Federal District Court Upholds FDA’s GRAS Self-Determination Process

On September 30, 2021, the federal court in the Southern District of New York dismissed a lawsuit challenging a Food and Drug Administration (FDA) process for demonstrating that a food substance is Generally Recognized as Safe (GRAS).¹ The lawsuit challenged FDA’s 2016 Final Rule, Substances Generally Recognized as Safe, (GRAS Rule) which codified FDA’s practice of allowing any person to notify FDA that a particular food substance is GRAS by submitting a GRAS notice, and which recognized in the preamble, the practice of independently concluding a substance is GRAS for its intended use without notifying FDA of this conclusion.² The court concluded that FDA did not unlawfully delegate its statutory duties, exceed its statutory authority, or contradict its statutory authority by issuing the GRAS Rule, and ultimately upheld this regulation. This Advisory provides background on FDA’s oversight over, and regulation of, the GRAS notification process, summarizes the litigation challenging the GRAS Rule, and discusses the implications of the lawsuit’s dismissal for food manufacturers.

Background

Under the Federal Food, Drug, and Cosmetic Act (FDCA), new food additives must be approved by FDA before the additives may be used in food. Food additives are defined in the FDCA as “any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food.”³ Unapproved food additives are considered unsafe, and such additives and any foods containing such additives are considered adulterated, a violation of the FDCA, which prohibits the introduction, sale, receipt, and delivery of adulterated food.⁴

Food substances found to be GRAS, however, are not considered food additives for purposes of the FDCA and thus may be used in food without prior FDA approval. The definition of a “food additive” exempts substances that are “generally recognized . . . to be safe under the conditions of their intended use,” or GRAS.⁵ FDA regulations provide criteria for classifying a food substance as GRAS: there must be “common knowledge” throughout the relevant scientific community that there is a reasonable certainty that the substance is not harmful under conditions of intended use. The basis for this knowledge may be either scientific procedures or, for food substances used prior to 1958, experience based on common use in food.⁶ A substance that is GRAS for a particular use can be marketed for that use without FDA review and approval.

FDA Regulation of GRAS Substances

Following the Food Additives Amendment to the FDCA in 1958, FDA amended its regulations to include a list of food substances considered GRAS for certain uses and would issue non-binding opinion letters in response to industry inquiries as to food substances’ GRAS status. In 1973, this approach was replaced with a petition process whereby industry members would submit GRAS affirmation petitions to FDA, FDA would publish a notice of filing and request comments, and FDA would issue a final rule affirming that the substance was GRAS if appropriate following the comment period. FDA used this “resource-intensive rulemaking process”⁷ until 1997, when FDA proposed the rule that would eventually be finalized as the GRAS Rule in 2016.⁸ From 1997 until the issuance of the GRAS Rule in 2016, FDA operated under an interim policy announced in the proposed GRAS Rule under which FDA would accept and administer GRAS notices as described in the proposed rule until FDA published a final rule.⁹ Pursuant to this policy, FDA invited interested persons who determine that a use of a substance is GRAS to notify FDA of such GRAS determinations according to the GRAS notice procedures laid out in the proposed rule, that formed the basis for the procedures codified in the final GRAS Rule.

FDA published the final GRAS Rule in August 2016. The GRAS Rule establishes a voluntary pathway under which “any person” can determine that a food substance is GRAS under conditions of its intended use and inform FDA of its determination by filing a GRAS notice.¹⁰ A GRAS notice must include certain information (required by regulation) supporting its conclusion, including scientific evidence of safety and a basis to conclude that that evidence is generally known and accepted among qualified experts.¹¹ Following review of the GRAS notice, FDA will respond to the notifier in a letter stating that either FDA does not question the GRAS determination, or that the GRAS notice does not provide a sufficient basis for a GRAS determination. A redacted copy of the GRAS notice and FDA’s response is published to FDA’s public GRAS Notice Inventory.

As the above summary suggests, FDA’s GRAS notification process established in regulation is voluntary. Companies may, but are not required to notify FDA that a substance is GRAS for its intended use. Companies may self-affirm the GRAS status of an ingredient for a particular intended use without notifying FDA, a pathway recognized by FDA in the preamble to the GRAS Rule and in guidance for industry. That said, FDA does recommend that companies that intend to use a substance in food based on a conclusion of GRAS status, but that do not intend to submit such conclusion to FDA, use the provisions of 21 C.F.R. Part 170, subpart E as guidance.¹² In either case, FDA retains the authority to act when a food substance does not qualify for GRAS status.¹³ However, the ability of manufacturer’s to self-certify food substances as GRAS without FDA’s approval or knowledge can be controversial and spurred the litigation in opposition to the GRAS Rule, described below.

