FDA bans red dye No. 3 in Biden frenzy for regulations

The Food and Drug Administration said Wednesday that it was banning red dye No. 3 from food and drugs because it causes cancer in laboratory rats. This move was part of a last-minute regulatory frenzy by the Biden administration that also included a bid to cap nicotine in cigarettes.

Red dye No. 3 gives food and drinks a bright, cherry-red color. It is also known as erythrosine, or Red No. 3, and is found in cough syrups and other medicines.

The FDA said food manufacturers will have until mid-January 2027 to remake their products without the substance, and producers of ingested drugs will have until January 2028.

The administration approved the ban as it cleared the regulatory decks before ceding control to President-elect Donald Trump and his team on Monday.

Regulators revoked the authorization of red dye No. 3 under the Delaney clause, allowing them to crack down on substances that induce cancer in humans or animals.

Industry groups highlighted parts of the FDA statement that found cancer links in rats, though not in humans, while consumer groups hailed the ban as a big step forward.

“Today’s action by the FDA marks a monumental victory for consumer health and safety,” said Ken Cook, president and co-founder of the Environmental Working Group, a nonprofit that promotes health. “For years, Red 3 remained in food products, despite growing evidence linking it to health problems, particularly in kids.”

A groundbreaking 2023 California law has banned red dye No. 3 and other food additives. The California ban takes effect in 2027, and other states are working to enact similar laws.

Red dye No. 3 is banned for most purposes in Europe, Australia and New Zealand, though it is permitted in some types of cherries.

Many companies that use the dye have begun phasing it out.

Multiple reports indicate that Ferrara, which makes Brach’s candy, started its phaseout in early 2023, and Just Born, which makes Peeps sweets, started to ban it in 2024.

The FDA banned red dye No. 3 in cosmetics years ago, but it was permitted in food because of a lack of evidence showing it had the same cancer-causing effects in humans as in rats.

The Delaney clause argues in favor of a ban if cancer is found in humans or animals, so regulators said they banned the substance “as a matter of law” after reviewing petitions highlighting the findings in rats.

“The petitioners provided data demonstrating that this additive induces cancer in male rats,” the FDA said in its published order. “Therefore, FDA is revoking the authorized uses in food and ingested drugs of [Red No. 3] in the color additive regulations.”

The National Confectioners Association highlighted the lack of proven risk to humans, as opposed to rats, and pointed out that the FDA relied on a legal requirement. It said it appreciates the FDA’s lead as states pursue patchwork bans.

“Food safety is the number one priority for U.S. confectionery companies, and we will continue to follow and comply with FDA’s guidance and safety standards,” the industry group said. “Our consumers and everyone in the food industry want and expect a strong FDA, and a consistent, science-based national regulatory framework. We have been saying for years that FDA is the rightful national regulatory decision maker and leader in food safety.”

Others said the FDA caved to pressure without evidence that the dye causes cancer in humans.

“The campaign against Red No. 3 has been a scientific empty vessel from the start,” said Stephen Kent, a spokesman for the Consumer Choice Center. “Proponents of this ban will say that it’s not a big deal to have cereal, frozen treats and cupcakes be less colorful when public health is at stake, but they’ve failed to show evidence of harm and have instead relied on misinformation campaigns by social media influencers to frighten the public.”

President-elect Donald Trump’s nominee to lead the Department of Health and Human Services, Robert F. Kennedy Jr., has spoken out against additives in the food supply and condemned cereal companies and others that use specific coloring in food given to U.S. customers but not foreign consumers.

It is unclear whether the Trump administration will be as eager to follow through on a proposed rule that would cap nicotine at 0.7 milligrams per gram of tobacco in cigarettes.

“For comparison, the average nicotine content in the top 100 cigarette brands for 2017 is 17.2 mg/g of total tobacco,” the FDA said in its filing.

Smoking is the leading cause of preventable death and kills more than 480,000 Americans annually, according to the Centers for Disease Control and Prevention.

More than 4 in 10 Americans smoked cigarettes in 1965. The rate declined to 12.5% by 2020.

Capping nicotine levels in cigarettes would be a significant effort to decrease the rate further. Although the toxins in combustible tobacco cause health problems, the nicotine is what keeps smokers hooked.

Public health advocates are cheering the move, though it faces a long regulatory road and could be thwarted or reined in if the incoming administration feels it amounts to governmental overreach.

Tobacco industry lobbyists are expected to contest the move.

Mr. Trump, who does not smoke or drink alcohol, has a mixed regulatory record on cigarettes and vaping.

During his first term, he signed legislation that raised the purchasing age for e-cigarettes and other tobacco products to 21.

He leaned toward a significant crackdown on vapes in the 2018-2019 period but backed off when campaign personnel showed him evidence that his supporters liked the products.

Mr. Trump, writing on social media in September, said he “saved Flavored Vaping in 2019” and planned to “save Vaping again!”