More than 100 chemicals of unknown safety are hiding in the food Americans eat every day – including sports drinks, snack bars, cereals, and much more, according to a new analysis by the Environmental Working Group, an advocacy organization.
The study identified at least 111 food chemicals that companies have secretly added to the U.S. food supply, without notifying the Food and Drug Administration or the public.
Of those, 49 chemicals were found in thousands of products listed in the U.S. Department of Agriculture’s Branded Foods Database, which provides public access to nutrient and ingredient information about branded and store-brand food.
It’s the strongest evidence yet that food with unreviewed chemicals are being sold in the nation’s grocery stores, Melanie Benesh, EWG’s vice president for government affairs, said in a statement.
“This is a wake-up call for every American who assumes the FDA is reviewing the safety of chemicals in their food,” Benesh said. “Instead, food and chemical companies are exploiting a loophole to keep both the government and the public in the dark.”
The GRAS loophole
Under federal law, food companies can bypass FDA safety review of chemicals by saying they’re “generally recognized as safe,” or GRAS.
The loophole, created in 1958, was intended for common ingredients with a long history of safe use, such as vinegar, salt, and yeast.
But in 1997, the FDA created a voluntary notification system. A company can give GRAS status to its own new chemical and then bypass agency notification.
Research by the EWG shows companies now routinely use the GRAS loophole to introduce new, highly processed substances – including plant extracts, alternative proteins, and supplement ingredients – without public safety data.
In July, an EWG analysis found that nearly 99 percent of food chemicals introduced since 2000 were added through the GRAS loophole rather than through FDA review.
“For decades, the GRAS loophole has allowed companies to secretly introduce novel chemicals into our food without meaningful oversight or transparency,” said Emily Broad Leib, faculty director of the Harvard Law School Food Law and Policy Clinic.
“This report makes clear that the public and regulators are flying blind when it comes to the safety of many substances in our food,” said Broad Leib.
She said reform is needed to ensure decisions about food safety are based on science and are visible to the public – not left to companies with a financial stake in the outcome and without any oversight.
Unreviewed chemicals in food
The report highlights several potentially concerning substances in U.S. food:
- Aloe vera. Banned in over-the-counter laxatives by the FDA in 2002 due to concerns about health risks such as cancer, kidney harms, and more. It’s been found in more than 450 food and drink products, including national brands.
- Mushroom extract. Found in 428 products, including coffee and soup. The FDA banned a different mushroom extract in 2024 over potential risks to the central nervous system.
- Green tea extract. Some types of green tea extract are linked to heart and brain defects, fetal leukemia, suppression of estrogen, and other harm to the liver, kidney and intestines. However, various green tea extracts, some added through secret GRAS determinations, continue to be found in dozens of products.
- Alternative proteins. New proteins derived from fermentation, fungi, or animal-free sources are entering the market without FDA review, raising concerns about allergens and byproducts of the manufacturing process.
Public health risks
When companies covertly declare chemicals GRAS, there’s often no publicly available data on identity, composition, safe consumption levels, or potential health hazards, Broad Leib said.
By law, a substance can’t be GRAS if any uncertainty about its safety lingers or if the scientific evidence of its safety isn’t widely known or recognized. But because notification is optional, many of these chemicals haven’t been tested, or test results haven’t been disclosed.
Lack of oversight of these substances’ safety can lead to public health harms, she said. For example, in 2022, food made with the GRAS ingredient tara flour was believed to have caused over 300 illnesses and 113 hospitalizations.
“This system leaves the public unprotected,” said Maricel Maffini, researcher and report co-author. “The FDA only acts after people are harmed.”
Maffini said the tara flour incident in 2022, which sickened hundreds, is proof that the GRAS loophole is a public health hazard.
Call for reform
The report calls on the FDA to:
- Ban secret GRAS determinations.
- Withhold the GRAS designation from substances that are new, high-risk, or poorly studied.
- Close the withdrawal loophole, which lets companies pull a GRAS notice and continue to market a chemical without FDA review
- Launch a strong post-market review program for older food chemicals.
- Revoke GRAS designation of ingredients the FDA deems unsafe and take them off the market.
States are leading efforts to tackle the GRAS problem. New York and Pennsylvania have introduced GRAS transparency bills.
Other states have enacted legislation to ban or require labeling on harmful food chemicals, including Arizona, California, and Texas. And more than 30 states have introduced similar bills this year.
“The FDA’s failure to act for more than 60 years has made state leadership essential,” said Benesh. “Congress must close the GRAS loophole to restore trust in our food system.”
