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Animal Food Ingredients

Submitting Ingredients for Premarket Review

Premarket Review

The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that any substance that is added to or is expected to become a component of animal food, either directly or indirectly, to be used in accordance with a food additive regulation, unless it is generally recognized as safe (GRAS) for a particular intended use. Typical animal food ingredients, such as forages, grains, and most minerals and vitamins, are frequently GRAS as sources of nutrients. A substance that does not become a component of a finished animal food product but that is used in preparing an ingredient of the animal food to give it a different flavor, texture, or other characteristic may also be a food additive.

Premarket Submissions

Anyone intending to market animal food ingredients may connect with CVM to discuss their animal food substance. See the descriptions below with links to more information on the various submission processes that may apply to animal food ingredients:

  • Food Additive Petitions: Food additive petitions (FAP) are a regulatory approval process for animal food ingredients and technical additives. Regulations applicable to FAPs are published in 21 CFR 571, including regulations describing the FAP process, the types of data that should be submitted, and the required format for the petition.
  • GRAS Notices: GRAS notifications are a process used by industry to notify the FDA of their conclusion that an animal food ingredient or additive is generally recognized as safe under the conditions of its intended use. Regulations applicable to GRAS notices are found under 21 CFR 570, including eligibility for GRAS and information on submission.
  • Investigational Food Additive Files: Investigational food additive (IFA) files are a method for industry to communicate data and information to the FDA regarding animal food additives and substances still undergoing development. The information in an IFA is confidential within the bounds of the FDA’s Public Information regulations. FDA may use these files to conduct various protocol reviews at a firm’s request.
  • Plant Biotechnology Notification Files: Plant biotechnology notification files are a voluntary program that allows industry to communicate with FDA on novel plant varieties prior to bringing food from a genetically engineered plant to market. Interested firms may use this mechanism to communicate with CVM about foods from genetically engineered plants intended for use in animal foods and feeds.
  • Animal Food Ingredient Consultations: Animal food ingredient consultations (AFIC) are a method for industry to consult with the FDA regarding animal food ingredients. The AFIC process supports industry in the development of animal food ingredients which may have utilized the Association of American Feed Control Official’s ingredient definition process prior to October 1, 2024.
  • Other processes: FDA has recently published additional information for firms seeking to market novel animal food substances. Please see the link below for further information:

Guidance on Premarket Submissions

Several guidance documents are available for use in preparing premarket animal food submissions. 

  • Information on pre-submission activities - GFI #262.
  • Food Additive Petition preparation and submission – GFI #221
  • Generally recognized as safe – FAQ
  • Animal Food Ingredient Consultations – GFI #294

In addition, FDA participates in the International Cooperation for Convergence of Technical Requirements for the Assessment of Feed Ingredients (ICCF). This organization aims to develop and establish common guidance and brings together animal food regulators and industry associations to work collaboratively on the technical information needed for the assessment of animal food ingredients. The members are from the United States, Canada, and the European Union. This organization has been developing guidance documents on identity, safety, and utility.

Animal Food Products Made from Cultured Animal Cells

The FDA is continuing to work with firms that are developing food made from cultured animal cells to ensure that the processes used to produce them are safe and meet applicable regulatory requirements. FDA encourages firms with potential animal food products derived from cultured animal cells to contact CVM. 

Contact CVM Regarding Premarket Animal Food Substances

To obtain additional information on the animal food ingredient premarket approval process or on how to submit a regulatory package for a substance to be used in animal food, please contact the Division of Animal Food Ingredients at: Animalfood-premarket@fda.hhs.gov or Center for Veterinary Medicine, Division of Animal Food Ingredients, MPN 2, Room E429, 12225 Wilkins Avenue, Rockville, Maryland 20852.

Additional Information



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