US FDA Bans Food Dye Red No.3

The U.S. Food and Drug Administration on January 15, 2025, announced its decision to ban Red Dye No. 3 also referred to as Erythrosine.

It is a synthetic food dye that gives certain foods and drinks a bright, cherry-red color, and is found in certain candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings, and ingested drugs. Like other color additives, its uses must be approved by the FDA, and it is used in small amounts. The FDA requires manufacturers to list FD&C Red No. 3 in the statement of ingredients when added to food.

Besides, it does not offer any nutritional value and poses potential risks. It has been linked to cancer in animals. American health officials have barred the use of artificial food colouring Red No. 3, decades after the dye was removed from cosmetics.

However, its history has been clouded by controversy, due to its link to cancer in animal studies—a step long overdue. Red Dye No. 3 is already banned or restricted in many countries, including Australia and Japan. California announced a ban of the dye in food throughout the state in 2023, and other states began introducing legislation to restrict its use, according to the Center for Science in the Public Interest.

Regulatory Information

The FDA will no longer allow for the use of FD&C Red No. 3 in food and ingested drugs Following this ban, manufacturers who use FD&C Red No. 3 in food and ingested drugs will have until January 15, 2027 or January 18, 2028, respectively, to reformulate their products.

Consumers could see FD&C Red No. 3 as an ingredient in a food or drug product on the market past the effective date in the order if that product was manufactured before the effective date.

The FDA determined that the data presented in a 2022 color additive petition show that this ingredient causes cancer in male laboratory rats exposed to high levels of FD&C Red No. 3 because of a hormonal mechanism that occurs in male rats. While the FDA cites no direct evidence of Red 3’s carcinogenic effect in people, it acknowledges that animal studies provide sufficient basis for regulatory action.

The US agency said its decision was based on the federal law called the Delaney Clause, which prohibits the use of any additive that causes cancer in humans or animals in food.

Further the agency also emphasized  that harmonizing global standards on regulating and evaluating synthetic dyes is essential to protect consumer health.

Reference:

FD&C Red No. 3 | FDA