On October 20, 2014, the Food and Drug Administration (FDA) entered into a consent decree under which the Agency is obligated to finalize its 1997 Proposed Rule, “Substances Generally Recognized as Safe (GRAS),” by August 31, 2016. The consent decree settles a lawsuit in which the Center for Food Safety sued FDA for accepting and responding to GRAS notifications under the 1997 Proposed Rule without completing the required notice-and-comment rulemaking. While the consent decree does not require FDA to make specific changes to the GRAS notification process, it is possible that the Agency will use the rulemaking to implement more stringent standards both for GRAS notifications and for GRAS self-affirmations.
Under the Federal Food, Drug, and Cosmetic Act, all substances added to food must be either approved as “food additives” or established as GRAS. Currently, a substance may be established as GRAS in one of three ways: (1) notification by an applicant to FDA of the applicant’s own conclusion that a substance is GRAS, pursuant to the Proposed Rule; (2) self-affirmation of the GRAS status of a substance without notification to FDA; or
(3) affirmation of GRAS status upon the initiative of FDA (FDA proposed to withdraw the GRAS affirmation petition process in 21 C.F.R. 170.35 in the Proposed Rule and ceased accepting such petitions). The GRAS notification Proposed Rule was intended to make the process of establishing GRAS status more efficient, and it appears to have been successful. Between February 1, 1999 and December 31, 2009, FDA received approximately 26 GRAS notifications each year, while more than 40 GRAS notifications were completed in 2013 alone, and at least that many have been submitted or are pending in 2014.
The final rule may respond to criticisms made over the years that GRAS standards should be more rigorous and there should be greater transparency around conflicts of interests by GRAS panels and the existence of GRAS self-affirmations. FDA has many inputs to draw on in this process: in addition to the Center for Food Safety’s lawsuit and FDA’s own experience with the notification process, it has received two rounds of comments on the Proposed Rule (1997 and 2010), and has been the subject of critical reports on the safety of GRAS ingredients and the GRAS notification process from the Government Accountability Office, the Pew Charitable Trust and the Natural Resources Defense Council. FDA has indicated that it is committed to ensuring the safety of ingredients in the food supply and it will consider enforcement action within its available resources. Moreover, the Agency has suggested a willingness to revisit past notifications as part of a cyclical review process to reassess safety in light of changes in ingredient usage and resulting exposure.
Notably, FDA also recently announced that it may update the GRAS standards outlined in the “Redbook,” which provides guidance for toxicity studies for food safety assessments. On October 30, 2014, FDA issued a notice of a public meeting and a request for comments on changes to the Redbook, which specifically invites comment on how the Redbook can “more fully support the development and submission of safety assessments for substances introduced into food.” Taken together with FDA’s commitment to finalize the GRAS notification process, this announcement makes clear that the Agency is moving toward formalizing and clarifying its processes for ensuring the safety of food ingredients.