Double Shot Thursday: Express Preemption Based on an OTC Drug Monograph and the Delaney Clause and Personal Injury Litigation — FDA Delists Color Additive Red No. 3, But Will It Be Enough to Attract Even Dyed-in-the-Wool Plaintiffs Lawyers?
Product Liability attorneys Eric Alexander and Justin Kadoura authored pieces featured in Drug & Device Law about a proposed over-the-counter (OTC) class action and the U.S. Food and Drug Administration's (FDA) delisting of Red No. 3 under the Delaney Clause.
Mr. Alexander authored the first part of the blog, an analysis of the case Eisman v. Johnson & Johnson Consumer Inc., which concerned the inclusion of benzene in Coal Tar, an active ingredient in therapeutic shampoos. The plaintiffs alleged omissions of benzene from product labeling and misbranding of the products based on that omission. The court found the FDA had approved the product's monograph, meaning the agency was aware of the presence of benzene, and the claims were preempted. Mr. Alexander characterizes this case as straightforward while acknowledging leadership changes at the U.S. Department of Health and Human Services (HHS) could create new opportunities for challenging FDA decisions regarding the safety and efficacy of a product or category of products.
Mr. Kadoura wrote the second portion of the blog, a summary of the FDA's decision to delist the color additive Red No. 3 and a history of the Delaney Clause. On Jan. 15, 2025, the agency granted a citizens petition to repeal the approval of Red No. 3 in foods based on the Delaney Clause of the 1958 Color Additive Amendments to the Food, Drug & Cosmetics Act (FDCA). This clause prohibits approval of food and color additives shown to cause cancer in humans and animals, in addition to the delisting of products that may have been allowed previously. Mr. Kadoura explains that with delisting comes a concern about personal injury claims, but historically significant tort litigation has not followed these developments. He points to the law's history and purpose – its test is not dose-dependent, it does not allow for the consideration of other factors such as a study showing a de minimis risk of cancer, and it is a strict prohibition – to explain why.