FeaturesApril/May 2010 Issue

A Closer Look at Gluten-Free Labeling

The number of products designated "gluten-free" is exploding. Can you trust every claim?

Gluten-Free Labeling


In late 2008, a newspaper investigation revealed that certain gluten-free products manufactured by Wellshire Farms and specifically marketed to children were mislabeled. As news spread about the faulty designation, parents of food allergic kids became furious—and scared. At least two children with wheat allergies developed anaphylaxis to the mislabeled food and required hospitalization. In addition, countless children with celiac disease were sickened, including 2-year-old James Fourie.

“We had just started him on the gluten-free diet,” explains James’ mom, Stephanie Fourie of Boulder, Colorado. “I cook a lot from scratch but I also rely on packaged foods from time to time, especially when I was first learning the gluten-free diet.”

Fourie had purchased mislabeled chicken bites and given them to James. Within an hour or two, his behavior changed, explains Fourie. He crouched down in a corner of his room and was saying something but he was too young to verbalize how he was feeling. From his body language, it looked like he was having severe stomach cramps.

Trusting the product was properly labeled, it didn’t cross Fourie’s mind that the chicken bites were to blame for her son’s symptoms. When she offered them to James at a second meal, he refused them. At the time, it was frustrating.

“The chicken bites weren’t cheap and I didn’t want to make several different things for dinner,” says Fourie, who has two other small children.

Gluten-Free Labeling

When she read the newspaper report that Wellshire Kids Gluten Free Dinosaur Shapes Chicken Bites, Chicken Corn Dogs and Beef Corn Dogs contained up to 2,200 parts per million of gluten—more than 100 times what celiac experts generally view as acceptable—it was like a light bulb went off. That was why James had mysteriously fallen ill!

Fourie was outraged. She immediately contacted the store where she bought the chicken bites and told them about the mislabeling. But without an official product recall, the store would not pull the products from its shelves.

“It was so upsetting,” Fourie recalls, “I couldn’t stop thinking about all the other parents out there who hadn’t read the newspaper story and were feeding their kids these mislabeled products that were making them sick. Who knows how many kids may have had reactions to the mislabeled food? I was so disappointed that no one was doing anything about it.”

Wellshire Farms has since posted a response to the mislabeling episode on its website. Although the company pointed to contaminated corn batter as the culprit—it's now working with a new batter supplier—Fourie says the experience has made her wary of the gluten-free label. “I’ve lost a lot of trust,” she says.

Cause for Concern

Shortly after the incident with the chicken bites, Fourie began reading up on gluten-free labeling. She was surprised—and frustrated—to learn that currently in the United States, there is no definition for the use of the term “gluten free” with regard to food labeling. Neither the U.S. Department of Agriculture, which oversees egg, meat, and poultry products, nor the Food and Drug Administration, which covers packaged and most other foods, specifically define the term “gluten free.”

Yet both agencies permit gluten-free labeling, as demonstrated by the increasing assortment of gluten-free foods available. The USDA reviews “gluten free” and other so-called health claims on a case-by-case basis—Wellshire Farms reportedly received USDA approval for its chicken bites in 2001—while the FDA allows manufacturers to affix a gluten-free label on FDA-regulated products provided the claim is “truthful and not misleading.” Generally, if a food labeled “free” of a substance actually contains that substance, the FDA considers the claim misleading.

But this line of reasoning falls short with gluten-free claims.

With other “–free” claims, such as sodium-free or calorie-free, free means zero. But with gluten-free foods, there’s no way to test for zero gluten. The technology just isn’t there yet, says attorney Andrea Levario, executive director of the American Celiac Disease Alliance (ACDA).

Instead, extremely small quantities—known as parts per million (ppm)—of gluten can be reliably tested. Current analytic techniques can consistently detect 20 ppm of gluten in a variety of foods, including raw, cooked and baked foods. Since celiac experts generally agree that 20 ppm of gluten is a safe threshold for people with celiac disease, many countries have adopted gluten-free standards at or below 20 ppm.

The FDA proposed a less than 20 ppm gluten-free standard in 2006—its first explicit attempt to define the term gluten free—but the agency has yet to finalize it. And the USDA is awaiting the FDA’s decision before moving ahead on the subject.

