The U.S. Food and Drug Administration (FDA) has published an order to ban the use of FD&C Red No. 3, also known as erythrosine, in foods (including dietary supplements) and ingested drug products in the Federal Register through a rule published January 16, 2025, 90 Fed. Reg. 4628. The order repeals the color additive regulations that permit the use of this dye. FDA's order will be effective January 15, 2027, for food products and January 18, 2028, for ingested drug products. The procedure is rulemaking on a formal record. FDA will accept objections to the order and requests for a hearing related to this order until February 18, 2025.
This article aims to inform companies about the reasons for the ban, the implications and potential legal risks involved, and the steps they can take to protect themselves from liability, including challenging the ban.
What is FD&C Red No. 3?
FD&C Red No. 3 (Red No. 3) has a long history in the food and drug industries, primarily used for its "cherry-red" color in products such as candies, desserts, and even medications. Although the FDA has convened advisory committees to investigate color additives in the past, banning FD&C Red No. 2 in 1976, Red No. 3 has survived decades of scrutiny. In 1992, the FDA first announced its intention to remove authorization for Red No. 3 based on findings related to its carcinogenic effects in male rats, as published in a study from 1987. This study gained renewed attention in 2023 when it was cited in a petition proposing that the FDA reevaluate the color additive regulations for Red No. 3, ultimately leading to the recent ban.
The FDA's recent ban is based on the Delaney Clause of the Federal Food, Drug, and Cosmetic (FD&C) Act, which prohibits any food or color additive that has been found to induce cancer in humans or animals. This prohibition must be read broadly to ban color additives that pose even de minimis or trivial risks to...
