Labeling Update from Chicago Tribune

"Garrett County" Also a Problem Brand

Sam Roe's recent Chicago Tribune reporting on food labeling was a high point of media coverage for the gluten-free community in 2008, ending with the article "Whole Foods pulls 'gluten-free' products from shelves after Tribune story" (December 31, 2008).

Roe and his colleagues did something that was long overdue: They examined food labels and tested foods for compliance when it came to gluten and allergens, then brought their findings to public attention.

In the December 31 article, Roe reports that Whole Foods has pulled three "gluten-free" Wellshire Farms products off its shelves due to their gluten content and stated that it "will devise a strict definition of 'gluten-free' for products sold in its stores and begin monitoring the items so such problems don't recur." Whole Foods was initially reluctant to pull the products but did so after receiving at least 20 consumer complaints or inquiries, the article states. Wellshire Farms apparently stopped producing the products in June but continued to sell them to Whole Foods without changing the labels, reports Roe.

Louis Colameco, owner of New Jersey's Wellshire Farms, still seems have misplaced priorities.

Colameco said he was disappointed Whole Foods decided to pull the products. "But they're the customer," he said. "What are you going to say?"

He said his firm has found a new batter supplier that can guarantee less than 20 ppm of gluten. The newly formulated products should be back on shelves in a couple of months, he said. And before distributing them, he said, Wellshire will conduct gluten tests throughout the production process.

Asked why he does not contact regulators and formally issue a recall for the three products, Colameco said the items do not violate any law and that a recall might suggest an admission of guilt, opening him to lawsuits.

The Wellshire Kids products aren't the only Wellshire items with gluten problems.

Colameco acknowledged that his firm markets products identical to the three Wellshire Kids items under a different brand name: Garrett County. This brand, he said, is not sold at Whole Foods but mostly at health-food stores nationwide.

The Gluten-Free Grocery, on Mannheim Road in Westchester, had carried the Garrett County "gluten-free" chicken and beef dogs. But owner Cindy Day Erwin said she pulled them in November after reading about the Tribune report on the Wellshire Kids brands.

"I would be doing a disservice to my customers to allow a product that has known gluten concerns" to be for sale, she said.

The Tribune recently purchased the Garrett County brand chicken bites, chicken dogs and beef dogs and had them tested at a University of Nebraska laboratory specializing in food allergens. The results showed gluten levels as high as 2,000 ppm.

Colameco said his firm stopped making the Garrett County brand products the same time it halted production of the Wellshire Kids items. He said he no longer had either brand in stock and did not know how much Garrett County product remained in stores.

GFNYC notes that Wellshire Farms had questionable labeling practices well before the influential Tribune articles.

Still more on Whole Foods, Wellshire Farms, and Labeling

Below are updates related to The Chicago Tribune's food labeling articles. (For previous GFNYC coverage, see the posts from Friday and Sunday.)

As you might recall, the Tribune's reporting dealt in part with products marketed by Wellshire Farms and sold at Whole Foods as "gluten-free" even though, on investigation, they appear to have harmful amounts of gluten in them.

* In a follow-up article, "A recipe for disaster: Whole Foods' handling of chocolate bar shows how warnings fail" (November 23, 2008), reporter Sam Roe critiques the unreliability of some manufacturing processes as well as the warnings and assurances found on products sold at Whole Foods. Curiously, the article's gluten-free example has to do with tortillas that seem to qualify as gluten-free even though they are apparently made at high risk of cross-contamination.

* For at least a limited time, you can hear an informative interview with Roe on Chicago's Steve and Johnnie Show. (Co-host Steve King has celiac sprue.)

Part One
Part Two
Part Three

* Chicago-based Enjoy Life Foods president Scott Mandell issued a statement saying that "This kind of investigation is long overdue."

* Wellshire Farms president Louis Colameco has posted a response to the article. As you can see, the response focuses largely on one product and avoids addressing many of the serious issues—such as the >200ppm levels of gluten found in several of Wellshire's "gluten-free" products—raised in Sam Roe's article and this blog.

QUALITY CONTROL
November 21, 2008
To Whom It May Concern:
There have been some questions about the status and production of our Wellshire and Garrett County gluten free Dino Bites as a result of a recent article printed in the Chicago Tribune. Our understanding after speaking with the author is that this article relates solely to reactions from children with anaphylaxis, that is, with severe reactions to any level of allergens.
We have not discontinued making this product, but we are in the process of improving its formulation. Our products are governed by the USDA and its regulations, not the FDA's regulations. We are in complete compliance with the USDA regulations. However, in light of a new FDA proposal under consideration to re-define "gluten-free" to a lower level of gluten parts per million (ppm) in the product than is currently allowed under FDA regulated foods, we are also working on our products conforming to their definition of "gluten-free." As the FDA considers setting a new regulation, this does not affect our legal obligation to comply with USDA regulations, which specifically govern the food products we produce. Our effort to reduce permitted gluten content is a proactive improvement of our product to meet our customer's needs, and an effort to comply with the strictest standards.
Our Wellshire products are tested at a level of 200 ppm or less, which is equivalent to 99.98% gluten free. The FDA is now considering a new proposal that would reduce the amount of gluten to be 20 ppm or to 99.998% gluten free. This will be difficult to achieve as wheat and other grains can become cross contaminated from growth in the fields, or milling in the combines. It becomes very, very difficult if not impossible to control.
The FDA interprets the definition of gluten free to concern the level or amount of gluten in the product; thereby recognizing that there is still a contaminate of gluten in the product. The USDA bases the gluten free claim on the identity of the ingredients listed in the product, that is prohibiting the use of ingredients that contain gluten, such as wheat, barley, or rye.
It may take a month more to fully complete the transition of the Wellshire products, but the Dino Bites will be returning to store shelves as soon as possible. This new Dino Bite will be a better tasting product, suitable for child and adult palates alike.
Wellshire is committed to improving the quality of our products. We apologize for any inconvenience this confusion between the USDA and FDA regulations may have caused our customers.
Thank you.
Louis B. Colameco, III President

* I have yet to see any response or statement from Whole Foods.

Warning: Deceptive Labeling from Wellshire Farms

Whole Foods, USDA, FDA May Also Be Passing the Buck

It's bad when a company mislabels food as "gluten-free" when it isn't. It's even worse when, after being "caught," it continues to do so. And that seems to be the case with Wellshire Farms and, by association, Whole Foods Market.

In 2006, GFNYC shared a report about mislabeled Wellshire Farms Lemon Herb Turkey Breast bought at Whole Foods Columbus Circle. Now Sam Roe of The Chicago Tribune reports the mislabeling of Wellshire Kids' Dinosaur Shapes Chicken Bites (which, Roe writes, are marketed exclusively by Whole Foods) as well as Chicken Corn Dogs and Beef Corn Dogs, both marked as "gluten-free."

In the article "Children at risk in food roulette" (November 21, 2008), Roe writes

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.

* * *

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.

GFNYC encourages you to spread the word and bring this matter to the attention of your local Whole Foods Market. And keep an eye on your legislators to ensure that labeling becomes more reliable and enforceable. Budget cuts could make the situation worse.