With the number of products making unregulated gluten-free claims on the rise, the marketplace can be potentially dangerous for consumers with gluten sensitivity and wheat allergy.

And it’s no longer just people with celiac disease buying gluten-free foods, notes celiac nutrition expert Shelley Case, RD. Sales far exceed what the portion of the U.S. population diagnosed with celiac disease might purchase. Consumers are scooping up gluten-free products for reasons that range from weight loss and general health concerns to simple curiosity.

Delayed Regulation

There may be as many as a dozen variations in gluten-free claims, such as “no gluten,” “without gluten,” “free of gluten,” and “no gluten ingredients used.”

Is the purity of a product labeled ‘no gluten ingredients’ the same as one labeled ‘gluten free,’ wonders Fourie. “It’s very confusing.”

She and other consumers aren't the only ones confused. According to a recent FDA report, many food manufacturers would welcome a gluten-free standard to eliminate uncertainty or misunderstanding regarding labeling, as well as to help level the playing field. These companies argue that a standardized definition could assist the industry by promoting fair competition. With a standard in place, all manufacturers would have to adhere to the same labeling requirements.

Why hasn’t the FDA finalized its 2006 definition of gluten free? As part of sweeping legislation known as FALCPA, the Food Allergen Labeling and Consumer Protection Act of 2004, Congress ordered the FDA to define and permit the voluntary use of the term gluten free on the labeling of foods by August 2008. As directed, the FDA issued its proposed gluten-free regulation on schedule but has failed to follow through with a final ruling.

While there has been no official explanation for the nearly two-year delay, Levario speculates that the voluntary nature of the gluten-free regulation could have something to do with it. Because it’s not mandatory, it may not be viewed as an immediate priority, she says. In addition, the 2008 deadline for the final ruling coincided with changing White House administrations.

“It might have been a bit of bad timing,” Levario says.

In November 2009, the FDA announced plans to conduct an experimental study on gluten-free labeling. The agency hopes the study will gauge public perceptions of various gluten-free claims (e.g., free of gluten, without gluten, no gluten), in addition to related statements (e.g., made in a gluten-free facility, not made in a facility that processes gluten-containing foods). While the study will likely provide the FDA with useful information, Levario advises that it may further delay nailing down a definitive gluten-free standard.

Flimsy Oversight

Without regulation in place, enforcement of gluten-free labeling is feeble at best.

“Until the FDA regulations are finalized, it’s a question mark at what point the agency would say a product is mislabeled or misleading. Right now, there’s no way to know that,” says Levario. When gluten-free products have received attention for potential mislabeling in recent years, it’s been primarily from consumer groups, not the FDA.

Gluten-Free Labeling

In contrast, when peanut labeling errors have occurred, the FDA requires immediate product recalls. The difference is that there is a labeling standard in place for peanuts, in part because there is an immediate risk to consumers with an allergy, explains Levario, “Someone could die from eating mislabeled peanut products. Gluten doesn’t fall into the same risk category.”

While Wellshire Farms may not have been required to issue a recall of its mislabeled products, it could have done so voluntarily. For Fourie, this is hard to swallow.

“A recall would have been the responsible thing to do. Mislabeling a product is bad, but failing to recall it is unacceptable,” she says. “Companies should want to make the highest quality product. When they issue a recall, it speaks volumes about the company, that they’re trying to do the right thing.”

A problem with recalls is that many people never hear about them, says Levario. Typically, a recall starts with a press release that’s subsequently picked up by various media outlets, blogs and support groups. To stay current, Levario suggests signing up with the Food Allergy and Anaphylaxis Network’s (FAAN) special allergy alert listserv at foodallergy.org. FAAN’s focus is on product recalls of allergens like milk, eggs, peanuts and soy. Wheat is also covered, but not gluten.

Making Progress

Despite the challenges, considerable progress has been made in product labeling that’s been a God-send for food-allergic consumers. FALCPA requires clear identification of the top eight allergens (milk, eggs, tree nuts, peanuts, fish, shellfish, soy and wheat) and Levario points out that the law indirectly benefits those on the gluten-free diet.

“Labeling wheat dramatically reduced the label-reading burden for gluten-intolerant consumers,” agrees dietician Shelley Case. “The majority of gluten in the North American diet—up to 95 percent of it—comes from wheat.”

