July 23, 2015 -- For Donna Pierre, there’s no more important job than reading food labels.
Her 7-year-old daughter has a life-threatening peanut allergy. So every day Pierre pores over every word of every food package, even when they’ve eaten the product before.
She knows peanut protein can be hiding in ingredients with names like arachis, goober peas, and monkey nuts.
“You have to check every label, every time. That’s kind of my mantra,” says Pierre, 45, who lives in Worcester, MA.
Still, in 2012, her best efforts to protect her daughter weren’t enough. Pierre is convinced that a package of egg noodles that listed only the ingredients in enriched wheat flour and eggs sent her daughter to the emergency room.
After a bite of the pasta, her daughter broke out in hives and her face started to swell. They took an ambulance to the hospital.
After it was over, Pierre walked back through the entire day, carefully taking note of everything her daughter ate. “It was the only thing that was different,” she says.
Pierre phoned the company that manufactured the noodles. The company told her there was no way the noodles could have contained peanuts or been processed on the same equipment, she says. The whole ordeal is still an unsettling mystery -- but one that has become frighteningly common.
For the last several years, allergens that get left off food labels have been the largest source of problems submitted to the FDA’s Reportable Food Registry.
Companies are supposed to file a report with the FDA when they become aware of foods that could cause serious harm to consumers. Many times these reports trigger food recalls.
In 2012 and 2013, unlabeled allergens were the reason behind 38% of all reports to the registry -- which got a total of 1,153 and 1,471 total reports for both of those years. In 2014, unlabeled allergens were the problem behind 44% of 1,534 total reports for that year, government records show.
“So this is more than salmonella, more than E.coli, more than listeria in terms of the number of recalls that they’ve had. They don’t get quite the same public recognition,” says Steven Gendel, PhD, the former food allergen coordinator for the FDA. He has since joined a laboratory testing company called IEH.
In a study published in 2012 in the Journal of Food Protection, Gendel found that from 2007 to 2012, the number of foods recalled because of undeclared allergens more than doubled, rising from 78 to 189.
Similarly, the USDA, which issues recalls of meat and poultry products, has also seen big increases in the number of those products with hidden allergens. The number of recalls for undeclared allergens in processed meats rose from 25 in 2013 to 43 in 2014, a 72% increase.
The rise in hidden allergens in foods has continued despite a 2006 law that was supposed to make things easier for people with food allergies. The Food Allergen Labeling and Consumer Protection Act requires food manufacturers to clearly indicate when they’ve used one of eight major allergens: milk, eggs, fish, shellfish, peanuts, tree nuts, wheat, and soy.
Experts say some of the increase is probably because of better testing and detection of allergens in food and because of greater awareness. But they don’t think those things entirely explain the rise.
And the lapses are causing harm.
WebMD filed a Freedom of Information Act request to find out how many times companies are aware of harm that’s resulted from undeclared allergens in their foods. Since June of 2012, government records show 60 instances of harm to a person reported by food companies related to undeclared allergens.
Nichole Nolan, the FDA analyst who oversees the registry, says she thinks that number is low, however, because food companies are prompted to limit their legal liability before they fill out the form. Checking the box to report harm is voluntary.
The number also doesn’t represent instances when consumers contacted the FDA directly to report their reactions.
“There are obviously still a lot of problems,” says Jacob Kattan, MD, a pediatric allergist at the Icahn School of Medicine at Mount Sinai Medical Center in New York City.
“If there are that many contaminations and that many recalled products, the products are not being recalled until children and adults with food allergy have already had reactions. So I do think it’s probably necessary for companies to do a better job of preventing the problems instead of dealing with them after,” he says.
FDA spokeswoman Megan McSeveney says the agency is working on several fronts to reduce recalls because of undeclared allergens -- researching the cause of the errors, working with the food industry on best practices, and developing new ways to test for the presence of allergens.
Unreliable Labels Investigated
In 2012, Gendel and a team of FDA experts drilled down to find out why all these recalls are happening.
They discovered the most common reason that allergens get left off food labels is that the company accidentally puts similar products in the wrong packages. Peanut butter Cheerios might get packed in the boxes labeled plain Cheerios, for example.
The second most common reason is the food makers use the wrong terminology on their ingredient lists. Flour gets listed, but companies fail to warn that the product contains wheat, for example. Butter gets listed, but not the milk that’s used to make it.
“It is not clear why there are so many terminology problems or why the number of these recalls is not decreasing over time,” Gendel and his co-authors said in an article for the trade magazine Food Safety News.
According to the law, the companies are supposed to list ingredients by their “common and usual names.” And in some cases, the FDA has provided guidance about what those names should be. But there’s some wiggle room, and sometimes companies take advantage of it -- scrubbing labels of ingredients that sound like chemicals consumers want to avoid.
