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

Published date30 October 2021
Subject MatterConsumer Protection, Food, Drugs, Healthcare, Life Sciences, Product Liability & Safety, Food and Drugs Law
Law FirmArnold & Porter
AuthorMs Raqiyyah Pippins, Howard Sklamberg and Elizabeth Trentacost

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...

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