This story was published by The Center for Public Integrity, a nonpartisan investigative news organization in Washington, D.C.
Rebecca Fattell was enjoying breakfast at a hotel in Berlin last summer when, after a few bites of a roll, her mouth started to itch, her gums started to hurt and before long, hives covered her skin.
“My face, trunk, arms, legs,” Fattell said, “they were all beet red.”
She rushed to the emergency room.
Fattell, who is allergic to peanuts, is vigilant about what she eats and had been assured by hotel staff that her breakfast didn’t contain any. Hidden in the pastry, however, was lupin flour, which is made from a peanut-related legume that caused her reaction.
“I’m extremely careful,” said the 23-year-old New Yorker. “I just had no idea about lupin.”
Lupin is considered a "major food allergen" in Europe and must be labeled accordingly on packaged foods. In the United States, where lupin is less commonly used, there is no such requirement, leaving Fattell and others who suffer from peanut allergies vulnerable.
The U.S. Food and Drug Administration has known about lupin’s effects since at least 2008, but has made no move to require companies to identify it as an allergen on products sold in the United States.
Lupin is just one of thousands of ingredients companies have added to foods with little to no oversight from the FDA. They’ve taken advantage of a loophole in a decades-old law that allows them to deem an additive to be “generally recognized as safe” — or GRAS — without the agency’s blessing, or even its knowledge.
The loophole is so big that companies can market additives, like lupin, that the FDA has found to pose dangers. Even ingredients the agency has agreed are GRAS are now drawing scrutiny from scientists and consumer groups who dispute their safety.
Critics of the system say the biggest concern, however, is that companies regularly introduce new additives without ever informing the FDA. That means people are consuming foods with added flavors, preservatives and other ingredients that are not at all reviewed by regulators for immediate dangers or long-term health effects.
People are consuming foods with added flavors, preservatives and other ingredients that are not at all reviewed by regulators for immediate dangers or long-term health effects.
‘Life threatening reactions’
When George Weston Foods — an Australia-based food manufacturer — sought the FDA’s agreement that its lupin flour, protein and fiber were safe to add to breads, pastas and cereal in the United States, regulators feared it could trigger “life-threatening reactions” in peanut-allergic consumers.
The FDA said merely listing lupin on ingredient labels would not be enough warning. The ingredients, the regulators said, “failed to meet the standards for general recognition of safety,” according to documents obtained by the Natural Resources Defense Council through a Freedom of Information Act request.
George Weston withdrew its applications and decided not to sell the additives in the United States, its parent company said in an email to the Center for Public Integrity. Other companies do market them, however. Lupin, also spelled lupine, can be found as an additive in products on supermarket shelves today with no warning for people who suffer from peanut allergies.
The companies that make and supply these ingredients never had to seek the FDA’s opinion on safety, or even inform the agency that it was including lupin in products sold in the United States.
Rather than going through a painstaking FDA-led review process to ensure that their new ingredients are safe, food companies can determine on their own that substances are GRAS.
They can then ask the FDA to review their evaluation — if they wish. Or they can take their ingredients straight to market, without ever informing the agency.
"FDA doesn't know what it doesn't know," said Steve Morris of the Government Accountability Office, which published a report in 2010 that found that “FDA’s oversight process does not help ensure the safety of all new GRAS determinations.”
“It’s really clear that we have no basis to make almost any conclusions about the safety of the current food supply,” said Laura MacCleery, an attorney with the Center for Science in the Public Interest, a consumer advocacy group. “We don’t know what people are eating.”
‘He was crying … He couldn’t breathe’
Miles Bengco certainly didn’t know what he was eating when he chomped on a Quorn Turk’y Burger while watching a Los Angeles Lakers game with his family in 2013. Shortly after eating the burger, the 11-year-old started having trouble breathing.
“He started changing color. He turned purple and green, and then he went completely white,” his mother, Ann Marie Cote, remembered, tearing up as she relived that night. “He was crying … He couldn’t breathe."
By the time paramedics arrived to the house, Bengco was unresponsive and foaming at the mouth.
“I knew at that moment he was gone,” Cote said.
He died in a hospital the next day.
In a lawsuit filed last month, the boy’s parents blamed their son’s death on mycoprotein, a fungus-based ingredient used to make the burger Bengco ate. The lawsuit claims that their son, who had an allergy to mold, died after suffering “a severe anaphylactic reaction” caused by mycoprotein, which the family says was mislabeled on the package.
