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Federal Court Upholds GRAS Rule

On September 30, 2021, the U.S. Food and Drug Administration (“FDA”) prevailed in the federal lawsuit brought by the Center for Food Safety and the Environmental Defense Fund (“NGOs”) challenging FDA’s final rule titled Substances Generally Recognized as Safe (“GRAS Rule”), 81 Fed. Reg. 54960 (Aug. 17, 2016). The U.S. District Court for the Southern District of New York granted the FDA’s motion for summary judgment and rejected all causes of action asserted by the NGOs. Specifically, the NGOs argued that the GRAS Rule unlawfully subdelegates the FDA’s authority to the food industry, exceeds the FDA’s statutory authority and constitutes arbitrary and capricious rulemaking under the Administrative Procedure Act (“APA”), and is otherwise in conflict with the Food, Drug, and Cosmetic Act (“FDCA”). Devon Wm. Hill and Eric Gotting of Keller and Heckman filed an amicus curiae (“amicus”) brief in support of the GRAS Rule on behalf of the Safe Food Ingredients Coalition (“SFIC”). The court cited the amicus brief on several occasions in support of its decision.

Unlawful Subdelegation of Authority

The NGOs argued that the GRAS Rule impermissibly shifts responsibility for ensuring that food is safe from the FDA to food manufacturers who, according to the NGOs, can decide “for themselves, in secret, whether the chemical substances they have synthesized may be added to food.” Unlawful delegation occurs when an agency transfers all its decision-making authority to an outside party, thus abdicating its statutory obligations. The court agreed with the FDA’s argument that there was no unlawful subdelegation of authority given that the FDCA does not require GRAS notifications at all, nor does it require the FDA to perform a pre-market review of GRAS substances. The court noted that “[i]f the FDA has delegated anything at all to manufacturers, it is simply the ability to notify the FDA of a GRAS determination, with which the FDA can agree or disagree.” The NGOs further argued that the GRAS Rule fails to ensure that the FDA retains oversight over GRAS determinations, which deprives the public of the ability to hold the FDA accountable, such as through court challenges, and avoiding conflicts of interest. The court pointed out that the FDA retains the power to bring enforcement actions if it disagrees with a GRAS determination, and that the FDCA otherwise allows for public participation in the food additive process. 

APA Challenges

The NGOs next argued that the GRAS Rule violates the APA and the FDCA because the statute unambiguously requires food manufacturers to disclose all GRAS determinations or, to the extent the FDCA is unclear on this point, the FDA impermissibly construes the statute to allow for a voluntary disclosure program. As to the first argument, the court noted that the FDCA does not expressly require mandatory disclosures and, in fact, signals that such a requirement does not exist as the Food Additives Amendment specifically exempts GRAS substances from the more rigorous statutory scheme for approving food additives. 

Regarding the second argument, the court held that the FDA complied with the APA because it reasonably interpreted the FDCA to allow for a voluntary program and adequately explained the grounds upon which its decision was made. For instance, in addition to the exemption for GRAS substances in the Food Additives Amendment, the FDA pointed to the fact that voluntary GRAS notifications had only increased since the proposed GRAS Rule was issued nineteen years ago. 

The court then turned to SFIC’s amicus brief for additional support. Specifically, the court relied on SFIC’s assertion that the FDA has long interpreted the FDCA to exempt GRAS substances from premarket review. The court then noted that Congress had not otherwise elected to amend the statute’s language to require mandatory disclosures. The court then cited SFIC’s brief to support that a mandatory program would potentially overwhelm the FDA and take agency resources away from higher priority food programs and result in consumer confusion, and that the FDA’s resources would be better spent on initiating enforcement actions where it did not agree with a given GRAS determination.  

GRAS Rule Conflicts with the FDCA

The NGOs argued that criteria set out in the GRAS Rule for determining GRAS status contradict the plain language of the FDCA. Among a handful of arguments, the NGOs maintained that GRAS determinations must be based on “generally recognized” scientific data, information, and procedures. As the court noted, the GRAS Rule provides for such an approach in a number of provisions and nothing in the statute prohibits reliance, in part, on unpublished material. Moreover, the NGOs alleged that the GRAS Rule does not deal with supposed financial conflicts of interests involving experts making GRAS determinations. Although the court said that conflict of interest concerns may be valid, the FDA has issued guidance on the issue and, again, the FDCA is silent on what steps must be taken to address conflicts of interest. Finally, the NGOs maintained that the GRAS Rule fails to clarify that carcinogenic substances can never be deemed safe for use in food (i.e., that the Rule is in conflict with the Delaney Clause). The court responded that the Delaney Clause governs food additives, not GRAS substances, and that criteria inherent in the GRAS Rule likely prevent a carcinogenic substance from being deemed GRAS. 

Having lost at the District Court, the NGOs have, from the entry of final judgment (which occurred on September 30, 2021), 28 days to file a motion to alter or amend the judgment or 60 days to file an appeal with the United States Court of Appeals for the Second Circuit. We will continue to monitor this case for new developments.