The 1958 Food Additive Amendment to the Federal Food, Drug, and Cosmetic Act created an approval process for new food additives, but that same law provided an exemption for food ingredients “generally recognized as safe,” or GRAS. This exemption was intended to allow common food ingredients—like vinegar, flour, baking soda, or standard spices—to bypass safety reviews and become available to all food manufacturers.

Since then, though, the food industry and FDA have turned the GRAS exemption into a loophole so big it has almost completely eclipsed the requirement that new food chemicals receive premarket FDA approval. Congress hardly could have intended this absurd result, yet that is exactly what is now occurring for most new food chemicals entering the food supply in the US.

Legally, companies are still required to make a full safety assessment based on publicly available data before they can start using new food chemicals. However, because they are not required to provide the FDA with that assessment, some companies simply start using the chemicals in food without sufficiently assessing the risks or publishing their safety data.  

While it is illegal for companies to use food ingredients in new ways without conducting a safety review, the FDA’s weak regulations cannot compel companies to demonstrate that they conducted an adequate safety review before using the chemical. 

Companies should provide evidence that their chemicals are safe to eat

The New York Food Safety and Chemical Transparency Act would reform the way food companies introduce new food ingredients. The bill, introduced by NY Assemblymember Dr. Anna Kelles and Senator Brian Kavanagh, would require companies that sell, distribute, or market food products in New York to report all secret GRAS substances to the New York Department of Agriculture—including those hiding inside “natural flavor,” “artificial flavor,” and “spices.” If the bill becomes law those ingredients and the safety information submitted by industry will be published in a public database, offering a level of transparency into food chemical safety previously unavailable to consumers or even the FDA. 

FDA fails to protect consumers from unsafe food chemicals

FDA’s inadequate oversight puts consumers at unnecessary risk from unsafe food chemicals, allowing harmful substances to remain in use in food long after evidence of harm emerges.

Some additives authorized by FDA, like Red 3 and potassium bromate, have the potential to cause cancer according to the FDA itself or according to other authorities, like the US National Toxicology Program and the World Health Organization. Others, like propylparaben, are linked to reproductive harm. The FDA’s inaction needlessly exposes the public—including those especially susceptible to toxic exposures like children and pregnant individuals—to dangerous food additives.

Synthetic dyes cause behavioral problems and don’t belong in schools

Synthetic food dyes, like Red 40 and Yellow 5, are commonly used in a wide variety of foods and beverages sold in the U.S., but they can cause health problems. CSPI has been calling on the FDA to protect consumers from synthetic dyes for years, but the FDA has taken no action. See our resources below to learn more about synthetic dyes, how to avoid them, and how to help us prevent the harm caused by dyes in our food system. That’s why we’re working at the state level to remove synthetic dyes from foods served in schools.

The seven most widely used synthetic food dyes—Blue 1, Blue 2, Green 3, Red 3, Red 40, Yellow 5, and Yellow 6—can cause or exacerbate neurobehavioral problems in some children, according to a comprehensive report published in 2021 by California’s Office of Environmental Health Hazard Assessment (OEHHA), which is part of the California Environmental Protection Agency.

The report found that consumption of synthetic food dyes can lead to hyperactivity, inattentiveness, restlessness, and other behavioral problems in some children. These types of effects could directly impair children’s ability to succeed academically and socially.

OEHHA also pointed out problems with the FDA’s approvals for these unnecessary color additives. OEHHA determined that current levels of safe intake set by the FDA for synthetic food dyes may not sufficiently protect children because the studies FDA used to set these levels were not designed—or even capable—of detecting neurobehavioral impacts.

This decisive report was published in 2021, and the FDA has never even responded to it publicly, let alone taken action to protect children.

See our resources below to learn more about synthetic dyes, how to avoid them, and how to help us prevent the harm caused by dyes in our food system. 

NYC, California, and Europe protect kids from synthetic dyes and other harmful additives

The FDA has fallen behind New York City, California, and Europe, where protections are in place against synthetic dyes.

NYC public schools have banned all artificial colors, including synthetic food dyes, from their menus for years.

The California School Food Safety Act—signed into law in 2024—banned the use of synthetic dyes in foods served in California public schools, and a year prior the California Food Safety Act banned Red 3 (plus potassium bromate, propylparaben, and brominated vegetable oil) statewide.

In the EU, potassium bromate and propylparaben are banned from use in foods, and Red 3 (called erythrosine there) is only allowed in certain kinds of cherries. The EU also requires that foods with certain synthetic dyes, including Yellow 5, Yellow 6, and Red 40, bear a warning label stating that the dyes “may have an adverse effect on activity and attention in children.” This requirement has been in place since 2010. Many food manufacturers that sell foods in Europe have chosen to reformulate their products to eliminate those dyes and thus avoid the label. But many of those same products still contain synthetic dyes in the U.S. That’s right, Europeans get to enjoy the exact same foods and beverages as Americans, but with safer alternatives to synthetic dyes.