Overview
California is once again stepping out ahead of the Food and Drug Administration and all other states with the California Food Safety Act, banning four chemicals in food— brominated vegetable oil, potassium bromate, propylparaben, and red dye 3. By January 1, 2027 the chemicals must be removed from food products sold in California, with violators subject to a $5,000 civil penalty for the first violation, and $10,000 for each subsequent violation. The act is not clear as to what constitutes a single violation as opposed to multiple violations. While enforcement is limited to actions brought by the Attorney General, city attorneys, district attorneys, or county counsel, there is little doubt plaintiffs will attempt to use the banning of the chemicals as the hook to plead class claims should the act survive court challenges. While these chemicals are widely described as carcinogens, none of them are among the chemicals listed by the State of California and subject to Proposition 65.
The FDA already regulates the four chemicals and describes what they are primarily used for. The FDA describes “brominated vegetable oil (BVO)… [a]s a vegetable oil that has bromine added to it. It is used in small amounts to keep the citrus flavoring from floating to the top in some beverages.” The FDA limits it to 15 parts per million in food. https://www.fda.gov/food/food-additives-petitions/brominated-vegetable-oil-bvo, content current as of June 14, 2023.
Potassium Bromate used in wheat flour, is also already regulated by the FDA, limiting it to 0.0075 parts per 100 of the flour by weight. 21 CFR 136.110 (c)(14).
Probylparaben is used as an “anti-microbal agent,” a technical way of saying it’s a preservative. It is also regulated by the FDA to limit it to 0.1 percent in food. 21 CFR184.1670
Red Dye 3, as it’s name implies, is a coloring agent. It has been banned by the FDA in skin applied cosmetics, but is still allowed in food and ingested drugs. https://www.fda.gov/industry/color-additive-inventories/color-additive-status-list, content current November 8, 2021.
California’s governor pointed to the over 3 year period for companies to come into compliance, and to the fact that the European Union has already banned the four ingredients that are the subject of the act as proof that compliance is possible. As has been the case with California’s Proposition 65, companies generally make one version of a product for sale in the United States, meaning food companies will likely be reformulating products that are sold nationwide so that they comply with the California’s Food Safety Act
Given that the ingredients banned by the California Food Safety Act are already the subject of FDA regulation for use in foods, it seems that the law will end up before a court on an argument that the preemption clause of the Food, Drug and Cosmetics Act makes it so that California’s new law is not enforceable. It is also likely that the law will have an impact regardless of how legal battles around it turn-out, as many companies will likely start the lengthy process of reformulating and bringing to market products that do not have the chemicals to account for the possibly that courts allow California’s new ban to stand.
