American children with food allergies are suffering life-threatening--and completely avoidable--reactions because manufacturers mislabel their products and regulators fail to police store shelves, a Tribune investigation has found.
In effect, children are used as guinea pigs, with the government and industry often taking steps to properly label a product only after a child has been harmed.
The Tribune investigation revealed that the government rarely inspects food to find problems and doesn't punish companies that repeatedly violate labeling laws.
In disclosing ingredients, labels must clearly identify major allergens such as peanuts, milk, eggs and wheat. Millions of parents, teachers and baby-sitters scrutinize these labels to ensure that they are not giving children unsafe food.
But an alarming number of products sold as allergen-free actually contain harmful amounts, the Tribune found.
Many of the problems occur with foods marketed to children--candy, cookies, cakes and ice cream. Iconic childhood favorites such as Oreos, Pop-Tarts, Frosted Flakes, Jello-O and Campbell's Spaghettios have been recalled for hidden allergens in recent years.
An estimated 30,000 Americans require emergency-room treatment and 150 die each year from allergic reactions to food. A large percentage were children, researchers say.
To determine the full scope of the problem, the Tribune created an unprecedented computer database of 2,800 recalls related to food allergies over the last 10 years. The newspaper found that roughly five products a week are recalled because of hidden allergens, making it one of the top reasons any consumer product in America is recalled.
But that doesn't mean the government or companies are vigilant.
Take the example of Peggy Pridemore, a Kentucky woman who bought Wellshire Kids' Dinosaur Shapes Chicken Bites because her son Patrick has a severe wheat allergy. Bold letters on the packaging said the item was "gluten free," or contained no wheat, rye and barley proteins.
After Patrick, then 3, ate the nuggets in December, he started coughing, his eyes swelled and he had trouble breathing. His mom jabbed his leg with a large needle containing epinephrine, a drug to help him breathe, then raced him to the hospital, where he recovered in the emergency room.
Pridemore said she contacted both the U.S. Department of Agriculture and the food manufacturer and that neither offered to test the chicken nuggets.
The Tribune recently bought the product on two occasions at a River Forest supermarket and sent the samples to one of the nation's leading food-allergy labs, at the University of Nebraska. Both times, the lab found gluten. The item remains on shelves across the U.S.
"I'm stunned it hasn't been recalled," Pridemore said. "I thought somebody somewhere would do something."
Recalls swell, but misleadThe nation has seen a mysterious rise since the 1990s in the number of children with food allergies, now estimated to be 3 million kids, or 1 in every 25 children.
As awareness has skyrocketed so have recalls. But they are voluntary. Food companies themselves--not regulators--decide whether to do so. If they do, the companies work with regulators to coordinate the recalls and issue news releases to inform the public.
Yet the official recall statements by the Food and Drug Administration often downplay the true risks or lack basic information, such as where the tainted products were sold. One reason for the soft pedaling: The FDA allows the food companies to write their own recalls.
A recent recall statement, for instance, read more like an advertisement than a warning. "While the product is good and wholesome," it stated, "these soups may contain wheat or soy as ingredients not identified on the label."
In many cases, the government and companies never inform consumers. The Tribune found that nearly half of the allergy-related recalls in the last 10 years were not announced to the public. This was true even in dozens of cases where the FDA classified products as likely to cause serious harm or death.
Alarms sounded by consumers seldom result in products being pulled.
The Tribune examined 260 complaints to the FDA since 2001 where people with known food allergies--many of them children who had to be treated at hospitals--reported a reaction from products they claimed were mislabeled. Yet just 7 percent resulted in recalls.
Even when authorities concluded a product was at fault, the regulatory wheels moved slowly. On average, it took 32 days to issue a recall.
In one case, a girl, 14, with a known milk allergy was taken to the emergency room after eating muffins made from Duncan Hines chocolate chip mix. The illness was reported to the FDA, but the distributor, Pinnacle Foods, did not recall the mix until seven months later.
When asked by the Tribune why the recall took so long, Pinnacle said it immediately had the product tested but found no milk. A few months later, the company received a second complaint of an allergic reaction to the mix. Pinnacle said it investigated, this time finding a likely culprit overlooked before: a batch of chocolate chips.
Many manufacturers test their products for allergens and have set up special assembly lines to prevent cross-contamination. But other companies, particularly small ones with limited resources, acknowledge taking limited precautions.
Others do little or no testing, and the government does not require them to do so.
The FDA, which oversees the vast majority of packaged foods, said it trusts firms to police themselves.
The USDA, which regulates meat, poultry and egg products, is even more lax. It said it never tests for undeclared allergens, such as eggs or peanuts, because these ingredients by themselves are not prohibited foods--ignoring the fact that products containing hidden allergens are potentially illegal and deadly.
Testing shows riskThis broken system leaves families vulnerable.
