FDA Releases GRAS Guidance Document

WASHINGTON—The Food and Drug Administration (FDA) in December released a guidance for industry, “Frequently Asked Questions About GRAS.” According to the agency, the document represents its current position on the food ingredient classification known as “generally recognized as safe” (GRAS), and includes common questions about the regulatory process and considerations.

FDA noted GRAS substances are distinguished from food additives on the basis of safety of the substance for an intended use. GRAS determinations are based on the use of a substance, rather than the substance itself; therefore, not all applications for all foods, for example, would be covered by a single GRAS determination.The full document is available online www.cfsan.fda.gov/~dms/grasguid.html).