California Bans Several FDA-Authorized Food Additives; New York May Soon Follow

The additives in question are brominated vegetable oil, potassium bromate, propylparaben, and Red Dye No. 3. They are currently used in such products as soft drinks, cereal, bread and other baked goods, and candy. However, some major manufacturers no longer use them, and reportedly their use in food is not permitted in the European Union (EU).

According to current FDA regulations:

• Brominated vegetable oil may be used as a stabilizer for flavoring oils used in fruit-flavored beverages, at levels up to 15 ppm in the finished beverage. 
• Flour may be treated with up to 50 ppm potassium bromate (or up to 75 ppm for whole wheat flour) if baking qualities are improved by such addition. The potassium bromate in bromated flour is deemed to be an additional optional ingredient in any bread, rolls, or buns made with the flour. In addition, potassium bromate may be used in the malting of barley used in the production of fermented malt beverages or distilled spirits, at levels of up to 75 ppm (calculated as bromide) in the malt, but no more than 25 ppm bromide from all sources in the finished beverage.
• Propylparaben (also known as propyl p-hydroxybenzoate) may be used as an antimicrobial agent at up to 0.1% in food. It may also be used as a synthetic flavoring substance.
• Red Dye No. 3 (or FD&C Red No. 3) conforming to FDA specifications may safely be used for coloring foods in general, in amounts consistent with good manufacturing practice. (FDA requires all batches of the food colorant to be certified prior to use.) However, it may not be used to color cosmetics or externally applied drugs.

Assembly Bill AB-418, as initially introduced, sought to ban an additional FDA-authorized food ingredient, titanium dioxide (a white colorant). However, this was removed from the list when the bill was subsequently amended in the state Senate. According to current FDA regulations, titanium dioxide conforming to FDA specifications may safely be used for coloring foods in general, in amounts up to 1% by weight of the food, and no certification of batches of the colorant is required.

A comparable bill, New York AB 6424, was introduced in April 2023 into the General Assembly and has been referred to the Agriculture Committee. However, this bill still includes titanium dioxide on its list of food additives that would be banned. Interestingly, as if to emphasize the conflict between such a state-level ban and current FDA regulations, AB 6424 also contains the following stipulation:

In an action instituted by the commissioner under section two hundred two-c of this article to enforce compliance with this subdivision or any rule or order promulgated pursuant to this subdivision, the recognition by the federal food and drug administration of any of these substances as safe may not be alleged as a defense. [Emphasis added.]

The new California legislation was applauded by the Environmental Working Group (EWG) and Consumer Reports, which co-sponsored the bill. In a statement, EWG implied that where California goes on this issue, industry will be obliged to follow:

Given the size of California’s economy, A.B. 418 would set an important precedent for improving the safety of many processed foods. 

Industry, however, has a different perspective. For example, the National Confectioners Association (NCA) issued the following statement upon the bill’s signing:

California is once again making decisions based on soundbites rather than science. Governor Newsom’s approval of this bill will undermine consumer confidence and create confusion around food safety. This law replaces a uniform national food safety system with a patchwork of inconsistent state requirements created by legislative fiat that will increase food costs. This is a slippery slope that the FDA could prevent by engaging on this important topic. We should be relying on the scientific rigor of the FDA in terms of evaluating the safety of food ingredients and additives.

Regardless, it seems likely that battles over the safety of various food additives will continue at the state level.