FDA’s Role in Protecting Animal Health
Animal Food, Drugs, and Devices…and More
FDA cannot give veterinary medical advice. If your animal is sick or has a veterinary emergency, call your veterinarian. If your veterinarian is unavailable, call your local emergency animal hospital or an animal poison control center. For more information, see Who Do You Call if You Have a Pet Emergency?
Each week, FDA receives a variety of phone calls and e-mails from consumers asking questions like, “Who makes sure my dog’s food is safe?” and “My horse had a side effect to a drug. How do I report that?” FDA protects animal health by regulating the food, drugs, and devices given to or used on the millions of companion and food-producing animals in the U.S.
FDA also receives questions like, “How do I treat my cat’s urinary tract infection?” and “How do I report my ferret’s reaction to a rabies vaccine?” While FDA is happy to direct consumers to the appropriate resources, it’s helpful to know that several other federal, state, and non-government agencies also play important roles in protecting animal health.
Under the federal Food, Drug, and Cosmetic Act , FDA is responsible for regulating food, drugs, and devices for animals. FDA also evaluates problems with FDA-regulated animal products that are reported to the agency.
Under the federal Public Health Service Act, FDA is responsible for enforcing the ban on the sale of pet turtles with a shell less than 4 inches long.
Other federal, state, and non-government agencies, or a combination of agencies, including FDA in some cases, are responsible for regulating other areas of animal health.
- Flea and Tick Products
- Animal Vaccines
- Animal Transport and Travel
- Pharmacies and Animal Drug Compounding
- Practice of Veterinary Medicine
- Miscellaneous Animal Products (for example, cat litter, pet accessories, grooming aids, and bedding)
Animal Food
FDA is the federal agency responsible for regulating animal food. Animal food is also regulated at the state level under the animal food laws of each state.
Food is any product or component of a product that is used mainly for nutrition, taste, or aroma. Animal food includes food for all species of animals and covers pet food, pet treats, food for horses, and food for food-producing animals. Animal food also includes the vitamins, minerals, and raw ingredients used to make the food.
FDA does not review and approve the final packaged formulation of animal food, such as a bag of dry dog food, a can of wet cat food, or a bag of cattle feed pellets, before a company can legally market the product. However, the agency makes sure that the ingredients used to make the food are safe and have an appropriate function, and many ingredients must be reviewed and approved by FDA before they can used in animal food. If the food is for food-producing animals, FDA evaluates the “human food safety” of ingredients used to make the animal food. This evaluation ensures that it’s safe for people to eat food (like meat, milk, and eggs) from animals that ate the food.
FDA is also responsible for regulating medicated feed for animals. A medicated feed is animal feed that contains an approved animal drug.
More Information about Animal Food
FDA Regulation of Medicated Feed
Please talk to your veterinarian if you have questions about your animal’s diet or if you think your animal is having a problem related to pet food or other animal food.
Animal Drugs
FDA is the federal agency responsible for regulating animal drugs. An animal drug is intended to diagnose, treat, or prevent disease in animals or to affect the structure or any function of the animal’s body. Under the Food, Drug, and Cosmetic Act, FDA must review an animal drug for safety and effectiveness before a company can legally market it. There are three pathways to legal marketing status for animal drugs.
Approval
An approved brand name animal drug has gone through the New Animal Drug Application (NADA) process, and an approved generic animal drug has gone through the Abbreviated New Animal Drug Application (ANADA) process. FDA approves the animal drug only if the information in the application meets all the requirements for approval.
FDA’s approval means the drug is safe and effective when it’s used according to the label. FDA’s approval also ensures that the drug is properly manufactured and adequately labeled. If the drug is for use in food-producing animals, FDA evaluates the “human food safety” of the animal drug. This evaluation ensures that it’s safe for people to eat food (such as meat, milk and eggs) from animals treated with the drug. For more information about the approval process for animal drugs, see From an Idea to the Marketplace: The Journey of an Animal Drug through the Approval Process.
Conditional Approval
Conditional approval is only available for some animal drugs for use in a minor species or in a major species under special circumstances (see call-out box). A conditionally approved animal drug has gone through FDA's approval process except the drug has not yet met the effectiveness standard for full approval. FDA’s conditional approval means that when the drug is used according to the label, it’s safe and has a “reasonable expectation of effectiveness.” FDA's conditional approval also means that the drug is properly manufactured and adequately labeled. For more information about the conditional approval process for animal drugs, see Conditional Approval Explained: A Resource for Veterinarians.
