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)

Chicago Tribune Exposes Poor Labeling

Sam Roe and Ted Gregory's article "Tribune investigation prompts stores to pull food items" (December 20, 2008) is the latest in the Chicago Tribune's look at labeling practices.

Says the article: "In one of the nation's largest examinations of undisclosed ingredients in food, the Tribune reviewed thousands of items at more than 60 locations, finding dozens of products obviously mislabeled. The newspaper also conducted 50 laboratory tests—more than the U.S. Department of Agriculture and the Food and Drug Administration combined over the last several years—to try to determine precise ingredients."

Can you believe how little testing the USDA and FDA do?

Many of the cases in the article have to do with milk, but there are some items of special interest to those on wheat-free or gluten-free diets. Perhaps the most important is the finding that "Oats are often tainted with wheat." This is well-known in wheat-free and gluten-free circles, but research supporting the claim only surfaces sporadically. And the article draws attention to one of the big flaws of current labeling regulations: The cross-contamination of wheat with oats is not something that must be disclosed, no matter how substantial it might be.

The Tribune tested six brands of oat cereal, and all had hidden gluten, most likely traces of wheat....

By law, labels need to disclose only ingredients in the product's formulation. Substances that might slip in through cross-contamination do not have to be declared, though more and more companies are putting such warnings on labels.

Tricia Thompson, author of "The Gluten-Free Nutrition Guide," said many people suffering from celiac disease, which can cause stomach cramps, know to avoid oats. But oat products, she said, should warn that they might contain wheat.

None of the six oatmeal products tested by the Tribune clearly warned consumers about the possibility of wheat, a major allergen.

But after the Tribune informed New York based-HappyFamily that its HappyBellies Oatmeal Cereal contained gluten, chief operating officer Jessica Rolph said she would relabel the product.

She added that consumers have been asking her company whether the cereal contains wheat. "Parents are definitely concerned about this," Rolph said.

The oats that tested highest for gluten in the Tribune examination were made by the Quaker Oats Co. Spokeswoman Candace Mueller said Quaker is aware that cross-contamination can occur in its oats, but "we are confident that our labels are accurate and our products are safe."

Thanks a lot, Quaker Oats.

Some good news for New Yorkers: "New York state authorities test many imports for mislabeled food, but few other regulators do." However, the article goes on to say that "With few checks on foreign labels, many imports pose a significant risk to U.S. children with allergies" and offers this cautionary note: "'If I had a food allergy, I wouldn't eat imported foods,' said Dan Rice, director of the New York state food laboratory."

Now I'm curious to see the results of all 50 lab tests.

ADDENDUM (12/21/08) From an email on the international celiac disease mailing list, it seems that the findings for oats were as follows.

920 ppm Quaker Old Fashioned Rolled Oats
190 ppm Jewel (Albertson's) Old Fashioned Oats
160 ppm McCann's Imported Steel Cut Irish Oatmeal
130 ppm HappyBellies Baby Oatmeal Cereal
79 ppm Whole Foods 365 Organic Rolled Oats
36 ppm Country Choice Irish Style Oats

None of them would qualify as gluten-free according to the current international standard of 20ppm maximum.

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.