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:
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 challenging 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.
At AFIA’s request the FDA CVM has withdrawn their policy interpretation which historically prohibited products that work within the digestive tract of the animal to provide health or production benefits to be regulated as an animal drug instead of an animal feed. An animal food ingredient that chooses to claim actions to address disease conditions, provide production benefits, change bodily structures or functions, affect the byproducts of digestion or reduce the incidence of pathogens of human health concern must undergo further FDA review to determine if the claims are allowable.