A GRAS substance is not subject to premarket review and approval by FDA. A firm can market a substance intended for use in animal food based on its own determination that the intended use is GRAS. A firm marketing an animal food substance on this basis does so at its own risk. If FDA determines the intended use of the substance is not GRAS, the substance and firm marketing it for this use may be subject to enforcement action by FDA.
Although not required to do so, firms that have determined that the intended use of a substance in animal food is GRAS may participate in FDA’s GRAS notification pilot program. On June 4, 2010, FDA announced that it would begin a voluntary pilot program for GRAS notifications for substances added to animal food. This program is based on a 1997 proposed GRAS notification rule. Under FDA’s pilot program, a firm may submit to FDA a notice of its claim that a particular use of a substance in animal food is exempt from the statutory premarket approval requirements for food additives based on the notifier’s determination that such use is GRAS. FDA will evaluate these notices and will inform each participant (notifier) in writing either that the notice provides a sufficient basis for the GRAS determination (i.e., a “no questions” letter) or that FDA has identified questions as to whether the intended use of the substance is GRAS. These letters will be made available to the public on FDA’s website.