9.4: Regulation of Veterinary Products

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Jack O'Grady
Austin Community College

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The FDA has regulatory oversight over Animal & Veterinary Products.

Veterinary products are a diverse area of regulation by the FDA and include:

Animal Drugs
Animal Food & Feeds (which includes pet food)
Animal Medical Devices

Because of this, the regulations and marketing approval that apply depending on the product itself. In this chapter, we briefly touch on some of the more prominent areas of veterinary products. For more information, see the Center for Veterinary Medicine (CVM) as well as the USDA and EPA, all of which oversee the regulations of veterinary products.

Center for Veterinary Medicine, and (CVM)

The CVM oversees the regulation of food, food additives, drugs, and biologics used on animals. They also conduct research that helps the FDA ensure the safety of animal drugs, food for animals, and food products made from animals.

Test Your Knowledge!

Explore the CVM FAQ website: www.fda.gov/animal-veterinary/safety-health/frequentlyasked-questions-about-animal-drugs

Does the FDA oversee vaccination regulations for animals? Why or why not?

Drugs for Animal Use

The CVM regulates veterinary drugs under the authority of the Animal Drug Amendments to the FD&C Act (in 1968) in which provisions were added to ensure animal drugs, as well as human drugs, were safe and effective. Animal drugs must be produced under CGMP conditions outlined in 21 CFR 211. There are several central regulatory pathways for animal drugs; Investigational New Animal Drug (INAD), New Animal Drug Application (NADA), and Abbreviated New Animal Drug Application (ANADA).

New animal drugs are reviewed and approved through a pathway like human drugs. They first must get approval for clinical studies in animals through the INAD. To manufacture and sell a drug for use in animals, the company must seek approval through a NADA. This application shows the drug has been tested in animal clinical studies and provides data demonstrating its safety and effectiveness. For generic animal drugs, again, the process is like in humans, and the company must apply for an abbreviated application – ANADA – before marketing.

Regulation of Pet Food

There is no requirement that pet food products have pre-market approval by the FDA. However, the FDA ensures that the ingredients used in pet food are safe and have an appropriate function (nutrition) in the pet food. Many ingredients, such as meat, poultry, and grains, are considered safe and do not require pre-market approval. https://www.fda.gov/animal-veterinary/animal-food-feeds/pet-food

Other substances such as sources of minerals, vitamins, or other nutrients, flavorings, preservatives, or processing aids may be generally recognized as safe (GRAS) for intended use or must have approval as food additives. For more information about pet foods and marketing pet food, see FDA’s Regulation of Pet Food. https://www.fda.gov/animal-veterinary/animal-health-literacy/fdas-regulation-pet-food

Medicated pet foods, however, do require a regulatory pathway depending on the class of medicated feed. Class A requires NADA (or ANADA), and Class B/C follows a unique route – Veterinary Feed Directive (VFD). VFD foods are available only under veterinarian supervision.

How to report complaints: www.fda.gov/animal-veterinary/report-problem/how-reportpet-food-complaint
Pet Food Recalls: https://www.fda.gov/animal-veterinary/safety-health/recalls-withdrawals

Other Categories

Grooming devices are not regulated unless they show claims of therapeutic treatment. Medical devices for an animal are subject to regulation.
Veterinary biologics are licensed through the USDA and Center for Veterinary Biologics (CVB) and are defined in the Virus-Serum-Toxin-Act (VSTA). These biologics follow the same regulatory and approval pathway as other animal drugs and must be safe and effective for the diagnosis, prevention, and treatment of animal diseases.
Pesticides for pets are regulated by EPA under FIRFA and includes topical flea treatments and insecticide dips – which intend to prevent, destroy, or repel pets externally. It is important to note that products for internal pests are treated as drugs. Pesticide regulation mainly focuses on safety to humans that handle the pets through or after treatment with pesticides, including disposal.