Author: Jim Kelly

California Bans Red Food Dye: Should the FDA Follow Suit?

In a bold move, California Governor Gavin Newsom recently enacted legislation banning four commonly used additives, including Red Dye No. 3. As the Golden State takes this proactive stance to protect public health, the Food and Drug Administration (FDA) is facing pressure to take similar action on a national scale.

            The four additives at issue in the legislation, which are all commonly used in United States food and beverage production, are brominated vegetable oil, potassium bromate, propylparaben, and Red No. 3. Red No. 3 is a dye used for coloring in foods such as Nerds, Peeps, and many Halloween treats.

            The bill put forth by Governor Newsom, titled The California Food Safety Act, prohibits the use of these four additives in California beginning in 2027. Newsom notes that the four additives in the bill “are already banned in various other countries;” Newsom also cited the  European Union’s near-complete ban on Red No. 3. By delaying the bill’s implementation until 2027, Newsom stated in the bill that he intends to give brands significant time to revise their recipes to avoid these harmful chemicals. Newsom also pressured the FDA to review and establish updated national safety levels for these additives.

            Given the pressure from Governor Newsom and consumer advocacy groups to ban the use of Red No. 3 and other additives in foods, the FDA may take action. The definition of food additives in the Federal Food, Drug, and Cosmetic (FD&C) Act contains a provision for the use of ingredients that are “Generally Recognized as Safe” (GRAS) without pre-market approval from the FDA. There is no GRAS exception for Red No. 3 and other color additives, as they are not included in the definition of food additives. Instead, Red No. 3 and other synthetic dyes are subject to a formal FDA certification process based on safety and purpose to be listed. Should the FDA wish to reverse its certification and ban the use of Red No. 3 for all purposes, it could easily do so via the same regulatory action it took to restrict its use in 1990.

The FDA restricted Red No. 3 in 1990 by banning its use in cosmetics and externally applied drugs, citing their own studies that determined that FD&C Red No. 3 is an animal carcinogen. By banning Red No. 3 from being used in cosmetics and externally applied drugs but not banning its use in food, the FDA implicitly stated that Red No. 3 was somehow safe enough to be ingested, despite not being safe enough to be applied to the skin.

The FDA still has not banned the dye from being used in foods, despite its website reading, “The FDA does not approve the use of a color additive that is found to induce cancer in people or animals.” This language stems from the Delaney Clause of the FD&C Act, which forbids any additives in food shown to be carcinogenic in any species of animal or in humans. Despite their studies determining it to be carcinogenic, the FDA currently allows Red No. 3 to be used in food and drugs. This policy contradicts the Delaney Clause and the FDA’s stance of not approving carcinogenic color additives.

            California can use its economic strength to influence the FDA’s decision-making regarding the fate of Red No. 3. Because California contributes significantly more to the U.S. GDP than any other state, corporations heavily consider California’s regulations. The FDA should proactively promote a state of uniformity by banning Red No. 3 nationwide because national food companies currently using Red No. 3 will likely have to adjust their formulas to accommodate California law anyway.

In addition to its influence on corporations, the California Food Safety Act could serve as model legislation for other states seeking to ban additives including Red No. 3. This would lead to an industry-wide state of disarray, where every state allows its own different set of additives. The FDA can and should prevent this chaos by implementing a national ban on Red No. 3.