A Look at California’s Newest Bans on Chemicals in Food

October 16, 2023 - On October 7, 2023, California Governor Gavin Newsom signed a bill prohibiting the manufacturing, sale, delivery, distribution, or carrying of food products for human consumption containing four presumably harmful chemicals: brominated vegetable oil, potassium bromate, propylparaben, Red Dye 3.

This bill, also called the California Food Safety Act, has made California the first state to ban these four additives.

However, this ban has caused an incongruency between state and federal food safety regulations. In this article, PharmaNewsIntelligence dissects the bill, evaluates safety data on these four chemicals, and assesses how misalignment between state and federal food regulations may alter public perceptions of the United States Food and Drug Administration (FDA) authority.

California Food Safety Act

Assembly Bill 418, also known as the California Food Safety Act, notes that by January 1, 2027, no companies should manufacture, sell, deliver, carry, or offer the following substances in food products for human consumption across the state of California:

• Brominated vegetable oil (CAS no. 8016-94-2)
• Potassium bromate (CAS no. 7758-01-2)
• Propylparaben (CAS no. 94-13-3)
• Red Dye 3 (CAS no. 16423-68-0)

Those who violate these guidelines may be subject to a civil penalty of up to $5,000 for the first offense and up to $10,000 for each subsequent offense.

The ban results from perceptions and some data that indicate these chemicals have harmful health effects when consumed excessively. California representatives maintain that prohibiting these substances will protect residents against the potentially dangerous impacts of these medications.

“The state is stepping up to protect people,” Assemblymember Jesse Gabriel, who introduced the bill alongside Assemblymember Buffy Wicks, told NBC News.

“The first and foremost objective is to protect kids and families and consumers in the state of California,” he said. “But a secondary objective here was to make a point and to send a message to the FDA and to folks in Washington, DC, about just how badly the FDA process is broken.”

The remaining question is how these regulations and undermining FDA procedures will impact the public perception of the administration’s regulatory authority. To date, the FDA has not banned these substances, with their rationale being that not enough evidence has been gathered to warrant regulatory changes.

“California is once again making decisions based on soundbites rather than science. Governor Newsom’s approval of this bill will undermine consumer confidence and create confusion around food safety. This law replaces a uniform national food safety system with a patchwork of inconsistent state requirements created by legislative fiat that will increase food costs. This is a slippery slope that the FDA could prevent by engaging on this important topic. We should be relying on the scientific rigor of the FDA in terms of evaluating the safety of food ingredients and additives,” said the National Confectioners Association in a statement responding to the bill.

With conflicting viewpoints and regulations, conducting evidence-based evaluations on the link between these substances and human health is critical. PharmaNewsIntelligence explores each of the four chemicals and whether or not the regulatory changes are warranted.

Brominated Vegetable Oil

According to the FDA, brominated vegetable oil is a type of vegetable oil with bromine that prevents citrus flavoring from rising to the top of some beverages. Brominated vegetable oil (BVO) may also be listed as a specific type of oil, such as brominated soybean oil. The Environmental Working Group (EWG) categorizes BVO as a higher concern in food.

According to an article by ThermoFisher, in 1958, the FDA deemed BVO as “generally recognized as safe” (GRAS). Federal regulations enforced by the FDA allow companies to include small amounts of BVO in their products as long as they do not exceed 15 parts per million (ppm). The FDA website notes that very few companies still use BVO in their product formulations, with most companies — excluding some who use it as a stabilizer for fruit flavoring in beverages — opting for an alternative. 

The Center for Food Safety in Hong Kong notes that BVO is not approved as a food additive in the European Union, Australia, New Zealand, Mainland China, Singapore, and Japan; however, certain levels are approved in America and Canada.

The global bans are based on several studies that have evaluated the safety of BVO and found that it can negatively affect human health.

For example, a 1997 case study published in the Journal of Toxicology: Clinical Toxicology revealed that a patient who consumed 2–4 liters of cola daily eventually presented with neurological symptoms, including headache, fatigue, ataxia, and memory loss. The patient also presented with right eyelid ptosis and continued deterioration, causing immobility.