“It was a loaded gun in his mouth,” Cote said.
In a written response to reporters’ questions, Quorn stated, “we categorically reject the claims made by attorneys representing the Bengco family that our products were in any way associated with this unfortunate event.”
Quorn’s statement added that the company submitted all of its safety data on mycoprotein to the FDA years ago as part of an extensive agency review. The company said that the FDA had concluded that mycoprotein was safe but that “there would be a lengthy period before” the agency issued a formal decision. That's when Quorn decided to pursue an expedited GRAS review, according to the company’s written response.
The FDA did not respond to questions about Quorn's claims. But in 2002, it OK’d the GRAS status of mycoprotein for use in certain foods. Many consumer groups and scientists, however, dispute that the additive should be deemed safe.
Consumers have previously reported suffering a range of reactions after eating foods containing mycoprotein, including nausea and anaphylactic shock. The complaints prompted the Center for Science in the Public Interest to urge the FDA in 2011 to revoke the ingredient’s GRAS status.
GRAS ingredients are supposed to meet the same safety standard as food additives that undergo a full FDA review — a standard of “reasonable certainty” that no harm will result from consuming them.
For a company to determine that an ingredient is “generally recognized as safe,” it must establish that the additive’s safety is commonly understood by qualified scientific experts.
But some ingredients defy consensus, as consumers, scientific groups and sometimes even the FDA have pointed out.
Even GRAS additives that have been used in food for decades are now coming under fire as their uses expand and science doubting their safety emerges. For example, studies have found that carrageenan, widely used to provide a thick, creamy texture in foods like yogurt, ice cream and soy milk, can cause gastrointestinal inflammation in animals and humans.
The Cornucopia Institute, a Wisconsin-based nonprofit group, sent a letter to the acting FDA commissioner yesterday urging the agency to ban carrageenan as a food additive, an action the agency declined to take after a scientist made a similar request a few years ago. The group also sent the FDA a petition signed by nearly 39,000 individuals seeking the FDA to revoke the ingredient's GRAS status, including many who have blamed the ingredient for contributing to their digestive problems, including diarrhea and constipation.
An industry-regulated system
But it’s the ingredients unknown to the public that have critics of the GRAS system most worried.
Researchers for the Pew Charitable Trusts and Natural Resources Defense Council say that allowing companies to make safety determinations without telling the FDA makes it nearly impossible to identify whether there are health effects caused by long-term exposure to certain ingredients.
Their concerns are heightened because safety decisions often rest in the hands of a small group of scientific experts selected by companies or consulting firms with a financial incentive to get new ingredients on the market. Several of these scientists, a Center for Public Integrity investigation found, previously served as scientific consultants for tobacco companies during the 1980s and 1990s, when the tobacco industry fought vigorously to defend its products.
In many cases, researchers say companies are declaring ingredients to be safe without reporting the results of important toxicity tests to prove it.
Even the Flavor and Extract Manufacturers Association, an industry trade group whose program for assessing the safety of flavor ingredients has been praised in the past, is now drawing increased scrutiny from critics who contend that the organization lacks transparency and approves additives using limited relevant public safety data.
“Congress had a clear understanding of what ‘generally recognized as safe’ means, but that’s not the understanding that basically prevailed,” said Scott Faber, vice president of government affairs for the Environmental Working Group, a nonprofit advocacy group seeking reforms to the GRAS system. “There are plenty of ingredients that are receiving GRAS status, the safety of which are in dispute.”
Safety decisions often rest in the hands of a small group of scientific experts selected by companies or consulting firms with a financial incentive to get new ingredients on the market. Several of these scientists previously served as consultants for tobacco companies.
An outdated law
The GRAS loophole was born in 1958. Americans were growing concerned about the increased use of preservatives and other additives in food, so Congress passed — and President Dwight Eisenhower signed — the first law regulating ingredients added to food.
To restore confidence, the law set up a system requiring companies to submit new ingredients to an extensive FDA safety review before going to market.
But Congress didn’t want the FDA wasting time and resources approving common ingredients such as vinegar and table salt. So the law included an exemption to bypass the agency-led safety review process. Companies could prove on their own that ingredients are “generally recognized as safe.”
In the past five decades, the number of food additives has skyrocketed — from about 800 to more than 10,000. They are added to everything from baked goods and breakfast cereals to energy bars and carbonated drinks.
Meanwhile, the FDA’s food additive approval system has slowed to a crawl — the average review takes two years, but some drag on for decades. As a result, ingredient manufacturers have increasingly turned to the GRAS loophole as a quicker road to market.
