Gluten-Free Guidance

May 14, 2010

Originally Published

Originally Published NO May 2010

The gluten-free diet is quickly becoming one of the fastest-growing nutritional movements in the country, gaining significant attention for its health and therapeutic benefits. This is largely due to the increasing number of Americans diagnosed with celiac disease, a serious autoimmune disorder that can only be treated through a gluten-free diet. This group aside, however, gluten-free customers also include a group of people who just feel better eliminating or reducing the amount of gluten in their diet.

As more gluten-free products are making their way to mainstream stores and shelves, there are still many concerns surrounding the regulation of gluten-free foods. Consumers and manufacturers alike can stay safe by educating themselves about what it means to truly be gluten-free.

Celiac Disease: What's That?

If you've never heard of celiac disease, you're not alone. Of the three million Americans living with the genetic autoimmune disorder, only about 150,000 have been formally diagnosed.

Celiac disease is triggered by an autoimmune response to gluten-a protein found in wheat, barley, and rye-which affects the body's ability to absorb nutrients in the small intestine.

Nearly one in 100 Americans, or 1% of the U.S. population, has the digestive disorder. Celiac disease can be passed genetically from parent to child. In some cases, the onset of celiac disease, like other autoimmune diseases, can be triggered by stressful events like pregnancy, surgery, infection, or severe emotional distress.

Left untreated, individuals with celiac have a fourfold increased risk of early death, or can develop further complications such as other autoimmune diseases, osteoporosis, thyroid disease, and even cancer.

Despite being the most common autoimmune disorder in the United States, celiac disease has gone largely undiagnosed both because of its vast and varied symptoms and the fact that these symptoms often mimic other conditions such as Crohn's disease, chronic fatigue syndrome, fibromyalgia, and irritable bowel syndrome.

With nearly 300 associated symptoms, celiac disease is often difficult to identify. In addition, some people with celiac disease may not exhibit symptoms, but are still at risk for the complications associated with the disease.

The Gluten-Free Market: A Booming Business

The population with celiac disease is only a small portion of Americans who are looking for gluten-free products. While celiac disease is the most severe form of gluten sensitivity, and gluten-free products are a medical necessity for individuals with celiac disease, many Americans also have gluten sensitivities and are seeing health benefits from going gluten-free.

Nearly 10 million people, or one in three Americans, are said to have gluten sensitivities. Like celiac disease, gluten sensitivities are being diagnosed more frequently and accurately. Wheat is also considered a top-eight allergen by the Food and Drug Administration (FDA). Unlike celiac disease, gluten sensitivities do not pose many of the serious risks and complications associated with having an autoimmune disorder. However, as more is known about the diet's effects on serious health conditions such as autism spectrum disorders, multiple sclerosis, thyroid disease, and cystic fibrosis, more Americans are joining the rapidly growing gluten-free consumer base.

Due to the growing number of Americans looking for gluten-free options (nearly 15 to 25% of all consumers, estimates U.S. News and World Report), many entering the gluten-free market have enjoyed tremendous success and profits.

Leading industry organizations such as the National Restaurant Association and American Culinary Federations have also highlighted the enormous potential in this market, and even named gluten-free a top food trend for 2010.

However, categorizing gluten-free as a market trend often generates misconceptions about this developing industry, as well as about the American population who adheres to the diet. Gluten-free is frequently misrepresented as a fad diet in the popular media, when in actuality, the core population of this consumer market is comprised of those who require the gluten-free diet out of medical necessity and who must adhere to the diet for life.

What Does It Mean to Be Gluten-Free?

So what is gluten exactly? Gluten is a protein particle found in wheat, barley, and rye. People with celiac disease have to adopt a lifelong 100% gluten-free diet. Eating any amount of gluten, not matter how small, can cause long-term health problems.

Easier said than done. The sheer prevalence of gluten in foods and other products is what poses the greatest challenge to newly diagnosed celiacs when first adopting a gluten-free diet. Gluten's elastic properties are what give so many staple American foods like breads and baked goods their shape, absorbency, and texture. So for celiacs, many of the foods we've come to know and love-such as pasta, pretzels, beer, cookies, and cakes-are off limits in their traditional form.

And it doesn't end there. Gluten is also an ingredient in additives derived from wheat, the most common additive used in U.S. food products today. You can even find gluten in everyday products such as medicines, vitamins, and lip balms.

Safety and Labeling Issues Surrounding Gluten-Free

Toxicologists measure gluten levels in parts per million (PPM). Research to date asserts that the amount of gluten that someone with celiac disease can tolerate is no more than 20 PPM. This is also the threshold adopted by Codex, which is jointly run by the World Health Organization and the Food and Agriculture Organization. International bodies such as the European Union (EU) and Food Standards Australia New Zealand have made efforts to regulate manufacturing practices and labeling of gluten-free products according to this threshold.

The United States, however, is significantly far behind.

