On January 15, 2025, the FDA made a significant move in food and drug safety by revoking the authorization for FD&C Red No. 3, a synthetic food dye commonly used to give products a bright cherry-red color. This decision is based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which prohibits the use of any food or color additive found to cause cancer in humans or animals. But what does this really mean for consumers, manufacturers, and the food industry at large?
The Delaney Clause and why It matters
The Delaney Clause was introduced in 1960 as part of the Color Additives Amendment to the FD&C Act. It’s a law that places a strict ban on any food or color additive that has been shown to induce cancer, regardless of how low the risk might be. This “zero tolerance” policy aims to protect public health by ensuring that harmful substances don’t make their way into the foods and drugs we consume.
It’s a powerful tool, and one the FDA has used before. In 2018, the FDA revoked the authorization for certain synthetic flavors based on cancer risks, using the same reasoning. While the clause is designed to prioritize consumer health, it does leave room for interpretation, particularly when it comes to the way chemicals affect different species. In the case of FD&C Red No. 3, the evidence of cancer risk was found in laboratory rats, not humans. Still, the FDA’s hands were tied by the law.
What is FD&C Red No. 3?
FD&C Red No. 3, also known as erythrosine, is a synthetic dye used to color a wide variety of foods and beverages. It’s most commonly found in candies, cakes, cupcakes, cookies, frozen desserts, and frostings. Additionally, it’s used in some ingested medications. The dye has been around for decades and, for the most part, has been considered safe for human consumption based on prior safety evaluations.
However, concerns about its safety resurfaced after a 2022 petition challenged the FDA to review its use in light of new scientific data. Specifically, two studies were cited that showed a higher incidence of cancer in male rats exposed to high levels of FD&C Red No. 3. But here’s the important part: the way the dye causes cancer in rats does not apply to humans. The hormonal mechanism responsible for the cancerous growths in rats is species-specific, meaning it doesn’t pose the same risk to humans.
The risk to humans: Is it really that dangerous?
Despite these findings in rats, there’s no solid evidence that FD&C Red No. 3 poses a risk to humans at the levels we’re typically exposed to. The FDA noted that the exposure levels in humans are far lower than those used in the studies showing adverse effects in rats. Furthermore, additional studies in other animals and humans have not demonstrated similar cancer risks.
So why revoke the authorization? According to the FDA, it’s not about human risk directly—it’s about the Delaney Clause. Since cancer was observed in lab animals, even though the specific risk doesn’t translate to humans, the law requires the FDA to act. This decision ensures that the agency remains compliant with the strict standards set by the Delaney Clause.
What’s next for manufacturers?
Manufacturers who use FD&C Red No. 3 in their products will need to reformulate by January 15, 2027 for food products and by January 18, 2028 for drugs. This gives companies a few years to find suitable alternatives and make adjustments to product labels and formulations.
It’s important to note that the dye isn’t banned globally. Other countries still allow the use of erythrosine in food and drugs, though imported products into the U.S. must adhere to U.S. regulations. This means that, for now, consumers outside of the U.S. might still see FD&C Red No. 3 on their product labels.
What alternatives are there?
So, what are manufacturers going to use in place of FD&C Red No. 3? Well, there are a number of natural and synthetic alternatives already in use. Some companies may switch to other red food dyes like FD&C Red No. 40 (also known as Allura Red AC), which is commonly used in candies and drinks. Others may look to natural dyes, such as beet juice powder or paprika extract, which can provide similar hues without the concerns associated with synthetic dyes.
The growing demand for natural and plant-based ingredients also aligns with a broader trend in the food industry to move away from artificial additives. It’s possible that this shift could lead to even more innovative solutions for achieving vibrant colors without compromising consumer health.
The bottom line
While the revocation of FD&C Red No. 3 might seem like a small change on the surface, it’s a reflection of the FDA’s commitment to ensuring the safety of the food and drug supply. Although current scientific evidence suggests that the dye doesn’t pose a major risk to human health, the strict standards of the Delaney Clause leave little room for discretion. Manufacturers will need to act quickly to reformulate their products, and consumers may start seeing new colors on their favorite treats. Staying informed about FDA updates is crucial for buyers, suppliers, customers, and manufacturers alike.
For those who are concerned about the chemicals in their food, this move is another step toward ensuring that only the safest ingredients make their way to the market. Whether or not you’ll miss FD&C Red No. 3, it’s clear that the conversation around food additives and their safety is far from over.
