FDA Bans Red Dye No. 3... A Preamble for What is About to Come

Author: Jeffrey Wacks, MD

If you had said in 2024 that Red Dye No. 3 was potentially unsafe for human consumption, you might have been labeled a "conspiracy theorist." But as of January 15, 2025, those still loyal to the establishment health authorities might be left scratching their heads. 

It's not that regulators aren't allowed to change their minds. To the contrary, true science necessitates that we do change our minds when new evidence is presented that contradicts our beliefs. But here's the problem... this decision is not based on new evidence. The FDA banned Red Dye No. 3 in response to a 2022 petition from an independent advocacy group called the Center for Science in Public Interest (CSPI). Their legal argument was that Delaney Clause of the Federal Food, Drug and Cosmetic Act prohibits the FDA from approving a color additive that is ingested if it causes cancer in animals or humans when ingested. As it turns out, in 1990, the FDA itself banned Red Dye No. 3 in cosmetics and topical medications after studies showed that it led to cancer in rats. According to the FDAs website, in 1992, the FDA considered banning Red Dye No. 3 in food based on this experimental animal data, but did not take action at that time due to "the resources required to remove this authorization" and stating that "available data does not raise safety concerns for humans." 

The part of all this that is difficult to explain is why the FDA felt they had the authority to disregard the Delaney Clause and why it took 30 years for there to be pushback on the agency. To be fair, there is an argument to made that the Delaney Clause is too aggressive. For example, it is theoretically possible for a chemical to have a benefit and a infinitesimally small risk of cancer in humans, and it could be argued that chemicals with this type of profile should not be banned. But if that is your opinion, you should work on going through the process of changing the law. As it stands today, the law of the land is that we should be aggressive with keeping carcinogenic chemicals out of the food supply. While we are not lawyers, nor food scientists, as healthcare professionals, we would tend to agree with this stance, particularly in the context of the growing sentiment that the toxicity of the food supply is a significant contributor to the epidemic of chronic diseases we are seeing in this country. Additionally, there are more natural food coloring products that are sourced from fruits and vegetables that can be used in these products.

A Sign of Things to Come?

Taken as an individual data point, we might chalk this up to incompetence. Many health establishment loyalists, those who believe there is nothing wrong with the food supply, will say that the process worked, the FDA responded to the petition and were successful at fixing a mistake. Organizations are made of people and people make mistakes... move on. But what if this not an individual data point? What if connecting the dots leads us to a different picture? What about Red Dye No. 40, Yellow Dye No. 5, and all the other artificial dyes? What about other toxins such as glyphosate, plastics, potassium bromate, heavy metals, etc. What if in reality, the FDA is allowing hundreds of chemicals in the food supply that are known toxins and/or banned to varying degrees in other countries? At some point, we have to consider the idea that this is not just incompetence. We have to be open to the possibility that, yes, our regulatory agencies work more in the interest of the food industry than they do the public health, a term sometimes referred to as regulatory capture. 

If we take a step back, remove ourselves from the politics, and look at this unemotionally, it seems that the writing on the wall is clear: this is just the beginning. We are likely going to see more and more chemicals be re-evaluated and re-analyzed as the incoming administration goes through the process of restructuring these regulatory agencies. We are not necessarily saying this is good or bad, it is just a reality of the direction the country is taking. The potential concern would be that a large restructuring of our institutions may create unintended consequences and a chaotic environment if there is too much change at once. It is for this reason that we must be cautious and remain vigorously scientific as we go through this process. However, it seems clear to us that if we care about the health of our children, our communities, and our country, this is a problem that must be tackled. We believe that Red Dye No. 3 will be the first casualty of many that will follow. But only time will tell how this plays out in the long run.

Sources:

https://www.cnn.com/2025/01/15/health/red-dye-no-3-ban-fda-wellness/index.html

https://www.cnn.com/2025/01/17/health/red-40-food-dyes-wellness/index.html

https://www.nytimes.com/2025/01/16/well/red-dye-3-foods.html