California bans FD&C Red Dye #3 and other additives: Top points for industry

On September 11, 2023, the California Senate passed AB 418, which will ban four substances from food including brominated vegetable oil, potassium bromate, propylparaben, and FD&C Red Dye #3. As originally drafted, AB 418 also called for the ban of Titanium Dioxide (TiO2), but this provision has since been removed. 

As discussed below, AB 418’s ban on FD&C Red Dye #3 in particular has broader implications for potential new US Food and Drug Association (FDA) regulations and the food industry as a whole. 

Background

Currently, all four ingredients may legally be added to food under FDA regulations. However, FDA continues to evaluate safety information for authorized substances through post-market assessments. 

Over thirty years ago, FDA banned FD&C Red Dye #3 in cosmetic products but declined to ban FD&C Red Dye #3 in food due to insufficient evidence that FD&C Red Dye #3 causes cancer in humans. However, AB 418 adds pressure on FDA to re-examine its regulation of artificial colors, including FD&C Red Dye #3.

In response to a press inquiry about California’s actions, FDA stated that it “evaluates and regulates ingredients added to food to ensure that the authorized use of these ingredients is safe. This includes the four ingredients included in the California bill.” In fact, FDA is currently re-evaluating the safety of FD&C Red Dye #3 in response to a citizen’s petition.  FDA has also indicated that it may issue a proposed rule to remove the authorization of BVO as a food ingredient by the end of this year. Any changes at the federal level will have vast implications for the food industry. 

Individual bans on ingredients at the state level could prove challenging for companies conducting business in multiple states. National food safety standards allow companies to streamline compliance rather than navigate a patchwork of state regulations. 

Historically, FDA has been slow to act in this area, but the Agency appears committed to a number of improvements in response to a critical Evaluation of FDA's Human Foods Program by the Reagan Udall Foundation, including the following:

• FDA has named a new Deputy Commissioner for Human Foods with a background in chemical safety.
• FDA is creating a new office of Food Chemical Safety, Dietary Supplements, and Innovation.
• FDA is seeking $133 million in investments to the food program, including resources to update the Agency’s approach to assessing chemicals and food ingredients.
• FDA is re-instituting its Food Advisory Committee, which will enable FDA to seek a formal opinion by outside experts. 

All of this may be a sign that FDA is paying increased attention to this important area.  

Going forward

The California state law will become effective on January 1, 2027. After that date, it will be illegal for any person or entity to manufacture, sell, deliver, distribute, hold, or offer for sale  any food product for human consumption that contains any specified substance, including, among others, FD&C Red Dye #3.

We will continue to monitor developments in this area. For more information on compliance with AB 418, please contact the authors.