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Animal Feed Regulatory Pathways
Animal Feed Regulatory Pathways
Food is regulated by the FDA under the Federal Food Drug and Cosmetic Act (FFDCA). In brief, it defines food as articles used for food or drink for man or other animals and defines food additives as any substance which may result, directly or indirectly, in becoming a component of food or affecting its characteristics, unless it is generally recognized as safe (GRAS) for its intended use (21 U.S.C. section 321).
It is the FDA Center for Veterinary Medicine (CVM) and Division of Animal Food Ingredients that oversees the regulation of animal feed and pet food. There are currently four (with a fifth pending) options to address the regulatory status of a new ingredient for livestock, poultry, aquaculture, or pet food.
Click on each pathway in the list below for a detailed description.
Which Pathway to Choose?
Which Pathway to Choose?
When it comes to choosing a regulatory path for a new or revised feed ingredient/additive for livestock feed or pet food, the options can be confusing and overwhelming. For a lot of ingredients, any of the paths will work and it is simply an issue of personal choice. For others, it would be wise to carefully choose the path best suited to the ingredient in question and its unique characteristics or political implications. If you would like assistance choosing a regulatory pathway or navigating a current submission, ask for a free consultation to discuss your situation.
Click on each pathway in the list below for a detailed description
Food Additive Petition (FAP)
Food Additive Petition (FAP)
The FDA follows the authority of the Federal Food Drug and Cosmetic Act (FFDCA). It defines food as "articles for food or drink for man or other animals ... and articles used for components of any such article". It further defines "food additive" as any substance that may reasonably be expected to becoming a component or affect the characteristics of any food. This includes any substance used in the production, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, if not if not Generally Recognized as Safe (GRAS).
Food additives require pre-market approval by FDA to establish the conditions of safe use, which is achieved by filing a petition with the FDA Commissioner. The petition process for animal use is described beginning in Title 21 Code of Federal Regulations Part 571 (21 CFR 571).[1] Once accepted for filing, a notice is published in the Federal Register. Upon favorable review of the petition and data contained within, an official action by FDA is taken to draft and publish a regulation prescribing under what conditions the additive may be used. This regulation is then published in the Federal Register and in 21 CFR part 573.[2]
The petition itself will contain roughly nine technical sections including Additive identity and composition, Intended use and use rate, Data supporting the intended effect, Analytical methods, Target animal Safety, Human food safety, Environmental safety, Label, and Proposed regulation. The review of these sections are conducted on an iterative basis and can proceed back-and-forth between FDA and firm as many times as needed to address any outstanding questions. Each individual review cycle should take no more than 180 days.
[1] https://www.ecfr.gov/current/title-21/chapter-I/subchapter-E/part-571
[2] https://www.ecfr.gov/current/title-21/chapter-I/subchapter-E/part-573?toc=1
GRAS Notification
GRAS Notification
If the use of an article is GRAS, then it is not subject to the pre-market approval requirements of food additives. However, a firm may notify the FDA regarding its conclusion that a use of an ingredient is GRAS. The agency will then provide comments related to the firm’s conclusion, but the Agency does not make a conclusion of its own regarding the ingredient or its use.
The GRAS Notification process for animals was completed in 2016 and is codified beginning in 21 CFR 570.203. A firm is not currently required to notify the FDA of its GRAS conclusion, but if it chooses to notify FDA, once the notice is accepted for filing, it will be published on the FDA-CVM Current Animal Food GRAS Notices Inventory (rather than the Federal Register).[3] Note the GRAS Inventory for human foods and animal feeds are two separate lists. When FDA completes its evaluation of the Notice, it will publish a letter to the GRAS Inventory indicating that it “had no questions” or “had questions” related to the firm’s GRAS conclusion. There is one round of review for FDA to evaluate your Notice, including one opportunity to make minor revisions.
GRAS notifications receiving a no questions letter from FDA-CVM will also be listed in the AAFCO Official Publication. This is an advantage to submitting a notice to the FDA-CVM, as once published in the OP, States generally will not question your use of the ingredient on labeling of livestock feed and pet food.
The future and the scope of the GRAS program is uncertain. The Health and Human Services Secretary, Robert F. Kennedy Jr will seek rulemaking to eliminate GRAS self-determination provision, making Notification manditory.[4]
Additional relevant links related to the GRAS Notificaiton program are located below.
