On this page:
- What’s food and what’s a drug?
- Is it food or a drug?
- Pre-Market Review: Animal Drugs vs. Food for Animals
- FDA Food Safety Modernization Act, Food Facility Registration, and Current Good Manufacturing Practices
- Food Additives
- Generally Recognized As Safe
- The Dietary Supplement Health and Education Act Addresses Dietary Supplements for People
- FDA’s Partnerships with Local and State Agencies and AAFCO
- Complete Pet Food Diets Intended to Treat or Prevent Disease
- Relevant Regulations and Federal Register Notices
- Resources for You
- FDA: Food and Drug Administration
- FD&C Act: Federal Food, Drug, and Cosmetic Act
- FSMA: FDA Food Safety Modernization Act
- GRAS: Generally Recognized As Safe
- DSHEA: Dietary Supplement and Health Education Act
- AAFCO: Association of American Feed Control Officials
To understand how FDA regulates pet food, it’s important to first understand several key concepts and some of the laws and regulations regarding food for animals.
The basic food and drug law in the U.S. is the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under this law, FDA is responsible for making sure food for both people and animals is safe, properly manufactured, and adequately labeled. The agency is also responsible for ensuring that drugs for people and animals are safe, effective, properly manufactured, and adequately labeled and packaged. Knowing if something is a food or drug is a good start to understanding how FDA regulates the product.
What’s food and what’s a drug?
The FD&C Act defines the term “food” as “articles used for food or drink for man or other animals...and articles used for components of any such article." Courts have interpreted this to mean products or components of a product that are used mainly for nutrition, taste, or aroma.
The FD&C Act defines the term “drug” to include, among other things, “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”
Is it food or a drug?
FDA uses the above definitions of “food” and “drug” in the FD&C Act to determine if a product marketed as a food product is indeed food or if it’s a drug instead.
The agency typically considers a product to be food if the product affects the structure or function of the body and this effect is derived mainly from its nutrition, taste, or aroma. Examples include a dog food containing calcium that may affect bone structure in puppies and a cat food containing the amino acid taurine that may help with heart health in cats.
In determining if a product marketed as a food product is actually a drug, the agency considers the product’s intended use. If the intended use is to treat or prevent a disease, then the product is a drug. If the intended use is to affect the structure or function of the body and this structure or function effect isn’t derived mainly from the product’s nutrition, taste, or aroma, then it's a drug. Examples include a product intended to make a cat’s urine more acidic to maintain urinary tract health and a product intended to improve joint function in an arthritic dog.
Pre-Market Review: Animal Drugs vs. Food for Animals
In most cases, the FD&C Act requires that an animal drug be approved by FDA before a company can legally sell the drug. During this pre-market review, the agency evaluates information submitted by the company to make sure the drug is safe and effective for its intended use and that the drug is properly manufactured and adequately labeled and packaged.
As opposed to an animal drug, food for animals doesn’t need FDA’s pre-market review to be legally marketed (unless the substance is a food additive). However, the FD&C Act still requires that food for animals, like food for people, be:
- Safe to eat;
- Produced under sanitary conditions;
- Free of harmful substances; and
- Truthfully labeled.
Canned pet food must also comply with the regulations for low-acid canned food.
FDA Food Safety Modernization Act, Food Facility Registration, and Current Good Manufacturing Practices
To help ensure that the nation’s food supply is safe, Congress amended the FD&C Act by passing the FDA Food Safety Modernization Act (FSMA) in 2011. FSMA allows FDA to better protect public health by strengthening the food safety system and shifting the focus from responding to contamination of the food supply to preventing contamination. The law applies to food for people as well as food for animals, including pet food.
FSMA requires animal food facilities to create and implement a food safety plan. In the first part of the plan, the facilities assess food safety hazards that are potentially associated with the animal food (this is called “hazard analysis”). In the second part, the facilities take steps, when necessary, to reduce or eliminate identified food safety hazards (these steps are called “preventive controls”).
The above FSMA requirements apply to companies that must register as an animal food facility because they manufacture, process, pack, or hold animal food for consumption in the United States.
Besides having to follow the requirements under FSMA, registered animal food facilities must also comply with current good manufacturing practices (unless an exemption applies). These practices provide baseline standards for manufacturing, processing, packing, and holding animal food to ensure it’s safe for animals to eat.
In 1958, in response to public concern about the increased use of chemicals in food and food processing, Congress amended the FD&C Act to require FDA’s review and approval of food additives before they can be marketed. A food additive is any substance that directly or indirectly becomes a component of a food or that affects a food’s characteristics. One exception to this definition is that a substance that’s generally recognized as safe by qualified experts for a specific use in food isn’t considered a food additive (see next section).
To be legally marketed, a food additive must have an approved food additive petition. A company submits a food additive petition to FDA to prove that the additive is safe for its intended use and works as expected. For example, the company must show that a preservative is safe for animals to eat and works to maintain the food’s freshness.
Briefly, the petition describes the chemical identity of the additive and the process for manufacturing it. The petition also includes safety data and the company’s proposed labeling. If FDA agrees with the information in the petition, the agency approves the food additive for its intended use.
It’s illegal to use an unapproved food additive in pet food. Food for either people or animals that contains an unapproved food additive is unsafe and adulterated according to the FD&C Act.
Generally Recognized As Safe
As mentioned in the section above, substances added to food that are generally recognized as safe (GRAS) by qualified experts aren’t food additives and don’t need to be reviewed and approved by FDA before being marketed.