Researchers conducted an in-depth evaluation, noting serum bromide levels of 3180 mg/L, which caused them to issue a diagnosis of severe bromism. Clinicians reported that hemodialysis helped clear clinical symptoms and reduce serum bromide levels.

Although BVO is currently approved as a food additive under a particular concentration, the FDA is working with the National Institutes of Environmental Health Sciences (NIEHS), a subset of the National Institutes of Health (NIH), to adjust their guidelines as recent evidence demonstrated the potentially harmful effects of BVO.

The updated considerations will be based on a Food and Chemical Toxicology study, which showed that oral exposure to BVO increased the tissue levels of bromine and detrimental thyroid effects.

The study evaluated the effects of consuming BVO through a 90-day dietary exposure experiment on Sprague–Dawley rats at various rates, including 0%, 0.002%, 0.02%, 0.1%, and 0.5% BVO by weight.

According to the research, a statistically significant increase in serum bromine was detected in rats given the highest dose of BVO, regardless of sex.

Additionally, the researchers found that male rats given the highest two doses of BVO and females given the highest concentration had an increased incidence of thyroid follicular cell hypertrophy.

Other impacts on the thyroid included an increased serum TSH level in both genders receiving the highest dose and a decrease in T4 for high-dose males.

An earlier  rats fed 0%, 0.25%, 0.5%, 1.0%, and 2.0% BVO for two weeks before mating determined that chronic exposure to BVO can have behavioral and reproductive effects.

The study found that excessive consumption of BVO yielded significant reproductive issues, with rats fed 2% being completely infertile. Beyond infertility at the highest rate of BVO consumption, researchers also noted that a 1.0% BVO diet caused difficulty reproducing and other health concerns, including reduced maternal body weight and smaller litter sizes.

Despite no evidence of offspring malformations, 1% BVO was linked to higher postnatal mortality rates and behavioral impairments in surviving offspring.

As the dose declined, the risk of postnatal death and behavioral impairments declined; however, they were not eliminated.

Researchers in the study concluded, “A clear dose–response was observed in di- and tetra-bromostearic acid levels in the heart, liver, and inguinal fat. These data expand upon previous observations in rats and pigs that oral exposure to BVO is associated with increased tissue levels of inorganic and organic bromine and that the thyroid is a potential target organ of toxicity.”

Potassium Bromate

The Michigan State University Center for Research on Ingredient Safety notes that potassium bromate is often added to baked food to oxidize dough quickly.

The chemical properties of this compound can enhance gelatinization in starches, improve volume and structure in proteins, and form protein-fat structures in lipids to improve quality.

FDA regulations allow 0.0075 parts of potassium bromate for every 100 parts of flour for uncooked products; however, fully baked products should only contain 20 parts per billion (ppb) of the compound.

The New Jersey Department of Health and Senior Services notes that potassium bromate should be handled like a carcinogen. It is a laboratory agent, oxidizing agent, and food additive.

The acute health effects of potassium bromate exposure include irritated or burning skin and eyes, coughing, wheezing, and shortness of breath. Prolonged exposure to potassium bromate has been linked to kidney, thyroid, and gastrointestinal cancer in animals, suggesting similar effects on human health.

The compound has also been linked to neurological changes, including headache, irritability, cognitive impairment, and personality changes.

Despite the potential risks, Michigan State maintains that, at low levels, potassium bromate is safe and should not affect human health. However, studies on rats have shown that high doses or increased exposure to potassium bromate can cause DNA mutations, damage cells, and cause cancer.

In Europe, potassium bromate is banned as a food additive. However, the university notes that the differences between European and American regulations are due to the fundamental strategies of the regulatory organization.

European organizations function based on the precautionary principle. These organizations ban and regularly use potentially toxic chemicals based on the possibility that any health risks may occur. However, in the US, the FDA uses risk assessments and evaluations from studies to determine how to regulate products.

