FDA Food Safety: 100+ Chemicals Avoided Review – EWG Report
More than 100 substances commonly found in U.S. Foods, supplements and beverages have undergone no health and safety review by the Food and Drug Administration (FDA), according to a new analysis by the Environmental Working Group (EWG). The findings, released on , raise concerns about the potential for undisclosed health risks associated with ingredients added to the food supply.
The EWG’s investigation revealed that companies are utilizing a loophole in federal law – the “generally recognized as safe” (GRAS) rule – to introduce new chemicals into food products without notifying the FDA or undergoing the agency’s rigorous safety assessment. Originally intended for common ingredients with a long history of safe use, such as salt and vinegar, the GRAS rule has been increasingly exploited by food and chemical manufacturers to self-determine the safety of novel substances.
“This is a wake-up call for every American who assumes the FDA is reviewing the safety of chemicals in their food,” said Melanie Benesh, EWG’s vice president for government affairs. “Instead, food and chemical companies are exploiting a loophole to keep both the government and the public in the dark.”
The GRAS Loophole: A History of Self-Regulation
The GRAS rule dates back to , but a significant shift occurred in when the FDA created a voluntary notification system. This allowed companies to independently grant GRAS status to new chemicals and bypass agency notification altogether. The EWG’s research indicates that this voluntary system has led to a surge in the introduction of unregulated substances into the food supply, including plant extracts, alternative proteins, and supplement ingredients.
The analysis identified at least 111 food chemicals that have been added to the U.S. Food supply without FDA review. Of these, 49 are listed as ingredients in thousands of products within the Department of Agriculture’s Branded Foods Database, suggesting widespread exposure for consumers. Products identified in the report include Capri Sun drinks, Kettle and Fire organic broth, Acme smoked fish, and Quaker Oats snack bars.
Potential Risks and Unknown Effects
While the presence of a substance on the list does not automatically indicate harm, the lack of FDA review raises concerns about potential unknown health risks. The EWG’s investigation highlighted several examples of ingredients with questionable safety profiles. For instance, mushroom extract, found in 428 products, has been linked to liver inflammation, and the FDA issued a warning in regarding a strain of mushroom extract causing neurological problems.
Other ingredients of concern include green tea extract, present in over 900 products, which has been linked to heart and brain defects, fetal leukemia, and liver toxicity in some studies. Aloe vera extract, banned in some medicines due to its toxicity, was also identified among the unreviewed substances. The report also points to the potential for contamination during the extraction process, with some extracts being produced using toxic solvents like benzene or methyl chloride.
The investigation also revisited the case of caffeine, initially approved through GRAS, but later linked to adverse effects when added to highly alcoholic beverages like Four Loko in the early 2000s. This ultimately led to the FDA banning caffeine in alcoholic drinks in .
The Challenge of Ingredient Complexity
The report emphasizes that simply identifying an ingredient isn’t enough to assess its safety. Extracts, for example, undergo chemical changes during processing that can alter their nutritional value and impact on the body. Maricel Maffini, an independent food safety consultant and report co-author, explained that the extraction process itself can introduce new risks, particularly if toxic mediums are used.
The GRAS rule also doesn’t cover all food additives. Food colorings and chemicals used in packaging, for example, are subject to different regulatory pathways. Companies are not required to disclose which products contain these unreviewed substances, making it difficult for consumers to make informed choices.
Calls for Regulatory Reform
The EWG’s findings have prompted calls for stricter regulation of food chemicals. Robert F Kennedy Jr, the U.S. Health and human services secretary, initially pledged to close the GRAS loophole, but is now proposing a less comprehensive action. Experts argue that the FDA, rather than industry, should be responsible for reviewing the safety of novel food chemicals.
“FDA – not industry – needs to be reviewing novel food chemicals for safety,” said Tom Neltner, executive director of the Unleaded Kids non-profit. “We need Kennedy to fulfill his promise to close a loophole that undermines the integrity of our food supply.”
The EWG’s report suggests that the 111 substances identified represent only a fraction of the unregulated chemicals present in the U.S. Food system, highlighting the need for greater transparency and oversight to protect public health. The findings underscore the importance of a robust and independent FDA review process to ensure the safety of the food Americans consume.