Salmonella Threat Results in Food Recalls, Presidential Review of FDA

Gluten Free Cafe Asian Noodles are part of a precautionary recall by the Hains Celestial Group due to current concerns over salmonella in peanut products; see here for more information.

Out of similar concerns, General Mills voluntarily recalled the peanut-butter cookie flavor of Lärabars, which are all gluten-free. See here for more information.

As you can see here, many other foods have been recalled due to recent salmonella contamination in peanut products, which has resulted in eight deaths and hundreds of illnesses. The recalls are of historic proportions.

The business that seems to be at the source of the contamination is Peanut Corporation of America (PCA). According to USA Today,

The government...accused the peanut butter manufacturer Peanut Corp. of America (PCA) of shipping products in 2007 and 2008 after internal tests found bacterial contamination, violating food safety regulations.

The company's actions "can only be described as reprehensible and criminal," said Rep. Rosa DeLauro, D-Conn., who oversees Food and Drug Administration funding. "Not only did this company knowingly sell tainted products, it shopped for a laboratory that would provide the acceptable results they were seeking. This behavior represents the worst of our current food safety regulatory system."

The alleged misbehavior of PCA reminds me of the poor practices of Wellshire Farms, which has repeatedly released food mislabeled as gluten-free and failed to have them removed from store shelves.

There are probably many responsible food producers who can self-govern and refrain from selling toxic or dangerously mislabeled foods. But the above examples indicate that there are others who seem unconcerned that sickness and even death can result from their irresponsibility. People on medical diets can try to limit risks by avoiding processed foods, but otherwise the only answer to malfeasance seems to be stricter food regulation.

In response to the salmonella scare, President Obama heeded the calls of food safety advocates in ordering a review of the Food and Drug Administration (FDA). I hope that this review will consider issues such as gluten contamination and extend to the USDA and other agencies involved in evaluating food safety.

Here is an AP video segment on the story.



Source (1:28)

Bad Labeling

Newman's Own Organics Takes Years to Respond to FDA

As I've been reporting ad nauseum, Wellshire Farms seems to have used inaccurate or misleading labels for years, hoping that it can get away with the practice, no matter the damage that might be done to children and other consumers.

Sometimes the FDA clamps down on bad labelers: In 2006, the agency actually confiscated French Meadow Bakery spelt bread that was marketed as wheat-free; French Meadow has since tried to make amends.

Food labels should be accurate and informative, but when it comes to bad labels, other possibilities exist between the two poles of getting busted or trying to get away with them. In December, Nature's Path undertook a "voluntary" recall of its Penguin Puffs cereal because the kamut was not identified as a form of wheat.

Companies may also get warnings from the FDA—but they might not respond promptly to the warnings. This can happen with companies that appear to very sensitive to consumer needs. I believe this was the case prior to the big French Meadow Bakery bust, but here's another examples: Apparently, the FDA issued a December 26, 2006 warning to Newman's Own Organics stating that the company failed to note the presence of wheat in its Spelt Pretzels, and then issued a December 22, 2008 warning letter noting that the problem had still not been addressed sufficiently. Newman's Own Organics now says that will change the packaging. But why does it take years for companies that market themselves as health-oriented to improve their poor labels, even after the FDA brings the problem to their attention?

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.

Even More on Wellshire Farms, Whole Foods, and Labeling

Here are two more updates related to the revelations regarding substantial levels of gluten that have been found in Wellshire Farms products labeled as gluten-free.

* There's word that the Celiac Sprue Association (CSA) facilitated the testing of the products and found that Wellshire Farms seemed unconcerned about the alarming levels of gluten.

* Glutino president Steve Singer issued a statement saying in part that "the Tribune's report [November 21 and November 23, 2008] is a great step forward to making sure we all join this effort to protect Americans and our children living with food allergies."

Regarding the FDA in general:

* Mark Schlosberg and Elanor Starmer of Food & Water Watch declared "Food safety must be a first priority under the new administration. This is one area where individuals should not - and cannot - go it alone" in an Op-Ed piece in the San Francisco Chronicle.

* Representative Charles Dingel (D-Michigan) stated that the House Committee on Energy and Commerce "has found that FDA not only failed in its basic mission, but refused to admit its failures and take steps to protect Americans from unsafe food and drugs."

* The FDA attempted to stand up for itself.

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.

More on Wellshire Farms

A Look at the Findings

Following up on Friday's post, let's focus on some of the Chicago Tribune's test findings.

The Tribune wrote the following in a kind of sidebar:

The FDA doesn't define "gluten free," but generally "free" means a product contains none of the substance in question. The FDA has proposed adopting a 20 parts per million standard. In July, an international health commission recommended a similar standard.

The USDA, which has jurisdiction over meat products (including those below), has no policy specifically addressing "gluten-free" claims. The agency OKs labels before products go to market....

The Tribune bought three popular Wellshire Farms products advertised as "gluten free" and sent multiple samples to a lab for testing.

Chicken Bites: Tested at 204 parts per million and 260 ppm

Chicken Corn Dogs: Tested at 116 ppm and 2,200 ppm

Beef Corn Dogs: Tested at 191 ppm and 1,200 ppm

Wellshire Farms provided the Tribune with its own testing results, conducted in the spring. Their results showed: chicken nuggets tested at 200 ppm, chicken corn dogs 150 ppm, and beef corn dogs 120 ppm.

Prior to the adoption of the 20 ppm standard, the standard for many was 200 ppm, which might explain why Wellshire Farms claims the 200/150/120 levels (though I think that 200 ppm for the chicken nuggets was really pushing it).

Setting those numbers aside, the Chicago Tribune story, which seems credible, strongly suggests that, in practice, test levels are actually very variable with the possibility of highly problematic levels of contamination.

This makes me lean more toward labeling standards that include a ppm rating that indicates the probable level of gluten plus the possible high level, based on up-to-date testing (using the most appropriate testing equipment, which varies according to product). I'm not sure if a score of <20/120 or (in the case of the beef corn dogs, perhaps 120/1200) would be the best solution, but something in that direction should be seriously considered. And, as Ben Cappel has suggested, label dates would be good to heighten understanding of how up-to-date (or out-of-date) a food rating might be.

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.