CVM Plans to Initiate GRAS Notification Pilot Program

April 17, 2009

By Ricardo Carvajal –      

According to a CVM Animal Feed Safety System update, the CVM Division of Animal Feeds has formed an Ingredient Safety Team that will begin accepting GRAS notification submissions for animal feed ingredients as part of a pilot program starting this summer.  According to the update

The Team will work with other components of CVM to review the notices.  Under the GRAS notification program, a notifier submits a summary of publicly available information in support of its claim that a substance (as described in the notification) should be considered GRAS under specific conditions of its intended use and not be considered a food additive, which requires pre-market approval by FDA. The information supplied by the notifier would address both the safety and utility of the substance. CVM will evaluate the submitted notification to determine whether it provides a sufficient basis for a GRAS determination or whether information in the notification or otherwise available to FDA raises issues that cause the Agency to question whether use of substance in feed, which includes pet food, is GRAS.

It appears that CVM’s program would be similar to the program that CFSAN has been operating for human food ingredients for several years, but CVM would consider “utility” in addition to safety.  At this time it is unclear what CVM means by "utility" and therefore whether consideration of "utility" would be consistent with the statuory definition of general recognition of safety in 21 U.S.C. § 321(s).  We look forward to learning more about the basis for CVM’s consideration of “utility” in the context of GRAS notifications, as well as what CVM ’s criteria for “utility” are.

Categories: Drug Development