FDA Revoked Authorization for the Use of Red No.3 in Food and Ingested Drugs

The FDA revoked the authorization for the use of FD&C Red No. 3 as a matter of law, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The FDA amended its color additive regulations to no longer allow for the use of FD&C Red No. 3 in food and ingested drugs in response to a 2022 color additive petition. The petition requested the agency review whether the Delaney Clause applied and cited, among other data and information, two studies that showed cancer in laboratory male rats exposed to high levels of FD&C Red No. 3 due to a rat-specific hormonal mechanism. The way that FD&C Red No. 3 caused cancer in male rats did not occur in humans. Relevant exposure levels to FD&C Red No. 3 for humans were typically much lower than those that caused the effects shown in male rats. Studies in other animals and in humans did not show these effects; claims that the use of FD&C Red No. 3 in food and in ingested drugs put people at risk were not supported by the available scientific information.

About FD&C Red No. 3

FD&C Red No. 3 is a synthetic food dye commonly used to give foods and beverages a bright, cherry-red color. It has been primarily used in products like candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings, as well as certain ingested drugs. Despite its usage in these products, FD&C Red No. 3 is not as widely used compared to other certified colors. This conclusion is based on information from third-party food product labeling databases, food manufacturers’ websites, other public information, and the FDA’s certification data.

The FDA estimates that the use of FD&C Red No. 3 is limited when compared to other synthetic food dyes, as its application in food and drugs has declined over time. Despite this, it still appears in some food and drug products, particularly those aimed at providing a vibrant red color. However, due to safety concerns and studies linking high doses of the dye to cancer in laboratory animals, the FDA has revoked its authorization for use in food and ingested drugs, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act.

Manufacturers using FD&C Red No. 3 in food and ingested drugs have been given until January 15, 2027, or January 18, 2028, respectively, to reformulate their products to comply with the new FDA regulations. While the use of FD&C Red No. 3 is restricted in the U.S., other countries continue to allow its use in certain products, where it is known as erythrosine. However, any food products imported to the U.S. must meet the U.S. regulatory requirements, which no longer permit the use of FD&C Red No. 3 in food and ingested drugs.

About The Delaney Clause

The Food Additives Amendment of 1958 was a pivotal piece of legislation that amended the United States’ Food, Drugs, and Cosmetics Act of 1938. This amendment was created in response to rising concerns about the safety of new food additives being introduced to the market. It established a critical exemption from the “food additive” definition and its associated requirements for substances that were “generally recognized as safe” (GRAS) by qualified scientific experts. Substances that had been in use before 1958 or had substantial scientific evidence supporting their safety could avoid the strict testing protocols normally applied to new food additives. However, all new food additives were subjected to rigorous testing under the new regulations, which included the “Delaney clause.”

The Delaney Clause, an integral part of the Food Additives Amendment, was a provision that banned the approval of any food additive found to cause cancer in humans or animals. This clause was named after Congressman James Delaney of New York, who championed its inclusion in the law. The Delaney Clause required that no chemical additives, if they were determined to induce cancer in either humans or animals after testing, could be used in food products. The intention behind this provision was to protect consumers from the potential dangers of carcinogenic substances in their food, and it applied specifically to pesticide residues found in processed foods. However, the law did not extend to pesticides found in raw foods, which made its application somewhat limited.

One of the most notable instances where the Delaney Clause was invoked occurred in 1959, when the FDA identified the herbicide aminotriazole as a carcinogen. This chemical had been used in large quantities in cranberries grown in Oregon and Washington. The discovery led to widespread fear and panic, particularly in the cranberry industry, and the event became known as the “Cranberry Scare of 1959.” The situation was further exacerbated by the timing of the announcement during Thanksgiving week, resulting in a sharp decline in cranberry sales. Despite government officials reassuring the public and expressing their intentions to consume cranberries, the scare marked a significant moment in food safety history and became one of the first modern food scares linked to a chemical additive. This event highlighted the impact of the Delaney Clause on public perception and the food industry, and it demonstrated the power of legislation in shaping food safety standards.