Earlier this month, the Center for Food Safety ("CFS") announced it had reached a settlement agreement with FDA requiring the agency to finalize the interim policy for its generally recognized as safe ("GRAS") food additive approval process by the end of August 2016. In February of this year, CFS sued FDA for operating the GRAS food additive process under a proposed rule since 1997, alleging FDA had failed to properly regulate food additives by operating under a proposed rule rather than finalizing it. FDA reopened the comment period for the proposed rule on December 28, 2010, but has yet to issue a final rule. Instead, for 17 years, FDA has operated under the interim policy CFS argues is a "lax regulatory system" falling "far short of what is required to protect consumers from potentially unsafe food additives." Furthermore, because the proposed rule is not final agency action, it cannot be challenged in court, frustrating the efforts of anyone who wishes to dispute the 1997 GRAS scheme.
The settlement agreement requires FDA to submit a final rule regarding GRAS substances to the Federal Register no later than August 31, 2016. The settlement provides a procedure by which FDA can request an extension of the deadline. If FDA fails to meet its deadline and has not sought to modify it, CFS can move the court to enforce the terms of the settlement.
Under the Federal Food, Drug, and Cosmetic Act ("FDCA"), any substance that is intentionally added to food is considered a food additive and subject to premarket review and approval by FDA, unless the substance is GRAS, meaning the substance is generally recognized among qualified experts to be safe under the conditions of its intended use. Organizations may demonstrate a food additive is GRAS in one of two ways: (i) through scientific procedures showing general recognition of safety; or (ii) for additives used in food before 1958, through experience based on common use in food.
Prior to the 1997 proposed rule, if a substance was not already GRAS, manufacturers had to seek premarket approval for any new substances they wanted to add to a food. FDA issued the 1997 proposed rule under the rationale that it could no longer devote sufficient resources to the GRAS affirmation process. The 1997 proposed rule established a voluntary notification procedure along with an interim policy that essentially put the procedure into effect without the rule being finalized. The voluntary notification procedure allows manufacturers to self-determine whether an additive is GRAS and, at their option, notify FDA of its self-determination.
FDA's responses to the voluntary GRAS notifications generally have fallen into one of three categories: (i) the agency does not question the notifier's GRAS determination; (ii) the agency concludes the notice does not provide a sufficient basis for a GRAS determination; or (iii) the response letter states the agency has ceased to evaluate the GRAS notice at the notifier's request. None of these categories requires FDA to substantively evaluate whether the substance is safe for human consumption. Critics of the current process contend that some food producers have been able to use additives in their products based on undisclosed GRAS safety determinations. By compelling FDA to finalize the proposed rule, the settlement requires FDA to take final agency action, which will then be open to challenge by those who believe the regulations are not adequate to fulfill FDA's obligations under the FDCA.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
