California was the first state to ban four food additive ingredients approved by the U.S. Food and Drug Administration (FDA) decades ago, via the California Food Safety Act (CFSA). Companies selling food and beverages in California have until January 2027 to purge the four banned ingredients from products. 
 
The CFSA ends the use of brominated vegetable oil, potassium bromate, propylparaben, and Red Dye No. 3.
 
Before its passage, CFSA also sought to ban a popular additive in supplements called Titanium Dioxide (TiO2), but lobbying efforts by the nutraceuticals industry prevailed in convincing legislators to remove it from the ban. TiO2 is a whitening/opacity agent commonly used in supplement capsules, among other products.
 
Other trade associations including the International Association of Color Manufacturers, National Confectioners Association, and the American Bakers Association continued to oppose the legislation, as the remaining four additives are commonly used in candies, sodas, and other processed foods.
 
In New York’s State Senate (S6055A) and New Jersey’s Assembly (A5436) bills are in progress which seek to ban the same four additives as CFSA, as well as titanium dioxide.
 
FDA is catching up with California, having now proposed a federal ban on brominated vegetable oil in the U.S. food and beverage supply. The agency also reported that it plans to review safety data on the other additives as well.

Why Are These Additives Concerning?

Since the four additives in question were declared GRAS by FDA decades ago, studies which vary in relevance to real-world human exposure suggest the potential that there are toxicity risks associated with their consumption.
 
Erythrosine, more commonly known as red dye no. 3, is abundantly used in several types of candies, cakes, and other foods solely for cosmetic reasons. FDA banned the use of red dye no.3 in cosmetics and externally-applied drugs in 1990, due to animal studies suggesting its carcinogenic effects. Organizations such as Center for Science in the Public Interest (CSPI) have spent years petitioning FDA to ban the ingredient, which the agency deems too dangerous for topical applications, from ingestible products. According to CSPI, the food and drug industries used more than 200,000 pounds of red dye no. 3 in 2021 alone.
 
Brominated vegetable oil is an oil modified with bromine, which is used as an emulsifier to disperse citrus flavors, primarily in soft drinks. According to FDA, recent toxicology studies conducted in collaboration with the National Institutes of Health have yielded conclusive evidence that the additive can lead to the bioaccumulation of bromine and toxic effects on the thyroid at levels “more closely approximating real-world human exposure.” 
 
Propylparaben is used as a food additive for its antifungal and antimicrobial properties, and is most commonly used in baking applications. However, mounting evidence suggests that this additive can disrupt endocrine function. Citing a study by researchers in Tokyo, the European Food Safety Authority removed propylparaben from its list of approved food additives due to reproductive toxicity concerns.
 
Potassium bromate is commonly used as an additive in baked goods to strengthen dough or enhance texture. A review published this year in Heliyon concluded that this additive may have several chronic health effects, including abdominal pain, diarrhea, irritation of the upper aerodigestive mucus membranes, and vomiting. It may also exert carcinogenic activities, and cause injury to the tissues of the central nervous system and kidneys, the review concluded. 

FDA Catching Up

In the wake of California’s ban, FDA announced that it is proposing to ban the use of brominated vegetable oil (BVO), citing safety concerns about the bioaccumulation of bromine and toxic effects to the thyroid.
 
FDA initially declared that BVO was no longer Generally Recognized as Safe (GRAS), and limited its use to small amounts in beverages, in order to keep citrus flavoring from separating and floating to the top. But more recent toxicology studies conducted in collaboration with National Institutes of Health have resulted in more conclusive evidence to ban BVO.
 
“This is an example of how the agency monitors emerging evidence and, as needed, conducts scientific research to investigate safety related questions, and takes regulatory action when the science does not support the continued safe use of additives in foods,” said James Jones, deputy commissioner for human foods at FDA. “We recognize that California recently took steps to ban the use of four food ingredients, including BVO, in that state. The agency is continuously reviewing and reassessing the safety of a variety of chemicals in food to ensure the science and the law support their safe use in food, including all four ingredients that are part of the recent California law.”
 
FDA is presently reviewing Red No. 3 in drugs and foods, and a decision is forthcoming based on the agency’s determination whether it causes cancer in animals or humans when ingested. 

State-Federal Tensions

Duffy MacKay, senior vice president of dietary supplements at the Consumer Healthcare Products Association (CHPA), previously spoke with Nutraceuticals World about the problems that a patchwork of state bills banning select groups of additives could have.
 
“Without relying on a strong, science-driven federal food safety agency, our country is left with a state-by-state patchwork of different, emerging regulatory standards that would weaken our nation’s food system and food safety efforts. Our nation is better when each state can help feed the rest of the states with a uniform standard of safe, available food,” Gutierrez said. 
 
Frank Yiannas, former deputy commissioner of food policy and response at FDA, expressed a similar outlook in an op-ed published in the Orange County Register. He said that while his concern isn’t necessarily about the four additives in question, CFSA poses a dangerous precedent.
 
“Some have said the food ingredient ban in California is necessary because the FDA isn’t moving fast enough. While I’m sympathetic to this argument, this doesn’t mean we should bypass their authority,” Yiannas said. “While many support accelerating the FDA review process, it doesn’t mean the current process isn’t working at all.”
 
According to a statement from Jones, “one of the key reasons for the proposed Human Foods Program (HFP) transformation currently underway is to enhance our review of food chemical safety. The proposed HFP would include the creation of the Office of Food Chemical Safety, Dietary Supplements and Innovation where we intend to develop a faster and more nimble process for evaluating chemicals in the food supply.”