In 2004, FDA passed the Food Allergen Labeling and Consumer Protection Act, which requires all products manufactured after January 1, 2006, to indicate on labels the presence of any of FDA's eight top allergens: milk, eggs, peanuts, tree nuts, fish, shellfish, soy, and wheat. Noticeably missing from this list? Gluten. The FDA Food Allergen Labeling and Consumer Protection Act does not require labeling of products containing barley, rye, and their many gluten-containing derivatives.

Although indicating the presence of gluten in food products is not yet mandatory, FDA is taking steps toward this goal by proposing a definition for gluten-free for voluntary use in the labeling of foods. The proposed definition prohibits the presence of gluten, or gluten-containing ingredients derived from wheat, rye, barley, and their derivatives, in gluten-free products. Gluten-free products made without these gluten-containing grains, as well as those with prohibited grains that have been processed to remove gluten (e.g., wheat flour, distilled alcohols), would be required to test at less than 20 PPM of gluten.

A standard definition for gluten-free would hopefully lead to more-regulated labeling of gluten-free products. It would change the way many gluten-free foods on the market are currently packaged and tested.

Many companies assume that if they do not use gluten-containing grains, their products are gluten-free. This completely ignores the issue of cross-contamination in transport or production. Failing to properly test final products is a big problem that often has serious consequences for consumers who may get sick if contaminated.

In fact, food allergens have accounted for more than 2800 FDA and U.S. Department of Agriculture recalls since 1998. Back in February 2009, a North Carolina bakery owner was charged with six counts of obtaining property by false pretenses, all felony charges, for falsely labeling and selling gluten-free products that in fact were not gluten-free. This was an issue of fraud, not just production.

Cases like this illustrate just how desperately FDA regulation is needed to provide an umbrella of safety for American gluten-free consumers, and to empower the food industry to tackle the challenge of providing safe and tasty gluten-free foods.

There is currently no timetable for the FDA gluten-free proposal, although consumer studies and research are ongoing. The agency had originally proposed an August 2008 deadline.

It's important to note that while less than 20 PPM is the maximum gluten threshold for most individuals with gluten sensitivities, there are exceptions. Many people with celiac disease react even to products and foods that meet the less-than-20-PPM recommended threshold. The causes for this hypersensitivity are largely unknown, and more research toward understanding celiac disease needs to be done.

What Can You Do to Stay Safe?

Manufacturers and consumers alike can protect themselves by investigating product ingredients and accurate package labeling. Educated celiac consumers are often already wary of many products because while ingredients may be gluten-free, processes of manufacturing may have caused contamination, such as through the use of shared equipment or dusting by airborne flour.

Many grocery stores and chains publish frequently updated lists of the gluten-free products they carry. There are also product guides and iPhone applications on the market that can help consumers locate gluten-free products sold near them.

Consumers should be aware that food manufacturers are also not required to notify consumers of product-ingredient and recipe changes. It is important to always double-check product labels each time a food is purchased because the gluten-free status of a particular product may change at any time.

So, how can you be certain a product is safe? The National Foundation for Celiac Awareness (NFCA) offers many resources for the gluten-free consumer. NFCA has created a registry for gluten-free business organizations and products to help the food industry and consumers alike find safe, registered, and delicious gluten-free products.

Members of NFCA's Gluten-Free Resource Education Awareness Training (GREAT) association can proudly display a gluten-free certification seal on their packaging. Consumers can learn more about the food manufacturers and products that are GREAT-registered through NFCA's website, www.celiaccentral.org.

For manufacturers, the GREAT association includes access to and discounts for gluten-free education, marketing tools and opportunities, and operational support. Consulting services such as on-site inspection, HACCP development, testing, and staff training help manufacturers address four main concerns for producing safe gluten-free products:

  • Identifying gluten-free ingredients and machinery.

  • Preventing cross-contamination by utilizing systematic, monitored gluten-free protocols for transport and manufacturing.

  • Developing good manufacturing practices, including HACCP, which describes how a product will be protected from contamination with gluten, from entrance of a facility to exit.

  • Scheduling ongoing testing to ensure product safety. Testing begins at the entry door, includes mid-run tests, and ends with testing of each batch.

Savvy manufacturers will also host their registration credentials and other important information regarding the gluten-free status of their products and practices on their websites. As more consumers search online for information on gluten-free products, it's an easy way for manufacturers to communicate directly, openly, and honestly with the gluten-free community and generate consumer confidence.

Moving Forward

The gluten-free market is moving full-steam ahead. According to a 2008 Packaged Facts report, the gluten-free market continues to experience double-digit growth (over 20%), in spite of the current economic recession. The industry is expected to reach $2.6 billion by 2012.

For the millions of individuals who suffer from celiac disease or gluten sensitivities, gluten-free is so much more than a market movement-it's a necessity. Food and proper nutrition is central to our lives, our health, and our happiness. While a gluten-free diet has long been a source of isolation, loneliness, and fear, now, growing awareness and increasing choices are making it easier to manage.

Nancy Baker is the director of education for the National Foundation for Celiac Awareness. Visit to learn more. Whitney Ehret is director of communications.