A ban on FDA-approved food additives should come from experts

California and New York, among about a dozen other states, have pending proposals to ban several FDA-approved food additives. The glaring issue is that there is no scientific basis for these bans, and no one supporting the bans has the expertise required to make these very technical regulatory determinations.

Compounded by the significant media attention given to this topic, there is no accountability and little to no fact-checking within the legislation and the coverage that has accompanied it.

Support for the proposed bans is implausible. All color additives must be approved by FDA without exception, including Red Dye 3 and titanium dioxide. The FDA also continuously reviews colors and other food additives and proactively addresses consumer concerns. Both Red Dye 3 and titanium dioxide are currently under review and findings are expected to be announced later this year. In the case of Brominated Vegetable

Oil, the FDA recently conducted its own studies and has initiated steps to remove BVO from the U.S. food supply. No authoritative body in the world has identified any safety concerns with the use of Red Dye 3 in food, including the FDA, the European Food Safety Authority (EFSA), and the United Nations Food and Agriculture Organization and World Health Organization Joint Expert Committee on Food Additives (JECFA). Although there are broader uses permitted in the U.S., the EU has determined that Red Dye 3 is safe in food.

The EU banned titanium dioxide in food, but there are no actual safety concerns to justify the ban. FDA deemed titanium dioxide safe in 2021 and JECFA agreed with the findings in October 2023. Europe’s 2021 opinion was based on safety data not representative of the material approved for use as a food color. Since then, highly regarded food agencies from the U.S., U.K., Canada, Australia, New Zealand, and Japan have reviewed Europe’s data and confirmed that titanium dioxide is safe to use in food.

Titanium dioxide is argued to be banned in the U.S. because regulators in the European Union called it unsafe. But how much would a person have to eat to reach the genotoxicity levels used by EU food safety regulators? If you make estimates based on the assumption that titanium dioxide is used at the maximum level permitted by FDA (1% by weight of food), a person would have to eat:

• 318 pizza rolls per day, every day, for 3 years, or
• 246 mini powdered donuts per day, every day, for 3 years, or
• 4,080 pieces (more than 70 bags) of colorful chewy candy per day, every day, for 9 years.

These amounts are not representative of the way that people eat. Yet the rhetoric carelessly deployed in this debate would lead consumers to believe that the food additives in question are harmful and there is a systematic failure on behalf of the U.S. food safety system. 

With the recent FDA announcement that it added potassium bromate and propylparaben to its science-based review process, all of the original additives subject to the new California law and many of the copycat state proposals are now under review by the FDA — again. This is a very positive step forward and it signals that the FDA is modernizing its review process to meet growing demands. This was not lauded as something positive by any of the groups that favor the ban proposals, because the FDA is taking action where those outside groups said the agency would fail.

But we cannot rest on our laurels as a country that has for generations led the way in safely feeding hundreds of millions of people within our borders and beyond. We agree that science-based evaluation of food additives is needed and we support FDA’s recent actions on food additives because we know that this is critical to maintaining our food safety system – which is the envy of the world.

The FDA and other regulatory bodies around the world have deemed our products safe. We follow and will continue to follow regulatory guidance from the authorities in this space, because consumer safety is our chief responsibility and priority. We see a path forward where we can work together with all groups interested in this topic, but usurping FDA’s authority does nothing but create a state-by-state patchwork of inconsistent state requirements that increase food costs, create confusion around food safety, and erode consumer confidence in our food supply.