Limitations on GRAS Substances: Not All GRASes Created Equal

FDA has made it abundantly clear on several occasions that there is no “blank check” to use a GRAS[1] substance in any food, at any level of use or for any purpose.  Regardless of the origin of a GRAS determination for a substance, the use[2] of the substance has limitations — whether it is a substance from the original 180 GRAS substances proposed in December of 1958[3], from an FDA GRAS affirmation[4] or from a “self-GRAS” in expectation of a “no objection” response to a GRAS Notification (with some possible gentle arm twisting by FDA at the pre-filing review or during the actual review period).  Even those substances listed in the CFR[5],[6] as “Multipurpose GRAS Food Substances” have at least some restrictions, if only limited to [current] good manufacturing practice (cGMP).  However, cGMP also imposes limits, including, “The quantity of the substance added to food does not exceed the amount reasonably required to accomplish its intended physical, nutritive, or other technical effect in food.”[7] The take home message is that there are always limitations and, when the substance is added to food outside of the approved limits, the use of the substance may no longer be GRAS[8] and may be treated as an “unapproved food additive” subject to recall.

Following the passage of the 1958 Amendment to the Food Drug and Cosmetic Act (hereinafter referred to as the Act) that defined GRAS, substances with a history of use in food were first published in a Federal Regist