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Definition of Food & Drugs

Under the Federal Food, Drug and Cosmetic Act (FFDCA) 201(f), a "food" is defined as articles used for food or drink for man or other animals...and articles used for components of any such articles. In part, a drug is defined in the FFDCA 201(g)(1)(B) as a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and 201(g)(1)(C) an article (other than food) intended to affect the structure or function of the body of man or other animals. The word “food” in the parenthetical "other than food" has been interpreted by the courts as an article that provides taste, aroma, and/or nutritive value. Claims on animal feed labels are limited to those that can be attributed to the taste, aroma, or nutritive value of the food. Claims that indicate that a product can be used to diagnose, cure, mitigate, treat or prevent disease, or alter the structure or function of the body, in a manner or extent that exceeds its nutritive value, are not permitted on animal feed labels.

For animals, the Food and Drug Administration Center for Veterinary Medicine (CVM) regulates two classes of products: food or drugs. Depending on the intended use, an animal food supplement product is considered either a food or drug. There is no separate category for "supplements" for animals. The term "dietary supplement" is defined in the Dietary Supplement Health and Education Act (DSHEA). On April 22, 1996, CVM published a notice in the Federal Register to explain that DSHEA does not apply to animal products. CVM has objected to the use of the terminology "dietary supplement" and their respective labeling on animal products. Federal laws and regulations do not recognize a category of products for animals called dietary supplements. Depending on the stated intended use, a product is either a food or drug.

For more information on drug claims, please refer to the CVM Program Policy and Procedures Manual Guide 1240 "Regulating Animal Foods with Drug Claims". The Policy Matrix, appearing on pages 3-5 of Guide 1240.3605, provides a visual reference for explaining how CVM interprets claims on animal feed labels. Another good resource is the guidance document Structure/Function Claims Small Entity Compliance Guide.

DISCLAIMER

The information contained in this website is designed to provide advice to small petfood and treat manufacturers on regulatory requirements and to assist them in the development of proper labeling for these products.

AAFCO has no statutory authority to regulate pet products.

Rather, enforcement of violations is the purview of the state feed control officials, so companies must comply with each state's requirements.  While most states follow AAFCO model regulations, exact language and interpretation may differ between states. While these documents offer guidance that are helpful in the vast majority of states, it is the responsibility of the manufacturer to ensure compliance with individual state requirements.

Did you know?

AAFCO does not regulate, test, approve or certify pet foods in any way.

AAFCO establishes the nutritional standards for complete and balanced pet foods, and it is the pet food company's responsibility to formulate their products according to the appropriate AAFCO standard.

It is the state feed control official's responsibility in regulating pet food to ensure that the laws and rules established for the protection of companion animals and their custodians are complied with so that only unadulterated, correctly and uniformly labeled pet food products are distributed in the marketplace and a structure for orderly commerce.