A substance added to food may be GRAS for one use but may not be GRAS for another. For example, sodium aluminosilicate is GRAS when added to food as an anticaking agent. But adding this substance to food to bind fungal toxins and prevent the food from being absorbed by the digestive tract is not GRAS. Also, a substance added to food can’t be GRAS if the intended use is to prevent or treat a disease. So, chondroitin sulfate can’t be GRAS when added to food to prevent or treat arthritis in pets. For this intended use, chondroitin sulfate is an animal drug.
The GRAS standard is actually harder to meet than the standard required for a food additive approval. For a substance to be GRAS, there must be a “general recognition of safety.” This means that qualified experts must agree that the substance is safe when added to food. General recognition of safety must be obtained through either:
- Experience based on common use in food. There must be information to prove that the substance has been commonly used in food for animals since before 1958, with a lengthy and known history of a significant number of animals consuming the food; or
- Scientific procedures. These procedures require the same quality and quantity of scientific data needed for FDA to approve a food additive petition. Also, the data must be published in scientific literature or a similarly trusted source such as a textbook. Data in a company’s annual report do not meet this standard.
Under FDA’s GRAS notification program, companies can make their own GRAS determination, meaning they can determine for themselves if a substance is GRAS for a particular use and then notify the agency of their determination. The notification needs to include:
- A description of the substance;
- A description of how the substance will be used and in what species (the conditions of use); and
- The basis for the company’s determination that the substance is GRAS for the intended use.
FDA evaluates the information included in the notification as well as other available information to make sure the agency has no questions about the company’s determination that the substance is GRAS for the intended use. A list of the current GRAS Notices for animal food provides a summary of each notification as well as the agency’s response.
The Dietary Supplement Health and Education Act Addresses Dietary Supplements for People
In 1994, the Dietary Supplement Health and Education Act (DSHEA) amended the FD&C Act to create a special category for dietary supplements for people as well as a new regulatory framework for these products. This framework places dietary supplements for people under the general umbrella of “foods,” not drugs or food additives. FDA isn’t authorized to review dietary supplement products for people for safety and effectiveness before they are marketed.
In 1996, FDA determined that DSHEA didn't apply to products for use in animals, and at least one court case has upheld the agency’s thinking. Therefore, products marketed as dietary supplements for animals don’t fall under DSHEA and FDA doesn’t recognize them as a special category. Rather, the agency regulates these products as either food for animals or animal drugs, depending on their composition of ingredients and intended use.
FDA’s Partnerships with Local and State Agencies and AAFCO
FDA and local and state agencies all play a role in regulating pet food and participate in the Association of American Feed Control Officials (AAFCO). While AAFCO itself has no regulatory authority, this voluntary association of local, state, and federal feed control officials works to promote a safe feed supply by:
- Developing definitions for ingredients used in animal feed and pet food. Having definitions helps ensure that the ingredients are uniform and safe for the animal that will eat the food; and
- Developing uniform language that states may adopt or reference in their animal feed laws. Having common language in these laws helps with interstate commerce, allowing animal feed and pet food to flow between states without interruption.
FDA staff serve on AAFCO’s Board of Directors, Pet Food Committee, and other committees. FDA staff also act as scientific resources for AAFCO and local and state feed control officials. By helping FDA’s limited resources go farther and be used more efficiently, these partnerships are vital to effectively regulating pet food and ensuring safe food for animals.
Complete Pet Food Diets Intended to Treat or Prevent Disease
Some pet food products are formulated as a complete diet intended to meet an animal’s nutritional needs and to treat or prevent a specific disease, such as kidney disease or diabetes. In April 2016, FDA finalized a Compliance Policy Guide that outlines the agency’s current thinking about such products. Under the FD&C Act, FDA can regulate them as drugs, food, or both.
As stated above, the FD&C Act defines the term “drug” to include “articles intended for use in the…treatment, or prevention of disease in man or other animals.” However, most complete pet food diets intended to treat or prevent a disease aren’t approved animal drugs, and without such approval, FDA considers them to be unapproved animal drugs.
The Compliance Policy Guide explains the factors that FDA will consider when determining whether to take regulatory action against a company that may be illegally selling complete pet food diets intended to treat or prevent a disease. FDA thinks these products should be available to pet owners only through veterinarians or through retail stores or Internet sellers under the direction of a veterinarian. A veterinarian’s involvement is important because these products are formulated for specific health needs and may not be suitable for all pets.
Relevant Regulations and Federal Register Notices
- Section 201 of the FD&C Act defines the terms:
- Food – Section 201(f) and;
- Drug – Section 201(g)(1)(B) & (C).
These definitions are set by law in Title 21 of the United States Code, Chapter 9, Subchapter II, Section 321(f) and 321(g)(1)(B) & (C) .
Section 21 of the Code of Federal Regulations, Part 571, Food Additive Petitions – this part describes the information required in an animal food additive petition.
- Section 21 of the Code of Federal Regulations, Part 573, Food Additives Permitted in the Feed and Drinking Water of Animals – this part lists all the food additives approved for use in food for animals.
- Federal Register, Vol. 61, No. 78, April 22, 1996: Inapplicability of the Dietary Supplement Health and Education Act (DSHEA) to Animal Products – this Federal Register notice outlines the reasons why FDA determined that DSHEA doesn’t apply to products for use in animals.
Resources for You
- “Complete and Balanced” Pet Food
- Safe Feed
- Tips for Safe Handling of Pet Food and Treats
- Get the Facts! Raw Pet Food Diets can be Dangerous to You and Your Pet