On January 16, 2025, the Food and Drug Administration (FDA) revoked the color additive listing for use of Red Dye No. 3 in food and ingested drugs. This decision was in response to a petition filed by the Center for Science in the Public Interest (CSPI) and other stakeholders to ban Red Dye No. 3 under the Delaney Clause of the Food, Drugs, and Cosmetics Act (FDCA). To read the full amendment published in the Federal Register, click here.
Background of Red Dye No. 3
Red Dye No. 3 is a synthetic food dye that colors food and drinks a bright, cherry-red color. This dye is primarily used in candy, cakes, cupcakes, cookies, frozen desserts, frostings, and some ingested drugs. For example, it is used in Brach’s conversation hearts and TruMoo’s strawberry milk. As a food dye, Red Dye No. 3 is considered a “color additive” under the FDCA. Color additives are distinguished from food additives, and defined as “a dye, pigment or other substance, which is capable of imparting color when added or applied to a food, drug, cosmetic or to the human body.” The FDA considers color additives to be useful because it provides consistency in coloring that helps consumers identify products on sight. For example, the pink/red coloring produced by Red Dye No. 3 in strawberry milk helps the customer know the milk is strawberry flavored. Through Red Dye No. 3 has been permanently listed for use in foods and ingested drugs since 1969, the FDA banned its use in cosmetics and topical drugs in 1990. Additionally, Red Dye No. 3 is banned for food use in Japan, China, Australia, New Zealand, and other countries.
Color Additive Approval Process
Since 1960, to be used in food, drugs, cosmetics, or medical devices, the FDCA requires that color additives be approved by the FDA. This means that a manufacturer must first request approval from the FDA to market a new color additive or to use a color additive already approved for one use in a manner not yet approved. This request is called a Color Additive Petition, and it must provide evidence that the substance is safe for the ways in which it will be used. For example, color additives will generally be used for the purpose of coloring foods, thus when submitting a Color Additive Petition, a manufacturer must submit evidence that proves the color additive is safe when used to color the food it is in.
Once the petition is approved, a regulation identifying the conditions of use is published in the Federal Register. There are two categories of published color additives listed in the Code of Federal Regulations. First, there are color additives that are exempt from certification. These color additives are naturally occurring. An example of a naturally occurring color additive is titanium dioxide. Second, there are color additives subject to certification. These color additives do not occur naturally and are instead synthetically created. For example, Red Dye No. 3 is a color additive that is synthetically produced, and before it was banned, each batch had to be certified by the FDA before use in foods or ingested drugs. FDA’s certification process for batches of color additives requires a chemical analysis of a sample of the batch to ensure it meets the required identity and specifications.
The regulations for these categories are found in 21 CFR parts 73 and 74. Each listing provides the color additive’s chemical specifications, identifies uses and restrictions, includes labeling requirements for the marketed color additive, and lists the requirements for certification. For example, the listing for FD&C Blue Dye No. 1 includes the identity, or the chemical combination that creates the color additive, the specifications of creating Blue Dye No. 1, the uses and restrictions Blue Dye No. 1 is approved for, its labeling requirements, and explains that Blue Dye No. 1 must be certified. 21 CFR § 74.101. According to the FDA, it may “revoke or amend” a color additive’s “regulations of current authorized uses as needed.” This allows the FDA to revoke or amend the regulatory listings for color additives without undergoing the formal rulemaking process that is typically required for agency actions. Here, the FDA is revoking the regulations formally found at 21 CFR §§ 74.303, 1303 authorizing the use of Red Dye No. 3 for coloring in foods and ingested drugs.
Petition History of Red Dye No. 3
Red Dye No. 3 has been in commercial use since the early 1900s, but it was not permanently listed under the FDA’s color additive regulations until 1969. Following the Color Additive Amendments of 1960 to the FDCA, the FDA updated the procedural regulations for the color additive petition process – this is the current petition process color additives undergo today. After the petition process was updated in 1960, all additives that had been in commercial use at the time were provisionally listed and could be used on an interim basis until they were either permanently listed or terminated. Per the FDA, “permanently listing a color additive for a proposed use was prohibited unless scientific data established its safety.” Thus, Red Dye No. 3 was provisionally listed in 1960 and stayed under that classification until it was proved safe through the petition process in 1969 and permanently listed for use in food and ingested drugs. However, after the FDA revoked the authorization of Red Dye No. 3 for uses in cosmetics and topical drugs in 1990, the FDA announced two years later that, under the authority of the Delaney Clause, it intended to revoke the permanent listings for the uses of Red Dye No. 3 in food and ingested drugs. Despite the 1992 announcement, FDA never revoked the authorization. According to the FDA, “the agency decided not to take action at that time, given the resources required to remove this authorization,” but maintained that “available data does not raise safety concerns for humans.”
