policy issues

How are Ingredients Approved for Use in Animal Food?

There are roughly 900 ingredients, or feed additives, approved by federal or state law for use in animal feed and pet food in the United States. These ingredients can be approved for animal food manufacturers’ use in one of three ways:

  • using the Generally Recognized as Safe (GRAS) provisions required by the Federal Food, Drug and Cosmetic Act (FFDCA);
  • recognized by the Association of American Feed Control Officials (AAFCO) in its annual Official Publication (OP), the legal listing recognized by the states and by other countries for ingredient definitions allowed on commercial feed labels; or
  • by the Food and Drug Administration through the food additive petition (FAP) process, also mandated by FFDCA.

The first process of certifying an ingredient as GRAS does not require pre-market review and approval by the FDA as a food additive. In general, to have an ingredient determined as GRAS, companies must prove that the substance: meets the same safety standards as existing food additives, will not cause harm if used appropriately, and is recognized as “safe” by the scientific community, based on publicly available scientific information. Companies can go to market based on this conclusion or voluntary notification can be made to the FDA. The notification review process typically takes around 270 days, once the FDA accepts the company’s notification, compared to the FAP process, which takes several years.

In general, state feed laws require the ingredient to either be recognized with a “common or usual name,” an approved food additive, or defined and listed in the AAFCO OP. However, it should be noted that not all state feed agencies recognize GRAS ingredients, creating a patchwork of regulations and making it impossible for manufacturers to sell their ingredients in all states.

The process of gaining recognition through AAFCO’s OP is very similar to the FDA’s FAP process. In either instance, the FDA requires the submitting company to provide the agency and AAFCO with: animal and human safety data, the analytical methodology used to cultivate that data, detailed lists of the manufacturing processes involved, toxicology results on any harmful substances in the ingredient, data to show the ingredient will be manufactured consistently, and a proposed legal definition for the product. If, during the AAFCO review process, the FDA finds any potential problems in the data submitted, then the FDA may require a more formal FAP to be submitted.

The FDA’s FAP process is the most thorough of the three, typically requiring more data and several more years for the FDA’s Center for Veterinary Medicine (CVM) to review.

Health and Safety Claims for Ingredients on Product Labels

An animal food ingredient must not use marketing claims which purport that its nutrients will provide other animal health (e.g., reduce the incidence of scours in livestock) or production benefits (e.g., increase milk production). Ingredients that are claimed to cure, prevent, treat or mitigate disease conditions or change bodily structures or functions (unless explicitly recognized, such as calcium for building strong bones) are considered “drugs” under the FFDCA, requiring a long and thorough approval process by the FDA. The AFIA has requested the FDA CVM to update their policy interpretation to allow products that work within the digestive tract of the animal with these product claims to be regulated as an animal feed ingredient instead of an animal drug. This process is under review by CVM.