed and used consistently with their approved labeling, subject to additional state pesticide requirements.
• Animal Health Protection Act, 7 USC §§ 8301–8322 – Provides USDA with broad authority to prevent, detect, control, and eradicate animal diseases and pests, including authority concerning imports, exports, interstate movement, quarantine, inspections, disease surveillance, and emergency response. It also provides for veterinary accreditation and zoonotic-disease surveillance.
• Federal Meat Inspection Act, 21 USC §§ 601 et seq. – Establishes USDA inspection and food-safety requirements for meat and meat products, including ante-mortem and post-mortem inspection for disease and requirements concerning humane slaughter.
• Humane Methods of Slaughter Act, 7 USC §§ 1901–1907 – Requires covered livestock to be handled and slaughtered using humane methods and is administered in conjunction with USDA’s federal meat-inspection responsibilities.
• Horseracing Integrity and Safety Act, 15 USC §§ 3051 et seq. – Establishes a national regulatory framework for Thoroughbred horseracing, overseen by the FTC and administered by the Horseracing Integrity and Safety Authority. The framework establishes uniform rules addressing racetrack safety and anti-doping and medication control, including requirements affecting veterinarians, medications, testing, and enforcement.
• State Feed and Pet Food Laws/AAFCO-Based Requirements – States extensively regulate animal food, including facility registration or licensing and product labeling. Many states incorporate all or portions of AAFCO model regulations, definitions, labeling standards, and related requirements, however, AAFCO materials themselves are not law.
• State Controlled-Substance Laws – State controlled-substance statutes and regulations generally operate alongside the federal CSA and may impose additional or differing requirements, including prescription drug monitoring program obligations.
• State Veterinary Practice Acts – State veterinary practice acts and implementing board regulations generally govern the practice of veterinary medicine, including veterinarian and veterinary technician licensure, scope of practice, delegation and supervision, VCPR requirements, prescribing and dispensing, medical records, telemedicine, professional conduct, facility requirements, and disciplinary proceedings. Corporate-practice/ownership restrictions and permitted business structures can also vary significantly by state.

HOW WE CAN HELP

Our team draws on a deep background of advising clients on the intricate landscape of animal health. We work with all levels of the drug, vaccine, and food/feed supply chains for livestock and companion animals, including ecommerce and retail sales of pet products, advising on the patchwork of federal and state laws affecting manufacturing, labeling, licensing, and distribution requirements.

We advise veterinary product companies on animal food and feed manufacturing issues, including during FDA inspections, and responding to FDA 483s. We assist in recall notification to FDA and implementation. We also have experience assisting with corporate transactions involving pet and veterinary products and pet insurance.