Five public advocacy groups have filed suit against the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA) seeking to vacate FDA’s “Substances Generally Recognized as Safe” (GRAS) rule, which allegedly allows “potentially unsafe food additives to be used in the food supply (human and animal) without FDA review, approval, oversight, or knowledge, in violation of the Federal Food, Drug and Cosmetic Act (FDCA).” Ctr. for Food Safety v. Price, No. 17­3833 (S.D.N.Y., filed May 22, 2017).

The plaintiffs argue that the GRAS rule allows manufacturers to certify that a substance is GRAS without notice to FDA or the public, although the rule gives them the option to notify the agency about certification. However, they allege, the Food Additives Amendment to the FDCA requires food additives to go through an FDA approval process. FDA allowed manufacturers to begin using the proposed rule’s optional notification process in 1997, although the rule was not finalized until 2016.

The plaintiffs also argue that the rule lacks a recordkeeping requirement, making enforcement and review impossible, and that the lack of FDA review means consumers are not warned of potential drug interactions with or allergic reactions to new additives. The complaint alleges that (i) the GRAS rule permits an unconstitutional sub­-delegation of FDA authority to private parties; (ii) the FDA criteria for GRAS classification conflicts with the criteria in the FDCA; and (iii) FDA has foreclosed from judicial review the regulatory decisions it is statutorily required to carry out.

“Most Americans would be shocked to learn that FDA allows novel chemicals onto the market without a safety review,” a representative of the Environmental Defense Fund said in a May 22, 2017, press release. “Yet, FDA’s practice on GRAS additives flouts the law and leaves the agency unaware of what chemicals are being added to our food and with no way to ensure that these additives—and the food that contains them—are safe.”


Issue 636

About The Author

For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.

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