On September 22, the US Food and Drug Administration (FDA) moved to dismiss a lawsuit filed by several public interest groups challenging its final rule that outlines how food manufacturers can establish food substances as “generally recognized as safe” (GRAS Rule). The Federal Food, Drug, and Cosmetic Act (FDCA) does not require premarket review by or notification to FDA of substances that are GRAS for their use in food. The GRAS Rule was finalized in August 2016 and sets forth a voluntary process whereby food manufacturers can choose to seek FDA confirmation of their own GRAS conclusions. This GRAS Rule is consistent with the informal process in place since 1997.

In Center for Food Safety v. Price, five advocacy organizations are challenging the GRAS Rule, alleging that it is deficient because it is not a mandatory reporting system. Specifically, the plaintiffs take issue with what they refer to as the “secret GRAS system”; they allege that the GRAS Rule is unconstitutional because it does not require FDA to conduct an independent review of all GRAS conclusions and fails to require food manufacturers to provide FDA or the public with notice of GRAS conclusions. Further details on the allegations in the complaint are available in our May 2017 LawFlash.

The plaintiffs allege three types of harm stemming from the GRAS Rule:

• Harm from diversion of resources, i.e., expending resources on providing education and information about the “secret GRAS system” 

• Informational harm, i.e., deprivation of information about substances that manufacturers have concluded are GRAS 

• Harm to members (alleged by two plaintiff groups only), i.e., deprivation of information to unspecified members of these organizations and potential increase of risks to members’ health and safety

The FDA moved to dismiss plaintiffs’ complaint pursuant to Federal Rule of Civil Procedure 12(b)(1) for lack of standing. FDA asserted that plaintiffs fail to meet the long-established requirements for the “irreducible constitutional minimum of standing,” specifically, that a “plaintiff must have (1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the defendant, and (3) that is likely to be redressed by a favorable judicial decision.” FDA argued that plaintiffs could not meet the elements of standing under either of two standing theories applicable to entities—organizational standing (which requires an organization to meet the same standing requirements applicable to individuals) or associational standing (which requires an organization to show that a member of the organization would have had standing to bring the suit individually).

FDA made the case that plaintiffs lack standing because they cannot establish an injury-in-fact, arguing the following:

• Plaintiffs’ purported harms are advocacy-related activities that have been held insufficient to confer organizational standing by the US Supreme Court and other federal courts. For example, plaintiffs’ alleged need to educate the public on the purported problems with the GRAS Rule is an advocacy effort, and conducting such an activity is not a harm recognized under Article III. Plaintiffs choose to expend resources in the ordinary course of their advocacy.

• Plaintiffs could not state an informational injury based on failure to receive certain information because such injuries are only cognizable where a statute has explicitly created a right to information. The FDCA is not one of those statutes—it does not guarantee consumers access to information about GRAS conclusions.

• Plaintiffs cannot establish associational standing because they have not identified any particular member suffering harm, and allegations of potential risks that food substances may pose are insufficient.

• Plaintiffs’ purported injuries are not traceable to the GRAS Rule. Instead, plaintiffs’ alleged injuries result from either their own independent actions or those of food manufacturers. Any diversion of resources was a result of plaintiffs’ choice to expend resources on advocacy efforts relating to the GRAS Rule. The GRAS Rule has increased the amount of information about substances being submitted to FDA, thus eliminating the traceability of the purported informational injury to the GRAS Rule. To the extent that plaintiffs allege an actual or impending injury to their members as a result of consumption of a substance, the injury would result from the food manufacturer’s decision to include the substance.

• The relief sought by plaintiffs would not redress their purported injuries. Even if the court were to order FDA to require GRAS notices from food manufacturers, several things would have to happen after a manufacturer submits a GRAS notice for plaintiffs to obtain relief: (1) FDA would need to determine the substance is not GRAS and (2) the manufacturer would have to voluntarily decide to refrain from marketing the substance or FDA would have to recommend enforcement action to the US Department of Justice, which would then have to agree to file and prevail in that enforcement action. These contingencies are fatal to the redressability requirement and plaintiffs’ standing to bring the lawsuit.

Anticipated Timeline for Decision

Plaintiffs’ response to FDA’s motion is due on October 30, 2017. FDA has until November 22, 2017 to file a reply in support of its motion. It is likely that the court will not issue a decision until 2018. It is possible that the court could dismiss some or all of plaintiffs’ claims without prejudice, allowing plaintiffs to file an amended complaint and attempt to plead the requirements for standing. In the long run, however we anticipate that it is not likely that the court will grant plaintiffs relief because the FDCA’s mandatory premarket review process excludes GRAS substances. Stay tuned.