December 2013 Issue

Claiming Victory
By Lori Zanteson
Today’s Dietitian
Vol. 15 No. 12 P. 36

The dietetics community celebrates the FDA’s decision to standardize labeling requirements for gluten-free foods, but nutrition professionals have some concerns.

Since the FDA published a new regulation defining the term “gluten free” for voluntary food labeling, the gluten-free community and its advocates have been celebrating the fact that the more than 3 million Americans diagnosed with celiac disease and nonceliac gluten sensitivity now can feel more confident that the foods they buy claiming to be gluten free really are safe to eat.

Despite the excitement, however, concerns remain about labeling requirements. Today’s Dietitian interviewed RDs and experts from celiac disease research organizations who express their views and apprehensions about the new labeling standard and offer guidance to help the health care community understand who must comply with it.

A Long Road
The gluten-free community, the Center for Celiac Research, and other major advocacy groups have been working toward standardizing the definition of gluten free since the ruling was first proposed in 2007. It was set in motion when the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 spurred the US Department of Health and Human Services to define and permit the use of gluten free on food labels. Subsequently, the FDA conducted a safety assessment to determine the minimum amount of gluten that a product can contain without negatively affecting the health of people with celiac disease. It wasn’t until August of this year, after the FDA received a petition calling for standardized gluten-free labeling, that the final ruling was made.

The new federal ruling standardizes the definition of gluten free for the entire food industry. To use the term gluten free on labels, the food must contain fewer than 20 parts per million (ppm) of gluten. The rule also requires foods with the claims “no gluten,” “free of gluten,” and “without gluten” to meet the same standard.

“We’re really celebrating here,” says Pam Cureton, RD, LDN, a dietitian at the Center for Celiac Research and the chair of Dietitians in Gluten Intolerance Diseases, a subunit of the Academy of Nutrition and Dietetics Medical Nutrition Therapy dietetic practice group. “All of the celiac centers have worked really hard to get this passed. These are the leaders who have all agreed that this level is a safe amount. We actually have a definition for gluten free after years of fierce advocacy.”

Labeling Requirements
According to the FDA, the definition of gluten free must meet four criteria. The food either is inherently free of the protein gluten or doesn’t contain an ingredient that’s a gluten-containing grain (eg, barley, rye, spelt wheat), or that’s derived from a gluten-containing grain that hasn’t been processed to remove the gluten (eg, wheat flour), or a result of a gluten-containing grain that has been processed to remove the gluten but the use of that ingredient still would result in 20 ppm or more of gluten in the food. In addition, any unavoidable presence of gluten in the food must be fewer than 20 ppm.

The standard, which goes into effect on August 5, 2014, applies to all FDA-regulated foods, including dietary supplements. It doesn’t apply to foods whose labeling is regulated by the USDA (eg, meats, poultry, some egg products) or the Alcohol and Tobacco Tax and Trade Bureau, which includes most alcoholic beverages made with barley and hops.

The FDA has given manufacturers one year from the announcement to comply with the new ruling. Those found to be noncompliant after that point will be subject to regulatory enforcement action.

Guesswork Gone
Certainly, millions of people stand to benefit from this ruling. For people with celiac disease, “Random exposure to even minute amounts of gluten damages the intestines and can lead to serious health issues,” says Rachel Begun, MS, RDN, a food and nutrition consultant and gluten-related disorders expert. “The ruling takes the guessing game out of gluten free for both consumers and manufacturers. Consumers can feel safe knowing that gluten free means the same thing for every product making the claim, and manufacturers have a rule book to play by.”

It’s widely accepted that 20 ppm of gluten is safe for most people with celiac disease. However, before the ruling, the definition of gluten free was left to interpretation, a difficult position for manufacturers trying to develop safe products for consumers. “We needed a standard, and we have it,” Cureton says. “The FDA has finally set a goal manufacturers can live with. They don’t have to guess anymore. Now they can feel safe about their products.”

Label Confusion
What concerns some dietitians is the fact that gluten-free labeling is voluntary and, as a result, can be misleading. “That’s what’s critical,” says Alice Bast, founder and president of the National Foundation for Celiac Awareness (NFCA). Carrots, for example, are naturally gluten free, but there are packages of carrots on the market labeled as gluten free, giving consumers the impression that if a package of carrots doesn’t say gluten free, the carrots contain gluten. What’s more confusing, even foods that typically don’t contain gluten, such as meats, may contain the protein if they’re breaded, for example.