What are major and minor species?
There are seven major species: cattle, horses, pigs, chickens, turkeys, dogs, and cats. Minor species are all other animals. Ferrets, fish, and sheep are examples of minor species. For more information about minor species, see Lions and Tigers and Bears! OMUMS!
Indexing
An indexed animal drug is a drug on FDA’s Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, referred to simply as “the Index.” As the name says, a drug listed on the Index is unapproved but has legal marketing status, and a company can legally sell the drug for a specific use in certain minor species (see call-out box). The safety and effectiveness of indexed animal drugs are affirmed through an alternative FDA review process. For more information about the indexing of animal drugs, see Drug Indexing.
More Information about Animal Drugs
Animal Drugs @ FDA is a searchable online database that includes most FDA-approved and conditionally approved animal drugs.
FDA’s Regulation of Animal Drugs
How can I tell if a drug is legally marketed for animals?
Please talk to your veterinarian if you have questions about a specific drug for your animal or if you think your animal is having a side effect to a drug.
It’s also important to know that FDA does not have authority over the price of animal drugs.
Animal Devices
FDA is the federal agency responsible for regulating animal devices. The key difference between an animal device and an animal drug is how the product works. If it relies on a chemical action occurring in or on the animal’s body to work, the product is a drug, not a device. If it needs to be metabolized by the animal’s body to work, the product is a drug, not a device.
Antibiotics, anesthetics, and insulin are examples of drugs. Needles, syringes, bandages, thermometers, glucose meters, and X-ray equipment are examples of devices.
Unlike for animal drugs, FDA does not review and approve animal devices before a company can legally market them. Manufacturers and distributers of animal devices are responsible for making sure they are safe, effective, and properly labeled. FDA has the authority to take action against a company marketing an animal device that is unsafe, ineffective, or improperly labeled. For more information about the regulation of animal devices, see How FDA Regulates Veterinary Devices.
Reporting Problems with Animal Food, Drugs, or Devices
To report problems with animal food (including pet food), animal drugs (approved by FDA or unapproved), or animal devices, see Report a Problem.
Pet Turtles
In 1975, the Public Health Service Act banned the sale of turtles with shells less than 4 inches long because of concerns that the turtles may spread the dangerous bacteria Salmonella to people. FDA is the federal agency responsible for enforcing this ban to protect public health.
More Information about Pet Turtles and Salmonella
Pet Turtles: A Source of Germs
Flea and Tick Products
FDA regulates some flea and tick products for animals as drugs while the Environmental Protection Agency (EPA) regulates others as pesticides. If a flea or tick product is regulated by EPA, its label will have an EPA Registration Number (sometimes written as “EPA Reg. No.”). If a flea or tick product is regulated by FDA, its label will have the statement “Approved by FDA under NADA # XXX-XXX” if the product is an approved brand name animal drug, or the statement “Approved by FDA under ANADA # XXX-XXX” if the drug is an approved generic animal drug (see “Approval” section).
Reporting Problems with Flea and Tick Products
To report problems with a flea or tick product regulated by FDA, see Report a Problem.
To report problems with a flea or tick product regulated by EPA, see Report Pesticide Exposure Incidents Affecting Pets or Domestic Animals.
More Information about Flea and Tick Products
Protecting Pets from Fleas and Ticks (EPA)
Safe Use of Flea and Tick Products in Pets
Please talk to your veterinarian if you have questions about a specific flea or tick product for your animal or if you think your animal is having a side effect to a flea or tick product.
Animal Vaccines
Although FDA regulates vaccines that prevent diseases in people, the agency does not regulate vaccines that prevent diseases in animals. The U.S. Department of Agriculture (USDA) is the federal agency responsible for regulating vaccines for preventing animal diseases, such as rabies, canine and feline distemper, and bovine rhinotracheitis.
More Information about Animal Vaccines and Reporting Problems (Adverse Events) with Animal Vaccines
Veterinary Biologics (USDA)
Adverse Event Reporting (USDA)
Please talk to your veterinarian if you have questions about which vaccines your animal needs or if you think your animal is having a vaccine reaction.
Animal Transport and Travel
FDA does not regulate animal transport and travel. Importing an animal into the U.S. from a foreign country or exporting an animal from the U.S. to a foreign country may involve multiple federal and state agencies, depending on the type of animal. You should plan well in advance if you want to import or export an animal and you must meet all the requirements of each responsible agency.