FALCPA was also a huge step in getting food manufacturers on the side of the food-allergic and food-intolerant community, explains Levario, “We really need to partner with manufacturers and continue to encourage them. Most have been working very hard to comply with the law.”

In fact, many companies started proactively planning for gluten-free regulation as soon as FALCPA passed. Some began researching product-testing protocols from countries with established gluten-free standards. Many looked to Canada, which has had a gluten-free policy in place since 1995. Canada officially defines “gluten free” as no gluten; however, practically speaking, detection analsyes used put the cut-off for gluten-free foods at 20 ppm.

Internationally, gluten-free labeling standards vary considerably but that may be changing. In 2008, the Codex Alimentarius Commission, which sets international standards for food and food safety, revised its widely referenced gluten-free guideline. Codex now stipulates that gluten-free foods may not contain more than 20 ppm of wheat, rye, barley or oats,* a definition comparable to FDA's proposed gluten-free regulation.

Certification Programs

While some companies voluntarily observe the less than 20 ppm standard, others have gone further and sought certification from one of several gluten-free certification organizations. In recent years, the Gluten Intolerance Group (GIG), the Celiac Sprue Association (CSA) and the National Foundation for Celiac Awareness (NFCA) have each developed their own certification program to help consumers identify gluten-free foods with more confidence. GIG’s program is the Gluten Free Certification Organization (GFCO).

“We modeled GFCO after the top-notch kosher and organic certification programs,” says GIG executive director Cynthia Kupper, RD.

To obtain GFCO certification, companies undergo an application process that, according to Kupper, is not a walk in the park. “Making a gluten-free product is different than certifying a product. Companies that apply for GFCO certification are the cream of the crop. They’re doing more than they have to,” she says.

The standard for GFCO-certified products is much stricter than even the proposed FDA standard. GFCO sets 10 ppm as its upper limit. (Once FDA rules on its gluten-free standard, GFCO expects to maintain its 10 ppm limit).

Companies with certification want to win consumer confidence—and they are, reports Kupper. “Consumers used to rely on product lists to identify gluten-free products. Now they’re looking for the GFCO stamp. We’ve grown phenomenally since starting the certification in 2004.”

The Bottom Line

Next to buying certified products, the best safeguard you can take remains reading food labels, says dietician Shelley Case. Because companies can reformulate products or packaging at any time, reading ingredient labels every time is absolutely paramount for gluten-free consumers, she says. If you’re unsure about an ingredient, she recommends contacting the manufacturer directly. If you’re unsure about the meaning of a gluten-free claim, she suggests asking the manufacturer questions like these:

  • Is the product made in a dedicated gluten-free facility?
  • If the product is made in a shared facility (one that produces both gluten-containing and gluten-free foods), is the product made on dedicated equipment?
  • What steps does the manufacturer take to prevent cross contamination?
  • Does the manufacturer regularly test the final product for gluten? If so, does the product consistently fall below 20 ppm?
Rebuilding Trust

It’s been more than a year since Fourie’s son, James, ate the mislabeled chicken bites. Happily, he hasn’t had any subsequent episodes of painful stomach cramps.

“I’ve been reading labels diligently,” reports Fourie. She also seeks out products that bear GFCO certification. “I’m willing to spend a little more on products that have certification. When I need an item that doesn’t, I call the company to make sure the final product is tested. If they can’t give me an answer I’m comfortable with, we don’t eat it.”

She says she now cooks from scratch more than ever. “Even though it’s very time-consuming, I try to provide as many homemade meals and snacks for my children as possible.”

Fourie is certain these precautions help keep James healthy. But she worries that a mislabeling fiasco could happen again.

“I can take lots of preventative measures but there may be a time when a product is mislabeled and I won’t figure it out. To me, it demonstrates the urgency of passing a gluten-free standard.”

She looks forward to the day when there’s accountability behind every gluten-free claim. “That peace of mind will be wonderful,” she says. 

Medical writer Christine Boyd lives in Baltimore, Maryland.
*The 2008 Codex standard allows oats provided they’re not cross contaminated with wheat, rye or barley. However, it’s up to individual countries to determine how they handle the use of oats.