Ban

On March 18th, 2024, the U.S. Environmental Protection Agency’s ban of Chrysotile asbestos became the first rule to be finalized under the 2016 amendments to the nation’s chemical safety law, the Toxic Substances Control Act (TSCA). Chrysotile is currently the only known form of asbestos being imported or used in manufacturing in the United States. Since the ban, there have been numerous appeals filed, all of which have since been consolidated and are pending in the Fifth Circuit Court of Appeals. Most recently, the EPA requested that the Fifth Circuit stay the litigation so that it may conduct a regulatory review mandated by a recently issued executive order. The stay was granted on February 14, 2025, and will pause the litigation for 120 days, allowing the EPA to review the ban in light of broader policy considerations.

Overview of the Ban

On January 16, 2025, the U.S. Food and Drug Administration (FDA) announced a significant regulatory change by revoking the authorization for use of Red Dye No. 3 in food (including dietary supplements) and ingested drugs. As noted in a prior Husch Blackwell Legal Update, the FDA based its decision on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which prohibits the approval of additives found to induce cancer in humans or animals. The FDA recognizes that although the hormonal mechanism causing cancer in rats is not applicable to humans, Red Dye No. 3’s presence in the food and drug supply is sufficient to require a ban under the Delaney Clause. The FDA’s decision marks a pivotal shift in food and drug safety regulations.