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

According to the article, the U.S. Food and Drug Administration recently banned the use of red dye No. 3 in food, beverages and ingested drugs, more than 30 years after scientists discovered links to cancer in animals.

A synthetic color additive made from petroleum and chemically known as erythrosine, red dye No. 3 is used to give foods and beverages a bright cherry-red color.

The move acts on a November 2022 petition submitted by multiple advocacy organizations and individuals, including the Center for Science in the Public Interest and the Environmental Working Group, which cited links to cancer.

The decision by the federal agency also follows in the footsteps of California, whose government banned the additive in October 2023.

Manufacturers using red No. 3 in food and ingested drugs have until January 15, 2027, and January 18, 2028, respectively, to reformulate their products, according to the FDA. Foods imported to the United States also must comply with the requirements.

“Today’s action by FDA is long overdue, is a small step in the right direction, and hopefully signals a renewed effort by FDA to do its job despite the many barriers the food industry places in its way,” said Dr. Jerold Mande, adjunct professor of nutrition at the Harvard University T.H. Chan School of Public Health, via email.

A “Monumental Victory” for Consumer Health

The decision marks a “‘monumental victory” for consumer health and safety,” said Ken Cook, cofounder and president of the Environmental Working Group, in a news release. “We wouldn’t be celebrating this historic decision today without the relentless leadership of public health champions like Michael Jacobson and others who took up this fight decades ago on behalf of consumers.”

Ferrara

Red dye No. 3 is found in at least dozens of candy, food and beverage products, but some of the most popular brands either never used, or have already stopped using, the additive. Fewer than 10 percent of products made by the candy company Ferrara, which produces Brach’s candies, for example, contain the additive, as the company began phasing out the use of it in early 2023, a Ferrara spokesperson said via email.Bottom of Form

Peeps

Just Born, the company behind PEEPS, stopped using red dye No. 3 in its production after Easter of 2024, according to a spokesperson.

Some companies instead utilize red dye No. 40, which has been considered a healthier alternative as it hasn’t been as extensively associated with cancer in animals.

However, California also banned red No. 40 from foods and drinks sold in public schools in September due to concerns over links to behavioral and attention difficulties among children.

One study found a potential link to accelerated immune-system tumor growth in mice, and other sources say the dye contains benzene, a known carcinogen.

 

The “Regulatory Paradox”

Red dye No. 3 has been permissible for use in food despite the Delaney Clause of the FDA’s Federal Food, Drug, and Cosmetic Act. The clause, in part, “prohibits the FDA from approving a color additive that is ingested if it causes cancer in animals or humans when ingested,” according to the agency.

The FDA already banned the use of red dye No. 3 in cosmetics and topical drugs in 1990 under the Delaney Clause after research found the additive to be carcinogenic at high doses for rats in lab tests. The mechanism for the dye causing cancer in rats doesn’t occur in humans, so those studies didn’t raise safety concerns, and therefore the FDA didn’t revoke the authorization for red dye No. 3 in food, according to the agency.

The FDA has reevaluated the ingredient’s safety multiple times since its initial approval — based on trials conducted in animals, not humans — in 1969, according to the agency.

There don’t appear to be any studies establishing links between red dye No. 3 and cancer in humans, and “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,” the FDA said in its recent constituent update. “Claims that the use of FD&C Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information.”

But “it doesn’t matter, because the FDA mandate under the Delaney Clause says that if it shows cancer in animals or humans, they’re supposed to keep it from the food supply,” said Dr. Jennifer Pomeranz, associate professor of public health policy and management at New York University’s School of Global Public Health.

The FDA’s decision to revoke the authorization for the use of red dye No. 3 is a matter of law, the agency said.

A few other studies have cast further doubt on the safety of red No. 3, including a 2012 report that found a link between the additive and cancer in animals. That same year, researchers concluded artificial food colorings “are not a main cause of (attention deficit hyperactivity disorder), but they may contribute significantly to some cases, and in some cases may additively push a youngster over the diagnostic threshold.”

Then in 2021, the California Office of Environmental Health Hazard Assessment study found red dye No. 3 can make children vulnerable to behavioral issues, such as decreased attention. The report also concluded that federal levels for safe intake of food dyes at that time may not protect children’s brain health. The study noted that the current legal levels, set decades ago by the FDA, didn’t consider new research, according to the Environmental Working Group.

