Regulatory Definitions, Processes, and Functionality Assessment for Animal Food
The Federal Food, Drug, and Cosmetic Act (Act) defines food as “articles used for food or drink for man or other animals.” The Act defines drugs as substances intended for diagnosis, cure, mitigation, treatment or prevention of disease or that affect the structure or function of the body. However, the Act recognizes that food may affect the body and excludes “food” from the drug definition. US courts have determined that food provides “aroma, taste or nutritive value.” The Center for Veterinary Medicine (CVM) in the Food and Drug Administration (FDA) regulates both animal food and drugs. Animal food includes both livestock feed and companion animal food. Food and substances added to food must be safe and achieve their intended purpose. CVM administers two regulatory processes for animal food. The food additive petition process is described in regulation 571 in Title 21 of the Code of Federal Regulations (21 CFR 571). The safety of the additive at the intended use rate must be addressed for the animal, the environment, and for food producing animals, the safety of human food products obtained from animals fed the additive must also be addressed. The second process is similar to the first except that the information concerning the safety of the substance for the intended use and its functionality are in the public domain, i.e., published in the scientific literature. When the safety and functionality of a substance’s use in animal food is generally available and recognized, qualified experts may determine that this use is exempt from the premarket requirements of the Act because the use is generally recognized as safe (GRAS). A GRAS determination generally requires the same quantity and quality of information needed for a food additive petition with the added burden that the information be public. Firms can notify CVM about a GRAS determination through the animal food GRAS notification program. Also, for substances that raise no safety concerns when used in animal food, firms can request the Association of American Feed Control Officials (AAFCO) to publish an ingredient definition in the AAFCO Official Publication. For all these processes, firms must establish what the substance does and determine how their intended use fits under the definition of food in the Act. Firms must also demonstrate that the substance achieves the intended effect.
Keywords: animal food, regulation, intended use, functionality