Doctor Reacts to “Clearly Not Evidence-Based” Ban of Red Dye No. 3

Jeffrey A. Singer, MD
Credit: Cato Institute

On January 15, 2024, the US Food and Drug Administration announced it was repealing the color additive regulations that permit the use of Federal Food, Drug, and Cosmetic Act (FD&C) Red No. 3 in foods (including dietary supplements) and in ingested drugs — a move receiving applause from many but also drawing the ire of others.

Also known as Red Dye No. 3, Red Dye 3 and erythrosine, the substance can be found in many popular food products, from conversation hearts and candy corns to Nesquik strawberry-flavored milk, Jack Link’s products, bacon bits and numerous others.

Celebrated by many consumers and legislators, the move is based on research indicating consumption of Red Dye No. 3, which has been banned in cosmetic products within the U.S. since 1990, was associated with an increased risk of cancer. However, many in medicine and other scientific disciplines have been quick to note significant debate exists among the applicability of these findings to human populations.

Among these individuals is Jeffrey A. Singer, MD, a general surgeon working in private practice and a senior fellow at the Cato Institute. For more on his perspective and why he feels this move is not evidence-based, we sat down with Singer for a Q&A.

The Educated Patient: The FDA decision to ban Red Dye No. 3 has raised some questions. Why do you believe this decision is not evidence-based?

Singer: It’s clearly not evidence-based, and the FDA even admits this. There have been no studies linking Red Dye No. 3 to human tumors. The last major study was conducted in 1981 on rats, which were fed massive doses of Red Dye No. 3, amounting to 4% of their total diet over their lifetimes. Only male rats showed an increased risk of thyroid tumors, some of which were malignant, but some were benign. That’s essentially it.

Now, I’m not saying everyone should consume unlimited amounts of Red Dye No. 3, but for the last 30 years, it’s been allowed in food products. It didn’t make sense back in 1990 when the FDA banned it in cosmetics but continued to allow it in food. There was no logical explanation for that inconsistency. Intuitively, many people assume these additives are harmful. Some have even said this is the beginning of banning other food colorings, claiming they’re responsible for health issues — but we don’t have evidence of that.

In a free country, autonomous adults should be able to make their own risk-benefit assessments. The FDA, after 30 years, suddenly decided to prohibit Red Dye No. 3, perhaps due to the current political mood around health. Some manufacturers have already moved away from it, like Peeps candy, which announced plans to remove it. Consumers can make choices — just as they do with organic produce, where the science on benefits is still unclear. The government should not impose a monopoly on these decisions, especially when the science doesn’t clearly support the ban.

If we find out someday that Red Dye No. 3 does cause cancer, manufacturers would be liable for lawsuits. That’s a better incentive for accountability than relying on political decisions. This reminds me of the saccharin scare in the 1970s, where products carried cancer warnings, but those warnings were later removed in 2001. Many people missed out on saccharin during that time, despite the lack of solid evidence against it. Consumers should have the freedom to make informed choices based on their own risk tolerance.

The Educated Patient: In your opinion, is there a way for regulatory bodies to strike a balance between protecting public health and respecting consumer freedom?

Singer: It’s very difficult when government bodies hold a monopoly on these decisions. Nongovernmental entities, such as consumer advocacy groups, often handle these issues more effectively. They commission research and pressure manufacturers when harmful products are identified. Manufacturers then face consequences like lawsuits or loss of business if they don’t respond appropriately.

When the government is the sole decision maker, political influence and lobbying inevitably affect outcomes. Reasonable disagreement among researchers is stifled because the government’s position becomes the final word. For example, the current political popularity of banning Red Dye No. 3 may have driven this decision, but it overrides the principle of individual choice.

The Educated Patient: Do you think this decision could impact the availability or cost of certain foods or medications?

Singer: Absolutely. While Red Dye No. 3 itself isn’t expensive, its removal affects the entire manufacturing process. Companies will need to find substitute colorings or forgo colorings altogether, which can be costly. The transition period helps, but lower-income individuals might feel the financial impact more than others. It’s unfortunate if these changes disproportionately affect those who might have been fine with taking the risk of consuming Red Dye No. 3.

I also question the assumption that artificial colorings are contributing to health declines. For example, life expectancy in the U.S. has increased slightly from 76.8 years in 2000 to 78.4 years in 2023, despite these additives being widespread. There’s no clear evidence linking them to reduced longevity.

The Educated Patient: What message would you share with patients worried about additives in their food and drugs?

Singer: I respect their concerns. If they prefer to avoid additives, there are plenty of products available that advertise being free of artificial colorings and preservatives. They should seek those out.

While it’s understandable to worry about potential risks, these additives are closely monitored by regulatory agencies and consumer watchdog groups. If credible evidence emerges linking additives to health risks, it will become widely known, and manufacturers will be pressured to act. For now, there’s no evidence that Red Dye No. 3 or similar additives pose significant risks. Like with organic produce, people can choose to avoid additives if they wish, but others should also have the right to make their own choices.

The Educated Patient: Is there anything else you’d like our audience to know or emphasize?

Singer: The most recent studies on Red Dye No. 3 date back decades, primarily involving rats fed extremely high doses. These levels far exceed what humans would ever consume. There’s no evidence linking Red Dye No. 3 to cancer in humans. This decision feels arbitrary, especially given that it’s been allowed in food and drugs for over 30 years without incident. Nothing substantial has changed scientifically since 1990 to justify this sudden ban — it appears to be a politically motivated decision.

Editor’s Note: This transcript has been edited for grammar and clarity using artificial intelligence tools.