The use of food products is governed by the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and the regulations issued under its authority. These regulations are published in the Code of Federal Regulations (CFR). The FD&C Act defines food as "articles used for food or drink for man or other animals...." Therefore, any article that is intended to be used as an animal food ingredient, to become part of an ingredient or food, or added to an animal's drinking water is considered a "food" and subject to regulation. FDA's Center for Food Safety and Applied Nutrition is responsible for the regulation of human food products. FDA's Center for Veterinary Medicine (CVM) is responsible for the regulation of animal food (feed) products.
The FD&C Act sets forth requirements for "foods" in sections 402 and 403. Failure to meet these requirements can result in a product being deemed adulterated or misbranded. Adulteration means food packaged or held under unsanitary conditions, food or ingredients that are filthy or decomposed, and food that contains any poisonous or deleterious substance, or other contaminant. A food may be considered misbranded if its labeling is false or misleading in any way or fails to include required information.
For "food for humans," the Dietary Supplement and Health Education Act (DSHEA) of 1994, exempts, for instance, substances from regulation as food additives or drugs if the product meets the definition of a dietary supplement. For food for animals, the agency's assessment of the law is that it does not apply to animal food, including pet food. This assessment was published in the Federal Register on April 22, 1996 (61 FR 17706). Thus, there is no "dietary supplement" regulatory classification for animal food substances and products. They are considered either "foods" or "new animal drugs" depending on the intended use (see below). The regulatory status of a product is determined by CVM on a case-by-case basis, using criteria provided in Guide 1240.3605.
FDA carries out its responsibility for the regulation of animal food in cooperation with State and local partners through a variety of mechanisms such as cooperative agreements, contracts, grants, memoranda of understanding, and partnerships. For instance, FDA cooperates with the Association of American Feed Control Officials (AAFCO) and the States for the implementation of uniform policies for regulating the use of animal food products, including the establishment of uniform feed ingredient definitions and proper labeling to ensure safe use of animal foods. The ingredient definitions are important because animal foods and ingredients must be correctly and truthfully labeled when they enter commerce. Although FDA has the responsibility for regulating the use of animal food products, the ultimate responsibility for producing safe and effective animal food products lies with the manufacturers and distributors of the products.
The FD&C Act requires that any substance added to or is expected to become a component of animal food, either directly or indirectly, must be used in accordance with a food additive regulation unless it is generally recognized as safe (GRAS) for that intended use. Typical animal food ingredients such as forages, grains, and most minerals and vitamins are GRAS as sources of nutrients. The legal definition for a food additive is found in section 201(s) of the FD&C Act. In section 409 of the FD&C Act, a food additive is unsafe unless its use conforms to an existing food additive regulation or is considered GRAS. Further, a substance that does not become a component of final animal food product but that is used, for example, in preparing an ingredient of the animal food to give it a different flavor, texture, or other characteristic may also be a food additive.
The basis for a food additive regulation is an approved animal food additive petition. Use of a food ingredient that is neither GRAS nor an approved animal food additive can cause a "food" to be adulterated and the food cannot be legally marketed in the United States. Section 409 of the FD&C Act sets forth the statutory requirements for approval of a food additive.
Under section 409(c)(3) of the FD&C Act, FDA is not to approve a food additive petition if a fair evaluation of the data fails to establish that the proposed use of the food additive, under the conditions of use to be specified in the regulation, will be safe. Only if the petitioner meets this burden can the food additive be approved. Food Additive Petitions for Animal Food, which apply specifically to food additives in animal foods, are published in Title 21 CFR 570. Part 571 describes the kinds of data that the petitioner should submit and the required format for the petition itself. While the actual content may vary from petition to petition, depending primarily on the composition of the animal food additive and its intended use, each of the following subject areas should be addressed:
a) human food safety;
b) target animal safety;
c) environmental impact;
d) utility (intended physical, nutritional or other technical effect);
e) manufacturing chemistry;
f) labeling (in addition to information required under 21 CFR 501, labeling may include cautions, warnings, shelf life, and directions for use); and
g) proposed regulation.
A list of approved food additives for use in animal food is found in 21 CFR 573, and a partial list of GRAS substances for use in animal food is found in parts 582 and 584. Irradiation is considered a food additive and approvals for the use of irradiation for animal foods are found in part 579. The Code of Federal Regulations is available online at https://www.govinfo.gov/app/collection/cfr/ or https://www.ecfr.gov/cgi-bin/ECFR?page=browse.
Labeling and Claims
An animal food label should contain information describing the product and any details necessary for the safe and effective use of the food. The federal regulations concerning the labeling of animal foods are published in 21 CFR 501. The FD&C Act defines "labeling" as all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such articles. The courts have interpreted labeling to include promotional brochures, promotional pamphlets, testimonials, product information sheets, books, etc. Also, promotion of an animal drug on the Internet for unapproved drug claims can cause the product to be misbranded under the FD&C Act.
In addition to meeting the federal labeling requirements, animal food products are also subject to individual state laws. Under many State regulations, an animal food label must include the following information:
- Brand Name, if any,
- Product Name;
- Purpose Statement;
- Guaranteed Analysis;
- List of Ingredients;
- Directions for Use;
- Warning or Caution Statements;
- Name and Address of Manufacturer; and
- Quantity Statement.
Additional information concerning State registration and labeling requirements may be obtained from the individual States where the products will be distributed or from the Official Publication of AAFCO. Copies of this publication, which is updated yearly, can be obtained from AAFCO Publications.
For more information about AAFCO, please visit https://www.aafco.org/.
Under the FD&C Act, expressed or implied claims that establish the intended use of the product to cure, treat, prevent, or mitigate disease, or affect the structure or function of the body in a manner other than food (nutrition, aroma, or taste) can identify an intent to offer the product as a "new animal drug." Unless the “new animal drug” product has been shown to be safe and effective for its intended use via approval of a New Animal Drug Application, it could be subject to regulatory action as an adulterated drug. Further, CVM has incorporated the philosophy of the Nutrition Labeling Education Act in its policies to permit meaningful "health" information on the label of some animal food products. For example, the use of "urinary tract health," "hairball control," and "dental health" claims on cat food diets fall under this policy. Animal food manufacturers provide substantiation that the desired statement(s) is (are) truthful and not misleading. CVM's review and acceptance of the claim is needed before the claim is used on product labeling.