What Does it Mean for a Food Substance to be Generally Recognized as Safe (GRAS)?

Substances that are intentionally added to foods are defined as food additives by the U.S. Food and Drug Administration (FDA), under the Federal Food, Drug, and Cosmetic Act (sections 201(s) and 409). Food additives require premarket review and FDA approval of safety before they can be used. However, substances that are considered "generally recognized as safe" (GRAS) are excluded from the definition of food additives. Unlike food additives, substances that are determined to be GRAS for their intended use do not require premarket review or FDA approval.

The FDA has established two means for determining that the use of a food substance is GRAS: (1) scientific procedures, or (2) experience. For the use of a substance to be GRAS as determined by scientific means, scientific data about the substance's use must be widely known. Furthermore, there must be consensus among qualified experts that the use of the substance is safe. GRAS determinations that are based on experience rely on a substantial history of safe consumption by many consumers and are limited to substances that were used in food before 1958. It is important to note that a GRAS determination is not made for a substance per se, but rather is limited to the intended use of a particular substance. This means that a substance that is GRAS for one use may not be determined to be GRAS for all uses.

In 1997, the FDA implemented a GRAS notification program. Individuals or companies can voluntarily notify the FDA if they have determined that the use of a particular substance is GRAS. This notification typically includes information about the substance, the conditions of its use (including the foods in which it is used and the levels present in those foods), and the population likely to consume the substance. Additionally, the notice contains a discussion of the data supporting the GRAS determination. The FDA evaluates whether the notice provides a sufficient basis for the GRAS determination. The FDA writes a response letter to the notifier, indicating either that: (1) the FDA does not question the basis of the GRAS determination, (2) the notice does not provide a sufficient basis of the GRAS determination, or (3) the notifier requests that the FDA cease to evaluate the GRAS notification. Over 600 notifications have been submitted to the FDA since 1997, and the FDA maintains a publically available inventory of these notifications and their FDA evaluation letters on their website.