Legality of the Self-GRAS process upheld in federal court

A federal judge in the Southern District of New York has sided with the Food and Drug Administration (FDA), upholding the legality of the FDA’s approach to regulating substances that are Generally Recognized as Safe (GRAS).

“What do enzyme-treated pea protein, oat polar lipid extract, rice bran wax, and refined shea butter have in common? These are substances that manufacturers have concluded to be generally recognized as safe (“GRAS”) for their prescribed uses in food. Such substances—substances generally recognized as safe—are at the heart of this case,”​ Judge Vernon Broderick said in a September 30, 2021 opinion.

The decision

The Southern District of New York judge sent a strong message​ confirming that the GRAS regulatory framework is a lawful implementation of Federal Food, Drug, and Cosmetic Act (FD&C Act).

“The ruling makes it very clear that substances that are self-determined to be GRAS are exempt from premarket review by FDA. The common list of complaints about the GRAS regulatory framework lack merit under the law,” ​explained Ashish Talati, Partner, Amin Talati Wasserman, LLP. “This is great news for the food and the dietary supplement industry. There have been attempts by the various ‘consumer groups’ and even some within the industry to portray an image that the self-GRAS process is a loophole and is not legally sound.”​

Background

In 1958, Congress amended Section 201(s) of the FD&C Act to define a "food additive" 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…if such substance is not 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.”​

Congress simultaneously also amended Section 409 of the FD&C Act to provide that substances qualifying as food additives must undergo premarket review. This created a legal framework that exempted substances that are GRAS from premarket review.

Over the past six-plus decades, FDA has interpreted the FD&C Act as substances that are GRAS under their intended conditions of use are exempt from the premarket review processes that apply to food additives.

How it started 

The exemption of GRAS substances from premarket review has drawn its fair share of criticism over the years. Calls for a GRAS overhaul got louder in 2010 when the Government Accountability Office (GAO) concluded in a report that FDA should strengthen its oversight over GRAS substances by finalizing a 1997 proposed rule; minimize conflicts of interest in GRAS assessments performed by third parties; and require any company that conducts a GRAS determination to provide FDA with information such as the substance's identity and intended uses.

The 2010 report caught the attention of not only the industry, but the FDA and non-governmental organizations (NGOs). As a result, in a 2014 lawsuit several NGOs accused the FDA of not being able to fulfill its statutory obligations under the FD&C Act—such as assessing the true cumulative exposure to substances in the diet.

The suit resulted in a consent decree wherein the FDA agreed to finalize its 1997 proposed rule by 2016. FDA consented and published a final rule in 2016 that retained the voluntary GRAS program and confirmed FDA's long-standing interpretation that GRAS substances are exempt from premarket review under the FD&C Act.

How it's going 

In 2017, a group of NGOs sued FDA and the Department of Health and Human Services (HHS) again, this time arguing that the FDA’s 2016 final rule was unlawful.

Fast forward to 2021, Judge Broderick has now issued his opinion, granting the government’s motion for summary judgment, effectively closing the case, finding that all of the NGOs causes of action lack merit under the applicable law.

Implications

The decision does leave the GRAS regulatory framework unchanged.

George Kimbrell, legal director for one of the plaintiffs, Center for Food Safety, said in a statement: "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. We are carefully reviewing the decision and considering all legal options, including appeal."​

While the NGOs do have the right to appeal their case, the GRAS regulatory framework only emerges stronger, bolstered by the court's affirmation of the rationale behind the FDA's interpretation and implementation of that framework.

Michael McGuffin, President of the American Herbal Products Association, welcomed the announcement: “This is an important decision that protects a regulatory option that many responsible suppliers use to bring safe ingredients to the U.S. market,"​ he said.