California Bans Four Federally Cleared Additives From Use in Food

On 7 October 2023, California Governor Gavin Newsom signed AB 418 (known as the California Food Safety Act) that bans four additives from use in food. The additives in question (brominated vegetable oil (BVO), potassium bromate, propylparaben, and red dye 3) are cleared for certain uses at the federal level under the US Food and Drug Administration’s (FDA) food and color additive regulations and will be prohibited for use in food in California as of 1 January 2027. The law, which is codified under the California Health and Safety Code, is a win for non-governmental organizations (NGOs) that have second-guessed the FDA’s ability to regulate additives in food. AB 418 has the potential to be a slippery slope that sets a precedent for further food additive bans in California and similar bans in other states. 

Background

At its heart, AB 418 is based on the proposition that the FDA does not adequately protect the population in the context of additives in food. Assembly members Jesse Gabriel and Buffy Wicks (the Authors) promoted the bill by stating that Californians “should not have to worry [about] the food they buy in their neighborhood grocery store.”         

In this regard, the bill demonstrates the success of NGO initiatives to cast doubt on the rigor of the food additive regulatory system. This effort ramped up in 2017 when Center for Food Safety, Breast Cancer Prevention Partners, Center for Science in the Public Interest (CSPI), Environmental Defense Fund, and Environmental Working Group sued the FDA to essentially dismantle the “generally recognized as safe” or GRAS exception that allows companies to use food additives (but not color additives) without FDA premarket approval. While the litigation challenge was not successful, this and similar efforts are part of an ongoing effort by one or more of these organizations to chip away at faith in the FDA’s regulation of additives.

The additives that have been targeted arguably have been the subject of controversy for some time. For example, prior to the introduction of AB 418, CSPI petitioned the FDA to remove red dye 3 from the list of approved color additives. In response to the CSPI petition, the FDA issued a Federal Register notice in early 2023, inviting the submission of public comments, additional scientific data, and other information related to issues raised by CSPI. With respect to BVO, the FDA published a study in May 2022 in Food and Chemical Toxicology evaluating the potential health effects of BVO and was considering a proposed rule to revoke the authorization of BVO as a food ingredient. On its website on BVO safety, the FDA notes that the beverage industry has largely moved away from its use, which is only permitted for stabilizing flavoring oils in fruit-flavored beverages.

Legislators’ Thought Process

The legislative history revealed the factors that California lawmakers took into account in passing the ban:

• The Authors of AB 418 relied heavily on European Union (EU) standards as a justification for the ban. The Authors and sponsors stated that “since the FDA is not taking a proactive approach in reviewing substances added to food, there is heavy reliance on the EU’s actions to ensure consumer protection.”
• A number of other jurisdictions are also cited for banning or limiting the relevant additives, including Australia, New Zealand, Argentina, South Korea, China, and India.  
• Safety data highlights concerns for each additive.
• The targeted additives are banned by retailers like Whole Foods, Aldi, Panera, and others. Some of these entities specifically list the banned additives, while others ban, for example, all artificial colors or preservatives as a class.
• Legislators noted the cost of the banned additive and available alternatives. For example, BVO is described as having a cost of US$21.51-47.85 per pound, and ester gum (having a cost of US$3.64-10.44 per pound) is described as a suitable alternative.  
• To demonstrate the need for the ban, the legislative analysis names several brand name products currently on the market that contain each of the listed additives. 

Originally, the list of chemicals in AB 418 included titanium dioxide, but it was removed shortly before the bill’s passage. If titanium dioxide had been included, it could have complicated the passage of the bill and its ability to survive a litigation challenge.

Enforcement

The law becomes effective on 1 January 2027 and authorizes the “California Attorney General, a city attorney, a county counsel, or a district attorney to enforce the ban.” Violators face a first time penalty not to exceed US$5,000 and a repeat offender penalty not to exceed US$10,000 “per violation,” which is not defined.

Takeaway

A state banning additives cleared by the FDA is unprecedented. It suggests that there could be a future in which food manufacturers are unable to rely simply on federal clearances and may face a patchwork of state bans that complicates the ability to formulate and market products. New York, for example, is considering a nearly identical ban currently, which continues to list titanium dioxide along with the four additives banned in California. The National Confectioner’s Association has criticized the law as “based on soundbites rather than science” and has asked the FDA to “engage” on the topic. It is not clear what type of FDA engagement would be helpful, however. To rescind food additive clearances, the FDA has to follow administrative procedures (such as notice-and-comment rulemaking), and these processes are burdensome and time consuming. California’s law is a striking precedent, and AB 418 adds to the ever-growing list of new laws—in California and elsewhere—targeting foods and food packaging materials nationwide.  

We acknowledge the contributions to this publication from our first year associate Elisabeth M. Lewis.