FDA bans red food dye

Currently, Red Dye No. 3 is used in dozens of candy, food, and beverage products. However, many brands have either never used or stopped using the additive entirely.

FDA first became aware that Red Dye No. 3 was potentially carcinogenic after a study in the 1980s found tumors in male rats who were exposed to it in high doses. Since Red No. 3's initial approval in 1969, FDA said it has reevaluated the dye's safety multiple times, and there don't currently appear to be any studies establishing links between Red Dye No. 3 and cancer 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," FDA said in its update on Wednesday. "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."

However, Red Dye No. 3 has been banned from use in cosmetics and topical drugs since 1990 under the Delaney Clause of FDA's Federal Food, Drug, and Cosmetic Act that "prohibits the FDA from approving a color additive that is ingested if it causes cancer in animals or humans when ingested."

At least 11 states have introduced legislation that looks to ban the use of Red Dye No. 3 in foods, and the dye is already banned or severely restricted in many places outside the United States, including Australia, Japan, and countries in Europe.

Food manufacturers will have until Jan. 15, 2027, to reformulate their products, and companies that make ingested drugs like dietary supplements will have an additional year.

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Peter Lurie, executive director of the Center for Science in the Public Interest, said FDA's decision to ban Red Dye No. 3 ends "the regulatory paradox of Red 3 being illegal for use in lipstick, but perfectly legal to feed to children in the form of candy."

Lurie added the decision "removes an unnecessary hazard from the American food supply, and we welcome that action, even though it should have occurred more than three decades ago."

According to Jennifer Pomeranz, associate professor of public health policy and management at New York University's School of Global Public Health, "[t]here 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.

"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 Jerold Mande, adjunct professor of nutrition at the Harvard T.H. Chan School of Public Health.

The National Confectioners Association in a statement said that food safety is the top priority for American confectionary 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. "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."

The proposal is open for comment through May 16, but it's unclear whether the incoming Trump administration will finalize the rule. If the rule is finalized, manufacturers with $10 million or more in annual food sales would have to comply within three years of the rule's effective date, while smaller manufacturers would have four years to comply.

The proposal comes after three years of research by scientists at FDA, who looked at front-of-package labels used in other countries. After reviewing each label's effectiveness, FDA tested potential designs with focus groups to determine if they were easy to comprehend. FDA's newly proposed labels scored highest among the 10,000 people who participated in the focus groups, the agency said.

FDA said the new labels could incentivize manufacturers to reduce the levels of salt, sugar, and saturated fat in their products, though that wasn't the agency's goal when proposing the new label. "We assume there may be manufacturers who would want to reformulate to move from the high to the medium category, or from the medium to low category," said Rebecca Buckner, FDA's associate deputy director for human food policy.

According to FDA, more than 60% of American adults suffer from Type 2 diabetes, heart disease, and high blood pressure — conditions driven in part by high levels of salt, sugar, and saturated fats.

"Nearly everyone knows or cares for someone with a chronic disease that is due, in part, to the food we eat," said FDA Commissioner Robert Califf. "It is time we make it easier for consumers to glance, grab, and go."

"If you're a retailer selling something that's just above the threshold, you have a lot of incentive to take a little bit of sugar out of your breakfast cereal so it doesn't bear the high label," said Anna Grummon, director of the Stanford Food Policy Lab. "That's a win for consumers." 

However, Christina Roberto, an associate professor of health policy at the University of Pennsylvania's Perelman School of Medicine, noted the effects aren't always straightforward. For example, the food industry has been lowering the amount of sugar in products for years, but that's resulted in the introduction of more sugar substitutes like aspartame. "There is reason to be concerned about that," she said. "You don't want to cause some other unintended consequences."

Roberto also added that the proposed label's high, medium, or low delineations "can be confusing to consumers. It's like pulling up to a traffic light that's red and green at the same time and you don't know what to do. It's low in sugar but it's high in sodium — is it good, is it bad?"

Sen. Bernie Sanders (I-Vt.) said the proposed labels are "pathetically weak" because they didn't clearly convey the health risks of ultra-processed foods.

"The proposed FDA rule fails to adequately warn the American people of the dangers of consuming these unhealthy products," he said.

Food and beverage companies also criticized the rule. Sarah Gallo, SVP for product policy at the Consumer Brands Association, said in a statement that the proposed labels lacked important information like calorie count and whether a product contained high levels of nutrients that are key to a healthy diet.

"The FDA's proposed rule for front-of-package nutrition labeling appears to be based upon opaque methodology and disregard of industry input and collaboration," she said.

Jennifer Hatcher, chief public policy officer for the Food Industry Association, said the label's focus on just three nutrients is "overly simplistic and will not help educate consumers on how to improve their overall dietary pattern." However, Hatcher added the group appreciated that calories could be voluntarily included alongside the label, as well as FDA's "decision to maintain a black-and-white FOP labeling scheme and to include at least some quantitative values."