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Source: fda.gov
On January 15, 2025, the FDA issued an order to revoke the authorization to use FD&C Red No. 3 in food and ingested drugs. 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.
FD&C Red No. 3, also referred to as Red Dye No. 3, Red Dye 3, and erythrosine, 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.
The FDA is revoking the authorization for the use of FD&C Red No. 3 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 food additive or color additive if it has been found to induce cancer in humans or animals.
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. Studies in other animals or in humans did not show the same effect and there is no evidence showing FD&C Red No. 3 causes cancer in humans.
In the case of color additives, manufacturers submit data and information to the FDA as a petition requesting approval of the intended use. The FDA evaluates the petition, and other existing data and information, and if the data available demonstrates that the substance is safe under the proposed conditions of use, the agency issues a regulation authorizing the use of the color additive. When evaluating the safety of a new color additive or a new use for a listed color additive, the FDA considers factors, including likely amount of consumption, intended use, the manufacturing process, and its physical and chemical properties, among others.
Under the FDA’s food labeling regulations, certified colors must be declared in the statement of ingredients on food labels by “FD&C Red No. 3” or without the “FD&C” prefix or the term “No.”– “FD&C Red 3” or “Red 3”.
Other countries allow the use of FD&C Red No. 3 under a different name, such as in Canada and Europe under the name erythrosine.
Past Regulatory Actions on FD&C Red No. 3
In 1969, FD&C Red No. 3 had already been in use in foods and ingested drugs and these uses were permanently listed under the FDA’s color additive regulations.
In 1990, the FDA responded to a petition requesting that the FDA permanently authorize the use of FD&C Red No. 3 in cosmetics and topical drugs. Before that time, the use of FD&C Red No. 3 in cosmetics and topical drugs was provisionally listed. As part of the process to request authorization, the petitioner needed to provide data that supported the safe use of the color additive. Due to the existence of data demonstrating that the use of FD&C Red No. 3 caused cancer in rats, the FDA denied the petition based on the Delaney Clause.
In 1992, the FDA announced its intention to revoke the permanent listings for the uses of FD&C Red No. 3 in food and ingested drugs (57 FR 16702) based on the Delaney Clause due to effects observed in male rats. The agency decided not to take action at that time, given the resources required to remove this authorization. However, available data does not raise safety concerns for humans.