“Is it up to the manufacturer to determine the common and usual name for the ingredient? Yes. Will FDA or consumers have issues with what you’re using? Possibly,” says Melissa Grzybowski, a regulatory and nutrition specialist with the Food Consulting Company, a group that advises food manufacturers on legal and appropriate names for ingredients.
“There’s a lot of gray in the regulations, so we always work with companies to make their product look the best that it can,” Grzybowski says.
The FDA’s McSeveney says firms are responsible for making sure their products are labeled appropriately; if a company fails to properly declare a major food allergen, the FDA can take action, although typically companies recall such products voluntarily in such cases.
Brian Kennedy of the Grocery Manufacturers Association says: “Our member companies are committed to ensuring that food-allergic consumers have the information they need on the food label to make informed choices about whether or not a particular food item is appropriate for them to eat.”
The third most common reason allergens get left off food labels has to do with the modern food manufacturing system. Many processed ingredients are shipped to companies as nondescript powders, syrups, or oils. If those aren’t labeled correctly, or if the supplier changes the way they make the ingredient and fails to alert the manufacturer, the information may not make it to consumers.
Sometimes, ingredients become contaminated with allergens, as was the case earlier this year when a large amount of peanut-tainted cumin spice was used to make a variety of cooking kits and seasoning mixes. The recall affected at least 18 different products and perhaps many more. A note on the FDA’s recall page admits that because the recipes companies use can be considered trade secrets, even they don’t know how many products were affected.
Steve Taylor, PhD, who co-directs the Food Allergy Research and Resource Program at the University of Nebraska-Lincoln, tested some of the tainted cumin spice. He believes there was too much peanut protein for the contamination to have been accidental. He and other experts in the U.K. suspect a poor cumin harvest encouraged overseas suppliers to stretch limited resources with ground up peanuts and almonds -- a case of intentional food adulteration Taylor concedes there’s no way to prove his theory, though.
“We had a number of patients who reported reactions that we believe were due to contamination in those products,” Kattan says.
One Parent's Fear Shared by Many
For most people, food labels that aren’t clear or complete don’t result in immediate harm. But that’s not true for people with food allergies, like the Pierre family.
“Our biggest issue is the labeling,” Pierre says, speaking for parents of kids with food allergies. She doesn’t understand why companies and restaurants aren’t more careful about it.
“They say they get it, but they kind of don’t,” she says of food companies. “The tiniest speck could kill my kid.”
The FDA has proposed a rule under which food manufacturers will be required to implement a plan including “safeguards to prevent or significantly reduce” hazards like undeclared food allergens, McSeveney says. The rule, scheduled to become final this year, also includes provisions to prevent unintended cross-contact between foods with allergens and foods without. Firms covered by the rule would have from 1 to 3 years to comply, depending on their size.
It’s hard to know exactly how many people get sick when allergens are left off food labels.
There’s also no central clearinghouse that keeps track of the number of times kids or adults have to go to the emergency room because of life-threatening reactions called anaphylaxis. The best estimates of these emergencies rely on numbers that are nearly a decade old.
Benjamin Young is president of a company called PearlDiver Technologies. Young mines a huge database of insurance claims to learn about health care trends for corporate clients.
At the requests of WebMD, Young checked records on more than 18 million patients who were covered by a major private insurance company between 2007 and 2014. The records contain no personal information to comply with privacy laws. He searched his data for a set of 10 diagnosis codes that doctors use for food anaphylaxis in medical records.
Jacqueline Pongracic, MD, a pediatric allergist and immunologist at Northwestern University’s Feinberg School of Medicine in Chicago, confirmed WebMD’s method. She’s done similar studies of trends in food anaphylaxis.
The search found the number of patients treated for food anaphylaxis in that population has doubled over that time period, rising from 80 patients in 2007 to 168 in 2014.
Those numbers are small and probably underestimate the true number of emergency visits each year for food allergies. That’s because doctors don’t always use those exact codes in medical charts. And the patients covered in this database only represent about one-seventeenth of the U.S. population.
But these numbers do show a trend, one that Pongracic thinks is solid and deserves more attention.
Pierre thinks so, too. After her experience with unlabeled allergens, she has a new rule at home. She won’t open any new food packages at night, even if she’s used the product before. They eat leftovers, instead.
Her fear is that her daughter might eat dinner and then have a severe allergic reaction overnight. Pierre is afraid that she could have a reaction in her sleep, since no one would be awake to spot her symptoms.
“It’s like everything is a landmine,” she says. “We depend on food labels. I think all food allergy parents do. But I don’t trust them anymore. It’s a hard enough road as it is for them not to be transparent.”