Federal Court Upholds GRAS Regulatory Framework - What Flavor Industry Needs to Know

Author: Patrick J. McNamara|October 28, 2021

The FDA's “Substances Generally Recognized as Safe” Rule, better known as the GRAS Rule, is a lawful exercise of the FDA’s authority, according to a recent decision by the U.S. District Court for the Southern District of New York...
Federal Court Upholds GRAS Regulatory Framework - What Flavor Industry Needs to Know

Federal Court Upholds GRAS Regulatory Framework - What Flavor Industry Needs to Know

The FDA's “Substances Generally Recognized as Safe” Rule, better known as the GRAS Rule, is a lawful exercise of the FDA’s authority, according to a recent decision by the U.S. District Court for the Southern District of New York...

The U.S. Food and Drug Administration’s (FDA) “Substances Generally Recognized as Safe” Rule, better known as the GRAS Rule, is a lawful exercise of the FDA’s authority, according to a recent decision by the U.S. District Court for the Southern District of New York. The much-anticipated decision means that substances that are self-determined to be GRAS will remain exempt from FDA premarket approval, which is good news for the flavor industry.

GRAS Regulatory Framework

Food additives were first regulated in 1958 when Congress enacted the Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FDCA), which mandates that any “food additive” must go through an FDA approval process. The Food Additives Amendment defines a “food additive” to include “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.”

While the FDA has premarket review authority over food additives, the Food Additives Amendment established an exception under which a food manufacturer can intentionally add a substance to human food or animal food without FDA premarket review or approval if the substance is generally recognized, among qualified experts, to be safe under the conditions of its intended use (GRAS).

In 1997, the FDA proposed to replace the existing GRAS affirmation petition process with a notification procedure whereby any person may notify the FDA of a conclusion that a particular use of a substance is GRAS. In 2010, GAO issued a report that raised concerns about the proposed GRAS Rule and proposed recommendations for FDA, including that the FDA seek to minimize the potential for conflicts of interest in GRAS determinations and require any company that conducts a GRAS determination to provide FDA with information such as the substance's identity and intended uses. The FDA operated under the proposed GRAS Rule for nineteen years before publishing the final GRAS Rule on August 17, 2016.

Under the final GRAS Rule, “[a]ny person may notify FDA of a view that a substance is not subject to the premarket approval requirements of section 409 of the Federal Food, Drug, and Cosmetic Act based on that person’s conclusion that the substance is GRAS under the conditions of its intended use.” The GRAS Rule provides two ways for demonstrating GRAS status. The first is through “scientific procedures,” which must be “the same quantity and quality of scientific evidence as is required to obtain approval of a food additive,” while the second mechanism is for substances used in food prior to January 1, 1958, and requires that a showing be made “through experience based on common use in food.” The GRAS Rule’s notification process is voluntary. However, the FDA retains authority to take various actions, including issuing warnings and stopping distribution, when a substance does not qualify for GRAS status.

Lawsuit Challenging FDA’s GRAS Rule

In 2017, several plaintiffs, including the Center for Food Safety (CFS) and Environmental Defense Fund (EDF), filed a lawsuit challenging the FDA’s GRAS Rule. They alleged that the GRAS Rule (1) unlawfully subdelegates FDA’s duty to ensure food safety in violation of the United States Constitution, the Administrative Procedure Act (APA), and FDCA; (2) exceeds FDA’s statutory authority and constitutes arbitrary and capricious agency action in violation of the FDCA and APA; and (3) conflicts with the FDCA.

 District Court Upholds FDA GRAS Rule

In a September 30, 2021 opinion, Judge Vernon Broderick dismissed the suit, ruling that the GRAS Rule is a lawful exercise of the FDA’s authority under the FDCA and is not unconstitutional. In reaching his decision, Judge Broderick applied the two-step analysis set forth in Chevron, U.S.A., Inc. v. Natural Res. Def. Council, Inc. to determine if FDA’s interpretation of the FD&C Act provisions governing GRAS substances was reasonable.

