Dive Brief:
- The FDA is banning Red No. 3, an artificial coloring popular in candy, cereal, cakes and other foods that has been linked in high doses to cancer in rats.
- The decision gives food manufacturers until Jan. 15, 2027, to reformulate products that include the synthetic dye.
- The decision to ban Red No. 3 in food and beverages comes more than 30 years after the FDA restricted its use in cosmetics and externally applied drugs in 1990. The Center for Science in the Public Interest and 23 other organizations and scientists petitioned the agency to ban the coloring in food in 2022.
Dive Insight:
Red No. 3, which was approved for use in foods in 1907, is made from petroleum and has become a popular coloring in everything from candy to sodas due to its bright red hue.
The Environmental Working Group found in 2022 that 2,876 brand-name food products contain Red No. 3. Food app GoCoCo estimated last year that roughly a quarter of baking decorations and dessert toppings have the dye, according to data cited by Bloomberg. Red No. 3 also was discovered in 16% of chewing gum and mints, 13% of candy, and 11% of cookies and biscuits.
Red No. 3, which was approved for use in foods in 1907, is made from petroleum. The food and drug industries used more than 200,000 pounds of Red No. 3 in 2021, according to the CPSI.
The FDA cautioned that the way Red No. 3 causes cancer in male rats does not occur in humans. Still, Jim Jones, deputy commissioner for human foods at the FDA, added that under a measure known as the Delaney Clause, the agency “cannot authorize a food additive or color additive if it has been found to cause cancer in humans or animals.”
Red No. 3 has been banned in other countries, including in Europe where it can only be used for certain cherries.
The decision by the FDA marks a win for consumer advocacy groups that have pushed for decades to have the approval for the coloring revoked.
“Today’s action by the FDA marks a monumental victory for consumer health and safety,” said Ken Cook, EWG’s president and co-founder, said in a statement. “For years, Red 3 remained in food products, despite growing evidence linking it to health problems, particularly in kids.”
CPSI president Peter G. Lurie echoed a similar sentiment, noting the FDA is finally “ending the regulatory paradox of Red 3 being illegal for use in lipstick, but perfectly legal to feed to children.”
As a result of consumers turning to clean-label ingredients and action by states, many food companies have started phasing out the dye. California banned Red No. 3 in foods in 2023, and 10 other states have introduced legislation seeking similar prohibitions, according to CSPI.
The National Confectioners Association, the trade group representing chocolate, candy, gum and mints, said food safety is the top priority for U.S. confectionery companies. It has pushed for the FDA to make a decision on Red No. 3, saying state-led bans are often emotionally driven and lack scientific backing.
“We will continue to follow and comply with FDA’s guidance and safety standards,” the group said in a statement. The “FDA is the rightful national regulatory decision maker and leader in food safety.”