When traveling with your pet either internationally or within the U.S., there may be animal health requirements specific to your destination. As soon as you know your travel plans, contact your veterinarian to help you with the pet travel process. Your pet may need a certificate of veterinary inspection, also known as a health certificate, to travel.
Plane Travel
The federal Animal Welfare Act, which is enforced by the U.S. Department of Agriculture (USDA), established certain requirements for transporting animals by plane. All airlines must follow USDA’s requirements and can also impose their own separate and additional requirements. Check with the specific airline you intend to use about its policies.
Car Travel
Some states have dog restraint laws that require dogs to wear a seat belt or otherwise be restrained when traveling inside a vehicle. Several states also have laws that require dogs to be properly restrained when riding in the bed of a truck. And be aware that driving with a dog or other pet in your lap may violate some state laws.
Transporting Horses, Livestock, and Poultry
You need to prepare well in advance if you plan to transport horses, livestock (such as cattle, pigs, goats, and sheep), and poultry. The National Veterinary Accreditation Program has detailed information about the regulations for intrastate (within the same state), interstate (state-to-state), and international shipment of these species. This program is managed by the USDA Animal and Plant Health Inspection Service (USDA/APHIS).
More Information about Animal Transport and Travel
Travel With a Pet (USDA/APHIS)
Bringing Live Animals and Germplasm into the United States From Another Country (Import) (USDA/APHIS)
Live Animal Exports (Moving Animals to Another Country) (USDA/APHIS)
U.S. State and Territory Animal Entry Regulations (USDA/APHIS)
Animal Transportation (USDA National Agriculture Library)
Importation (Centers for Disease Control and Prevention)
Animal travel and transport (American Veterinary Medical Association)
Plane Talk: Traveling with Animals (U.S. Department of Transportation)
Travel Training for Your and Your Pets
Pharmacies and Animal Drug Compounding
Although FDA does not regulate pharmacies, the agency does regulate drugs for people and animals and certain drug-related activities that occur in pharmacies, such as when pharmacies make (or “compound”) drugs. Animal drug compounding is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of one animal or a small group of animals. Pharmacies that compound drugs for animals must follow the federal law and may be inspected by FDA. For more information about the compounding of animal drugs, see Animal Drug Compounding.
State boards of pharmacy regulate the pharmacies in each state and license pharmacists to ensure they meet the requirements to practice in that state. FDA generally relies on these state boards of pharmacy to provide day-to-day oversight of routine pharmacy practices related to animal drugs, including compounding. For more information about boards of pharmacy, including contact information, see National Association of Boards of Pharmacy.
Please talk to your veterinarian or pharmacist if you have questions about a specific drug for your animal or about drug pricing. FDA does not have authority over the price of animal drugs.
Practice of Veterinary Medicine
FDA does not regulate veterinary clinics or how veterinarians practice medicine. Veterinary state boards regulate the practice of veterinary medicine in each state and license veterinarians to ensure they meet the requirements to practice in that state. However, veterinarians who prescribe drugs for animals in an extra-label manner (see call-out box) must follow FDA’s requirements for extra-label drug use in animals. FDA generally relies on veterinary state boards to provide day-to-day oversight of the practice of veterinary medicine. For more information about veterinary state boards, including contact information, see American Association of Veterinary State Boards.
What “extra-label” mean?
When a drug that is approved for people or animals is used in a manner other than what is stated on the drug’s label, it is an extra-label use. This is commonly called an “off-label” use because the drug is used in a way that is “off the label.”
More Information about Extra-Label Drug Use in Animals
Animal Medicinal Drug Use Clarification Act of 1994
The Ins and Outs of Extra-Label Drug Use in Animals: A Resource for Veterinarians
Miscellaneous Animal Products
Although not typically regulated by FDA, these animal products may fall under the jurisdiction of the U.S. Consumer Product Safety Commission or another agency depending on how the products are made, marketed, and distributed:
- Cat litter;
- Pet accessories (for example, toys, beds, and crates);
- Grooming aids (these are animal products, such as unmedicated dog shampoo, that are like cosmetics for people); and
- Bedding for pet birds and small animals, such as rabbits, guinea pigs, and hamsters.
For More Information
For more information about FDA’s role in protecting animal health, contact FDA’s Center for Veterinary Medicine by phone at 240-402-7002 or by email at AskCVM@fda.hhs.gov.