Pridemore recalled how she bought Wellshire Kids' dinosaur-shaped chicken nuggets, made by New Jersey-based Wellshire Farms, because the item specifically claimed to be gluten free. She also found the same claim on the Wellshire Farms Web site.
After her son had the severe reaction to the nuggets, she took some to his allergist, who ran tests, including gently rubbing a nugget on the boy's arm to see if it would cause a small welt. It did, and the allergist concluded the nuggets were to blame for his full-blown reaction.
Pridemore contacted the USDA, which sent agency investigator Michael Maxwell to her home just outside Cincinnati. He took photos of the package, but did not test the nuggets for undisclosed allergens.
The investigator also obtained a copy of a brief, unsigned in-plant inspection report, which found no problems with the nuggets. He later acknowledged to the Tribune he wasn't sure who wrote the report--another USDA inspector or a plant worker. The report said workers routinely sent the nuggets out to a lab for testing. The report stated that those lab results, from last fall, "were all negative for gluten."
In an e-mail in January, Maxwell indicated to Pridemore that in light of that inspection report and the fact that no other consumer had complained, no action would be taken. "You may want to have the product tested," he wrote, according to a copy of the e-mail exchange.
Pridemore said she was taken aback that the USDA suggested she test the food herself. But she sent the remainder of the nuggets in her freezer to the Nebraska lab.
The results showed high amounts of gluten. So she e-mailed a copy of the findings to the USDA and reminded Maxwell that the product advertises itself as gluten free.
The investigator wrote back that the government had "archived your complaint." The investigation went no further, according to Pridemore. She also e-mailed the test results to Wellshire Farms. The company, she said, never responded.
In May, several weeks after Maxwell told Pridemore her complaint was archived, a second child with a known wheat allergy-- Timmy Osterhoudt, 5, of Lemoore, Calif.--had a severe reaction after eating the same product, his mother said.
"He said, 'Mommy, I don't want to die!' " Michelle Osterhoudt recalled. "I told him, 'Mommy won't let you die.'."
She jabbed him with the epinephrine needle and raced him to the military hospital on the base where the family lives. There, he recovered.
Like Pridemore, Osterhoudt sent the chicken bites to the Nebraska lab for testing. Again, the results showed high amounts of gluten. She said she complained to Wellshire Farms, USDA and FDA, but to no avail.
USDA spokeswoman Amanda Eamich said one reason it did not ask Wellshire Farms to recall the chicken bites is because the agency did not trust the consumers' testing results. The consumers had sent samples of chicken nuggets from opened packages, raising the possibility that the product was contaminated somewhere between their homes and the lab.
Pridemore said it was the USDA's job--not consumers--to test samples from unopened packages.
"I'm not a doctor. I'm not a scientist," she said. "I'm just a mom trying to keep her child safe."
The Tribune recently bought two samples of the chicken nuggets and sent them to the same Nebraska lab. Both tested positive for gluten--including a sample from an unopened box.
The nuggets, said Steve Taylor, the lab's director and a leading allergy expert, "are not safe for people with wheat allergies or celiac disease," often characterized by chronic abdominal pain.
The newspaper also tested two other Wellshire Kids' products: the "Gluten Free" Chicken Corn Dogs and the "Gluten Free" Beef Corn Dogs, finding high amounts of gluten in both.
Wellshire Farms owner Louis Colameco said his products are safe. But he said that in light of the two consumer complaints and recent moves by regulators to tighten "gluten-free" rules, he halted production of the three Wellshire Kids' products in June.
Colameco said he would start making the food again when he finds a supplier who can guarantee that the batter used in the products is gluten free. The old supplier, he said, could not give such an assurance.
He said he has not recalled the Wellshire Kids products still on store shelves because he believes they are in compliance with federal regulations.
But weak and murky federal rules on gluten leave food companies wiggle room and consumers at risk.
The USDA, which has jurisdiction over meat-based products such as chicken nuggets, said it has no policy specifically addressing "gluten-free" claims. The agency must approve labels before products go to market, and packaging claims are reviewed on a case-by-case basis.
The FDA's rules are tougher. Though the agency has no specific rule for "gluten-free" products, the agency's policy generally is that absent a standard, products claiming to be "free" of an ingredient cannot contain it.
Recognizing that food companies may interpret these rules as they wish, the FDA has pushed a proposed rule that products advertised as "gluten-free" must contain less than 20 parts per million of gluten. A UN health panel this summer recommended a similar standard. Tribune tests of Wellshire products all far exceeded those levels.
Apart from online sales, the Wellshire Kids' gluten-free products are sold exclusively at Whole Foods Market, the upscale chain.
Whole Foods said it was investigating the issue, but that it was the supplier's responsibility, not Whole Foods', to ensure the Wellshire products are safe and legal.
Tribune reporters Annie Slezickey and Jason Grotto contributed to this report.Copyright © 2015, Los Angeles Times