The use of Red Dye No. 3, a synthetic food coloring added to various foods, candies, and medications for over a century, is set to be discontinued after new health concerns emerged. The U.S. Food and Drug Administration (FDA) recently announced a ban on this commonly used additive, citing studies linking it to cancer in rats.
Food manufacturers have been given until January 15, 2027, to reformulate their products, while drug manufacturers using the dye have a slightly longer deadline of January 18, 2028.
Why Was Red Dye No. 3 Banned?
Red Dye No. 3 was initially approved for use in food products in 1907. However, concerns over its safety have persisted for decades. In 1958, Congress passed a regulation prohibiting the approval of additives known to cause cancer in humans or animals. Despite this, Red Dye No. 3 remained in use in food and oral medications even after the FDA banned it from cosmetics and skin-applied drugs in 1990 due to findings that it caused thyroid cancer in rats.
More recently, public interest groups pushed for the dye’s removal, citing studies showing that male lab rats exposed to high levels of the chemical developed thyroid cancer. This pressure led to the FDA’s decision to finally ban the dye from consumable products.
While the FDA acknowledged that cancer risks were identified in some animal studies, it noted that no clear link had been established in other types of animals. The agency stated that current scientific evidence does not conclusively support claims that the dye poses a significant risk to human health.
Other Health Concerns Linked to Red Dye No. 3
Beyond cancer concerns, some research has explored a connection between synthetic food dyes, including Red Dye No. 3, and behavioral issues in children, such as hyperactivity. However, these studies have limitations, as many were conducted on a small scale, making it difficult to draw definitive conclusions about the dye’s impact on behavior.
Foods and Drugs That Contain Red Dye No. 3
Despite growing health concerns, Red Dye No. 3 is still present in hundreds of food and drug products in the U.S. Some states, including California, have taken steps to phase out the dye. In 2023, California became the first state to ban its use in foods, with the law set to take effect in 2027.
Red Dye No. 3 can still be found in various products, including:
- Candies such as candy corn, jelly beans, lollipops, and candy necklaces
- Vegan imitation meats, including plant-based bacon and sausages
- Icings, especially red or pink frostings
- Sausages and hot dogs
- Cotton candy
- Cereals
- Cookies, cakes, cupcakes, including red velvet and “funfetti” cakes
- Rainbow sprinkles
- Strawberry-flavored kinds of milk, drinks, and nutrition shakes
- Chewing gums
- Gummy vitamins
- Mashed potato mixes
- Certain medications
What Can Consumers Do Before the Ban Takes Effect?
Until the ban fully takes effect, consumers who are concerned about Red Dye No. 3 can take steps to reduce their exposure. Checking ingredient labels on packaged foods and medications can help identify products containing the dye. Additional resources, such as the U.S. Department of Agriculture’s branded food database and the Environmental Working Group’s database, can assist in verifying products.
Experts emphasize that it may not be possible to eliminate all exposure to food additives like Red Dye No. 3 but suggest limiting its consumption where feasible. Special occasions such as birthday parties and holidays may still involve foods with the dye, but reducing everyday consumption can help minimize potential health risks.
The FDA’s decision marks a significant step toward improving food safety in the U.S., aligning the country more closely with regions like the European Union, Australia, and New Zealand, where the dye has already been largely banned from food products.