The court ultimately concluded that the FDA’s determination that resources could be conserved by taking enforcement action after the fact, instead of requiring pre-market approval, is reasonable and commonplace in the administrative state. “In sum, I find FDA’s interpretation reasonable given that GRAS substances are specifically exempted from the rigorous review applicable to food additives, GRAS submissions increased under the proposed GRAS Rule, in more than sixty years Congress has never required mandatory GRAS submissions, and that FDA has limited resources to allocate to food safety,” Judge Broderick wrote.

Judge Broderick also rejected the Plaintiffs’ contention that if GRAS notifications were mandatory, the FDA could obtain all of the information it needs to make food safety determinations before ingredients are placed into food. While he acknowledged that the FDA could require companies that conduct a GRAS determination to provide FDA with basic information, such as the substance’s identity and intended uses, Judge Broderick noted that this is not the law. “FDA’s interpretation need not be ‘the only possible interpretation, nor even the interpretation deemed most reasonable by the courts,’” he explained. “Instead, it must simply be a reasonable interpretation of the FDCA.”

In his opinion, Judge Broderick acknowledged that there has been an increase in processed foods and food additives since the enactment of the Food Additives Amendment. However, he concluded that the issue must be addressed by Congress, writing:

I am cognizant of this reality, and of the fact that circumstances have changed since the enactment of the Food Additives Amendment. Still, as was recognized by both FDA and GAO, it remains unclear under the statute whether FDA even has the authority to make GRAS notifications mandatory. I decline Plaintiffs’ invitation to rewrite the statute. The remedy Plaintiffs seek lies with Congress, not me, and Congress has chosen not to act despite the increase in the number of food additives over the last five decades.

Key Takeaway

The district court’s decision serves as a welcome affirmation of the FDA’s authority to implement its GRAS Rule and ensures that the current regulatory framework will continue. Given that the plaintiffs may appeal, we encourage businesses in the flavor industry to stay tuned for further legal updates.

If you have questions, please contact us

If you have any questions or if you would like to discuss the matter further, please contact me, Pat McNamara, or the Scarinci Hollenbeck attorney with whom you work, at 201-896-4100.


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AboutPatrick J. McNamara

Patrick J. McNamara has extensive experience in environmental, redevelopment and land use law and related litigation. His activities include the representation of developers and public entities in preparation of and presentations before land use boards, redevelopment agencies, as well as county, regional and state agencies.Full Biography

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Federal Court Upholds GRAS Regulatory Framework - What Flavor Industry Needs to Know

Federal Court Upholds GRAS Regulatory Framework - What Flavor Industry Needs to Know
Author: Patrick J. McNamara

The U.S. Food and Drug Administration’s (FDA) “Substances Generally Recognized as Safe” Rule, better known as the GRAS Rule, is a lawful exercise of the FDA’s authority, according to a recent decision by the U.S. District Court for the Southern District of New York. The much-anticipated decision means that substances that are self-determined to be GRAS will remain exempt from FDA premarket approval, which is good news for the flavor industry.

GRAS Regulatory Framework

Food additives were first regulated in 1958 when Congress enacted the Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FDCA), which mandates that any “food additive” must go through an FDA approval process. The Food Additives Amendment defines a “food additive” to include “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.”

While the FDA has premarket review authority over food additives, the Food Additives Amendment established an exception under which a food manufacturer can intentionally add a substance to human food or animal food without FDA premarket review or approval if the substance is generally recognized, among qualified experts, to be safe under the conditions of its intended use (GRAS).

In 1997, the FDA proposed to replace the existing GRAS affirmation petition process with a notification procedure whereby any person may notify the FDA of a conclusion that a particular use of a substance is GRAS. In 2010, GAO issued a report that raised concerns about the proposed GRAS Rule and proposed recommendations for FDA, including that the FDA seek to minimize the potential for conflicts of interest in GRAS determinations and require any company that conducts a GRAS determination to provide FDA with information such as the substance's identity and intended uses. The FDA operated under the proposed GRAS Rule for nineteen years before publishing the final GRAS Rule on August 17, 2016.

