In a client alert posted on June 5, we described developments in a case that could have significant ramifications for the Food and Drug Administration’s (FDA) “generally recognized as safe” (GRAS) program. In Ctr. for Food Safety v. Sebelius, now Ctr. for Food Safety v. Burwell, no. 1:14-CV-267 (D. D. C., Feb. 20, 2014), the Center for Food Safety (CFS) sued FDA claiming that the agency’s current GRAS program was illegal, in that the procedures were never promulgated as final rules under the Administrative Procedure Act, 5 U.S.C. § 500, et seq. FDA originally indicated that it would vigorously defend its program and indeed, shortly after the case was filed, moved to dismiss the litigation. However, in a striking turn of events, 10 days later the agency joined with CFS in asking for a stay of the proceedings so that the parties could discuss settlement. The court granted the stay with a proviso that the parties file a progress report not later than July 28, 2014. In a recent filing with the court, the parties indicated that they were still negotiating.
The parties filed the required status report with the court on July 23, 2014. FDA and CFS asked for an additional 60 days, or until September 29, 2014, to complete negotiations. The parties stated that they had been “working diligently,” and remained “hopeful that this matter may be resolved without further litigation,” but they were very careful to hold their cards close to their vests and provided no additional details. They did say they would be ready to submit a briefing schedule on the motion to dismiss if the settlement was not reached in this time frame.
It is not possible to make any clear prediction based upon this meager filing. What does seem clear, however, is that FDA is willing to consider changes to the GRAS program. Otherwise, there would be no basis for further discussions or to offer any optimism to the court.
Thus, as discussed in our original alert, the implications of this case remain significant. The existing GRAS process has provided significant benefit and certainty to food companies looking to market their products within the confines of the law and a predictable and workable regulatory program. The goal that CFS announced in filing its case was the complete dismantling of the existing program which could only inject uncertainty into the market both going forward and for those products that were authorized under the old program.
As we previously advised, it is not too late for industry to attempt to take its place at the table. It should consider intervention in this suit. The future of the GRAS program is being debated and potentially changed here. While under the applicable law such intervention is by no means assured, the court could recognize that proposing major changes in a regulatory program without all affected parties present is unwise and only bound to create additional controversy and more litigation later.