Hidden Risks: 100+ Food Chemicals Avoid FDA Safety Review

A recent analysis has revealed that over 100 substances commonly found in US foods, supplements, and beverages have not undergone safety assessments by the Food and Drug Administration (FDA). The findings, released by the Environmental Working Group (EWG), raise questions about the oversight of chemicals entering the American food supply and highlight a potential gap in consumer protection.

The GRAS Loophole and Its Expansion

For decades, the FDA has relied on a system called “generally recognized as safe” (GRAS) to streamline the approval process for ingredients like salt and vinegar. Originally intended for substances with a long history of safe use, the GRAS rule allows companies to self-determine the safety of new ingredients without direct FDA review. However, the EWG’s investigation suggests that companies are increasingly exploiting this loophole, introducing potentially harmful substances into the food system with limited scrutiny. This isn’t a new issue; concerns about the GRAS process have been raised for years, as detailed in a 2022 report by the Environmental Defense Fund here.

The EWG’s review of FDA records identified 111 substances lacking a safety review. These ingredients are present in products from popular brands including Trader Joe’s, Whole Foods, PepsiCo, and Casita. While the absence of a review doesn’t automatically equate to danger, it does mean the potential health effects of these substances remain largely unknown. The report points to tara flour, a GRAS ingredient linked to over 300 illnesses and 113 hospitalizations in 2022, as a stark example of the risks associated with this system. You can find more information about the FDA’s assessment of tara flour here.

Beyond GRAS: A Wider System of Approval

It’s important to note that GRAS isn’t the only pathway for chemicals to enter the food supply. Food colorings and substances used in food packaging, for example, are subject to different approval processes and weren’t included in the EWG’s analysis. The focus of this report is specifically on the GRAS notification program, which allows manufacturers to voluntarily submit safety data to the FDA. However, as the EWG points out, this notification process is not mandatory, and companies can legally deem their own products safe without external verification.

Extracts and Unknown Impacts

The investigation also highlighted concerns surrounding the use of extracts from ingredients like mushrooms, green tea, cinnamon, and cocoa. While these ingredients are often perceived as healthy, the extraction process can alter their chemical composition, potentially diminishing their nutritional benefits and introducing unknown health effects. Maricel Maffini, an independent food safety consultant and co-author of the report, explained that the extraction process could even involve toxic mediums like benzene or methyl chloride, adding another layer of complexity.

Specifically, the purified extract of catechins found in green tea leaves – present in over 900 products – has been linked to heart and brain defects, fetal leukemia, suppression of estrogen, and toxicity to the liver, kidneys, and intestines. Similarly, some mushroom extracts have been associated with liver inflammation, and the FDA issued a warning in 2024 about a strain causing hallucinations and nervous system problems, though it remains available in supplements.

A History of Concerns and Regulatory Response

The potential for abuse within the GRAS system isn’t a new revelation. The report cites the example of caffeine, initially approved via GRAS, but later linked to adverse effects when added to highly alcoholic beverages like Four Loko in the early 2000s. This led the FDA to effectively ban caffeine in alcoholic drinks in 2010, demonstrating the agency’s capacity to respond to emerging safety concerns. You can read more about the Four Loko case here.

What’s Being Done, and What Could Change

Robert F Kennedy Jr., the current US Health and Human Services Secretary, initially pledged to close the GRAS loophole as part of his “make America healthy again” movement. However, his current proposal is considered a weaker action, according to reports. The EWG and other advocacy groups are urging the FDA to take a more proactive role in reviewing the safety of food chemicals, rather than relying on industry self-regulation. Tom Neltner, executive director of the Unleaded Kids non-profit, believes the EWG report only scratches the surface of a larger problem, emphasizing the need for the FDA to take ownership of the safety review process.

The FDA’s GRAS notification program details can be found here. The USDA’s FoodData Central database, used to cross-reference ingredients, is available here.

Looking Ahead: Increased Scrutiny and Potential Reform

The EWG report is likely to fuel further debate about the adequacy of food safety regulations in the United States. The FDA is currently reviewing its GRAS notification program, and the agency may consider strengthening its oversight of self-determined GRAS ingredients. Increased transparency and public access to safety data are also being advocated for by consumer groups. For consumers, staying informed about food ingredients and supporting policies that prioritize food safety are crucial steps in protecting their health. It’s important to remember that the lack of a safety review doesn’t automatically mean an ingredient is harmful, but it does highlight the need for greater vigilance and a more robust regulatory framework.