FDA Wants Input on Gluten-Free Labeling

"The FDA is charged with ensuring the safety of $417 billion worth of domestic food and $49 billion worth of imported food each year. That's no small task," observed a recent Chicago Tribune editorial ("Peanut Peril," March 7, 2009).

One part of the FDA's big task involves examining issues related to labeling food as "gluten-free." Here's info on a proposed study, garnered from a FDA web page on the project:

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency.....Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a voluntary consumer study entitled "Gluten-Free Labeling of Food Products Experimental Study."

* * *

The Gluten-Free Labeling of Food Products Experimental Study will collect information from both consumers who have celiac disease or gluten intolerance and those who do not have either condition. The purpose of the study is to gauge perceptions of characteristics related to claims of "gluten-free" and allowed variants (e.g., "free of gluten," "without gluten," "no gluten"), in addition to other types of statements (e.g., "made in a gluten-free facility" or "not made in a facility that processes gluten-containing foods") on the food label. The study will also assess consumer understanding of "gluten-free" claims on foods that are naturally free of gluten, and gauge consumer reaction to a product carrying a gluten claim concurrently with a statement about the amount of gluten the product contains.

The data will be collected over the Internet from samples derived from two sources: (1) A membership list from a celiac disease special interest organization and (2) an online consumer panel. Participation in the study is voluntary.

* * *

FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

* * *

DATES: Submit written or electronic comments on the collection of information by May 5, 2009.

ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number [FDA-2009-N-0083]....

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-3794.

So be sure to check out the FDA web page devoted to this project, put together your thoughts, feel free to air them here, and make sure you hit the May 5 deadline!

I'll offer my two cents eventually.

Thanks to Shelley Case for promptly spreading the word online.

Recognition for Allergic Girl Article

If the Chicago Tribune's investigative reporting on food labels was a high point of 2008, then a low point would have to be Meredith Broussard's hatchet jobs against the well-regarded Food Allergy and Anaphylaxis Network (FAAN), which Broussard recently attacked again with this Huffington Post item in which she still seems to be one of the only people in the world who would insist that the FAAN estimate of 150-200 deaths-by-allergy per year is a wild exaggeration.

Even if Broussard is right that the "real number" is actually 11, it's still a minor difference in terms of the entire US population—and a negligible quibble with FAAN considering how helpful the organization has been in educating families and the general public about allergies.

So it's great that Sloane "Allergic Girl" Miller took on Broussard in the healthcentral.com article "Everyone's Gone Nuts" (January 11, 2008). This interview with pediatric allergist Mike Pistiner just won third place in the Samter Journalism Awards, developed by the American Academy of Allergy, Asthma and Immunology (AAAAI) "to recognize the best reporting of the role of the allergist/immunologist and allergy, asthma and immunologic disease."

Yaaaai, Allergic Girl!

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.

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.

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.

"THE CHALLENGE OF GIVING UP GLUTEN"

Many recent articles about being gluten-free revolve around the diet being a medical necessity; other recent articles treat the diet as a fad. Today's Newsday picked up a Chicago Tribune article by Janet Helm entitled "The challenge of giving up gluten."—a well-sourced item that addresses both the medical issues and the possible trendiness related to the diet.

Some highlights:

Most definitely, people with celiac disease need to avoid gluten. Otherwise, this autoimmune disorder can damage the small intestine and interfere with the absorption of nutrients. For celiac sufferers, a gluten-free diet is far from a fad - it is the only treatment.

What appears less clear is whether gluten can be blamed for other problems such as autism. Carol Fenster has been gluten-free for 20 years even though she does not have celiac disease. She's part of a growing group who say they simply feel better avoiding gluten.


Experts say that the growing attention on gluten is a mixed blessing. On one hand, it may encourage more people to get tested for celiac - which still remains undiagnosed in about 97 percent of the people who have it in this country. A typical diagnosis often takes 10 years because the symptoms are mistaken for other conditions. But, ironically, the current fervor over gluten may be making a proper diagnosis even trickier.

Starting a gluten-free diet before being tested for celiac may cause the gut to heal temporarily and an accurate diagnosis will be missed, said Dr. Joseph A. Murray, a celiac disease specialist at the Mayo Clinic in Rochester, Minn.

"If you're concerned about celiac, you should be tested before treating yourself," he said.

Self-diagnosis is rampant, probably due to the increased awareness of the disease. People are more likely to know someone with celiac now, and they relate to the diverse and often vague symptoms associated with the disease, Murray said.


If celiac is ruled out, Murray said there is little or no evidence to support a connection between gluten and other ailments, including autism. Even so, he said there is nothing wrong with cutting out gluten as long as your diet is nutritionally complete.

Lately I've been wondering about a possible contributor to the trendiness of gluten-free diets that Helm's article doesn't mention. With the food industry's bullishness about gluten-free products, it seems that more and more products show up with "gluten-free" labels but no explanation that the labels are pertinent for people on medical diets. Consumers who see the labels possibly associate the labels as something generally positive (like "vitamin packed") rather than of most relevance to people with celiac disease and/or wheat allergies. Perhaps increased awareness of celiac disease causes people to go on the diet, but perhaps increased awareness of the "gluten-free" label—without increased awareness of celiac disease—might come into play, too.

Just musing, is all. I'd be interested in seeing studies of the phenomena discussed in the article. And I'm looking forward to seeing studies about possible relations between gluten and symptoms associated with autism. I think there are some coming.