On May 22, 2017, several organizations, including the Center for Food Safety (CFS), the Center for Science in the Public Interest, and the Environmental Defense Fund, filed a lawsuit against the Food and Drug Administration (FDA) to challenge a final rule issued by the agency on August 17, 2016, regarding the use of substances in food that are “generally recognized as safe,” or “GRAS.”

This is not the first time the Center for Food Safety has sued the FDA over its GRAS policy—the organization filed suit against the agency in February 2014, the settlement of which led to the issuance of the final rule challenged here. Nor are these lawsuits the only indication of controversy over the way that the FDA permits new substances to be used in foods. In 2010, the Government Accountability Office (GAO) published a report titled “FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS),” calling for increased FDA oversight over substances allowed into the food supply. In 2013, the Journal of the American Medical Association published an article on conflicts of interest in food additive approvals and the Pew Charitable Trusts issued a report calling for increased FDA oversight over the addition of chemicals to the food supply.

The Regulatory Background

There appears to be a rigorous premarket approval process for new food additives. Section 409 of the Food, Drug, and Cosmetic Act (FDCA) of 1938, added in 1958, provides that any new food additive must be approved by the FDA. A petition for approval must include a statement of the conditions of the proposed use of the additive and must show that the proposed use will be safe (defined by regulation as “a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use”). In short, a food manufacturer that wants to put a new substance into the food supply has to show it is safe, and then the FDA has to check that science and issue a formal approval.

A new food additive that has not been approved by the FDA for its intended use is therefore not allowed into the food supply. For example, in 2010, the FDA warned four beverage makers that the use of caffeine in alcoholic beverages was an unapproved use of caffeine and was therefore an “unsafe food additive.” A food containing an unsafe food additive is considered “adulterated,” and the manufacturer is subject to FDA enforcement.

In reality, however, many new substances do not go through this premarket approval process. The process described above applies to “food additives,” the definition of which has a big exception. That is, it does not include any substance that is “generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use.” This is the GRAS exception.

From 1972 to 1997, the FDA used a petition process for manufacturers to have substances (that were not in common usage before 1958) declared GRAS. Manufacturers had to demonstrate the safety of these substances through scientific procedures, which was an equivalent process to that required for new food additives. In 1997, the FDA published a notice of proposed rulemaking in the Federal Register to replace this process with an optional notification program, which the agency immediately implemented as an interim procedure. Companies no longer had to submit research to the agency but could send a summary of their findings, if they chose to submit anything. As the GAO noted in its report criticizing the GRAS process, although the FDA does review those submissions that manufacturers choose to submit, the agency does not have full information about many substances entering the food supply because “companies are not required to inform the agency of their GRAS determinations.”

The Lawsuits

In 2014, the CFS sued the FDA, alleging that the interim procedure violated the Administrative Procedure Act of 1946 because the FDA had never allowed for meaningful public participation before the rule became final (nor did the agency ever issue a final rule). In this 2014 complaint, the CFS identified three potentially harmful substances that had entered the food supply through the interim notification procedure—volatile oil of mustard, olestra, and mycoprotein—and argued that its members suffered an increased risk of harm because substances such as these were allowed into the food supply. The complaint also argued that the CFS’s members were harmed by the improper procedure the FDA had used to implement this interim rule.

In response, the FDA argued in 2014 that the CFS could not show that any of its members were specifically harmed by substances allowed into the food supply through the GRAS system. The FDA also argued that the organization’s allegations of procedural injury (its argument that its members lost the opportunity to comment on food additive petitions) could not support standing in the absence of a concrete injury. The FDA also responded by stating that the relief for which the plaintiffs asked—that the interim rule be rescinded—would not redress its alleged injury because even if the interim rule were vacated, manufacturers would still have to voluntarily submit food additive petitions to the FDA for approval. This chain of events was too attenuated to be adequate for standing, argued the FDA.

Nevertheless, the CFS and the FDA reached a settlement later that year, in which the FDA agreed to issue a final rule regarding the GRAS procedure by August 2016.

The FDA did, indeed, issue its final rule regarding the GRAS process in August 2016, codifying the interim notification program that had been in place since 1997. Because this program does not allow for citizen comment on specific food additive petitions, and because it “has allowed potentially unsafe chemical substances into the market,” the CFS and other organizations filed a new suit against the final rule.

The FDA is likely to make the same arguments in this case that it made in 2014. While the FDA’s initial motion for dismiss was not resolved in 2014 because the parties settled first, the agencies’ arguments are strong. Although the new complaint alleges that the plaintiff organizations are harmed because they have diverted resources to investigating substances designated as GRAS, a court may require a more direct injury to establish standing, and the complaint does not identify specific individuals who have been harmed by the notification process nor does it show how the requested relief will remedy the situation.

Moreover, even if the plaintiffs survive the standing challenge, there is a strong argument for a court to defer to the FDA. As the 2014 motion to dismiss explained, the FDA’s decision to move from the petition process to the notification process in 1997 was based on its analysis that the prior procedure was draining agency resources and deterring companies from trying to get GRAS approval for substances. Moreover, in the August 2016 final rule, the FDA indicated that it was addressing the recommendations made in the 2010 GAO report, and that it reopened the public notice and comment period in 2010 because of the long period that had elapsed since the issuance of the proposed rule, and in response to the GAO report. In light of the absence of a showing of individual, specific harm to any plaintiff, a court may find the agency’s decision making here to merit deference.

However, regardless of whether the plaintiffs prevail in court, the lawsuits here (in 2014 and in 2017) have drawn attention to the issue of new substances in the food supply. Media coverage may, hopefully, increase awareness among the public that many substances in our food supply have not been through any kind of premarket approval process except that which the manufacturer chooses to provide. Caveat emptor.