“The food additive review process is a highway that is constantly gridlocked. If the food additive road doesn’t go anywhere, what do I do?” asked Stuart Pape, a Washington, D.C., attorney who consults for companies that manufacture food additives. “GRAS is the other pathway.”
'It isn't the wild West'
The FDA has publicly acknowledged the GRAS system’s shortcomings.
“We simply do not have the information to vouch for the safety of many of these chemicals,” Michael Taylor, the FDA’s Deputy Commissioner for Foods, told the Washington Post last year.
Meanwhile, industry scientists and lawyers contend that safety concerns are overblown and that major reforms designed to increase government oversight would cripple the resource-depleted FDA and stifle food innovation.
“It isn’t the Wild West out there,” said Stanley Tarka, a toxicologist and industry consultant. “We have the safest food supply in the world.”
George Burdock, the president and founder of a food safety consulting firm, says requiring extensive FDA oversight for GRAS additives would stall food innovation and result in additives taking years to get approval. The FDA, he says, “has enough on its plate already.”
The FDA is currently busy implementing The Food Safety Modernization Act, a sweeping food safety reform bill signed into law by President Barack Obama in 2011. The agency also prioritizes responding to foodborne illness crises like the listeria outbreak that killed three people in March.
Industry consultant James Heimbach says he’s confident in the quality and detail of GRAS determinations, whether or not the FDA reviews them.
“None of us wants to be responsible for putting something on the market that’s going to do harm,” Heimbach said.
“The potential for consumer harm is all based on theory or the possibility of some untoward actions by unscrupulous people,” Burdock added. “There has been no documented harm to a consumer as a result of a GRAS” additive.
“I'm sure there are things that are GRAS that are problematic. I'd put money on it that somewhere there's abuse of the system.”
- David Acheson, former chief medical officer at the FDA's Center for Food Safety and Applied Nutrition
But the issue is not just with ingredients that cause immediate harm. Since the FDA, scientists and consumers often don’t even know when new additives hit the market, it’s difficult to track their potential long-term health effects.
“What we’re talking about here is not generally things that poison people immediately,” said Erik Olson, the NRDC’s senior strategic director for health and food. “These are chemicals that may cause cancer, they may be endocrine disruptors, which means they disrupt the hormone system, or they can affect your reproduction or they can have effects on a fetus in utero.”
This has become clear in the case of one of the most known — and vilified — GRAS additives: partially hydrogenated oil, or trans fats. Used to keep foods fresh for long periods of time, trans fats are commonly found in products including fried foods, cake mixes and microwave popcorn. The ingredient has been named by public health experts as a contributor to heart disease, stroke and Type 2 diabetes.
Despite strong pushback from industry, the FDA is expected this summer to officially revoke the GRAS status of artificial trans fats.
Other additives have been deemed safe despite animal studies that have linked them to cancer. Methyl eugenol, for example, is considered a safe flavor ingredient even though a 2002 National Toxicology Program study concluded that “there was clear evidence of carcinogenic activity of methyl eugenol in male and female rats.”
Even green tea extracts known for their health benefits have drawn scrutiny from scientists who worry that, when highly purified and added to food, they could pose long-term health risks, including liver damage.
Last year, the FDA issued guidance for industry about the growing use of botanical ingredients and extracts in foods and beverages that are often touted as healthy.
“We are concerned that some of the novel substances that are being added to conventional foods, including beverages, may cause the food to be adulterated because these added substances may not be GRAS,” the FDA stated. The “trend raises questions regarding whether these new uses are unapproved food additive uses.”
“I’m sure there are things that are GRAS that are problematic,” said David Acheson, former chief medical officer at the FDA’s Center for Food Safety and Applied Nutrition who now heads a risk management firm that consults for food companies. “I’d put money on it that somewhere there’s abuse of the system.”
‘Generally Recognized As Secret’
If there is, it’s almost impossible for the FDA to police it.
Under today’s system, manufacturers that establish that an ingredient is safe for a specific use can either submit their safety evaluation to the FDA for a cursory review or keep their determination private. The FDA encourages companies to choose the former option, but companies more often choose the latter.
The NRDC estimates that about 1,000 ingredients have been added to food without FDA review since 1958. They dubbed the process “generally recognized as secret.”
Two industry consultants told Center for Public Integrity reporters that two-thirds of their safety reviews are never sent to regulators. An international food company told the GAO that it introduces five new ingredients yearly without telling the FDA.
