cancer

In a recent case pending in Hawaii state court, a husband and wife sued a tobacco company defendant for various claims related to its manufacturing and marketing of tobacco cigarettes, including strict products liability, negligence, fraud, fraudulent misrepresentation, conspiracy, and loss of consortium. After more than a month-long trial, the defendant was found responsible for design defect, fraud, and conspiracy claims related to plaintiff’s laryngeal cancer. The case, pending in the Third Judicial District of Hawaii, resulted in an eyewatering $91 million dollar verdict for the plaintiffs.

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.