Law360, New York (October 08, 2014, 10:15 AM ET) -- Under the Food, Drug, and Cosmetic Act, any substance intentionally added to food is considered a “food additive” and subject to premarket review and approval by the U.S. Food and Drug Administration, unless generally recognized among qualified experts as having been shown to be safe under the conditions of its intended use. In short, a product need not await FDA review if it is “generally recognized as safe.”[1] In 1997, the FDA issued a proposed rule establishing a procedure whereby a party could notify the agency that a substance had been determined to be safe, allowing for marketing of products without preapproval.[2] The FDA began this GRAS notice program in 1998, under the terms of the proposed rule and has continued it to the present.

Settlement negotiations in an ongoing litigation could lead to significant change in the GRAS program. Indeed, the question needs to be asked if the Center for Food Safety and FDA have already rewritten GRAS? We are going to have to wait until Oct. 20, and potentially later, to find out.

How Did We Get Here? 

On Feb. 20, 2014, CFS sued the FDA in the U.S. District Court for the District of Columbia.[3] CFS’ complaint alleged the FDA’s proposed GRAS procedure violated the Administrative Procedure Act, 5 U.S.C. § 500 et seq. CFS claimed that because the GRAS policy had never been finalized, it had not been subject to proper notice and comment review and did not meet the requirements of the APA. CFS also asserted the FDA endangered consumers by exposing them to potentially unsafe food additives without adequate review. The complaint sought a judgment declaring all FDA actions since 1997 under the proposed rule unlawful, and ordering proper consideration and promulgation of a final GRAS regulation.

Initially, the government indicated it would vigorously oppose the litigation. The FDA announced it was going to file a motion to dismiss the case and did so on May 14. However, in a striking about face, the government and CFS filed a joint motion a little more than a week later asking the district court to stay the proceedings so both parties could pursue settlement negotiations. The joint motion indicated that some discussion had already occurred and that continued talks “would be constructive and in the best interests of all parties.”[4] The court granted the stay on May 28 and instructed the two sides to report back by July 28, 2014.

The parties filed their status report on July 23, 2014. The FDA and CFS asked for an additional 60 days, until Sept. 29, to complete negotiations. The parties asserted they had been “working diligently” and remained “hopeful that this matter may be resolved without further litigation.” Otherwise, they were careful and held their cards very close to the vest, providing no additional details. The FDA and CFS did say they would be ready to submit a briefing schedule on the motion to dismiss if the settlement was not reached in this timeframe.[5]

That did not happen. Another report was filed Sept. 29. In this update, the parties informed the district court that they reached a settlement “in principle,” but requested an extension until Oct. 20, in order to finalize the details. An agreement was close, but an additional three weeks were needed “to finalize the terms.”[6] The court granted the stay that same day, until Oct. 20. As it did with the first extension, the court indicated it expected a resolution of the matter or a schedule for completing the briefing on the motion to dismiss by the new deadline.[7]

The potential implications here cannot be overstated. The FDA created the GRAS program to ameliorate the considerable administrative burdens that were inherent in the old petition process, while still guarding public health by having knowledge of those GRAS ingredients on the market. The existing program has been very successful. The FDA has reviewed almost 500 GRAS notices in 16 years since 1997, whereas under the old petition procedure it took 26 years to complete approximately 350 submissions. The existing GRAS process has provided significant benefits and certainty to food companies looking to market their products in a safe manner within the confines of the law and a predictable and workable regulatory program. By contrast, CFS announced when it filed its suit that it was aiming to completely dismantle the existing GRAS program.

It certainly is possible that all that will emerge from the negotiations is a schedule for the FDA to restart the rulemaking and promulgate a final GRAS regulation at some point down the road. But would it require several months of negotiations (that are not yet concluded) and two stays of litigation to only determine a schedule for rulemaking? What else is being discussed?

The regulated community derives great benefit from the certainty concerning ingredient safety and regulatory compliance that is provided by successful completion of a GRAS notice under the current procedure. The potential impacts of any changes to this program are many fold. If the proposed rule is invalidated or altered, it could call into question the approval — and arguably the safety — of all previously reviewed ingredients. Creating uncertainty as to all materials marketed under the exiting program over the past 16 years could be extremely disruptive and exploited by those opposed to the program, or with other motives. In addition, the FDA might be forced to stop reviewing notices, whether the proposed rule is ultimately materially changed or not. Until the FDA could finalize a rule, there would be significant uncertainty regarding the safety and legality of many food ingredients, both foreign and domestic. Any new rule could also end up having new, significant and potentially negative modifications.

It is not possible to make any clear prediction as to what these negotiations may bring. What does seem clear, however, is that the FDA must be considering not insignificant changes to the GRAS program. Why else would the discussion take so long? Presumably no final rule will be forthcoming on Oct. 20. However, it is also possible that a newly proposed GRAS rule will have already been worked out — to be proposed for comment to be sure — but also arriving with a presumption in favor of what the FDA has already agreed to. If the FDA has spent months negotiating the outlines of a new program, it likely will be difficult, opportunity for comment not withstanding, to dissuade it from whatever track has been chosen.

The next word is due on Oct. 20.