On January 15, 2025, the U.S. Food and Drug Administration issued an order revoking the authorization for the use of FD&C Red No. 3 in foods, including dietary supplements (permitted under 21 Code of Federal Regulations (CFR) 74.303), and in ingested drugs (permitted under 21 CFR 74.1303). The final order stated that manufacturers who use FD&C Red No. 3 in foods and ingested drugs would have until January 15, 2027, or January 18, 2028, respectively, to reformulate their products.
The FDA’s action to revoke the authorization for the use of FD&C Red No. 3 was based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Delaney Clause, enacted in 1960 as part of the Color Additives Amendment to the FD&C Act, prohibits FDA authorization of a color additive if it has been found to induce cancer in humans or animals. The FDA determined that data presented in a 2022 color additive petition showed that FD&C Red No. 3 causes cancer in male laboratory rats when exposed to high levels.
On April 22, 2025, the U.S. Department of Health and Human Services (HHS) announced a series of new measures to phase out all petroleum-based synthetic dyes, also known as color additives subject to certification, from the nation’s food supply. As part of this phase out, HHS and FDA requested food companies to remove FD&C Red No. 3 sooner than the 2027 deadline required by the final order. To support this goal, the FDA encourages food manufacturers to, as soon as is practicably possible, reformulate to stop using FD&C Red No. 3 in foods, including dietary supplements, with the goal of completing phase out before the January 15, 2027, deadline. The FDA believes that accelerating the phase out of the use of FD&C Red No. 3 in foods will help further the goal of Making America Healthy Again.
The FDA recognizes that substituting FD&C Red No. 3 used in foods, including dietary supplements, with other color additives may require the expanded use of authorized color additives and/or the development of new color additives. The FDA also recognizes the widespread interest in substituting FD&C Red No. 3 with color additives derived from other sources, including plants. Regardless of the source material, each color additive must meet the legal safety standard of a reasonable certainty of no harm under the intended conditions of use. The FDA evaluates data in a petition to ensure that the use of a color additive meets the legally required safety standard and issues a regulation prescribing safe conditions of use. Information about color additive petitions is available on FDA’s website: Color Additive Petitions | FDA.