FDA wins lawsuit over its GRAS rule

Josh Long, Associate editorial director, Natural Products Insider

October 6, 2021

4 Min Read
FDA wins lawsuit over its GRAS rule

A federal judge in New York held last week that FDA lawfully exercised its authority in publishing a 2016 rule governing food substances that are generally recognized as safe (GRAS).

On Sept. 30, Judge Vernon S. Broderick granted a motion for summary judgment to the government after finding “FDA did not unlawfully subdelegate its authority.”

The GRAS rule provides a voluntary process for notifying the agency that a substance is GRAS under the conditions of its intended use and therefore exempt from premarket approval.

Plaintiffs including the Center for Food Safety contended the GRAS rule fails to ensure FDA has oversight over GRAS determinations, allowing manufacturers to covertly determine whether chemical substances may be added to food, according to Broderick’s 35-page order. Critics also have argued companies’ GRAS experts may have conflicts of interest, potentially undermining the integrity of the process.

FDA has the right to disagree with a GRAS determination and may bring enforcement action against a food manufacturer, the judge observed.

“Other than prudential concerns and citations to inapposite case law, plaintiffs provide no legal support for their argument that the GRAS rule violates the Constitution by adopting a voluntary notification system and allowing post-violation, instead of pre-violation enforcement,” Broderick, of the U.S. District Court for the Southern District of New York, wrote in his summary judgment order. “Moreover, FDA uses a similar voluntary notification system to regulate the marketing of cosmetics. Accordingly, I find that the GRAS rule is not an unlawful subdelegation of FDA’s authority.”

Broderick found FDA should be accorded so-called Chevron deference under long-established case law because Congress did not specifically address in the Food Additives Amendment of 1958 whether GRAS notifications to FDA are mandatory, and FDA’s interpretation of the statute was reasonable.

The 1958 statute required an approval process for food additives, but carved out an exception for certain substances that experts generally recognized to be safe.

“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,” Broderick wrote.

The judge also rejected plaintiffs’ argument that FDA’s decision was arbitrary and capricious.

Separately, he acknowledged the thousands of substances that have been added to food since the Food Additives Amendment became law, but he wrote, “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,” Broderick continued. “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.”

Broderick’s decision was a long time coming. Plaintiffs filed their lawsuit in 2017.

In response to the ruling, the Center for Food Safety said it was weighing its legal options.

"We are extremely disappointed by the court’s ruling that will continue to allow FDA to flout its regulatory duties and outsource the job to self-interested food corporations driven by their bottom line rather than the public interest,” George Kimbrell, legal director of the group, said in a press release.

Eve Gartner is a managing attorney with Earthjustice, which represented the Center for Food Safety and Environmental Defense Fund in the lawsuit against FDA.

“We are very disappointed by the court's ruling, which signs off on FDA allowing self-interested corporations to decide on their own—in secret, with no notice to FDA, and no recordkeeping requirements—if the chemicals they have synthesized are safe to add to food or use in food packaging or processing materials,” she said in an email. 

Gartner and Kimbrell both said in their statements, “We are carefully reviewing the decision and considering all legal options, including appeal.”

Since 1998—when FDA received its first GRAS notice—FDA has received a total of 1,011 GRAS notices, according to the agency’s database. Seventy-six percent of the notices are ones in which “FDA has no questions” and 2% represent ones in which FDA found “notice does not provide a basis,” an FDA spokesperson said.

Another 6% of notices are “pending” while FDA stopped evaluating 16% of notices at the request of the notifier, the spokesperson added.

Citing “pending litigation” since there is a period of time in which Broderick’s decision can be appealed, FDA declined to comment on the ruling.

“The ruling is significant as for a long time many NGOs [non-governmental organizations] and even some from the industry argued that the self-GRAS process was a loophole that needed to be closed, and somehow FDA had the ability to do it,” said Ashish Talati, a lawyer who counsels clients on GRAS determinations, in an email. “The ruling makes it very clear that the self-GRAS process is perfectly legal, and only Congress can change it.”

Editor's note: This article also was published on Natural Products Insider, a sister website to Food & Beverage Insider. 

About the Author(s)

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long has been a journalist since 1997, holds a J.D. from the University of Wyoming College of Law, and was admitted to practice law in Colorado in 2008. Josh is the legal and regulatory editor with Informa's Health and Nutrition Network, specializing on matters related to Natural Products Insider. Ping him with story ideas at [email protected].

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