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Children at risk in food
roulette
Mislabeling, lax oversight threaten people with
allergies
Source of Article: http://www.chicagotribune.com/news/local/chi-adv.hd.ajumpnov21,0,1515510.story
By Sam Roe | Tribune reporter
November 21, 2008
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, Jell-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 mislead
The 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 risk
This 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.
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