The 2010 GAO report said the FDA should require companies to submit basic information from safety evaluations, including a substance’s identity and use.
But the FDA says requiring this information is beyond its power. “If we tried to make it mandatory,” said Keefe, “we would be sued.”
Leaving regulators and the public in the dark means it’s nearly impossible to track how much exposure people have to some ingredients, NRDC researchers say.
Safety evaluations must legally “consider the cumulative effect from all probable sources,” said Tom Neltner, an attorney and chemical engineer who has co-authored many reports about the GRAS system for Pew and the NRDC. “And if you don’t know something’s there in food, how are you going to do an assessment?”
Consider how this could play out at a family’s breakfast table.
A company might privately conclude an ingredient is safe at a specific level in cereal. Another might do the same for its use in muffins. Ditto for a third company adding it to juices.
A family sitting down to a breakfast of all three foods could end up consuming much more of the ingredient than each company had anticipated.
“How can FDA fulfill its responsibility for protecting public health and safety of the food supply if they don’t even know all the chemicals that are being used in the food supply?” asked Lisa Lefferts, senior scientist at the Center for Science in the Public Interest.
In response to such concerns, the Grocery Manufacturers Association, a powerful food industry trade group, announced last year that it is working to increase transparency in the GRAS system by creating a database of safety determinations made by industry and making it available to the FDA.
The GMA, which also announced the establishment of the Center for Research on Ingredient Safety at Michigan State University, stated in an email response to reporters’ questions that industry is “committed to providing regulators and consumers with the important information they need about our products.”
Caffeinated jelly beans
Few ingredients demonstrate the FDA’s challenges in policing the GRAS system like caffeine.
While the FDA has long recognized the safety of caffeine at a certain level in cola-type beverages, companies have expanded that use to other products by making GRAS determinations on their own. In 2013, an FDA consumer update stated that “existing rules never anticipated the current proliferation of caffeinated products.”
In recent years, companies have added caffeine to jelly beans, sunflower seeds and energy drinks. The FDA noted in its consumer update that energy drinks are “aggressively marketed” to young people, despite links to deaths and other adverse reactions.
The latest concerns about caffeine-infused products follows one of the GRAS system’s most high-profile controversies: alcoholic energy drinks, which the FDA banned in 2010 after public outcry.
In September 2010, Bo Rupp, a 15-year-old high school sophomore from Centreville, Virginia, drank two 23.5 oz. cans of Four Loko, a popular alcoholic energy drink.
During a concert that night, Rupp went “completely, intoxicatedly manic and wired,” said his family’s attorney Jeffrey Simon. Event staff had to call the boy’s parents to pick him up.
Rupp acted paranoid, according to his mother, Karla, who drove home with one hand on the wheel and the other arm holding back her son from jumping out of the moving car.
When they arrived home, Rupp ran out of the car to a busy highway where he reportedly sat down in the road. He was struck by a vehicle and airlifted to a nearby hospital. He died the next day.
Three months before he died, a panel of experts convened by industry-consultant Burdock’s firm concluded the alcoholic energy drink was safe. The manufacturer, Phusion Projects, had notified the FDA of their conclusion less than a year after 18 attorneys general told regulators that they were concerned that caffeine-infused energy drinks like Four Loko were unsafe.
Some states like New York, Utah, Oklahoma, Michigan and Washington banned the sale of the beverages before the FDA acted. Two months after Rupp’s death, federal regulators told Phusion and three other companies that their products were unsafe, essentially banning them.
"While Phusion Projects does not comment on specific legal matters," the company said in a statement to the Center about the Rupp family's lawsuit, "it is important to remember that just because a lawsuit is filed does not mean it has merit."
Burdock declined to answer questions about caffeinated alcoholic drinks, stating in an email that he “can’t discuss client business.”
The story of caffeinated alcoholic beverages highlights the FDA’s limited ability to monitor many food additives. Because industry isn’t required to seek pre-market approval from the agency, the FDA is often left to police ingredients after they’ve already hit the market.
“Having pre-market authority, having people come to us and review what they plan to apply to the food supply is much more efficient for us,” the FDA’s Keefe said, adding that post-market reviews are resource intensive. “We strongly encourage them to come to us.”
Companies have taken advantage of a loophole in a decades-old law that allows them to deem an additive to be "generally recognized as safe" without the agency's blessing, or even its knowledge. The loophole is so big that companies can market additives that the FDA has found to pose dangers.
