In October 2023, California passed the California Food Safety Act becoming the first state to ban the manufacturing, distribution and sale of food and beverages containing the food and color additives brominated vegetable oil (BVO), potassium bromate, propylparaben, and red dye 3. Following passage of the California law, several other states have proposed legislation banning certain food additives. This follows a number of petitions to the Food and Drug Administration (FDA) advocating for the prohibition of specific food and color additives, and the FDA’s proposed rule banning BVO as a food additive in foods and beverages.
Background on food additives, color additives, and GRAS
Food Additives
A food additive is defined by the FDA as “any substance the intended use of which results or may reasonably be expected to result – directly or indirectly – in it becoming a component or otherwise affecting the characteristics of any food.” Simply put, a food additive is an ingredient added to food for a specific purpose. For example, food additives can be included in foods for purposes such as preservation, adding texture, or maintaining taste. A food additive is defined by the Federal Food, Drug, and Cosmetic Act (FDCA), and distinguished in the FDCA from ingredients that are generally recognized as safe, prior-sanctioned substances, color additives, and dietary ingredients. A food additive must be authorized by the FDA before it can be used in food on the market. To receive authorization, a manufacturer of food must submit a food additive petition that provides evidence that the substance is safe in the foods it will be used in and with the levels of use intended. The FDA will publish a notice of the petition and determine if science demonstrates it meets FDA’s safety standards – a reasonable certainty of no harm. This standard means that competent scientists have a reasonable certainty that under the conditions of the food additives intended use the additive will not be harmful. 21 C.F.R. 170.3(i).
“Generally Recognized as safe”
Distinguished from food additives, ingredients may also be included in a food without pre-market approval from FDA if the ingredients are “generally recognized as safe (GRAS).” This classification is given to food ingredients that are generally recognized by qualified experts as safe. For an ingredient to be considered GRAS, the necessary data establishing its safety must be available publicly, and the ingredient must meet the same safety standard as food additives – reasonable certainty of no harm. For more information on the FDA’s regulation of food additives and GRAS, please visit the NALC Food Safety Reading Room.
Color Additives
Additionally, the FDCA distinguishes color additives from food additives. According to the FDA, a color additive is “a dye, pigment or other substance, which is capable of imparting color when added or applied to a food, drug, cosmetic or to the human body.” Under the Food, Drug, and Cosmetic Act, color additives are subject to FDA approval before they may be used in food, drugs, cosmetics, or medical devices. FDA’s regulation of color additives includes two lists – chemicals exempt from certification and chemicals which are subject to certification. Color additives exempt from certification are those derived from natural sources, and color additives subject to certification are those synthetically produced. For example, titanium dioxide is a color additive exempt from certification because it is a naturally occurring mineral, while Red Dye 3 is subject to certification because it is human made. For more information on the regulation of color additives, click here to visit NALC article “FDA’s Color Additive Regulations and the Skittles Litigation.”
Background on specific ingredients
The following substances are food additives and color additives that states have sought to ban through proposed legislation.
Brominated vegetable oil (BVO) – Used primarily in citrus beverages to prevent the citrus flavor from separating and floating to the top, FDA has been regulating BVO as a food additive since the 1970s, but recently published a proposed rule banning it’s use. BVO is a vegetable oil modified with bromine that was authorized for use in small amounts not to exceed 15 parts per million. Most beverage makers have replaced BVO with an alternative ingredient; therefore, few beverages still contain BVO today.
Red Dye 3 – Authorized for use as a color additive in both food and ingested drugs, Red Dye 3 gives food and drinks a bright cherry-red color. Rye Dye 3 was approved for use as a color additive in 1969, but prohibited for use by the FDA in cosmetics and topical drugs because data showed it caused cancer in animals. The use of Red Dye 3 in food and ingested drugs is actively being reviewed by the FDA following a petition from concerned stakeholders. Red Dye 3 is banned as an additive in Australia, New Zealand, and the European Union (EU).
Titanium Dioxide – A white pigment used in a variety of FDA regulated foods like bakery products and candy. Though it is banned as a food additive in the EU, the FDA allows the use of titanium dioxide as a color additive if the quantity of titanium does not exceed 1% by weight of the food. The World Health Organization and the Food and Agriculture Organization Joint Expert Committee on Food Additives issued a statement in 2023 concluding that the use of titanium dioxide in food is safe. FDA is currently reviewing a petition to ban titanium dioxide.
