The Food and Drug Administration (FDA) is issuing this letter to clarify to animal food ingredient suppliers, animal food manufacturers, and the public that when a food substance is marketed as Generally Recognized As Safe, or GRAS, it does not necessarily mean that FDA has reviewed or concurred with the regulatory status of the substance.
Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act, if the intended use of any substance results or may reasonably be expected to result in the substance becoming a component or otherwise affecting the characteristics of any food, the substance is a food additive and is subject to premarket review and approval by FDA, unless its use is GRAS, or otherwise excluded from the definition of a food additive.
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.
A “no questions” letter from FDA is not equivalent to an affirmation by FDA that the intended use of the substance is GRAS because FDA neither receives nor reviews the detailed information that supports the notifier’s GRAS claim. FDA continuously evaluates the safety of substances in the food supply, and the agency may become aware of additional information about a notified substance that raises questions about the safety of an intended use of that substance. If, after issuing a “no questions” letter in response to a notifier, FDA questions the GRAS status of the use of that substance, the agency may advise the notifier and other interested parties of those questions. In such a case, FDA normally expects to advise the notifier by letter that the agency has identified questions as to whether the intended use of the substance is GRAS. Such a letter would be placed in a publicly accessible file so that other interested persons are aware of FDA’s position. When appropriate, FDA may also take action, including seizure or injunction, to remove from the market an unapproved food additive.
For further information about FDA’s GRAS notification pilot program, including links to the June 4, 2010, notice and 1997 proposed rule, go to: Generally Recognized as Safe (GRAS) Notifications. Questions about FDA’s GRAS notification pilot program may be directed to the Division of Animal Feeds at FDA’s Center for Veterinary Medicine (CVM) at 240-453-6879.