The story of food additives and banning of Red Dye No. 3

You may have heard in the news that the U.S. Food and Drug Administration will no longer allow the use of FD&C Red Dye No. 3 in food or ingested drugs.

Consumers are voicing questions about food additives and food additive safety. Additionally, information on social media often fuels confusion, fear and misconceptions. To make informed decisions, it is important to understand what food additives are, how they are evaluated for safety and how regulatory decisions are made about what additives are allowed in food.

The FDA defines a food additive as any substance that directly or indirectly affects the characteristics of food unless it has been excluded as an additive by regulations. Additives have been used for thousands of years; ancient Egyptians added natural colorants to candy, while the Greeks used sulfur to preserve wine and spices to enhance food flavor. The FDA notes that naturally occurring color additives like paprika, turmeric and saffron have long been used in food, cosmetics, and medicine. Salt, sugar, vinegar, and alcohol are all additives that have historically been used as preservatives.

Today, food additives can improve the appearance, flavor, color and texture; stabilize and thicken food products; and prevent spoilage or pathogen growth. Some additives, such as vitamins and minerals, are incorporated into products like milk, cereals and grains to improve nutrition and address deficiencies. Additives can be synthetic or natural, and there are many organic options.

You may be asking: If food additives have so many positive attributes, why was Red Dye No. 3 banned? Also known as erythrosine, this synthetic dye provides a cherry-red color to food, drinks and medications. On Jan. 15, the FDA revoked its use based on the Delaney Clause, enacted in 1960 as part of the Color Additives Amendment, which prohibits the use of any additive that has been shown to cause cancer in humans or animals. This law was created after many children a decade earlier had fallen ill after eating candy containing Orange Dye No. 1.

In 2022, a petition presented to the FDA showed that male laboratory rats exposed to high levels of Red No. 3 developed cancer because of a hormonal mechanism. These effects have not been observed in humans or other animals. Despite this, the Delaney Clause requires the FDA to revoke approval for any additive with proven cancer risks. As a result, the FDA decided to ban Red No. 3 in food and drugs, and manufacturers must reformulate their products by 2027 and 2028. The dye had already been banned in cosmetics in 1990, as the FDA had not received sufficient evidence to support its safe use in these products.

So how do we know which additives are safe? In the U.S., manufacturers must submit a petition to the FDA before a new additive can be approved. The petition must provide evidence that the additive is safe for its intended use. According to the FDA, the evaluation of a petition takes many facets of a new additive under consideration: the ingredient, how it is made, how much will be added to the food, what foods the ingredient will be added to, how much will be eaten, how the ingredient is broken down in the body and any scientific studies on safety. Some food additives, such as canola oil, vinegar, pepper, and other spices, have been defined by the FDA as “generally recognized as safe” (GRAS). These additives have often been used for decades and have undergone a stringent regulatory process to obtain GRAS approval.

Even after the FDA has approved an additive, the agency regularly provides public updates on the latest scientific findings. When an approved additive is shown to be unsafe based on the latest science, the agency can take steps to revoke the additive’s approval.

The case of Red Dye No. 3 reminds us that the safety of food ingredients must be continually evaluated based on the latest information and science and that regulatory agencies act when there are concerns about risks. As consumers, it is important to understand the regulatory process and obtain credible information so we can make informed decisions about the foods we eat.

Smith is an associate professor and statewide consumer food specialist for Washington State University in Pullman. Comments or questions may be emailed to food.safety@wsu.edu.