Last week, the California legislature approved Assembly Bill 418, the California Food Safety Act (AB 418), which is headed to Governor Gavin Newsom to sign or veto by October 14, 2023.
AB 418 seeks to prohibit the manufacturing, distribution, delivery, sale, holding, or offering for sale of food products for human consumption containing specific additive substances. This development follows similar actions taken by the European Union and other foreign jurisdictions, which have already banned or restricted the use of these additives in human food products. This aligns with California’s recent trend of adopting regulations on restricted substances in consumer goods that parallel those of the European Union.
Starting on January 1, 2027, AB 418 will forbid individuals or entities from engaging in the manufacturing, distribution, delivery, sale, holding, or offering for sale of food products for human consumption in California that contain any of the following four additives:
- Brominated Vegetable Oil (BVO) (used to prevent the separation of citrus flavor in various store-brand, citrus-flavored sodas);
- Potassium Bromate (commonly employed to enhance the rising properties of baked goods);
- Propylparaben (a preservative typically found in store-bought tortillas and shelf-stable icing); and
- Red Dye 3 (a color additive frequently used in brightly colored candies and snacks).
A prior version of AB 418 by the State Assembly included titanium dioxide (a color additive responsible for vivid whites and bold colors in products) on the list of banned additives, but the State Senate voted to strike the fifth additive. New York state is currently considering a similar bill that includes a ban on all five additives.
Titanium dioxide and potassium bromate are both already listed as harmful chemicals under California’s Proposition 65 (Prop 65), through which the California Office of Environmental Health Hazard Assessment maintains a list of what it deems harmful chemicals. Under Prop 65, manufacturers of products that contain any of the harmful chemicals above a certain threshold must include warning labels to consumers on their products (or in retail spaces). The U.S. Food and Drug Administration (FDA) is currently reviewing petitions that call for the FDA to revoke regulations that allow red dye No. 3 to be used in food and ingested drugs as well as the regulation that allows titanium dioxide to be used in food. The FDA is already reconsidering the use of BVO, introducing a proposed rule to remove its authorization earlier this year; on September 15, 2023, the National Confectioners Association requested a meeting to discuss the proposed rule.
AB 418 does not appear to include any exemptions, which means that any entity involved in the production, delivery, distribution, storage, sale, or sale offer of food products containing these chemicals would likely be subject to the bill’s prohibitions. Furthermore, the bill does not seem to establish any allowable levels of these additives, often referred to as “safe harbor” levels. The absence of definitions for terms like “deliver” and “hold” raises questions about the scope of the bill’s applicability and whether liability could extend to parties involved in transportation or even the purchase of items containing these additives.
Opponents of AB 418, including industry groups like the Consumer Brands Association and the National Confectioners Association, argue that the federal government already has a thorough food safety process for reviewing additives and ingredient labeling, and that California has sufficient existing laws on chemical removal, labeling, and allergy considerations. They contend that, while the four additives can continue to be evaluated, the four additives have already undergone rigorous assessments by federal, state, and international bodies that have deemed the additives safe for human consumption.
Notably, AB 418 does not specifically address provisions related to testing, labeling, or agency enforcement—though, as opponents of the bill point out, there are existing labeling requirements for additives. It remains uncertain whether businesses would be required to conduct their own product testing or provide certification on labels, in addition to disclosing ingredient lists to demonstrate compliance with this legislation. The bill also lacks clarity on additional enforcement measures, such as product registration or reporting to a state agency. While this legislation does not establish a private right of action, it does grant the California Attorney General, city attorneys, county counsels, or district attorneys the authority to pursue civil penalties against violators. Violators could face fines of $5,000 for a first violation, with a maximum penalty of $10,000 for each subsequent violation.
By restricting the sale of food products containing these substances, California is expected to prompt numerous manufacturers to modify the recipes of their products that are distributed across the country. This mirrors the broader impact California is having on a national scale by excluding poultry and pork producers who fail to meet its standards for animal housing from its market, as litigated in the U.S. Supreme Court case National Pork Producers v. Ross. Time will tell whether a similar dormant commerce clause-related lawsuit will follow AB 418 once it is signed into law.
We will continue monitoring the approval and impact of AB 418, as well as other state legislation for and federal regulation of food additives. If you have any questions about the regulation of food additives, please contact Georgia Ravitz, Eva Yin, Shawn Lichaa, Scott Cohn, Marissa Hill Daley, or any member of the firm’s FDA regulatory, healthcare, and consumer products practice.
Update: On October 7, 2023, over objections by the FDA, Governor Newsom signed AB 418 into law.