GRAS Rule Litigation

In 2014, the Center for Food Safety filed a complaint in the District Court for the District of Columbia alleging that FDA had violated the Administrative Procedure Act by operating under the proposed GRAS rule and by failing to promulgate a final GRAS rule. The complaint also criticized the voluntary notification process instituted by the proposed GRAS rule. The parties eventually reached a settlement agreement that required FDA to finalize its GRAS Rule by August 2016, which the Agency did.¹⁴

In 2017, the Center for Food Safety and the Environmental Defense Fund filed a complaint in the Southern District of New York alleging that the GRAS Rule creates a “secret GRAS system” that “deprives FDA of the ability to verify that a use of a substance is truly [GRAS] within the meaning of the FDCA.” The GRAS Rule, Plaintiffs stated, “does not require a manufacturer to notify FDA about any self-certified GRAS determinations or to keep records documenting or explaining the basis of GRAS determinations,” which allows manufacturers to base GRAS determinations on the conclusions of their own consultants relying on unpublished data. Plaintiffs asserted that, as a result, the voluntary notification process is insufficient to ensure that unsafe food substances are not included in food products and thus creates an unacceptable risk of harm to consumers.

Specifically, Plaintiffs argued that the GRAS Rule:

1. Unlawfully delegates FDA’s duty to ensure food safety to outside parties,
2. Exceeds FDA’s statutory authority and constitutes arbitrary and capricious agency action, and
3. Conflicts with the FDCA.¹⁵

Plaintiffs argued that Congress delegated to FDA the responsibility of ensuring the safety of the nation’s food and that the GRAS Rule unlawfully subdelegates that responsibility to manufacturers, “allowing them to decide for themselves, in secret,” whether food substances may be added to food. FDA responded by asserting that the GRAS Rule does not subdelegate agency authority.¹⁶

The court concluded that FDA did not unlawfully subdelegate its authority under the FDCA and expressed skepticism that FDA had delegated “anything at all” to manufacturers. The court noted that the FDCA does not impose mandatory GRAS notification on manufacturers nor require FDA to review industry GRAS conclusions prior to marketing. Rather, FDA retains the right to agree or disagree with any GRAS determination and may take enforcement action if it does not agree with a manufacturer’s GRAS determination. Under the GRAS Rule, then, manufacturers have the same option they would have in the absence of any rule: “to act without notifying FDA and assume the risk of enforcement if FDA later determines that they violated the law.”¹⁷

Plaintiffs argued that the GRAS Rule contravenes plain statutory language by allowing manufacturers to make GRAS determinations without disclosure, depriving FDA of the opportunity to fulfill its statutory obligation to assess the risks of new food additives. Plaintiffs also argued that the GRAS Rule rests on an impermissible construction of the FDCA that ignores important aspects of food safety. FDA responded that the FDCA is silent regarding whether manufacturers must notify FDA of GRAS conclusions. FDA also asserted that it has reasonably determined that the voluntary notice approach for GRAS determinations constitutes the best use of FDA resources to effectuate the purpose of the statute.¹⁸

The court found that the FDCA is silent or ambiguous as to whether food manufacturers must notify FDA of GRAS determinations prior to marketing new food substances and deferred to FDA’s interpretation of the statute. The court further found FDA’s interpretation of the statute reasonable given that GRAS substances are exempt from the review applicable to food additives, GRAS notifications are not mandatory, GRAS submissions increased under the proposed GRAS Rule, and FDA operates with limited resources to allocate to pursue its statutory goals.¹⁹

Finally, plaintiffs argued that the GRAS Rule criteria for establishing that a food substance is GRAS differs from the FDCA’s requirements and fails to ensure the statutory requirements are met. Plaintiffs cited concerns with GRAS determinations supported by unpublished material and with financial conflicts of interest in the notification process.²⁰

The court, however, found that the GRAS Rule does not contradict the FDCA, noting that the FDCA does not prohibit consideration of unpublished material in GRAS determinations and that unpublished material is “just one potential part” of GRAS determinations. And while the court acknowledged the validity of Plaintiffs’ concerns regarding financial conflicts of interest, it noted that FDA had addressed the issue in draft guidance and that the FDCA was silent on how conflicts in GRAS determinations should be addressed.²¹

Implications

This decision upholds the current regulatory approach to GRAS determinations, meaning that companies may continue to choose to notify FDA of their conclusion that a substance is GRAS for a particular intended use, or may reach such a conclusion and elect not to notify FDA. Still, the court’s acknowledgment plaintiffs’ concerns regarding conflicts of interest (referring to them at separate points in the opinion as “legitimate” and “valid”) serves as a reminder to companies that some stakeholders consider the processes allowed by FDA to be less than fully transparent, and as such, to consider transparency where possible (particularly with respect to independent GRAS conclusions, as encouraged by FDA) and heed FDA’s recommendations for self-certification. Companies that empanel scientific experts to determine whether a food substance is GRAS should heed FDA’s previously issued draft guidance providing the Agency’s best practices for convening such a panel, including steps to avoid the risk that bias or reliance on unpublished data will undermine the panel’s credibility.

*Samuel Williams contributed to this Advisory. Mr. Williams is a graduate of the University of Michigan Law School and is employed at Arnold & Porter's Washington, DC office. He is not admitted to the practice of law.

© Arnold & Porter Kaye Scholer LLP 2021 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.