Product Regulation

The use of food products is governed by the provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA), and the regulations issued under its authority. These regulations are published in the Code of Federal Regulations (CFR). The FFDCA 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 feed ingredient, to become part of an ingredient or feed, or added to an animal's drinking water is considered a "food" and thus, is subject to regulation. FDA's Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the regulation of human food products. CVM is responsible for the regulation of animal food (feed) products.

The FFDCA sets forth requirements for "foods" in the Sections 402 and 403. Failure to meet these requirements can result in a product being deemed adulterated or misbranded. Adulteration includes, among other things, food packaged or held under unsanitary conditions, food or ingredients that are filthy or decomposed, and food that contains any poisonous or deleterious substance. A food may be considered misbranded if its labeling is false or misleading in any way or fails to include required information.

The Dietary Supplement and Health Education Act (DSHEA) of 1994, has affected the way FDA regulates "food for humans," i.e., among other things, it restricts substances from being food additives or drugs if the product meets the definition of a dietary supplement. However, the agency's assessment of the law is that it was not intended and does not apply to animal feed, including pet food. This assessment was published in the Federal Register on April 22, 1996 (61 FR 17706). Thus, products marketed as dietary supplements or "feed supplements" for animals still fall under the FFDCA prior to DSHEA, i.e., they are considered "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 in Program Policy and Procedures Manual.

FDA carries out its responsibility for the regulation of animal feed in cooperation with state and local partners through a variety of mechanisms: 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 feed products. This includes the establishment of uniform feed ingredient definitions and proper labeling to assure the safe use of feeds. The ingredient definitions are important because animal feeds and feed ingredients must be correctly and truthfully labeled when they enter commerce. Although FDA has the responsibility for regulating the use of animal feed products, the ultimate responsibility for the production of safe and effective animal feed products lies with the manufacturers and distributors of the products.

Premarket Approval

The FFDCA requires that any substance that is 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 for that use (GRAS). Typical feed ingredients such as forages, grains, and most minerals and vitamins are generally recognized as safe (GRAS) as sources of nutrients.  The legal definition for a food additive is found in Section 201(s) of the FFDCA.   In Section 409 of the FFDCA, a food additive is unsafe unless its use conforms to an existing food additive regulation.  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 food additive petition. Use of a food ingredient that is neither GRAS nor an approved food additive can cause a "food" to be adulterated, which cannot be legally marketed in the United States. Section 409 of the FFDCA sets forth the statutory requirements for approval of a food additive.

Under Section 409(c)(3) of the FFDCA, 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. Regulations, which apply specifically to food additives in feeds, are published in Title 21, Part 570 of the CFR. Part 571 prescribes the kinds of data that should be submitted by the petitioner 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 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 (cautions, warnings, shelf life, directions for use); and g) Proposed regulation.

A list of approved food additives for use in animal feed is found in Part 573 and a partial list of GRAS substances for use in animal feed is found in section 582 of Title 21 of the CFR. Substances affirmed as GRAS for use in animal feeds are listed under 21 CFR 584. Irradiation is considered a food additive and approvals for the use of irradiation for animal feed are found in 21 CFR 579. Copies of the CFR may be obtained by fax: 202-512-2233 or by mail: Superintendent of Documents, Government Printing Office, Washington, D.C. 20402.

Labeling and Claims

A feed label should contain information describing the feed product and any details necessary for the safe and effective use of the feed. The federal regulations concerning the labeling of animal feeds are published in Part 501 of the 21 CFR. The FFDCA 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 product on the Internet for unapproved drug claims can cause the product to be misbranded under the FFDCA, if the product label fails to bear adequate directions for the uses promoted on the Internet.

In addition to meeting the federal labeling requirements, animal feed products are also subject to individual state laws. Under many state regulations, the feed 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@aafco.org
Phone 217-356-4221
Fax 217-398-4119

For more information about AAFCO, please visit its website.

Under the FFDCA, expressed or implied claims that establish the intended use to cure, treat, prevent or mitigate disease, or affect the structure/function of the body in a manner other than food (nutrition, aroma, or taste), may 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 (NADA), it could be subject to regulatory action as an adulterated drug. Further, CVM has incorporated the philosophy of the Nutrition Labeling Education Act (NLEA) in its policies to permit meaningful "health" information on the label of some animal food products. For example, the use of "urinary tract health" and "dental health" claims on cat food diets falls under this policy. Feed manufacturers provide substantiation that the desired statement is truthful and not misleading. CVM review and acceptance of the claim is needed before the claim is utilized on product labeling.