FDA introduces new draft guidance on pre-submission consultations with the FDA for the development of FAP and GRAS notices for animal food

The Food and Drug Administration (FDA) has released draft guidance listing recommendations for stakeholders utilizing FDA pre-submission consultations for Food Additive Petitions (FAP) and GRAS notices for animal food ingredients. These types of consultations are used prior to submitting petitions in order to aid in the compliance of the FAP or GRAS notices, so that all products entering the market are safe.

The draft guidance lists nonbinding recommendations that will help during the pre-submission period. The types of recommendations the FDA provides range from proposed inclusions to bolster a stakeholder’s data development for FAP and GRAS submissions such as development of Investigational Food Additive (IFA) file submissions, study protocol content, as well as best practices for communicating with the FDA for pre-submission meetings.

The FDA also recommends being in contact with the Center for Veterinary Medicine early in the notice development process in order to discuss issues as they arise. This helps to mitigate roadblocks prior to FAP or GRAS notice submission, improving chances of approval.

This guidance is open for comments during a 60-day period. You can review the guidance here through this link to the Federal Register and also submit an electronic comment for alternative approaches to  the outlined recommendations. 

How TSG can help

TSG aids in the registration of animal feed at both the state and federal level working closely with the FDA and the Association of American Feed Control Officials (AAFCO). Consultants offer services starting with full product registration across all 50 states as well as the maintenance of that registration post approval. Our consultants have experience with GRAS notices as well as animal food additive petitions, providing guidance on regulations that may impact the client’s petition and product registration process.  Contact us at [email protected] in order to learn how we can assist you.

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If you have any questions about this new draft guidance, or inquiries about the regulation and registration of animal feed or food in the United States contact us here.