The FDA’s decision “ends the regulatory paradox of Red 3,” said Dr. Thomas Galligan, principal scientist for food additives and supplements at the Center for Science in the Public Interest in Washington, DC. But the agency “has a long way to go to reform the broken system that allowed Red 3 to remain in foods decades after it was shown to cause cancer when eaten by animals.”

The ban also moves the food landscape slightly closer to that of the European Union, which banned the dye in 1994, with the exception of some maraschino cherry products, Pomeranz said. “Europe takes the precautionary principle when it comes to these things.”

“There is not a rational reason within FDA’s mission that they did not ban red dye #3 from food in the 1990s,” and why the agency takes “so long to ban ingredients with known health harms” is unclear, Pomeranz said via email.

At least 10 other states — besides California — have introduced legislation seeking to ban red No. 3 from foods, according to the Center for Science in the Public Interest.

“Americans are sick because of our food,” Mande said. Though the United States is one of the wealthiest nations, in terms of overall life expectancy, the nation ranks as 49th out of 204 countries.

“This is because food companies have lost sight of their primary mission, providing food we will thrive on, and focusing entirely on their profits instead,” Mande added. “Unfortunately, the U.S. government doesn’t fund the research needed to determine the exact health risks posed by Red Dye #3. Industry works with Congress to block funding for the needed research.”

The National Confectioners Association

The National Confectioners Association said in a statement that food safety is the number one priority for U.S. confectionery companies.

“Our consumers and everyone in the food industry want and expect a strong FDA, and a consistent, science-based national regulatory framework,” the association said via email. “For years, our industry has been calling for more transparency, more funding, and more staff resources for the FDA to continue fulfilling its mission, and it’s time to put politics aside and work together to fund the FDA at levels that will allow it to continue its work.”

Food and beverage companies will continue to follow the latest science and comply with all food safety regulations to ensure safe and available choices for consumers, Sarah Gallo, senior vice president of product policy and federal affairs at the Consumer Brands Association, said in a statement via email.

 

Avoiding Dyes in Your Diet

The FDA has already required manufacturers to list red dye No. 3 as an ingredient on food labels — so if you’re concerned about avoiding products containing the dye until the ban is implemented, check ingredient lists before buying. Red dye No. 3 is also listed as “red 3” and “FD&C Red #3.”

Artificial food colorings are mostly found in ultra-processed foods and beverages you couldn’t make at home, Pomeranz said, so avoiding those products is another way you can eliminate red dye No. 3 from your diet. The Center for Science in the Public Interest recommends parents avoid all numbered dyes, such as yellow No. 5 and red No. 40, as well.

For medications that aren’t topical, look for dyes in the “inactive ingredients” section of the drug labeling or package insert, or search for dye-free versions of some drugs, Consumer Reports suggests. But always talk with your doctor before switching medications.

 

Discussion Questions

1. Describe the mission and purpose of the FDA.

According to its website at www.fda.gov, the FDA mission is the following:

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.

FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

For more information regarding the FDA mission and purpose, including several videos regarding the FDA’s protection of promotion of public health; the FDA’s regulatory responsibilities (laws and regulations); product approval; recalls, news, and events; guidance documents, rulemaking, and freedom of information; and medical product information for consumers, please see https://www.fda.gov/about-fda/what-we-do#mission

 

2. As indicated in the article, several states have introduced legislation seeking to ban red No. 3 from foods. Assume the FDA had decided not to ban the use of red dye No. 3 in foods. Would it have been illegal for those states to have proceeded to ban the use of red dye No. 3 in their respective jurisdictions? Explain your response.

States can have food regulations that are more stringent than FDA regulations. While the FDA sets federal standards for food safety and quality, individual states have the authority to implement their own regulations that are stricter than federal requirements. These state-level regulations often cover areas such as sanitation standards for food establishments, the sale of raw milk, pesticide use, and organic certification standards.

Each state has its own department of agriculture or health that enforces these regulations, ensuring that food safety measures are crafted to local needs and conditions. If a state finds that the federal standards are not sufficient to protect public health, it can adopt more rigorous rules.

 

3. In your reasoned opinion, is the FDA’s action in this case an example of “good government,” or is it an example of the so-called “nanny state” (defined as a government or its policies that are perceived as overprotective or interfering excessively with personal choice)? Explain your response.

This is an opinion question, so student responses may vary. Your author favors the “good” that can come about by government regulation, including greater safety for consumers. Had the FDA not acted on banning the use of red dye No. 3 in foods, it is questionable whether the public would have been aware of the inherent danger.