FDA bans red no. 3 in food and ingested drugs
Manufacturers who use red no. 3 in food and and ingested drugs will have until January 15, 2027 or January 18, 2028, respectively, to reformulate their products.
FDA bans red no. 3 in food and ingested drugs | Image Credit: © ksena32 - © ksena32 - stock.adobe.com.
The FDA has revoked the authorization of red no. 3 in food and ingested drugs according to a January 15, 2025 announcement, with basis from the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act).1
According to the federal agency, manufacturers who use FD&C red no. 3 in food and ingested drugs have until January 15, 2027 and Janurary 18, 2029, respectively, to reformulate products.1
The revoke of authorization follows a 2022 color additive petition that requested whether the Delaney Clause applied. The Delaney Clause, enacted in 1960 as part of the Color Additives Amendment to the FD&C Act, prohibits FDA authorization of a food additive or color additive if it has been found to induce cancer in humans or animals.1
The 2022 petition cited various data including 2 studies that demonstrated cancer in laboratory male rats that were exposed to high levels of FD&C red no. 3. The FDA noted the way the dye causes cancer in male rats does not occur in humans, and that claims that the "use of red no. 3 in food and ingested drugs puts people at risk are not supported by the available scientific information," wrote the agency.1
"FD&C Red No. 3 has been primarily used in certain food products, such as candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings, as well as certain ingested drugs," stated the FDA in the announcement.1
In a May 2023 interview with Contemporary Pediatrics, Jamie Alan, RPh, PharmD, PhD, associate professor, Department of Pharmacology and Toxicology, Michigan State University, noted that no. 3 was in over 2800 foods at the time.2
"Red dye No. 3 is also known as a risk erythrosine," Alan said in the interview. "Think Halloween candy. Lots of processed foods also have red dye no. 3."2
The FDA points out FD&C red no. 3 can also be referred to as red dye no. 3, red dye 3, and erythrosine, all of which could be on food labels, said Alan in the above video.1,2
Artificial food colors (AFC) have been associated with child behavior, a topic that has been studied for over 35 years, including attention-deficit/hyperactivity disorder (ADHD).3
In a summarized history article of AFC and child behavior published in 2012 and featured in Neurotherapeutics, authors noted that studies of this association have been flawed by aspects such as study sample selection, non-standardized diagnosis, and non-standardized outcome measures.3
In review of available data at the time of publication "suggest a small but significant deleterious effect of AFCs on children’s behavior that is not confined to those with diagnosable ADHD."3
"AFCs are not a major cause of ADHD per se, but seem to affect children regardless of whether or not they have ADHD, and they may have an aggregated effect on classroom climate if most children in the class suffer a small behavioral decrement with additive or synergistic effects," wrote the study authors, led by L Eugene Arnold, MD, MEd, of the Department of Psychiatry, at The Ohio State University.
In the video above, Alan also summarized available data of the association, which made additional headlines in 2022.
"[Investigators] looked at the effects of red dye No. 3 along with some of the other dyes like red dye No. 40 and yellow dye No. 5, and what they found was in a majority of studies, there is an increased association between red dye No. 3 consumption and an increase or an exacerbation of ADHD symptoms in children," Alan told Contemporary Pediatrics.
References:
1. FDA to revoke authorization for the use of red no. 3 in food and ingested drugs. FDA. January 15, 2025. Accessed January 2025. https://www.fda.gov/food/hfp-constituent-updates/fda-revoke-authorization-use-red-no-3-food-and-ingested-drugs?utm_medium=email&utm_source=govdelivery
2. Fitch, J. Potential impacts red dye No. 3 has on children. Contemporary Pediatrics. May 2, 2023. Accessed January 15, 2024. https://www.contemporarypediatrics.com/view/potential-impacts-red-dye-no-3-has-on-children
3. Arnold LE, Lofthouse N, Hurt E. Artificial food colors and attention-deficit/hyperactivity symptoms: conclusions to dye for. Neurotherapeutics. 2012 Jul;9(3):599-609. doi: 10.1007/s13311-012-0133-x. PMID: 22864801; PMCID: PMC3441937.
