On February 20, 2014, the Center for Food Safety (CFS) sued the US Food & Drug Administration (FDA) in the United States District Court for the District of Columbia. See Ctr. for Food Safety v. Sebelius, No. 1:14-cv-267 (D. D.C. Feb. 20, 2014). CFS’s complaint alleges FDA’s current practice for exempting from food additive regulations those substances “generally recognized as safe” (GRAS) violates the Administrative Procedure Act, 5 U.S.C. § 500, et seq. CFS claims the policy – proposed in 1997 but never promulgated as a final rule – has not been subject to required notice-and-comment review and has endangered consumers by exposing them to potentially unsafe food additives. The Complaint seeks a judgment declaring all FDA’s actions under the proposed rule unlawful and ordering promulgation of a final GRAS regulation.

Until very recently, the government indicated that it planned to vigorously oppose the litigation. Indeed, FDA stated it was going to file a motion to dismiss, which it did on May 14. However, in a striking about-face, the government and CFS filed a joint motion on May 23 asking the court to stay the proceedings so that the parties could pursue settlement negotiations. The motion indicated that some discussion had already occurred and stated that continued talks “would be constructive and in the best interest of all parties.” The court granted the stay on May 28 and instructed the two sides to report back as to progress by July 28, 2014.

WHAT IS AT STAKE?

The potential implications are significant. Up until the stay motion, FDA had indicated that it would fully defend its existing program, but now the picture is far less clear. FDA created the current program to eliminate the considerable administrative burdens of the old petition process, while maintaining the public health benefit of FDA having knowledge of GRAS ingredients on the market. The existing program has been very successful. FDA has reviewed nearly 500 GRAS notices in 16 years under the proposed rules, whereas under the old petition process, it took 26 years to complete approximately 350 submissions. In addition, the GRAS notice program at FDA has never approached the staffing that the petition program had in its heyday.

Most, if not all food companies, derive great benefit from the certainty about ingredient safety that is provided by successful completion of the GRAS notice process. The potential impacts of wiping out the current program are many-fold.  Primarily, if the proposed rule is invalidated, it would likely call into question the safety of all previously reviewed ingredients. GRAS assessments would still be in place but it would create uncertainty about safety which would be exploited by those opposed to the current program. In addition, FDA could be forced to stop reviewing notices whether the proposed rule is invalidated or not. The rule could also end up being re-proposed with significant and negative modifications. In fact, the outline of any new rule is likely the topic of conversation between the FDA and CFS now, and if a new proposed rule is outlined in the limited confines of a settlement agreement, there will be no industry input, and it likely will be difficult to make any significant changes thereafter. Moreover, until FDA finalizes a rule, there will be greater general uncertainty regarding the safety and legality of many food ingredients both domestically and abroad.

WHAT CAN BE DONE NOW?

Waiting to see the outcome of the settlement discussion, or of the litigation generally, is dangerous. Interested parties should consider a petition to intervene in the case now. The operative provision in the Federal Rules of Civil Procedure is Rule 24. Under this rule a party seeking to intervene must show a significant interest in the matter being litigated, and that the existing parties cannot be counted on to protect its interest. The intervener must also move in a “timely fashion.” The rule and case law implementing it invest considerable discretion in the court in making the decision. Accordingly, the success of a motion here cannot be absolutely guaranteed, particularly in light of the fact that the case has been pending since February, and has been highly publicized.  However, would be interveners who are operating under the proposed GRAS procedure have a very good argument that important interests are at stake, and that those interests are not being protected by the current litigants.

Timeliness might be another issue but there are good arguments here as well, since the case has not been pending for a significantly long period of time, and just took a turn in the opposite direction. If intervention is allowed, the intervening party has a very good argument that it should participate in all settlement discussions, or at a minimum, it will be in a better position to comment on any agreement that FDA and CFS may reach before it is finalized. As a party to litigation, its comments will be more carefully considered by the judge.

If a decision is made to intervene, it needs to be implemented immediately. The timeliness issue will only pose a greater hurdle the longer the matter proceeds.

Steptoe’s Life Sciences practice is located in Washington, DC. We are well-versed and have significant experience in FDA’s GRAS program and call on the services of many of our litigators who are very familiar with the general legal issues and this court. We would be pleased to represent any party or group seeking to have its voice heard in this now potentially very important litigation. Please call Mitch Cheeseman at 202-429-6473 or Mark Fitzsimmons at 202-429-8068.