On 15 January 2025, the U.S. Food and Drug Administration (FDA) issued an order revoking the authorization for the use of FD&C Red No. 3, a synthetic food dye, in food and ingested drugs, citing its potential to induce cancer. This action follows the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which prohibits the use of food and color additives found to cause cancer in humans or animals.
Manufacturers of food products containing FD&C Red No. 3 will have until 15 January 2027 to reformulate their products, while those using it in ingested drugs will have until 18 January 2028. Consumers may still encounter products containing FD&C Red No. 3 after the effective date if those products were manufactured before the ruling took effect. However, products containing the color additive that are still in shipment at the time of the FDA’s announcement will be blocked, held, and potentially destroyed by U.S. Customs and Border Protection (CBP).
The FDA’s decision is based on a 2022 color additive petition, which showed that FD&C Red No. 3 caused cancer in male rats exposed to high levels of the colorant. However, studies in other animals and humans did not show the same effect, and there is no evidence that FD&C Red No. 3 causes cancer in humans. Nevertheless, the U.S. FDA is compelled to revoke the authorization due to the Delaney Clause, which mandates that color additives proven to induce cancer be deemed unsafe for use.
Philippine food and drug exporters to the U.S. are advised to review and adjust their product formulations in light of the U.S. FDA’s ruling to avoid unnecessary delays and complications in shipments.
For more information, you may view the said order through this link: https://www.fda.gov/industry/color-additives/fdc-red-no-3.
For inquiries or further details, please contact the DTI’s Export Marketing Bureau (EMB) at exports@dti.gov.ph or the Philippine Trade and Investment Center (PTIC) – Washington D.C. at Washington@dti.gov.ph. ♦

Date of Release: 04 February 2025

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