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At least 111 substances of unknown safety have been added to foods, drinks, and supplements sold in the United States without alerting the US Food and Drug Administration, a new investigation found, reports BritPanorama.
“Food companies are deciding on their own to secretly add unreviewed chemical ingredients to products instead of following existing federal guidelines meant to assure food is ‘generally recognized as safe,’ or GRAS,” said Melanie Benesh, vice president for government affairs for the Environmental Working Group, a health and environmental health advocacy organization that conducted the investigation published Tuesday.
To meet the GRAS standard, companies must demonstrate a new food ingredient is safe by providing widely accepted scientific evidence that’s publicly available. Notifying the FDA of that safety data is customary and ensures regulatory compliance. It’s also voluntary — which means manufacturers can legally self-determine their products to be safe.
“Manufacturers now routinely exploit this GRAS loophole — it’s fast becoming more ‘generally recognized as secret’ instead of ‘generally recognized as safe,’” Benesh said.
The EWG investigation found 49 of the chemicals added by industry in approximately 4,000 products listed in the US Department of Agriculture’s FoodData Central database, which provides public access to nutrient and ingredient information.
“Because the government has never reviewed these chemicals, consumers have no way of knowing if they are safe or carry unknown health risks,” Benesh added.
Even though the GRAS loophole is legal in the United States, it’s difficult to justify from a “scientific and ethical standpoint,” said Mathilde Touvier, director of research at France’s National Institute of Health and Medical Research in Paris, who studies the health harms of additives in ultraprocessed foods.
CNN reached out to the American Beverage Association and the Consumer Brands Association, which both represent food and drink manufacturers. The ABA did not send a response before publication.
Sarah Gallo, senior vice president of the Consumer Brands Association, stated that the CBA was part of a coalition, Americans for Ingredient Transparency, advocating for “federal legislation establishing national uniformity for ingredient safety and disclosure.”
“We support GRAS reform being a part of that bill,” Gallo said, adding that the US has one of the “safest and most highly regulated food systems in the world.”
Adding extracts from ‘natural’ foods
Of the 49 chemicals found in foods, 22 were extracts, according to the investigation. Many appear natural and harmless: aloe vera, cinnamon, cocoa, cranberry seed oil, grape skins, green coffee beans, hemp, lemon balm, and mushrooms, to name a few.
“When you start taking substances from grape skin, aloe vera, and mushrooms, for example, you may have a concentrated extract or cocktail of substances that come out of it,” said biochemist Maricel Maffini, a former research assistant professor at Tufts University School of Medicine in Boston who coauthored the EWG investigation.
“You should be able to test that extract or cocktail if it is going to be in the marketplace.”
Green tea extracts never reviewed by the FDA were found in 901 products in the database, including granola and energy bars, candy and chewing gum, ice cream, sodas, teas, waters, and seafood, according to the EWG report.
“There is a major difference between the antioxidants in green tea you make at home and a purified extract of a green tea antioxidant done in a lab,” said Maffini, an independent consultant who has published 11 peer-reviewed journal articles and two book chapters on how chemicals impact the human body.
“That’s not green tea anymore. It’s a completely different, new substance synthetically extracted to make it more available as an antioxidant,” Maffini added. “It may seem natural, but it’s not — and what this new extract will do to your body is going to be very different.”
For example, loose-leaf green tea may fight cancer-causing inflammation, lower blood pressure, and cholesterol, boost brain health, and extend life. Highly concentrated green tea extracts, however, are linked to estrogen disruption and harm to the liver. There are at least 100 established cases of severe liver damage in people using concentrated green tea extracts sold for weight loss and muscle recovery.
Aloe vera and mushroom extracts
Aloe vera extracts that bypassed FDA review were found in more than 450 products in FoodData Central, a food and nutrient database managed by the USDA Agricultural Research Service, according to the investigation. Most of the usage appears to be in fruit and vegetable juice, fruit drinks, and nectars.
As a common treatment for burns, aloe vera is perceived as natural and therefore harmless by many consumers, experts say. However, unpurified whole-leaf aloe vera extract can cause cancer, and the FDA banned the use of a form of aloe vera in laxatives due to concerns about a link to cancer in animals and kidney failure in humans.
“Many people believe that products labeled ‘natural’ are always safe and good for them. This is not necessarily true. Herbal medicines do not have to go through the testing that drugs do,” the National Library of Medicine states on its website, adding that some herbs can be seriously harmful. “Some herbs can interact with prescription or over-the-counter medicines.”
The health impact of any substance, natural or not, can have significantly different effects depending on its form, dose, and interactions with other health conditions, Touvier said.
“Beta-carotene is safe at nutritional levels in fruits and vegetables, yet high-dose supplementation increases lung cancer risk, especially in smokers,” she noted. “Similarly, fiber from whole foods is beneficial, whereas certain purified fibers have shown adverse effects on gut inflammation or microbiota composition.”
Mushroom extracts never reported to the FDA were found in 428 products, including coffee, fruit and vegetable juices and nectars, soups, and milks, according to the investigation.
While mushrooms can be nutritional powerhouses, eating the wrong species of mushroom can kill you, while others can cause allergic reactions, digestive issues, and negatively interact with certain medications, especially blood thinners.
The FDA told manufacturers in 2024 to stop using the red-topped Amanita muscaria mushroom due to “serious adverse event reports associated with multiple food products.” The agency first called attention to A. muscaria 12 years earlier by including the species in a list of “toxic agents that cause poisoning following ingestion.”
Consumers may pay the price
Consumers have been hurt by a lack of oversight of GRAS substances in the past. A frozen vegetable-based meat substitute was voluntarily recalled in the summer of 2022 after the manufacturer received 470 complaints of gastrointestinal, liver, bile duct, and gallbladder illness.
Content creator Luke Wesley Pearson posted on Instagram that he underwent emergency gallbladder surgery after twice eating the meat substitute. Two other consumers told CNN they also had gallbladder surgery after consuming the product.
The culprit appeared to be tara flour, made from the seed pods of a thorny tree called Peruvian carob. Another ingredient made from the tree is tara gum, which has been safely used for years as a thickening agent or stabilizer in foods. However, tara flour is made differently than tara gum, and the flour has “not been adequately characterized nor previously utilized as a human food ingredient in the United States,” according to the FDA.
After the FDA investigation into tara flour, it took two years for the agency to remove the substance from the GRAS list.
“Tara flour is introduced into the food supply, and only because there’s an outbreak of liver injury does the FDA even look at whether or not it’s safe,” Dr. Pieter Cohen, an associate professor of medicine at Harvard Medical School in Boston, told CNN in 2024.
A decades-long problem
A 2014 report by the Natural Resources Defense Council, an environmental advocacy group, used federal Freedom of Information Act requests to review how companies communicate with the FDA on new food additives.
Fifty-six companies appeared to rely on undisclosed GRAS safety determinations for 275 chemicals, the investigation found. When the FDA was provided a GRAS request by a manufacturer, however, the agency was thorough, rejecting or triggering the withdrawal of 1 in 5 requests.
A 2022 analysis conducted by the Environmental Working Group found that nearly 99% of new chemicals used in food or food packaging since 2000 were green-lit for use not by the FDA but by the food and chemical industry. During that period, food manufacturers asked the FDA’s permission to introduce a new substance only 10 times, according to the analysis.
The Trump administration indicated it wanted to fix the GRAS loophole that allows companies to rubber-stamp products as safe without federal oversight.
“For far too long, the GRAS loophole has allowed ingredients to enter
