On this page:
- What’s a food and what’s a drug?
- When is a food a drug?
- Pre-Market Review: Animal Drugs vs. Food for Animals
- Food Additives
- Generally Recognized As Safe
- The Dietary Supplement Health and Education Act
- FDA’s Partnerships with Local and State Agencies and AAFCO
- Health Claims
- Pet Food Intended to Treat, Control, or Prevent Disease
- Relevant Regulations
- Resources for You
- FDA: Food and Drug Administration
- FD&C Act: Federal Food, Drug, and Cosmetic Act
- GRAS: Generally Recognized As Safe
- DSHEA: Dietary Supplement and Health Education Act
- AAFCO: Association of American Feed Control Officials
- NLEA: Nutrition Labeling and Education Act
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 properly labeled. The agency is also responsible for ensuring that drugs for people and animals are safe, effective, properly manufactured, and properly labeled. Knowing if something is a food or drug is a good start to understanding how FDA regulates the product.
What’s a 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 something used primarily 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 function of the body of man or other animals.”
When is a food a drug?
Some food products may affect the structure or function of the body. For example, a food containing calcium may affect bone structure in puppies, or a food containing the amino acid taurine may help with heart health in cats. FDA considers these products to be food, not drugs, because they exert their effect by providing nutrition, taste, or aroma.
If a food affects the structure or function of the body apart from its nutritive value, such as by making a cat’s urine more acidic or improving joint function in an arthritic dog, FDA may consider it a drug. Similarly, a food marketed with a claim that it improves or increases production and performance may be a drug. Another example of when a food may be a drug is if it’s intended to treat or prevent a disease.
Pre-Market Review: Animal Drugs vs. Food for Animals
As required by the FD&C Act, an animal drug must be reviewed by FDA for safety and effectiveness before a drug 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 properly labeled.
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—see next section). 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.
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
In 1994, the Dietary Supplement Health and Education Act (DSHEA) amended the FD&C Act to create a new category of substances as well as a new regulatory scheme. The new category was dietary supplements, and the new regulatory scheme placed these products in a special category under the general umbrella of “foods” instead of under food additives or drugs—both of which require FDA’s pre-market review. DSHEA allows companies to market dietary supplements without a pre-market review.
In 1996, FDA determined that DSHEA wasn’t meant to 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 classifies these products as either food for animals or animal drugs, depending on their 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 association of local, state, and federal feed control officials works to:
- Safeguard the health of animals and people;
- Ensure consumers protection; and
- Provide a level playing field of orderly commerce for the animal feed industry.
FDA representatives 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.
One of the ways the Nutrition Labeling and Education Act (NLEA) of 1990 amended the FD&C Act was to allow health claims on the labels of food products for people, provided specific requirements are met. Since 1990, FDA has approved a number of these health claims for various food products. For example, a company may be allowed to include this health claim on the label of a low-sodium food for people: “Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors.”
Although NLEA covers only food for people, FDA has incorporated the law’s philosophy into the agency’s policies regarding pet food. For example, on the label of certain cat food products, FDA may allow companies to state that the food “helps maintain urinary tract health by reducing urinary pH,” as long as the product is safe and achieves the stated effect.
Also, AAFCO developed model regulations—which many states have adopted—for pet food products that include a health claim of:
- Less or reduced calories;
- Lean; or
- Less or reduced fat.
Pet Food Intended to Treat, Control, or Prevent Disease
Some pet food products have therapeutic claims on their labels, indicating that they are specially formulated to address a specific disease (such as urinary tract disease in cats, kidney failure, or diabetes). In the past, pet owners could buy these products only through a licensed veterinarian and feed them only under a veterinarian’s supervision.
FDA has observed that pet food products with therapeutic claims on their labels are increasingly being marketed directly to pet owners over the Internet and in retail stores. This shift toward direct marketing, without veterinary direction or involvement, concerns FDA because these products are formulated for specific health needs and may not be suitable for all pets.
To protect animal health and safety, FDA thinks that dog and cat food products labeled with a therapeutic claim should be available only through licensed veterinarians or through retailers and Internet sellers under the direction of a veterinarian. Also, FDA thinks that comprehensive labeling information and other manufacturer communications for these products should be made available only through licensed veterinarians.
In April 2016, FDA issued a Compliance Policy Guide that outlines the agency’s current thinking regarding dog and cat food products that are intended to treat, control, or prevent disease. The guide explains the criteria FDA will consider when determining whether the agency should take regulatory action against a company that may be inappropriately selling or marketing these types of pet food products.
Relevant Regulations and Federal Register Notices
- Section 201(f), 201(g)(1)(B) & (C), and 201(ff) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321(f) and (g)(1)(B) &(C)] – this section defines the terms “food,” “drug,” and “dietary supplement,” respectively.
- 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.