As FDA
explains in the letter, a firm may market a substance as GRAS for use in animal feed 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 feed.
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 feed is GRAS.
FDA evaluates the GRAS notice to see if there is sufficient basis for the firm’s determination.