FDA Bans Red Dye No. 3: Decades-Long Fight Ends
FD&C Red Dye No. 3, a synthetic petroleum-based dye, has been used to give food and ingested drugs a cherry-red color. Concerns about its safety arose in the 1980s due to studies linking it to thyroid cancer in lab rats. While the FDA banned its use in cosmetics in 1990, its use in food remained authorized.
In January 2025, prompted by a 2022 petition, the FDA announced a nationwide ban. The agency cited the Delaney Clause, which prohibits additives found to cause cancer in humans or animals. Although the FDA noted the animal study findings weren't directly applicable to humans, the law required the ban.
Timeline and Regulatory Context
California's AB 418, signed in October 2023 and effective January 2027, banned Red Dye No. 3 at the state level. This state action, combined with consumer advocacy, contributed to the federal ban. The FDA's ban gives food manufacturers until January 15, 2027, and drug manufacturers until January 18, 2028, to reformulate products.
Other Dyes Under Scrutiny and Action
Beyond Red Dye No. 3, other synthetic dyes are facing state-level pressure and voluntary industry agreements. The FDA and HHS are encouraging the food industry to voluntarily phase out several synthetic dyes, including Red 40, Yellow 5, and Yellow 6, which have been associated with potential neurobehavioral issues in some children. California has also banned these six dyes in school meal programs starting December 2027.
Commonly Affected Products Red Dye No. 3 was historically used in many products, particularly those for children. Products potentially containing the dye until the 2027 deadline include:
- Candies (e.g., candy corn, gumdrops)
- Colorful icings and frostings
- Cakes, cupcakes, and cookies
- Flavored milk, juices, and shakes
- Gummy vitamins
- Cough syrups and other ingested drugs
Comparison: Artificial Dyes vs. Natural Alternatives
| Feature | Artificial Dyes (e.g., Red Dye 3) | Natural Alternatives (e.g., Beet Juice) |
|---|---|---|
| Source | Petroleum-based chemicals | Plant, fruit, vegetable, or mineral sources |
| Cost | Generally low and inexpensive | Often higher due to sourcing and processing |
| Color Intensity | Highly potent, creating vivid, consistent colors | Can be less vibrant and more sensitive to light and heat |
| Regulation | FDA-certified, though Red 3 now banned | Generally exempt from certification; FDA regulates based on source |
| Stability | Very stable, with long shelf life | Can fade over time, requiring different storage or application |
| Nutritional Value | None; provides only aesthetic appeal | Some can provide nutritional benefits, like vitamins or antioxidants |
| Consumer Perception | Growing demand for alternatives due to health concerns | Perceived as a safer, healthier option |
Transition to Safer Food Coloring
The FDA is working to approve and expand the use of natural color additives. In May 2025, the agency approved new natural sources such as Galdieria extract blue, butterfly pea flower extract, and calcium phosphate to aid manufacturers in transitioning from synthetic ingredients. This supports the creation of appealing products without potentially harmful chemicals.
Conclusion: A Shift Towards Cleaner Labels
The nationwide ban on Red Dye No. 3 is a notable public health achievement, driven by state actions, scientific evidence, and consumer pressure. This decision, along with a broader industry move towards natural alternatives, suggests a future with clearer food labels. It encourages innovation and prioritizes consumer safety, aligning U.S. standards more closely with those in Europe and other regions. Consumers can promote safer food by carefully reading labels and supporting companies that remove all artificial dyes.
For more information on Red 3 and the petition leading to its ban, refer to the Center for Science in the Public Interest.
