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Novel ingredients: Navigating regulatory pathways with the US FDA
A crucial component of successful animal agriculture lies in the utilization of functional feed ingredients, incorporating novel ingredients to support animal health and nutrition.
However, navigating the journey from developing a new feed ingredient to obtaining regulatory approval can prove intricate, demanding, and costly for unprepared ingredient producers (sponsors). This article delves into the realm of animal feed ingredients in the US, exploring their significance, regulatory framework, and pre-meeting consultation options crucial for securing approval for their utilization.
Per Code of Federal Regulations (CFR) Title 21, section 170.3, food (or feed) additives include all substances (other than GRAS or otherwise excluded substances) in which the intended use results (or may be reasonably expected to result), directly or indirectly, either becoming a component of the food or otherwise affecting the characteristics of the food.1 The term ‘animal feed’ typically denotes food fed to livestock animals, and encompasses those animals used for human food production.
Animal feed ingredients are added to enhance the feed’s attributes, including nutritional value, health maintenance, pathogen reduction, among other attributes. Feed ingredients may include substances such as vitamins, minerals, fats, proteins, amino acids, enzymes, probiotics, prebiotics, antioxidants, flavors, and more. They play an integral role in modern animal husbandry by fostering healthy animals and mitigating the environmental impact of livestock production.
Who regulates animal feed additives/ingredients?
The US Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) oversees animal feed and pet food, playing a pivotal role in ensuring the safety of new ingredients. CVM also works in partnership with the Association of American Feed Control Officials (AAFCO), an independent organization which sets standards for animal feeds and pet foods in the US.
Individual states adopt specific regulations and guidelines from AAFCO’s guidance, therefore ingredient sponsors should be aware of state-specific requirements for animal food, such as ingredient definitions, product labeling and laboratory standards. When filing for regulatory status with the CVM, various regulatory pathways exist for the approval of a new feed ingredient or pet food ingredient, including a Food Additive Petition (FAP) and a CVM GRAS notification.
Regulatory approval process for animal feed ingredients
An FAP or CVM GRAS submission undergoes FDA review to demonstrate the ingredient's safety and effectiveness in animal feed or to extend the use of an existing ‘approved’ ingredient. These submissions require extensive safety data specific to the target animal species and proof of utility adhering to the FDA's regulatory requirements outlined for FAP and animal GRAS submissions.
Given the lengthy, costly, and resource-intensive nature of the path to regulatory approval for a feed ingredient, it is imperative to consult FDA guidance documents on the submission process. Challenges may arise due to data gaps, evolving regulatory requirements, and safety information. To address these challenges, SGS Nutrasource recommends sponsors take advantage of the FDA’s pre-submission consultation meetings to discuss the ingredient early in the process. While not mandatory for FAP or GRAS submissions, these pre-submissions are highly encouraged.
There are multiple options for pre-submission communication with the FDA. The first is a general consultation that may include in-person, teleconference, or video conference meetings. A request can be submitted to the FDA CVM to schedule such a meeting. This meeting will often be scheduled several weeks in advance and can include any information and questions that the sponsor wishes to ask of FDA personnel regarding the ingredient’s safety, intended use, etc. In lieu of a meeting, written questions may also be submitted by email and the FDA will review and respond via a response letter.
An efficient tool for pre-consultation communication is the establishment of an Investigational Food Additive (IFA) file with the FDA CVM. With the creation of an IFA file, the sponsor may communicate directly with FDA using an IFA file number to discuss ideas, ask questions, and discuss confidential information. The IFA file allows for continuous and confidential communication between the sponsor and the FDA.
An IFA is particularly useful if more information is required for the regulatory submission and data collection is on-going. Key information or requests that can be submitted via the IFA file also include (but are not limited to) drafted study protocols, Food Use Authorization (FUA) requests, and study data. Under the current policies, any information discussed within the IFA file is shared only with the sponsor or with authorized third parties. It is important to note that the FDA does not publicly acknowledge the existence or establishment of an IFA file, and that the regulatory submission of a FAP or GRAS is independent of the file.2
Therefore, the IFA file should not be referenced within the regulatory submission, and all data or information obtained via the file should be incorporated into the final regulatory submission. One notable opportunity within an IFA file is the ability to submit a Food Use Authorization (FUA) request which, if accepted, permits the animals (or animal-derived products such as eggs or milk) involved in safety studies to enter the human food chain, offsetting a portion of the safety study cost.
A FUA request should include details of the safety study and address the safety of the proposed investigational ingredient in the target animal species and humans. The content of the FUA request can also be discussed with the FDA via the IFA file.
Recommended process for successful approval
When submitting a FAP or CVM GRAS notice for an animal feed ingredient, it is important to have sufficient information and data gathered for the best chance of success. It is strongly recommended that the sponsor take advantage of pre-submission communication with the FDA to receive feedback and address any preliminary concerns prior to submission. This is best done through the establishment of an IFA file. More information on pre-consultation for FAP and GRAS notices can be found in the CVM guidance for industry #262.
If you are navigating the regulatory approval process for a novel animal feed ingredient, SGS Nutrasource can assist in literature and data review, study placement and oversight, dossier writing, submission, and FDA communication on your behalf. As the regulatory landscape for animal food ingredients evolves, SGS Nutrasource can help you navigate this complex terrain and work towards a successful outcome.
Find out more about how SGS Nutrasource can help to navigate this process.
Authors: Kaiti Valm, Project Manager, Regulatory Sciences at SGS Nutrasource and Jake McDaniel, Project Manager, Regulatory Sciences at SGS Nutrasource
References
1. U.S Food and Drug. CFR - Code of Federal Regulations Title 21.
2. CVM Guidance for Industry #262. Pre-Submission Consultation Process for Animal Food Additive Petitions or GRAS Notices.