This month, California Governor Gavin Newsom signed into law the California Food Safety Act—a bill targeted at enhancing food safety within California. The law bans the manufacture, sale, and distribution of four food additives used in over 12,000 different food products: brominated vegetable oil, potassium bromate, propylparaben, and Red Dye No. 3.
The History and the Additives
The California Food Safety Act makes California the first state in the country to ban the use of brominated vegetable oil, potassium bromate, propylparaben, and Red Dye No. 3 in food products. But these types of bans are not novel. All four ingredients are currently banned in the European Union.[1]
- Brominated vegetable oil (BVO), which can be added to beverages to keep citrus flavor from separating, has also been banned in Japan in part over allegations about neurologic symptoms in people who drink large amounts of citrus soda.[2] While BVO is regulated as a food additive, the U.S. Food and Drug Administration (FDA) has stated that over the years, many beverage makers have reformulated their products to replace BVO with alternative ingredients, and few beverages sold in the United States today contain the additive.[3] In May 2022, the FDA published a study suggesting that high levels of BVO had negative effects on rodents and the FDA is currently working on a proposed rule to remove authorization for the use of BVO as a food ingredient.[4]
- Potassium bromate, which can be added to baked goods to help dough strengthen and rise, allegedly has harmful effects on the respiratory and nervous systems when consumed in large quantities. In addition to the European Union, potassium bromate is currently prohibited in China, South Korea, Sri Lanka, Canada, Brazil, Peru, India, Colombia, and Singapore.[5]
- Propylparaben, which is used in food preservation, has been allegedly linked to reproductive health concerns. In addition to the European Union, propylparaben is currently prohibited in Japan, China, Sri Lanka, and Singapore.[6]
- Red Dye No. 3, which is a color additive providing a bright, cherry-red color, has been banned for use in cosmetics and externally applied drugs in the United States since 1990, when the FDA determined that it “causes a carcinogenic response in rats.”[7] The European Union restricted its use in food to only candied cherries and cocktail cherries in 1994. Australia and New Zealand also restrict its use to just cocktail cherries and frosting.[8] In October 2022, 24 scientists and consumer and health groups, including the Washington, D.C.-based nonprofit watchdog and consumer advocacy group, the Center for Science in the Public Interest, called on the FDA to ban the use of Red Dye No. 3 in foods.
The Law and the Impact
The California Food Safety Act passed the state legislature on September 12, 2023, almost unanimously with only six no votes. The law will go into effect on January 1, 2027, allowing manufacturers time to reformulate products without the prohibited food additives. California Governor Gavin Newsom dubbed the law a “positive step forward” while the FDA reviews the additives and considers additional regulations.[9] The National Confectioners Association (NCA), however, has accused California lawmakers of “making decisions based on soundbites rather than science.”[10] The NCA further cautioned that this is a “slippery slope” and it could create confusion around food safety and increase food costs for consumers.[11]
Violations of the California Food Safety Act will be punishable by a civil penalty of up to $5,000 for the first violation and up to $10,000 for each subsequent violation.
While it is too soon to tell the impact that the law will have on California’s grocery store aisles, manufacturers may need to change their operations to accommodate the new California Food Safety Act. Given that these additives have been banned in several countries, it is likely the change will not be a complex one, but California’s law could kickstart a trend among other states. For example, a similar bill to ban the same four additives, plus titanium dioxide, was introduced by New York’s legislature in March 2023.[12] And California’s new law could signal a trend that may influence the FDA’s rulemaking on food additives. On the class action side, the law could further usher in a wave of “healthy” food lawsuits, where plaintiffs challenge the ingredients in and labeling of food products.
Morrison Foerster will continue to monitor the impact of the California Food Safety Act and any FDA actions on food additives and is available to provide legal guidance to clients on the potential regulatory, advertising, and class action litigation matters.
[2] https://www.foodnetwork.com/healthy/articles/ brominated-vegetable-oil-dangers-side-effects.
[3] https://fda.gov/food/food-additives-petitions/brominated-vegetable-oil-bvo.
[4] Id.
[5] Id.
[6] Id.
[7] 55 Fed. Reg. 3520 (Feb. 1, 1990), available at https://www.govinfo.gov/content/pkg/FR-1990-02-01/pdf/FR-1990-02-01.pdf.
[8] Id.
[9] Id.
[11] Id.
[12] https://legislation.nysenate.gov/pdf/bills/2023/S6055A.