The Delayed Justice: 35 Years in the Making
On January 15, 2025, the FDA finally banned Red Dye No. 3 from food and ingested drug products. This monumental decision came three and a half decades after the FDA already banned the use of red dye No. 3 in cosmetics and topical drugs in 1990 under the Delaney Clause after research found the additive to be carcinogenic at high doses for rats in lab tests. The FDA is amending its color additive regulations in response to a 2022 color additive petition. The timing raises uncomfortable questions about regulatory priorities and the influence of industry lobbying on public health decisions.
What Exactly Is This Synthetic Substance
A synthetic color additive made from petroleum and chemically known as erythrosine, red dye No. 3 is used to give foods and beverages a bright cherry-red color. Red dye 3, also known as erythrosine, is a synthetic dye made from petroleum that gives popular food and drinks a bright red cherry color. It was first approved more than a century ago in 1907 when little research had been conducted on the coloring agent. For context, this occurred decades before we knew that smoking causes cancer, back in the days when cigarettes were “physician-approved.”
The Cancer Connection That Changed Everything
Animal studies completed in the 1980s revealed that Red 3 causes thyroid cancer in rats. The agency first became aware that the additive was possibly carcinogenic following a study in the 1980s that found tumors in male rats who were exposed to it in high doses. 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. However, the FDA maintains that the way that FD&C Red No. 3 causes cancer in male rats does not occur in humans.
The Behavioral Bombshell Affecting Children
A 2021 study by California’s Office of Environmental Health Hazard Assessment found that synthetic dyes like Red 3 are linked to a greater risk of behavioral difficulties in children, including decreased attention span and memory problems. Out of about 25 studies, more than half pointed to an association with behavior. “I think the evidence is compelling from those human studies that children’s consumption of synthetic food dyes can contribute to increases in symptoms like inattention, hyperactivity in some children,” Mark Miller, a scientist with California’s EPA’s Office of Environmental Health Hazard Assessment told NPR in 2023. According to the Food and Drug Administration’s estimates, American children ages 2 to 5 consume twice as much Red Dye No. 3 as the general population when compared on a body-weight basis.
The Global Ban That Left America Behind
It’s also banned or severely restricted in places outside the U.S., including Australia, Japan and countries in the European Union. While the European Union restricted the use of Red 3 to only certain types of processed cherries in 1994, the U.S. allowed its continued widespread use in food products. Red dye no. 3 is already banned in food products (except for maraschino cherries) in Europe, Australia, and New Zealand, and has been banned in cosmetics in the U.S. since 1990. This regulatory disparity highlights how America has lagged behind international food safety standards for decades.
California Led the Charge When Federal Government Failed
The decision by the federal agency also follows in the footsteps of California, whose government banned the additive in October 2023. For example, in October 2023, California became the first state to ban the manufacture and sale of products containing Red No. 3 when Governor Newsom signed the California Food Safety Act. California as well as 10 other states have already made moves to ban the food dye, according to CSPI. State lawmakers took action when federal regulators remained stagnant, forcing the FDA’s hand through grassroots pressure and legislative momentum.
The Staggering Scale of Contaminated Products
“A search of the U.S. Department of Agriculture’s Branded Foods Database at FoodData Central identified 9,201 US food products that contain Red 3 – including hundreds of products made by the country’s biggest food companies,” the CSPI notes. According to the Center for Science in the Public Interest (CSPI), there are upwards of 9,200 products in America – McCormick and Wilton’s Red Food Coloring included – that currently contain the dye, some more popular than others. FD&C Red No. 3, also referred to as Red Dye No. 3, Red Dye 3, and erythrosine, is a synthetic food dye that gives certain foods and drinks a bright, cherry-red color, and is found in certain candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings, and ingested drugs.
Industry Giants Scrambling for Solutions
Food manufacturers will have until January 2027 to reformulate their products to comply with the new Food and Drug Administration (FDA) regulation, while producers of ingested drugs, such as certain cough syrups, have until January 2028 to remove the additive. Ferrara Candy Company, which owns Brach’s, said: “Ferrara’s roadmap to phase out the use of Red No. 3 began in early 2023. As such, less than 10% of Ferrara’s portfolio of products include Red No. Many manufacturers have already started phasing out Red Dye No. 3. For example, Abbott, the maker of PediaSure, has removed the dye from its products, and Dole eliminated it from fruit bowls in 2023.
The Natural Alternatives Revolution
Some companies have already replaced synthetic dyes like Red 3 with natural alternatives, including beet juice, red cabbage pigments, and carmine, a coloring made from insects. Some companies have already been using natural alternatives like betacyanin, which is the coloring derived from red beets, and anthocyanin, which is a pigment found in items such as radishes and purple sweet potatoes. “I’m hopeful that we’ll see more brands naturally coloring their products using ingredients like beets, spirulina and turmeric,” says Stefani Sassos. Bowen also predicts that other natural options may become more popular, including minerals such as calcium carbonate (white) and iron oxides (red, brown and black), fruit and vegetable extracts like blueberry (blue), grape (purple) and cherry (red).
The Broken Regulatory System Exposed
The agency has failed to effectively monitor the safety of chemicals after they come to market, which is why, after years of prompting by CSPI and our partners, the agency announced plans in 2024 to develop an enhanced framework for conducting post-market assessments of food chemical safety. At the time, the FDA said that it would “take steps” to ban it from food as well, but then … it didn’t. When CR asked the agency to explain its lack of action in 32 years, officials didn’t answer directly. Since 2000, the food and chemical industry has greenlighted nearly 99% of food chemicals introduced onto the market without federal safety review, according to a new EWG analysis.