Propylparaben

An article in Current Environmental Health Reports explains that parabens are compounds that can be preservatives with antimicrobial and antifungal properties that can extend the shelf-life of many foods. Propylparaben (PP) is a common type of paraben that has been added to personal care products, pharmaceuticals, cosmetics, and food.

Although multiple studies have linked paraben concentrations in urine to endocrine system disruption, researchers at the Yale School of Public Health published an article in September 2023 that noted no association between the two.

According to Chemical Safety Facts, a website run by the American Chemistry Council, some studies have insinuated that parabens cause endocrine disruption and increase cancer risk by mimicking estrogen. However, the site quickly notes that these studies on animal models have used higher and prolonged exposures that are unlikely to occur naturally.

Public perception of propylparaben safety is clouded by the results of a controversial 2004 study that connected parabens and breast cancer. Philippa Darbre, professor emeritus in the School of Biological Sciences at the University of Reading in Great Britain, who led the study, maintains that it did not make definitive conclusions on the link between

“It would be wonderful if a single chemical could be identified as a sole problem and then replaced by something ‘safe,’ but this is unlikely to happen,” Darbre told the Washington Post. “What often happens now is that one chemical with ‘bad press’ is replaced by a new chemical with less data.

Red Dye 3

According to an article by the Center for Science in the Public Interest (CSPI), Red Dye 3, also called Red 3, FD&C Red 3, and Red Dye No. 3, is a type of food coloring commonly found in candies, cakes, and other foods in the US.

Consumer Reports notes that Red 3 has been approved in the US as a food additive since 1907. The compound, also known as erythrosine, is used in various processed foods in the United States.

In an interview with Contemporary Pediatrics, Jamie Alan, PharmD, PhD, and associate professor, Department of Pharmacology and Toxicology, Michigan State University, discussed the potential health effects of Red Dye No. 3. Alan noted that some studies have associated increased consumption of Red Dye 3 with exacerbated attention deficit hyperactivity disorder (ADHD) symptoms in kids.

However, Red Dye No. 3 is often consumed with other dyes and chemicals, making determining what compound impacts symptoms difficult.

The Southern Vermont Medical Center notes that Red Dye No. 3 can be occasionally consumed safely; however, consumers may consider reading ingredient lists to minimize consumption.

Beyond the inability to definitively link Red Dye No. 3 to health outcomes, an article in the International Journal of Occupational and Environmental Health notes that other dyes, including Red 40, Yellow 5, and Yellow 6, have also been linked to intentionally carcinogenic effects.

A 2022 review published in Environmental Health analyzed the potential impacts of synthetic dyes on children and noted a need to reevaluate advised dietary intake and sponsor additional research on the matter.

Impacts on the Public

The California Food Safety Act will undoubtedly impact public perceptions about the FDA’s authority. Varying state-level regulations may cast doubt on the FDA’s ability to protect Americans and regulate chemical products.

Additionally, commentary from California representatives, such as Jesse Gabriel, may perpetuate mistrust between the public and the FDA.

Historically, incongruencies between federal and state regulations have caused increased confusion among the public and complicated rules down the line.

For example, although cannabis is a Schedule I drug not approved by the federal government, state-level approvals have allowed the sale of products in select locations. While this may seem like a relatively simple approach, the FDA is tasked with regulating CBD and hemp-derived compounds. However, the organization must reconcile federal and local regulations, which cloud the FDA approval and decision process.

Beyond complicated domestic regulatory guidelines, many advocates for this ban point to foreign regulations that have prohibited these additives. However, as researchers at Michigan State University have pointed out, the regulatory model in the US varies from other global rules.

It is challenging to compare US approvals or bans to those in the UK because they function on two fundamentally different approaches. Making changes based on potential harms rather than risk assessments and evaluations would require a complete transformation of the federal regulatory model in the US.

In lieu of a domestic regulatory metamorphosis, many experts emphasize the need for more research on these compounds to help supply the FDA with a more robust set of data to make regulatory decisions.