FDA’s Center for Veterinary Medicine has a voluntary process known as an Investigational Food Additive (IFA) file. Companies or individuals (stakeholders) can request that FDA open an IFA file to facilitate exchange of data, ideas, and information with FDA while the stakeholder investigates the safety and utility of a substance for its intended use in animal food. These substances may be unapproved animal food additives, including new uses for a previously approved animal food additive.
This process enables stakeholders to obtain scientific and regulatory expertise and insight from the FDA while considering whether to submit an animal food additive petition (FAP) or Generally Recognized as Safe (GRAS) notice.
The types of IFA submissions that FDA reviews include: (1) study protocols, (2) Food Use Authorization (FUA) requests, and (3) reports of existing data from completed studies.
An IFA file submission addresses one or more issues related to the proposed use of a substance in animal food. Examples of these issues are chemical composition, target animal safety, human food safety, and the impact on the environment. A submission to an IFA file is not required to contain all the elements that are required by Food Additive Petition or GRAS notice regulations.
Although information submitted to an IFA file will include some or all of the same information that would be provided in an FAP or GRAS notice, IFA files are independent of an FAP or GRAS notice. Stakeholders requesting FAP approval or GRAS notice evaluation of an animal food substance still must submit an FAP or GRAS notice to FDA, even if they have an existing IFA file.
Stakeholders are encouraged, but not required, to use IFA files. IFA files are kept confidential within the bounds of FDA’s Public Information regulations. There is no legally specified timeframe for the review of a submission to an IFA file, but FDA lays out informal goals in Draft Guidance for Industry #262: Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices.
- Draft GFI #262: Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices
- CVM Policies & Procedures Manual, Guide 1240.3310: Establishing and Processing Investigational Food Additive Files (IFA)
- Food Additive Petitions for Animal Food
- Generally Recognized as Safe (GRAS) Notification Program