Animal Food Ingredient Concultation (AFIC)
Animal Food Ingredient Concultation (AFIC)
In response to ending the Memorandum of Understanding (MOU) with Association of American Feed Control Officials (AAFCO), FDA-CVM established the Animal Food Ingredient Consultation (AFIC) program. It is stated to be an interim and temporary program but there is no indication when, of if, it would ever end. When drafted, it was limited to only ingredients intended as primary sources of nutrients, but that was revised in the final Guidance to include any feed ingredient. FDA will publicize on a dedicated website (as opposed to the Federal Register) a list of consultation requests which will identify the ingredient and sponsoring firms. Once accepted for filing, the general public will have an opportunity to submit comments to a docket and data to the file to support or oppose the ingredient. The FDA’s final letter of conclusion will also be publicly posted.
Ingredients accepted for us in animal feed or pet food through the AFIC pathway will also be published in the AAFCO Official Publication.
Additional relevant links related to AFIC are located below.
Submit Comments to Docket Related Specific Ingredient Under Review
AAFCO Scientific Review of Ingredient Submissions (SRIS)
AAFCO Scientific Review of Ingredient Submissions (SRIS)
Since 1920, AAFCO has printed the AAFCO Official Publication, which contained a comprehensive list of animal feed ingredients to help bring uniformity for feed among the States. Beginning in 2007, FDA-CVM entered into an MOU with AAFCO to provide scientific and technical expertise for the review of ingredients. These ingredients, though technically unapproved food additives, were accepted for use in animal feed and pet food under a policy of enforcement discretion. With the end of FDA’s MOU with AAFCO, the enforcement discretion policy will not be extended to new ingredient definitions published by AAFCO.
In January 2025, AAFCO voted to approve a proposal by Kansas State University (KState) to continue scientific review of new animal feed ingredients.[5] [6] The new program is referred to as Scientific Review of Ingredient Submissions (SRIS). As of October 2025, the SRIS program is accepting submissions.
The KState-reviewed ingredients will be based upon a GRAS self-determinations paradigm to address the legality of inter-state commerce of the ingredients. The SRIS program will require little to no confidential business information, as opposed to GRAS Notifications.
Note, as mentioned under the GRAS Notification Section, the FDA is seeking rulemaking to eliminate the GRAS self-determination provision; if that occurs the SRIS program will be directly impacted. The future of the AAFCO ingredient definition program remains unclear.
Additional relevant links related to AAFCO are located below.
Ingredients Definitions Committee
SRIS
[5] https://www.aafco.org/news/aafco-votes-yes-on-new-regulatory-pathway-for-animal-food-ingredients/
Zootechnical Addities (ZAF)
Zootechnical Addities (ZAF)
The Zootechnical Animal Food Substance is a pending category to evaluate applications as foods though they technically meet the definition of a new animal drug.
The categories of additives include:
1) environmental impacts,
2) impacts upon the gastrointestinal flora,
3) reduction of food-borne pathogens of human importance.
Congressional action will be required for this category to become an official FDA program, but in the mean time CVM is accepting submissions on a case-by-case basis which will be evaluated under enforcement discretion.
Color Additive Petitions
Color Additive Petitions
The Federal Food Drug and Cosmetic Act (FFDCA) defines color additive as a dye, pigment, or other substance capable of imparting color to food or flesh of an animal. Color additives can be classified as Certified Colors, or Exempt from Certification.
Color additive evaluation is overseen by the FDA Center for Food Safety and Applied Nutrition (CFSAN). For color additives used in aquaculture feed, livestock feed, or pet food, CFSAN will work closely with CVM to evaluate use and safety. The petition should initially be sent to CFSAN.
NOTE: The FFDCA states that Color Additives cannot be GRAS.
Additional relevant links related to Color Additives are shown below.
Color Additives General - 21 CFR 70
Color Additives not Certified
Color Additives Certified
Color Additive Petitions
Dietary Supplements
Dietary Supplements
Dietary Supplements are only authorized for use by humans. As noted in a Federal Registered Notice, the FDA states that the Dietary Supplement Health Education Act (DSHEA) does not apply to animals.
DSHEA FR Notice 61(78):17706-08
CVM has a working relationship with the National Animal Supplement Council and AAFCO.
Canadian Food Inspection Agency
Canadian Food Inspection Agency
Under the authority of the Feeds Act and regulations and the Health of Animals Act and regulations, the Canadian Food Inspection Agency (CFIA) administers a National Feed Program. Livestock feeds manufactured, sold or imported into Canada must be safe for livestock; for humans and for the environment as well as effective for their intended purpose.
https://inspection.canada.ca/en/animal-health/livestock-feeds
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