Delaney Clause
Now, the FDA is specifically banning Red Dye No. 3 because of the Delaney Clause of the FDCA. Under the Delaney Clause, a color additive shall be deemed unsafe for any use that will result in the ingestion of all or part of an additive, if the additive is found to cause cancer in man or animals. 21 USC § 379e(b)(5)(B). The CSPI petition requested the ban of Red Dye No. 3 under the Delaney Clause by citing two studies that showed cancer in laboratory male rats exposed to high levels of Red Dye No. 3. The FDA has noted, however, that the cancer in male rates was due to a rat specific hormonal mechanism that humans do not possess. The FDA states that available scientific information does not support the claim that Red Dye No. 3 in foods and ingested drugs puts people at risk. Nonetheless, in compliance with the Delaney Clause, the FDA is repealing the color additive regulations that permit the use of Red Dye No. 3 in foods and ingested drugs. This means the regulations permitting the authorized use of Red Dye No. 3 as a color additive are revoked. As the rule currently reads, food manufacturers who use Red Dye No. 3 in food will have until January 15, 2027 to comply, while ingested drug manufacturers will have until January 18, 2028. Additionally, the ban will also apply to food imported into the U.S.
State level bans
The FDA banning Red Dye No. 3 follows several states proposing legislation that sought to ban food and color additives. Additionally, in 2024, the FDA banned the use of the food additive brominated vegetable oil. On the state level, in October of 2023, California became the first state in the nation to ban certain color additives, including Red Dye No. 3. Specifically, the California Food Safety Act, codified at Cal. Health & Safety Code § 109025, banned the manufacturing, distribution, and sale of foods and beverages containing food and color additives brominated vegetable oil, potassium bromate, propylparaben, and Red Dye No. 3. Following California’s passage of the law, several other states proposed food and color additive bans in 2024. Currently, at least six states have legislation introduced in their legislative sessions similar to California’s banning certain food or color additives. These states include New Jersey, Arkansas, Missouri, Oklahoma, New York, and Delaware. Some of these states have multiple bills proposed on the subject – including companion bills in both chambers and some in the same chamber with language that is similar. To learn more about state bills proposed in 2024 to ban the use of certain food additives, click here to read NALC article “Update on Proposed Food Additive Bans.”
Additionally, in 2024, California passed legislation banning food with certain food and color additives from being sold in schools. California’s School Food Safety Act prohibits the sale of food and beverages containing the following substances: Blue Dye No. 1, Blue Dye No. 2, Green Dye No. 3, Red Dye No. 40, Yellow Dye No. 5, and Yellow Dye No. 6. So far, Texas, Hawaii, and Virginia have introduced similar legislation this session that seeks to ban the use of certain additives in food and beverages sold in schools. Similar to California, Hawaii and Virginia’s proposed bills lists color additives as prohibited from food sold in schools, while the proposed Texas legislation prohibits primarily food additives, such as potassium bromate, propylparaben, and azodicarbonamide. As most states are just beginning the 2025 legislative session, there might be more bills relating to these topics proposed in the coming months.
Next Steps for the Federal Ban
The agency action banning Red Dye No. 3 was published in the last few days of the Biden administration. As such, its future under the Trump administration remains uncertain. Unlike the majority of midnight rules the Biden administration promulgated, the banning of Red Dye No. 3 under the Delaney Clause was not through the formal rulemaking process and thus is not subject to the level of uncertainty many of the midnight rules face. Nonetheless, because its effective date had not occurred went President Trump signed an executive order that froze all agency actions for review and approval by a Trump administration official, it is still subject to review. The Trump administration has not spoken about its intentions regarding the issue, so the future of the Red Dye No. 3 ban remains unclear. To learn more about the Trump administration’s options for midnight rules that underwent formal rulemaking, click here to read NALC article “FDA Releases Final ‘Healthy’ Rule.”
To learn more about the regulation of color additives, click here to read NALC article “FDA’s Color Additive Regulations and the Skittles Litigation.”
To learn more about the California School Food Safety Act, click here to read NALC article “State Food Laws Enacted in 2024.”
To learn more about food safety generally, click here to visit NALC’s Food Safety reading room.
