FDA (CVM) issues new guidance for animal Food Additive Petitions and GRAS Notices

Per a directive from the passage of the Animal Drug and Animal Generic Drug User Fee Amendments of 2018, the US Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) was required to publish guidance on the pre-petition processes for food additives and guidance on study protocols. CVM fulfilled that requirement by publishing Guidance for Industry #262 .

The 27-page document details new guidance, particularly related to consultations with CVM prior to submission for animal food products that will fall into one of three major categories: Food Additive Petitions (FAP), Generally Recognized as Safe (GRAS) notices, and Investigational Food Additives (IFA). While pre-submission consultations are very common for medicated articles that CVM regulates, it has not been common in the food space. Feed companies will be particularly interested in guidance on the types of study protocols that CVM will evaluate for scientific validity and on which they will provide scientific advice.

Formalizing the pre-submission consultations for food is yet another step towards harmonizing the CVM process for animal food reviews with those of the Center for Food Safety and Applied Nutrition (CFSAN), which regulates human food. CVM also now provides additional time estimates for advising companies via their consultation process, another new step.

How TSG can help

As FDA and its processes continue to evolve, TSG’s consultants are prepared to assist with guidance, consultation preparation, scientific review, or any other needs that companies may have in navigating the federal review and approval process.