FD&C Red No. 3, a synthetic food coloring also known as Red Dye No. 3, Red Dye 3, or erythrosine, is widely used to give a vibrant cherry-red hue to various food and beverage products. You can often find it in candies, cakes, cupcakes, cookies, frozen treats, frostings, icings, and even some medications that are ingested. Like all color additives, the Food and Drug Administration (FDA) must approve its use, and it is typically used in small quantities. Manufacturers are required by the FDA to list FD&C Red No. 3 as an ingredient on product labels when it’s added to food.
FDA Regulatory Action on Red Dye No. 3
The FDA is set to prohibit the use of FD&C Red No. 3 in both food and ingested drugs. This decision follows an order issued by the FDA on January 15, 2025, to revoke the authorizations for these uses. Food manufacturers using FD&C Red No. 3 will have until January 15, 2027, to reformulate their products, while manufacturers of ingested drugs have until January 18, 2028. Consumers might still find products containing FD&C Red No. 3 on shelves after these dates if those products were manufactured before the deadlines.
The FDA’s revocation is grounded in the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Delaney Clause, established in 1960 as part of the Color Additives Amendment to the FD&C Act, prevents the FDA from approving any food or color additive found to cause cancer in humans or animals.
Cancer Concerns and the Delaney Clause
The FDA’s determination that FD&C Red No. 3 induces cancer is based on data from a 2022 color additive petition. This data indicated that the dye caused cancer in male laboratory rats exposed to high doses of FD&C Red No. 3. The mechanism is believed to be hormonal and specific to male rats. Studies on other animals or in humans have not shown the same carcinogenic effect, and currently, there is no evidence suggesting FD&C Red No. 3 causes cancer in humans.
Color additives, including FD&C Red No. 3, fall under FDA pre-market approval as mandated by the FD&C Act (Chapter VII, section 721). This requirement extends to their use in food, drugs, cosmetics, and medical devices that have prolonged direct contact with the body. Before a color additive can be used in food, the law requires proof of its safety under the intended conditions of use.
The FDA approval process for color additives involves manufacturers submitting petitions with safety data and information. The FDA evaluates these petitions alongside existing data to determine if the substance is safe for its proposed use. If safety is demonstrated, the agency issues regulations authorizing the color additive’s use, specifying permitted products, maximum usage levels, identity, specifications, and certification requirements. However, the Delaney Clause mandates that if a color additive intended for ingestion is shown to induce cancer in humans or animals through appropriate testing, the FDA must deem its use unsafe.
Labeling and International Use
FDA food labeling regulations require certified colors like FD&C Red No. 3 to be listed in the ingredient statement as “FD&C Red No. 3,” “FD&C Red 3,” or “Red 3.”
It is important to note that FD&C Red No. 3 is permitted in other countries under different names, such as erythrosine in Canada and Europe.
Historical Regulatory Context
FD&C Red No. 3 has been in use in foods and ingested drugs since 1969, with its uses permanently listed in FDA color additive regulations at that time.
In 1990, the FDA rejected a petition to permanently authorize FD&C Red No. 3 in cosmetics and topical drugs. Prior to this, its use in these products was provisionally listed. The denial was also based on the Delaney Clause, due to data indicating cancer in rats.
In 1992, the FDA considered revoking the permanent listings for FD&C Red No. 3 in food and ingested drugs due to the same rat study findings, but decided against action at the time, citing resource allocation priorities, despite acknowledging no direct human safety concerns from available data.
Ongoing Monitoring of Color Additives
The FDA remains committed to continuously evaluating scientific data and information to assess the safety of substances affecting the food supply. The food industry is responsible for ensuring the safety and regulatory compliance of marketed food products. FDA scientists continue to monitor and review the safety and toxicology of color additives to ensure their safe use under the FD&C Act.
For further information, you can explore additional resources provided by the FDA regarding color additives and food safety.
