The Red No. 3 ban has been at the forefront of many conversations since the Center for Science in the Public Interest submitted a petition to the Food and Drug Administration (FDA) in October 2022. The recent ban by the FDA will have widespread effect in the food industry.
Janet Johnson, an Alabama Cooperative Extension System food safety and quality agent, said the primary reason for the petition was based on two studies that showed cancer in male laboratory rats that were exposed to high levels of Food, Drug and Cosmetic (FD&C) Red No. 3.
Red No. 3
Johnson said the ban will affect foods, dietary supplements and ingested drugs that contain FD&C Red No. 3.
“The dye gives foods and drinks a bright, cherry-red color,” Johnson said. “The dye is used in food products such as candy, cakes, cupcakes, cookies, frozen desserts, frostings, icings and certain ingested drugs.”
According to the ruling, manufacturers who use FD&C Red No. 3 in food and ingested drugs have until January 15, 2027, or January 18, 2028, respectively, to reformulate their products and update package labeling.
“It is important to note that the food industry is about producing safe food for human consumption,” Johnson said. “Appearance and aesthetics of food are important for the acceptance of the product. That is basically the reason why additives are utilized in the food industry.”
Johnson said many additives are put into the category of Generally Recognized as Safe (GRAS), which means that in regulated and allowed amounts intended for use, there is no evidence to demonstrate or suggest that there is a hazard to the public. However, the Delaney Clause of the Federal Food, Drug and Cosmetic Act prohibits FDA authorization of additives if they are found to induce cancer in humans or animals, thus leading to this petition to revoke FD&C Red No. 3.
“This was due to a ratspecific hormonal mechanism,” Johnson said. “The way that Red No. 3 causes cancer in male rats does not occur in humans. Relevant exposure levels to FD&C Red No. 3 for humans are typically much lower than those that cause the effects shown in male rats.”
Background
Johnson said animal research testing takes place before human consumption and it includes a thorough process.
“Animal research is used to determine if a product is hazardous to humans,” Johnson said. “Many times, the amounts or doses given to the animal, based on weight, are higher than a human might consume in their lifetime.”
Johnson said research always errs on the side of safety for the human consumer.
“If you remember, Saccharin used to have the statement that it is carcinogenic and could cause cancer in humans because it caused cancer in rats,” Johnson said. “However, the amount given to rats is high for testing purposes and it would probably take more than a lifetime for a human to consume that amount based on their body weight.”
She said sometimes it is difficult to make the conversions from animal effects to human effects, but safety is always the priority.
What to Expect
Johnson said as petitions are submitted to the FDA to reexamine food additives, the FDA will look at research that is being done on those additives. If the risk is considered substantial, they may revoke use of that additive. She said this means the food industry and manufacturers will have to reformulate their products and update any labeling involved to remain in business.
“The food industry and drug manufacturers are constantly evolving and generating new products,” Johnson said. “They will roll with the punches. Their primary goal is to make a safe product following the rules and regulations that are in place.”
With Red No. 3 removed from the list of allowed additives, the concerns associated with it will diminish. However, Johnson said since there are still other food additives in the food processing industry, there is always the possibility that studies will show that highlevel exposure may cause issues for humans.
Johnson said the question is always whether or not the risk mitigates the usefulness of the additive.
More Information
Find more food safety and quality information by visiting www.aces.edu or contacting the food safety and quality agent who serves your area.
