FDA Announces Letter to Industry on Marketing of Animal Food Substances as Generally Recognized As Safe (GRAS)
October 15, 2010
The Food and Drug Administration (FDA) announced today the availability of a letter to suppliers of animal food ingredients and manufacturers of animal food. The letter explains the legal framework for marketing a substance as Generally Recognized As Safe, or GRAS, for use in animal food.
As FDA explains in the letter, a firm may market a substance as GRAS for use in animal food based on the firm’s own determination, not FDA’s determination. However, the firm markets the substance at its own risk. If FDA does not agree with the firm and determines that the use of the substance is not GRAS, the agency may take action against the firm and the substance being marketed.
The letter also explains FDA’s voluntary pilot program for GRAS notifications for substances added to animal food. A firm may participate in the program by submitting a notice (called a “GRAS notice”) to FDA. The GRAS notice summarizes the data and information the firm relied on to determine that the use of the substance in animal food is GRAS. FDA evaluates the GRAS notice to see if there is sufficient basis for the firm’s determination.