FDA Bans Red Dye 3 From Food

On January 15, the Food and Drug Administration (FDA) announced that after nearly 100 years on the market, Red Dye 3 — also known as FD&C Red No. 3, Red 3, and erythrosine — will be banned in food and medicine in the United States. The move comes as the result of a 2022 petition signed by dozens of food safety and health advocacy organizations, and a 35-year-long regulatory paradox that forbade the substance in cosmetics, but allowed it in thousands of food products.

Red 3 is a petroleum-based dye first approved for use in American foods in 1907. It is currently used to give a bright red or pink color in candies, baked goods, and other items like hot dogs, strawberry milk, and some medications. Based on that list of foods, it should come as no surprise, perhaps that children between the ages of 2 and 5 eat twice as much Red 3 by body weight than adults.

The federal-level ban, implemented under the 1958 Delaney Clause — which bans any substance from foods that have been found to be carcinogenic in humans or animals — gives food manufacturers until January 15, 2027 to reformulate their products without the dye and pharmaceutical companies until 2028. This corresponds with a 2023 state-level ban from California, which also goes into effect in 2027.

“Today’s action by the FDA marks a monumental victory for consumer health and safety,” said Ken Cook, president and co-founder of the Environmental Working Group, which helped bring the 2022 petition to the FDA. “For years, Red 3 remained in food products, despite growing evidence linking it to health problems, particularly in kids. This ban sends a strong message that protecting the health of Americans – especially vulnerable children – must always take priority over the narrow interests of the food industry.”

While some studies suggest that Red 3 may have an effect on children’s behavior and attention spans, the dye has not been linked to cancer in humans. In its announcement, the FDA noted that while two studies have found a connection to Red 3 in male rats, this is not in and of itself concerning for people as it can be connected to a hormonal mechanism unique to rats.

“The way that FD&C Red No. 3 causes cancer in male rats does not occur in humans,” the agency says. “Relevant exposure levels to FD&C Red No. 3 for humans are typically much lower than those that cause 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 puts people at risk are not supported by the available scientific information.”

Similarly, a 2018 study by the World Health Organization and the United Nations affirmed the safety of Red 3 in foods. But because the Delaney Clause specifically bans substances found to be carcinogenic in either humans or animals, legally, Red 3 nevertheless meets the criteria for banning under U.S. law. Essentially, the ban can be considered an “abundance of caution” ban… decades after the calls for such caution began.

“By banning Red Dye No. 3, the FDA will protect the public by encouraging manufacturers to switch to safer ingredients already used in products sold in Europe and numerous other countries,” says Brian Ronholm, director of food policy at Consumer Reports, which was also involved in the petition. “Red Dye No. 3 poses an unacceptable risk to our health, especially when safer alternatives are readily available.”

In a phone interview with Scary Mommy, Robert Hildebrandt, RDN, CDCES of the Diabetes Management Center of Hackensack Meridian Southern Ocean Medical Center, believes this ban is an “absolutely huge win” for public health and, moreover, a good sign moving forward.

“I think that it’s opening the gates,” he said. “I think it’s the way in to start having people pay more attention to all the odd things that have been put into food over the decades.”

“I teach patients and their parents how to read food labels, how to read ingredients, and I can tell you every time there is a 100% chance they’re shocked at what’s in their pickles, what’s in their cereals, what’s in their peanut butter,” he notes. “They always ask me ‘why are companies putting this or that in the product?’”

The answer, more often than not, has to do with increasing profits than public health.

While Hildebrandt concedes that the removal of a single additive in ultra-processed foods is not in and of itself a food revolution, he believes taking a more precautionary approach to food additives as demanded by the Delaney Clause is nevertheless beneficial.

“Removing the dye is not going to save the day,” he says. “We still have a lot of work to do … but this is a big deal. I’m really excited that people are going to start paying more attention to what’s in their food.”

This article was originally published on scarymommy.com.