Hidden ingredients? EWG report flags 111 food chemicals entering US supply without FDA review

A new analysis from the Environmental Working Group has reported that more than 100 food chemicals have entered the US food supply without formal safety review by the Food and Drug Administration, raising renewed scrutiny over the regulatory framework governing ingredient approvals.

The nonprofit advocacy group identified at least 111 substances that companies have introduced into foods without notifying the FDA or the public. According to the report, dozens of these ingredients appear in widely consumed products including sports drinks, snack bars and breakfast cereals.

• The Environmental Working Group identified at least 111 food chemicals introduced into the US food supply without formal FDA safety review.
• Forty-nine of those substances were found across thousands of products listed in the US Department of Agriculture’s Branded Foods Database.
• The report highlighted a regulatory loophole allowing companies to self-declare ingredients as 'generally recognized as safe' without notifying regulators.

The analysis found that 49 of the identified chemicals appear in thousands of items listed in the US Department of Agriculture’s Branded Foods Database, a public resource containing ingredient and nutrition information for branded and private-label food products.

EWG described the findings as the strongest evidence to date that foods containing unreviewed chemical ingredients are widely available in grocery stores.

Melanie Benesh, EWG’s Vice President for Government Affairs, said the findings raised concerns about how food safety oversight is currently functioning in the USA.

“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 report focused on the regulatory pathway known as GRAS, short for “generally recognized as safe.” Under US law, companies can introduce certain food substances without FDA pre-market approval if they determine the ingredient meets the GRAS standard.

The framework was originally established in 1958 to cover widely used food ingredients with established safety records, including substances such as salt, vinegar and yeast.

However, regulatory changes introduced in 1997 created a voluntary notification process that allows companies to determine GRAS status internally without informing the FDA.

According to EWG, this change has enabled manufacturers to introduce new ingredients without public disclosure or formal regulatory review.

The organization reported that nearly 99% of food chemicals introduced since 2000 entered the market through GRAS determinations rather than direct FDA approval.

Research cited in the report suggested that companies increasingly use this route to introduce novel substances including plant extracts, supplement ingredients and alternative proteins.

Emily Broad Leib, Faculty Director of the Harvard Law School Food Law & Policy Clinic, said the report highlighted longstanding concerns about the transparency of the GRAS system.

“For decades, the GRAS loophole has allowed companies to secretly introduce novel chemicals into our food without meaningful oversight or transparency,” Broad Leib said.

“This report makes clear that the public and regulators are flying blind when it comes to the safety of many substances in our food,” she said.

“We need urgent reform 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.”

Among the substances highlighted in the report were aloe vera extracts, mushroom extracts and green tea extracts that appear in a range of packaged foods and beverages.

The report stated that aloe vera ingredients have been identified in more than 450 food and beverage products despite the FDA banning aloe vera in over-the-counter laxatives in 2002 due to health concerns.

Mushroom extracts were found in 428 products, including coffee drinks and soups, while certain green tea extracts linked in some studies to potential health risks appeared in dozens of food products.

The report also pointed to emerging protein ingredients produced through fermentation, fungi and other nontraditional sources that may enter the market without FDA review when companies rely on internal GRAS determinations.

EWG said the absence of mandatory disclosure often means limited publicly available information about the identity, composition, safe intake levels or potential health risks associated with these ingredients.

Under federal law, a substance cannot qualify as GRAS if uncertainty exists about its safety or if evidence supporting its safety is not widely known among experts.

However, because the notification process is voluntary, companies can market ingredients without sharing safety data publicly.

The report also cited past incidents where ingredients introduced under GRAS determinations later raised safety concerns.

One example involved tara flour, an ingredient linked to a 2022 outbreak of illness associated with a food product that reportedly caused more than 300 illnesses and 113 hospitalizations.

Maricel Maffini, a researcher and co-author of the report, said the incident illustrated the risks associated with limited oversight.

“This system leaves the public unprotected. 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.”

The report concluded with a series of recommendations aimed at strengthening oversight of food ingredients.

EWG called on the FDA to prohibit undisclosed GRAS determinations, deny GRAS status to poorly studied or high-risk substances, and close what it described as the “withdrawal loophole,” which allows companies to withdraw a GRAS notification while continuing to market the ingredient.

The organization also urged the agency to establish a more robust post-market review system for existing food chemicals and to remove ingredients it determines to be unsafe.

At the state level, lawmakers have begun proposing new legislation aimed at increasing transparency around food chemicals.

New York and Pennsylvania have introduced bills addressing GRAS disclosures, while other states including Arizona, California and Texas have adopted measures banning or requiring labeling for certain food chemicals.

Benesh said the emergence of state-level initiatives reflected growing concern about federal oversight.

“The FDA’s failure to act for more than 60 years has made state leadership essential,” she said. “Congress must close the GRAS loophole to restore trust in our food system.”