But even if companies heed Keefe’s advice, some critics say the agency has given itself little power to protect the public from potentially unsafe food additives.
James O’Reilly, a professor at the University of Cincinnati College of Law, says the FDA essentially abdicated its responsibility as a food regulator in 1997, when it proposed rules to streamline a more robust review process that had become backlogged. The rules, he says, are a “sham.”
The system the rules created, which still operates today, excuses the FDA from actually declaring ingredients are safe. Instead, when companies determine their ingredients are safe, and then seek FDA review of that determination, the agency’s response is simply that it has “no questions.” The regulators don’t disagree but they are not formally approving the substance as safe.
“It’s a balloon in the shape of a regulator,” said O’Reilly, who specializes in food and drug law. “We have the appearance that there’s a regulator protecting us, but there’s not.”
The FDA’s Keefe, however, stresses that the agency reviews are thorough. Documents showing correspondence between regulators and industry officials confirm that the FDA asks tough questions.
But rarely does the agency reject a company’s GRAS determination. In fact, out of 524 notifications that have been submitted to the FDA and received responses to date, the agency has only rejected 17.
Instead, companies often withdraw their notifications when regulators indicate flaws with the submissions. Sometimes companies re-submit their notifications and receive a “no questions” letter. But even if they don’t, they are still allowed to market their ingredients without one.
The agency does not publicly report why notices fail to earn a “no questions” letter. And because the FDA’s concerns are not published, as in the case of lupin, other companies may end up marketing potentially harmful additives without ever knowing that the agency may have disputed their safety.
Marketing as 'FDA approved'
Companies like to leave the impression that the FDA is on the case, however.
At the Institute of Food Technologists annual exposition in 2013, manufacturers gathered at the sprawling convention center in Chicago to learn about the latest trends in food innovation.
Among the hundreds of exhibitors, including big-name food producers and suppliers, Neltner and Maricel Maffini, a scientist who has co-authored several NRDC reports on food additives, remember watching ingredient manufacturers hawking their additives as “FDA approved” — “even though they are not actual approvals” by the agency, Neltner said.
Others advertised them as “approved by FDA procedures,” suggesting that the ingredients were reviewed by the agency even if they weren’t.
“Statements like that are misleading,” Maffini said.
In March 2014, Senomyx, a San Diego-based biotechnology company, published a press release that appeared to suggest that the FDA had signed off on the safety of its new flavor, Sweetmyx S617.
That was news to the agency.
“In fact,” the FDA posted in a statement on its website, “the agency had not made this determination nor had it been notified by Senomyx regarding a GRAS determination for this food ingredient.”
Senomyx later clarified that the safety evaluation was conducted by a flavor industry trade group, not the FDA.
Additive makers who want to supply their ingredients to big food companies — like General Mills, Kellogg and Kraft — have an incentive to go to the FDA for a safety review: It makes selling ingredients much easier.
“It provides an additional level of assurance for them that the rigorous GRAS evaluation process has been met,” said Robert McQuate, a former FDA regulator who co-founded a consulting firm that specializes in reviewing food additives. The big companies “can impose the requirement that if you as a supplier of an ingredient want to sell to the 800-pound gorillas … you also have to get it cleared through FDA.”
General Mills told the Center for Public Integrity that it requires its suppliers to submit their additives to the FDA for review.
Kellogg did not say whether it requires the same of its suppliers. Spokesman Kris Charles said in a statement: “We adhere to all regulations concerning food additives and have robust measures in place for evaluating new food ingredients."
Kraft did not respond to multiple requests for comment.
Bypassing FDA review is common, but industry consultants say it’s not a nefarious tactic designed to disguise unsafe food additives — it’s smart business.
They say companies often make GRAS determinations on their own — or through an industry trade association — as a way to protect proprietary information from competitors. After all, the FDA publishes information it receives when companies seek agency review, meaning competitors can steal ideas for using ingredients in new ways.
Secret GRAS determinations are done “to retain confidentiality of your material,” McQuate said. “It’s a competitive issue.”
But that explanation offers little comfort to critics who find it troubling that food additives are often regulated by companies with a financial incentive to market them, rather than a federal agency whose chief responsibility is to protect public health.
“Most people in this country take for granted that the Food and Drug Administration has some ability to oversee what ingredients are added to food and [that it] actually reviews the safety of those ingredients,” said David Andrews, a senior scientist at the Environmental Working Group. “It’s extremely disconcerting to find out that they don’t.”