FDA encourages food manufacturers to phase out the use of FD&C Red No. 3 in foods before 2027 deadline

Published: 15-Jul-2025

On 15 January 2025, the US Food and Drug Administration issued an order revoking the authorisation 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 15 January 2027 or 18 January 2028, respectively, to reformulate their products.

The FDA’s action to revoke the authorisation 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 authorisation of a colour additive if it has been found to induce cancer in humans or animals.

The FDA determined that data presented in a 2022 colour additive petition showed that FD&C Red No. 3 causes cancer in male laboratory rats when exposed to high levels.

FDA encourages food manufacturers to phase out the use of FD&C Red No. 3 in foods before 2027 deadline

On 22 April 2025, the US Department of Health and Human Services (HHS) announced a series of new measures to phase out all petroleum-based synthetic dyes, also known as colour 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 practicably possible, reformulate to stop using FD&C Red No. 3 in foods, including dietary supplements, to complete the phase-out before the 15 January 2027, deadline.

The FDA believes that accelerating the phase out of the use of FD&C Red No. 3 in foods will help to further the goal of Making America Healthy Again.

The FDA recognises that substituting FD&C Red No. 3 used in foods, including dietary supplements, with other colour additives may require the expanded use of authorised colour additives and/or the development of new colour additives.

The FDA also recognises the widespread interest in substituting FD&C Red No. 3 with colour additives derived from other sources, including plants.

Regardless of the source material, each colour 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 colour additive meets the legally required safety standard and issues a regulation prescribing safe conditions of use.  

Information about colour additive petitions is available on FDA’s website

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