Potassium bromate – A “slow-acting oxidizer” used in flour, particularly for hamburger buns and dinner rolls. Potassium bromate is not regulated by the FDA as a food additive, but is regulated as a “prior sanctioned substance” by the FDA. This is a classification that includes foods sanctioned by the FDA for a specific use prior to 1958 when the Food Additives Amendment was added to the FDCA.
Propylparaben – Used as an antimicrobial agent for preservation in foods, but linked to health problems such as arthritic inflammation, reproductive issues, and breast cancer.
Azodicarbonamide – Used as a whitening agent in cereal flour and a dough conditioner in bread, azodicarbonamide is an FDA approved food additive. Though studies have shown that the breakdown chemical, semicarbazide, that forms from azodicarbonamide in the bread making process caused tumors in female mice, FDA still considers azodicarbonamide a safe food additive when used at the levels allowed in food.
Butylated hydoxyanisole – A synthetic food antioxidant that prevents oils, fats, and shortenings from oxidative deterioration and rancidity.
Proposed and enacted state laws
California
The California Food Safety Act prohibits the manufacture, distribution and sale of food and beverages containing the food additives BVO, potassium bromate, propylparaben, and Red Dye 3. Enacted in October 2023, the law will go into effect in January 2027.
Illinois
SB 2637 prohibits the manufacture, distribution, and sale of food and beverages containing BVO, potassium bromate, propylparaben, and Red Dye 3. Like the California law, if passed, this bill would go into effect in January 2027.
Missouri
Similar to California and Illinois, Missouri proposed HB 2474 to prohibit the manufacturing, distribution, and sale of food and beverages containing the food additives BVO, potassium bromate, propylparaben, and Red Dye 3. If passed, this bill would also go into effect in January 2027.
Washington
In its 2024 legislative session, the Washington House of Representatives introduced legislation similar to California, Illinois, and Missouri to ban the use of BVO, potassium bromate, propylparaben, and red dye 3 as food additives. However, the bill was not passed before the end of the legislative session.
New York
New York has proposed the most expansive of the bills banning food and color additives. Along with the four prohibited in California, Illinois, Missouri, and Washington, New York adds on three. In A 6424 and S 6055, New York proposes to prohibit the food and color additives BVO, potassium bromate, propylparaben, azodicarbonamide, butylated hydroxyanisole, red dye 3, and titanium dioxide. Unlike the California law, if this New York bill is enacted, it would go into effect one year after its passage.
Effect of state bans
If states follow in the footsteps of California and pass legislation banning the use of food additives that are federally permitted, a difficult hurdle could be created for food manufacturers. For example, red dye 3 – still permitted federally, but one of the banned additives in California – is used in the making of Branch’s Candy Corn, so Branch’s would have to alter the composition of their Candy Corn to manufacture, distribute, or sell the product in California or any other state that banned red dye 3. Essentially, this means California can influence how food manufacturers operating in other states produce their food products if that food manufacturer wants to sell their product within California. A similar issue was recently discussed in National Pork Producers Counsil v. Ross where California’s “Prop 12” regulation was deemed constitutional. Prop 12 is a California ballot initiative that created conditions on pork meat sold in California no matter where it was produced. The main issue the case determined was whether it was constitutional for a state government to pass laws that affect the actions of people in other states. The effects of Prop 12’s constitutionality will stretch beyond just pork production and will influence issues like the food additive ban and more. To read more on Prop 12, click here to visit NALC article “What’s Cooking with Prop 12?: SCOTUS Decision.”
Proposed FDA regulations
In November 2023, the FDA published a proposed rule to ban the use of BVO in food for human consumption. As mentioned above, BVO is a food additive that was primarily used in citrus flavored beverages to prevent the flavoring from separating and rising. For example, BVO was a long-time staple in beverages like Mountain Dew and Gatorade. However, most beverage companies have now replaced BVO with an alternative substance. Following a study in collaboration with the National Institutes of Health, the FDA determined that the use of BVO in food is no longer considered safe. The rule was proposed in November 2023, and is undergoing the review process following the close of the public comment period. The FDA is currently reviewing stakeholder petitions requesting the ban of red dye 3 and titanium dioxide.
Conclusion
California was the first state to ban the use of food and color additives – BVO, potassium bromate, propylparaben, and red dye 3 – in food. Following the California ban, several states have proposed legislation banning the four as well. New York goes beyond the other states to propose additional bans to titanium dioxide, azodicarbonamide, and butylated hydroxyanisole. The FDA proposed a federal ban on BVO in October 2023, and while FDA’s ban would apply across the country, the state bans could present a challenge to food producers who may have to contend with different standards across various states.
For FDA resources on the regulation of Food Ingredients, click here
For more NALC resources on the Prop 12 case, click here and here