The U.S. Food and Drug Administration’s Center for Veterinary Medicine launched on June 4, 2010 the beginning of a pilot program to accept and review GRAS (Generally Recognized As Safe) notices for substances used in animal food.
Through the program, individuals, also referred to as the “notifier” by the FDA, can submit “notices of claims that a particular use of a substance in food for animals is exempt from the statutory premarket approval requirements based on the individual’s determination that such use is GRAS.”
In short, the notifier can inform the FDA of their determination that the use of a substance is GRAS, rather than petition FDA to affirm that the use of a substance is GRAS, as in the case of food additives.
GRAS status is an exemption to the food additive definition. Under the 1958 Food Additives Amendment to the Federal Food, Drug and Cosmetic Act, food additive includes any substance that is intentionally added to food and is subject to premarket review and approval by the FDA.
However, if the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, it may be designated GRAS status, according to the FDA. Alternatively, a GRAS determination can be made through experience based on common use in food prior to 1958. A substance is GRAS only for its particular intended purpose.
The FDA will respond to the notifier with one of two types of letters. The first type of letter states that the FDA does not question the basis for the GRAS determination. In the second type of letter, the FDA states that the notice does not provide a sufficient basis for a GRAS determination. This conclusion may be based on the fact that the notice does not include appropriate data and information or because the available data and information raise questions about the safety of the substance, among other factors, according to the FDA.
Click here for an inventory of GRAS notices and the FDA’s response to those notices.
The FDA encourages potential participants in the animal food pilot program to contact the CVM’s Division of Animal Feeds prior to submitting notices to discuss their submission plans.
Click here for pilot program details, including notice submission requirements.