Senator Edward Markey (D-Massachusetts) sent a letter to the U.S. Food and Drug Administration (FDA) on April 26, 2016, characterizing the Generally Recognized as Safe (GRAS) exemption as a “loophole” that “challenges the statutory intent of FDA’s assignment to protect the safety of the food supply.” The letter criticizes the “loose structure” of FDA’s voluntary GRAS Notification program and expresses concern about the marketing of “self-determined” GRAS substances and perceived conflicts of interest in the system. The letter concludes with Sen. Markey requesting FDA’s response to questions about: (1) the Agency’s authority to require labeling on self-determined GRAS substances (e.g., “The safety of some ingredients in this product has not been evaluated by the Food and Drug Administration.”); (2) the Agency’s authority to mandate requirements to minimize conflicts of interest in GRAS self-determinations; and (3) steps the Agency has planned to strengthen its oversight of GRAS substances.
As part of a settlement of a lawsuit filed against FDA by the Center for Food Safety in 2014, FDA agreed to issue a final rule on the GRAS review program by August 31, 2016. For more information on that agreement, see the PackagingLaw.com article, FDA Agrees to Finalize the GRAS Notification Process.