Comments on Ingredient Guidance Document
The draft guidance is a helpful tool for the industry in understanding how to use the pre-submission consultation process and prepare ingredient submissions or food use authorizations for the most efficient review.GFI #262 is intended to assist the petitioner or notifier in submitting information to the agency for effective and efficient pre-submission consultations and food use authorization requests. Firms can use pre-submission consultations prior to submitting a food additive petition, a generally recognized as safe (GRAS) notification or preparing a food use authorization request to the FDA. A best practice is to use this consultation process early-on in the research and development phase for any new ingredient intended for use in animals to expedite the review process.
During congressional debate on the Animal Drug and Animal Generic Drug User Fee Amendments Act (ADUFA) (H.R. 5554), AFIA advocated for several technical improvements to the FDA's animal food ingredient review process. These changes increased transparency in the application process, removed conflicting language surrounding ingredients and provided further clarity on the submission process for pre-submission consultations and the submission of foreign data in food additive submissions. ADUFA serves as a first step toward a better review process.
AFIA appreciates the FDA Center for Veterinary Medicine's work in implementing these improvements, including publishing this draft guidance. AFIA supports the timelines provided in the guidance and urges the agency to strive to reduce the review times even further as additional staff are hired.
The details provided in the appendices will be very useful in helping the industry understand the agency's expectations for the quality of the study design and therefore, the data generated for the ingredient submission. Having this detail in a guidance document should assist submitters in understanding what is required in a properly designed study and reports and ultimately should improve the overall quality of ingredient submission packages.
AFIA urges the agency to finalize the guidance as soon as possible. AFIA Draft Letter