Moreover, it’s common for a product labeled gluten free to have wheat listed among the ingredients, a red flag for people avoiding gluten. Under the FALCPA, wheat must be mentioned as part of certain ingredients, such as wheat starch, but an asterisk stating that the product contains fewer than 20 ppm of gluten and meets FDA requirements for a gluten-free food will be noted. However, statements that include the phrase “may contain” aren’t federally regulated and can mislead consumers because there’s no guarantee the product contains fewer than 20 ppm of gluten.

While the FDA specifies and regulates the terms gluten free, free of gluten, without gluten, and no gluten, package labels may use other terminology, such as “made without gluten” or “not made with gluten-containing ingredients.” Nonetheless, the products must include a gluten-free claim to indicate that they meet all the FDA requirements for a gluten-free food.

These variations in terminology aren’t necessarily a problem, but people must make sure they know for certain whether a food is gluten free before eating it, Bast says. The NFCA is developing a tip sheet to help people understand the terminology and learn how to read food labels. In addition, the NFCA has an archived webinar led by nutrition consultant and celiac disease specialist Tricia Thompson, MS, RD, on ways consumers can better educate themselves. With so much media attention since the ruling announcement, Thompson says there’s plenty of misinformation circling around, and people need to be sure they’re getting accurate information from reputable sources.

Amid the confusion about labeling, Cureton recommends consumers continue to buy gluten-free foods from companies with a good track record. “The vast majority of reputable companies have been doing it right for a long time. This ruling really has no effect on them,” she explains. These companies maintain high standards; their products contain as few as 5 ppm of gluten, much less than the 20 ppm the FDA requires. Furthermore, they test product ingredients at the beginning of the manufacturing process and the finished product.

No Testing Necessary
Testing products for gluten isn’t required in the final FDA ruling, which concerns Thompson, who’s founder of Gluten Free Watchdog, a website that provides services to test products labeled as gluten free. However, some companies are voluntarily testing their products and even using third-party agencies to ensure their products’ gluten levels.

As the market for gluten-free foods continues to grow and new products are introduced, Thompson says the FDA’s requirements may confuse new manufacturers because some of the language is vague. Some manufacturers may not realize there’s more to complying with the labeling standard than just striving to make a product with fewer than 20 ppm of gluten; they must meet the four criteria that defines gluten free as mentioned on page 37. Manufacturers need guidance on testing methods and frequency, and they will need to work with a third-party testing agency or well-established certifying agency to help them understand what they need to do, she says. As it stands, some manufacturers aren’t testing products at all, while others are testing but using outdated methodology.

Consumer Enforcement
Since the FDA doesn’t require testing to confirm a product’s gluten content, Bast says consumers will need to help enforce the standard. The FDA soon will have a consumer complaint policy in place, so the NFCA plans to educate consumers on how to contact the FDA if they find a product not complying with the ruling. The NFCA also has created a fact sheet and a webinar accessible through its website to help people with the process.

“Our health is in the hands of our manufacturers and our own, too,” Bast says. “Our community has to be 100% gluten free, so our goal is to encourage manufacturers to go above and beyond the FDA standards. We want to educate the community, manufacturers, and RDs who we work with.”

Moving Forward
Though the FDA’s ruling regarding gluten-free labeling is a significant and important step forward, there’s still more work to be done regarding gluten-free education. Consumers need to know how the ruling affects them day-to-day and that not all gluten-free foods are necessarily healthful. “We know that the typical gluten-free diet is low in iron, B vitamins, and fiber. RDs can play an important role in helping people eat a gluten-free diet that’s both safe and meets all nutrition needs,” Bast says.

— Lori Zanteson is a food, nutrition, and health writer based in southern California.


The following websites provide accurate information about celiac disease and ideas on how to counsel patients in light of the new FDA gluten-free labeling requirements:

• Celiac Disease Toolkit, available from the Academy of Nutrition and Dietetics (

• Center for Celiac Research & Treatment, University of Maryland School of Medicine (

• Dietitians in Gluten Intolerance Diseases (

• National Foundation for Celiac Awareness (