FDA Red Dye No. 3 Ban One Week Out: What You Need to Know

Last week, the FDA issued a historic ban on the color additive Red Dye No. 3 – effective January 15, 2027, the colorant will be prohibited for use in food and beverage items.

The additive is primarily used in certain candies, cakes, cupcakes, cookies, frozen desserts, frostings, and drugs, and, although it is relatively less used compared to other colorants, the impact on F&B will be deeply felt.

The Food Institute spoke with industry stakeholders across the supply chain to evaluate the scale of the recent ruling.

“Though some food companies have already stopped the use of Red No. 3, this regulation will still impact thousands of food and drug manufacturers,” explained Michelle Anstey, regulatory affairs manager at the National Sanitation Foundation (NSF).

Why Ban Red Dye No. 3 Now?

The additive has been banned for use in cosmetics and topical drugs since 1990, so why did it take so long to bring restrictions to the F&B sector?

In late 2023, California Governor Gavin Newsom signed into law the country’s first legislation to ban four chemical food additives independent of the FDA, one of which is Red Dye No. 3. The controversial bill received backlash from national organizations like the National Confectioners Association, however, likely prompted the FDA to further scrutinize these chemicals.

The recent FDA ban asserted the decision followed evidence found in a 2022 petition that alleged it caused cancer in laboratory rats in high doses, as well as findings that suggest it may factor into behavioral outcomes for children, according to NPR.

Dr. Bryan Quoc Le, food scientist consultant, noted, however, that much of the research is likely incendiary as a result of unrealistic consumption metrics and the “mechanism of carcinogenicity” in rats not existing in humans.

“The decision was undoubtedly made due to pressure from the masses, and not from any realistic dangers from the compound, as the FDA, and many other scientists, have expressed,” he said.

Nevertheless, the result of the FDA order invoked The Delaney Clause, leading to the additive’s ban.

“The Delaney Clause is clear; the FDA cannot authorize a food additive or color additive if it has been found to cause cancer in humans or animals,” said Jim Jones, deputy commissioner for human foods for the FDA, in a statement.

Later in the statement, however, Jones corroborated Dr. Le’s findings: “The way that FD&C Red No.3 causes cancer in male rats does not occur in humans,” he said.

What Can Manufacturers Do?

“Options like beet juice, pomegranate juice, and Red Dye No. 40 may offer a reprieve,” Matt Riesenbach, product management director at ECI Software Solutions, told FI. These methods can produce color results that can mimic the soon-to-be-outlawed additive.

Margaret M. Quinlan, a professor of communication studies and director of health and medical humanities at the University of North Carolina at Charlotte, worries about the anticipated replacement of the dye with Red No. 40, one of six contentious chemicals banned in the California School Food Safety Act, signed into law last year. The Environmental Working Group noted that dye has also been linked to neurobehavioral issues in children, including brain development and hyperactivity.

Health implications aside, replacing Red Dye No. 3 could pose some logistics difficulties.

“Substitutions must be made with care, however, as, adjusting a single ingredient can disrupt the delicate balance of texture, flavor, and appearance that consumers have come to expect,” Riesenbach said.

Moreover, Anstey of the NSF notes that, even though the regulation doesn’t kick in until 2027, manufacturers are quickly adapting to its terms.

Building a Safer Food System

Environmental attorney Vineet Dubey told FI that many larger companies have already done the R&D to reformulate their products with out Red Dye No. 3.

“Companies already make the same products for the European market, where this petroleum-based dye isn’t allowed,” Dubey said, adding that, in the EU, many more food dyes are banned than in the U.S., and there is research to support their conclusions.

The country has the opportunity to leverage international scientific findings to ensure consumers are safe.

“Coordinating on something so vital to human flourishing – our food safety – should take priority over plodding, underfunded bureaucracy and political influence,” the attorney said.

Dubey advocated for working with and using insights from respected international organizations to promote a healthier country. Additionally, the attorney noted that the watershed California ban from 2022 may mean that other chemicals may undergo FDA scrutiny, including potassium bromate, brominated vegetable oil, and propylparaben.

It also set a precedent for states to have the potential to challenge governmental institutions around food safety-related topics.


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