FDA may take recent consumer group comments into account before finalizing GRAS proposal next year.

  • In recent years, the “Generally Recognized as Safe” or “GRAS” exemption has come under attack from consumer groups and consumers, who argue that it permits the marketing of new food substances in the United States without sufficient agency oversight.  In 1997, FDA issued a proposed rule that effectively replaced the old GRAS Affirmation petition process with a more streamlined approach in which companies voluntarily may “notify” FDA of their GRAS determinations and FDA can issue letters stating that the Agency has “no questions” about those determinations, where appropriate.  Although FDA never finalized its 1997 proposed rule, the Agency began accepting GRAS Notices in 1998 and continues to do so.  One group — the Center for Food Safety (CFS) — sued FDA seeking to vacate the Agency’s 1997 GRAS proposal; as part of a settlement in that case, FDA committed to finalize the GRAS rule by August 31, 2016.
  • On April 15, 2015, four groups — Center for Science in the Public Interest, Consumers Union, Environmental Working Group, and Natural Resources Defense Council — filed an extensive set of comments with FDA criticizing the GRAS process and urging the Agency to rein in the food industry’s reliance on the GRAS exemption to market food substances in the United States.  During the recent Food Safety Summit in Baltimore, FDA’s Michael Taylor — Deputy Commissioner for Foods and Veterinary Medicine — made comments suggesting that FDA will be reviewing the “substantial document” it has received from these groups, leading many to wonder whether, and the extent to which, the critique will influence the contents of the final rule.
  • Although Michael Taylor did not comment on the planned contents of the final GRAS rule, he noted that FDA is also considering the issuance of guidance documents to help the industry meet FDA’s expectations regarding the criteria for GRAS substances.  The food industry, consumer groups, and consumers alike still must wait a bit longer to see FDA’s proposed “resolution” of this issue.  Particularly because the GRAS exemption is expressly codified in the Federal Food, Drug, and Cosmetic Act, many question whether consumer groups truly will be satisfied with anything short of a legislative amendment.