The US Food and Drug Administration (FDA) issued a letter to clarify the marketing of a substance as generally recognized as safe (GRAS) for use in animal food.
A substance marketed as GRAS is not subject to premarket review or approval by FDA, the letter explains. This marketing is done at the company's own risk, however the substance and firm are subject to FDA enforcement action if the agency determines a substance is not GRAS.
The letter also explains FDA’s voluntary pilot program for GRAS notifications. A firm may participate in this program by submitting a "GRAS notice" to FDA, summarizing information the firm relied on as its basis for the GRAS label. FDA then evaluates the "GRAS notice" to determine if there is sufficient evidence for the firm's GRAS product marketing.
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