Introduction
As a dietitian with over 15 years of experience, I understand how overwhelming the world of food safety can be. The FDA ban on Red Dye No. 3 has raised questions, and it’s important to approach the issue with nuance. In this post, we’ll discuss Red Dye No. 3, why the FDA banned it, and what this means for you.
What Is Red Dye No. 3?
Red Dye No. 3 is a synthetic food coloring that gives products a vivid, bright red hue. Historically, it was widely used to make food with a duller color more visually appealing. Food manufacturers use it in candies, cakes, cookies, frosting, and some frozen desserts, as well as in certain medications.
Why Was Red Dye No. 3 Banned?
The FDA’s recent decision to ban Red Dye No. 3 in food and ingested drugs has sparked concern. So, why did this happen? The catalyst for this decision is a set of studies done in rats that indicated a potential link between Red Dye No. 3 and cancer. These studies, however, were conducted at extremely high doses, far beyond what any human would reasonably consume in their lifetime. Moreover, the mechanism by which this dye causes cancer in rats does not even apply to humans.
The FDA relied on the Delaney Clause (a provision in the 1960 Food Additives Amendment), which mandates that no food additive that increases cancer in animals or humans can remain in use, even if the risk is not relevant to human exposure. Although scientists critique the Delaney Clause, the FDA must act quickly and remove additives that meet this criteria.
The ban will take full effect in 2027 for food products and in 2028 for drugs. This gives manufacturers time to remove or replace Red Dye No. 3 from their products. However, this change does not automatically imply that Red Dye No. 3 poses a significant health risk to humans.
What Does This Mean for You?
It’s important to note that the FDA itself has stated that Red Dye No. 3 does not pose a cancer risk to humans at the typical consumption levels found in foods and drugs. The dye’s usage in food products has been steadily declining for years, and many major companies, including Ferrara Candy Company and Just Born, have already removed the dye from their products in recent years. While the ban is a regulatory decision driven by public concern and legal requirements, there is no significant scientific evidence that suggests Red Dye No. 3 is harmful to human health in the amounts typically consumed.
Stay tuned to read parts 2 and 3 on the FDA ban on Red Dye No. 3!
Citations:
- U.S. Food and Drug Administration (FDA). (2025). FDA revokes authorization of Red No. 3 in food and ingested drugs. Retrieved from FDA.gov
- Food and Drug Administration. (2021). Food Chemical Safety Review. Retrieved from FDA.gov
- Environmental Working Group. (2025). Why Red Dye No. 3 Shouldn’t Be Banned. Retrieved from EWG.org
This blog is not intended as medical nutrition therapy, medical advice, or diagnosis and should in no way replace consultation or recommendation from your medical professional.