Under the final GRAS Rule, “[a]ny person may notify FDA of a view that a substance is not subject to the premarket approval requirements of section 409 of the Federal Food, Drug, and Cosmetic Act based on that person’s conclusion that the substance is GRAS under the conditions of its intended use.” The GRAS Rule provides two ways for demonstrating GRAS status. The first is through “scientific procedures,” which must be “the same quantity and quality of scientific evidence as is required to obtain approval of a food additive,” while the second mechanism is for substances used in food prior to January 1, 1958, and requires that a showing be made “through experience based on common use in food.” The GRAS Rule’s notification process is voluntary. However, the FDA retains authority to take various actions, including issuing warnings and stopping distribution, when a substance does not qualify for GRAS status.

Lawsuit Challenging FDA’s GRAS Rule

In 2017, several plaintiffs, including the Center for Food Safety (CFS) and Environmental Defense Fund (EDF), filed a lawsuit challenging the FDA’s GRAS Rule. They alleged that the GRAS Rule (1) unlawfully subdelegates FDA’s duty to ensure food safety in violation of the United States Constitution, the Administrative Procedure Act (APA), and FDCA; (2) exceeds FDA’s statutory authority and constitutes arbitrary and capricious agency action in violation of the FDCA and APA; and (3) conflicts with the FDCA.

 District Court Upholds FDA GRAS Rule

In a September 30, 2021 opinion, Judge Vernon Broderick dismissed the suit, ruling that the GRAS Rule is a lawful exercise of the FDA’s authority under the FDCA and is not unconstitutional. In reaching his decision, Judge Broderick applied the two-step analysis set forth in Chevron, U.S.A., Inc. v. Natural Res. Def. Council, Inc. to determine if FDA’s interpretation of the FD&C Act provisions governing GRAS substances was reasonable.

The court ultimately concluded that the FDA’s determination that resources could be conserved by taking enforcement action after the fact, instead of requiring pre-market approval, is reasonable and commonplace in the administrative state. “In sum, I find FDA’s interpretation reasonable given that GRAS substances are specifically exempted from the rigorous review applicable to food additives, GRAS submissions increased under the proposed GRAS Rule, in more than sixty years Congress has never required mandatory GRAS submissions, and that FDA has limited resources to allocate to food safety,” Judge Broderick wrote.

Judge Broderick also rejected the Plaintiffs’ contention that if GRAS notifications were mandatory, the FDA could obtain all of the information it needs to make food safety determinations before ingredients are placed into food. While he acknowledged that the FDA could require companies that conduct a GRAS determination to provide FDA with basic information, such as the substance’s identity and intended uses, Judge Broderick noted that this is not the law. “FDA’s interpretation need not be ‘the only possible interpretation, nor even the interpretation deemed most reasonable by the courts,’” he explained. “Instead, it must simply be a reasonable interpretation of the FDCA.”

In his opinion, Judge Broderick acknowledged that there has been an increase in processed foods and food additives since the enactment of the Food Additives Amendment. However, he concluded that the issue must be addressed by Congress, writing:

I am cognizant of this reality, and of the fact that circumstances have changed since the enactment of the Food Additives Amendment. Still, as was recognized by both FDA and GAO, it remains unclear under the statute whether FDA even has the authority to make GRAS notifications mandatory. I decline Plaintiffs’ invitation to rewrite the statute. The remedy Plaintiffs seek lies with Congress, not me, and Congress has chosen not to act despite the increase in the number of food additives over the last five decades.

Key Takeaway

The district court’s decision serves as a welcome affirmation of the FDA’s authority to implement its GRAS Rule and ensures that the current regulatory framework will continue. Given that the plaintiffs may appeal, we encourage businesses in the flavor industry to stay tuned for further legal updates.

If you have questions, please contact us

If you have any questions or if you would like to discuss the matter further, please contact me, Pat McNamara, or the Scarinci Hollenbeck attorney with whom you work, at 201-896-4100.