Red dye #3, also known as erythrosine, is a food dye that gives food a bright-cherry red color. It is found in certain cakes, cupcakes, cookies, candy, frozen desserts, frostings and icings, fruit cocktails, and ingested drugs. Red dye #3 has been allowed in foods and ingested drugs since 1969, but its use in cosmetics and topical drugs was banned by the FDA in 1990.
The Delaney Clause
The Delaney Clause is a provision in the Food, Drug, and Cosmetic Act (FD&C Act) that was added in 1958 to address how the FDA must factor in carcinogenicity in its decisions to approve food additives, color additives, and animal drugs. The Delaney Clause states that
“no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal.” [emphasis added]
The use of the Delaney Clause means that an additive can be banned if it is shown to cause cancer in animals, particularly rats or mice since they are the animals used most often, even if it has not been shown to be unsafe for humans – it is based on the outdated idea that all substances causing cancer in animals cause cancer in humans.
As written in this ACSH article, rats are not people, and because an experiment shows cancer in rats, it does not mean it will occur in humans.
- What’s harmful to an animal might not be harmful to people due to differences in physiology, behavior, and genetics.
- The doses used in animal studies are magnitudes higher than the doses to which people are exposed.
- Placing animals in artificial environments (laboratories) can cause distress and abnormal behaviors among the animals, affecting the experiment results.
More importantly, the Delaney Clause is based upon old, incorrect science surrounding the “cause” of cancer. In 1958, when the Delaney Clause was written, it was widely viewed that cancer was caused by a “single-hit” mutation that caused changes in DNA. Subsequently, we have found that DNA repair enzymes routinely repair damaged DNA and that different mechanisms, including enhanced cell replication, can result in cancer. Today, scientists believe that cancer is unlikely to be caused by a single mutation and is a complex, multifactorial disease.
Scientists have long recognized the scientific fallacy of the Delaney Clause. In 2019 and 2020, scientific experts at the Society of Toxicology and the American Association for the Advancement of Science concluded that
“based on current scientific knowledge, there is a need to revisit the Delaney Clause’s utility. It is time to rethink the Delaney clause and harmonize US FDA actions on food additives with more current scientific understanding.”
However, changes to the Delaney Clause require legislative action, which is long overdue. Red dye #3 is an example of how the Delaney Clause is used today to thwart fact-based science.
The Petition
On February 17, 2023, the Center for Science in the Public Interest petitioned the FDA requesting the removal of red dye #3 in foods and ingested drugs. The petition said that the Delaney Clause obligates the FDA to remove red dye #3 in foods and drugs based on findings of tumors in rats.
The FDA concurred and revoked its authorization to use red dye #3 as a color additive. However, they stated,
“The way the red dye #3 causes cancer in male rats does not occur in humans. Relevant exposure levels to red dye #3 for humans are typically much lower than those that cause the effects shown in male rats. Studies in other animals and in humans did not show these effects; claims that the use of red dye #3 in food and in ingested drugs puts people at risk are not supported by the available scientific information.”
The Delaney Act was previously used to remove additives that cause cancer in animals but not in humans in 2018. Six flavor additives (benzophenone, ethyl acrylate, methyl eugenol, myrcene, pulegone, and pyridine) were removed because of studies demonstrating cancers in rats and mice. While “the FDA’s rigorous scientific analysis has determined that they do not pose a risk to public health under the conditions of their intended use,” they were removed due to the Delaney Clause.
The “Healthy Foods Movement” is just beginning to show its influence on food policy, and there is much to be applauded about a movement that emphasizes better nutrition intending to reduce diabetes, obesity, and other chronic diseases. In this country, we need to try new ways to improve our health.
However, the answer is not to throw away fact-based science in the quest for healthier food. Because the Delaney Clause equates animal testing as equivalent to human data, it is being used today as a barrier to fact-based science and a vehicle to block safe food additives. The old discarded scientific beliefs incorporated in the Delaney Clause should not be allowed to be used by lawyers and public policy advocates to overrule more accurate and sound scientific assessments. The Delaney Clause needs to be amended or repealed.
Source: A regulatory relic: After 60 years of research on cancer risk, the Delaney Clause continues to keep us in the past Toxicology and Applied Pharmacology DOI: 10.1016/j.taap.2021.115779
