http://www.fda.gov/cvm/Documents/AFSSUpdate6Draftfinal.pdf"Generally Recognized as Safe Status
CVM plans to start a pilot program this summer that will permit a sponsor to inform FDA of the sponsor’s determination that the use of a substance in feed, which includes pet food, is “Generally Recognized as Safe,” or GRAS.
Earlier this year, the Center’s Division of Animal Feeds formed an “Ingredient Safety Team” to handle GRAS notification submissions. When the pilot program begins, the Ingredient Safety Team will include five members. 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."
