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Gluten-Free Food Labeling: The Whole World is Watching and Listening

Posted Aug 11 2008 9:10pm

Diagnosis of celiac disease is increasing at a rapid pace. According to new research presented at Digestive Disease Week 2008, there have been about 50,000 new celiac cases recorded in the United States in the four years since the NIH Consensus Conference on Celiac Disease.

Overall, 1 in 133 Americans—about 3 million people—have celiac disease, meaning that gluten-free diets are no longer just a trend but a lifestyle adopted by millions of Americans to treat a medical condition.

As most of you already know, the only treatment is a 100% gluten-free diet. For those of us with celiac disease, the gluten-free diet can prevent the onset of cancer, osteoporosis, pregnancy complications and other autoimmune diseases. A simple change in diet can save our lives!

Additionally, Autism Spectrum Disorders affect roughly 1 in 150 children in the United States. A gluten-free casein-free diet has led to dramatic improvement in cognitive abilities amongst some autistic children. And, people with other diseases such as multiple sclerosis and lupus have seem improvement in their symptoms by eliminating wheat, rye and barley from their diets.

What does this mean? More patients being diagnosed translates into greater demand for gluten-free food. In fact, sales from gluten-free products topped $1.3 billion in 2007 – a 20% increase over previous years. Sales are expected to reach $1.7 billion by 2010.

Mainstream companies such as General Mills, Anheuser Busch, Giant, Stop & Shop, and event Wal-Mart are expanding into gluten-free markets. Today there are roughly 1,000 gluten-free products on Wal-Mart store shelves.

To highlight the growth even further, in the 52 weeks ending on February 12, 2008, there were 726 NEW UPC-coded packages with gluten-free claims, compared with only 442 during the same time period in 2005. The total number of gluten-free UPC codes was 3,209 in 2008, up from 1,709 in 2005.

However, with growth in industry production, comes the need for regulations to ensure that everyone with celiac disease is safe when they purchase food that is labeled gluten-free. The good news is that the entire world is listening and taking action to ensure patient safety. 

World Health Organization Rulings-1st in 25 Years

On July 1, 2008, the Codex Alimentarius Commission, a joint body of the World Health Organization, set a new benchmark for gluten-free, dictating that food labeled as gluten-free may not contain more than 20 milligrams per kilogram (20 parts per million) of wheat, rye, barley or oats.

Former guidelines passed in 1983 stated 500 milligrams per kilogram, but new advancements in technology for testing food products allowed the dramatic shift to 20 milligrams per kilogram.

The ruling will serve as a global reference for consumers, manufacturers, food processors, national food control agencies and international food traders. Although the standard is non-binding, it will be used and enforced by the 176 member countries and the European Union as they establish globally accepted food safety policies. Consumers with celiac disease will be protected by the standards as countries work the new rule into their national legislation.

How is the United States Going to Adopt the WHO Guidelines?

Before we get to what might happen in the United States, lets take a look at the history. The Food Allergy Labeling & Consumer Protection Act of 2004 (FALCPA) required labeling of the eight most common food allergens including milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans. All eight must be listed by their common name on the labels of packaged foods. This was a monumental event for everyone in the USA with food allergies and a huge help to people with celiac disease since at least wheat was included on the list. However, the absence of “gluten” on the list has still left celiac patients having to do extensive research to determine if packaged foods are indeed safe.

Although gluten was not included in FALCPA, a statute within the law directed the Secretary of Health and Human Service to propose and then make a final rule that defines and permits use of the term “gluten-free” for voluntary use on packaged foods.

To comply with the statute and follow recent acts by the WHO, the FDA is soon expected to define gluten-free for voluntary use in the labeling of foods to mean:

Food bearing a “gluten-free” claim in its labeling does not contain any one of the following:

  • An ingredient that is a prohibited grain (All species of wheat, rye barley and any crossbred hybrids).
  • An ingredient that is derived from a prohibited grain and that has not been processed to remove gluten.
  • An ingredient that is derived from a prohibited grain and that has been processed to remove gluten, if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food.
  • 20 ppm or more gluten.

**It is important to note that this is still only a proposal. To date, the FDA has not approved a standard.

Why 20ppm??

There has been great debate over what the standard for gluten-free should be. The 20ppm level is based on currently available analytic methods.  Data from peer-reviewed scientific literature demonstrates that current analytic technology can reliably and consistently detect gluten in wheat, rye, and barley at levels of 20 ppm in a variety of food structures.

Why are Oats Excluded from the FDA Proposal?

Oats have caused a huge controversy for the celiac community. Oats in their natural form do not contain the gluten protein. However, most mills that produce and store oats also manufacture wheat, making the chances of cross contamination inevitable. In addition, current research shows that approximately 1%- 5% of celiac patients react to oats in their pure form. Although the cause for this reaction is unknown, some literature suggests that a protein in oats can trigger a similar response to gluten. However, for the rest of us, oats in their natural form that are produced in a gluten-free facility are safe and can be enjoyed!

Bob's Red Mill, for example, has gone to great lengths to ensure that their Whole Grain Rolled Oats are prepared and kept safe from contamination. Their oats are grown, transported and processed in entirely gluten-free environments and tested a number of different ways for gluten. With this level of care given to avoiding gluten contamination, most people with celiac disease should be able to safely eat these oats. The back label of the product explains how the oats are prepared and protected from contamination. The folks at Bob's Red Mill even took the time to explain on their label that some celiacs may not be able to tolerate them.

The FDA is not expected to include oats as a prohibited grain for several reasons:

  • Lack of consensus amongst nutrition experts on exclusion of oats from the diet for celiac patients.
  • Research suggests that most celiac patients can tolerate oats that are manufactured in a gluten-free environment.
  • Oats  are good! They add texture, taste, fiber and nutrients to meals.
  • Adding a gluten-free label to SAFE oats will help consumers identify which brands are acceptable to purchase.
  • Potential incentive for manufacturers to produce gluten-free oats.

Enforcement of Gluten-Free Standard:

Although the FDA has not actually passed a standard yet, they have proposed a few ways to enforce the regulations once they go into effect. To enforce the new rules, the FDA has proposed conducting label reviews, on-site inspections of food manufacturers and analysis of food samples.

Benefits of the Regulations:

Once the regulations are enforced, people with celiac disease and those who maintain a gluten-free diet for other health conditions will be able to rest assured that products labeled “gluten-free” are in fact safe and held to a clear standard that is enforced by the FDA. Manufacturers will have a clear definition of the term “gluten-free” and be able to eliminate any confusion on how to label their products.

The best part in my opinion is that the United States is catching up! U.S food producers will be on equal playing field with manufactures around the world. There will be no more confusion about what is considered gluten-free in the U.S. compared with other countries.

NFCA Partners with Bob’s Red Mill for Gluten-Free Educational Webinar

To showcase how the world is responding to the growth and need for regulations, the National Foundation for Celiac Awareness partnered with Bob’s Red Mill on a fabulous webinar project. On August 5th, we hosted the webinar to educate lifestyle and news media about celiac disease, the gluten-free diet and the future of food labeling laws both domestically and internationally.

The panelists for the event included Dr. Aline Charabaty of Georgetown University Medical Center, Chef Edgar Steele of Cafe Atlantico,  Matt Cox from Bob's Red Mill, and yours truly! I spoke about the recent gluten-free labeling standards passed by Codex, a joint body of the WHO. I also spoke about how the U.S. FDA is expected to handle gluten-free labeling in the future. The panel was moderated by NFCA Executive Director Alice Bast.

The webinar was a HUGE success and you can watch the entire thing on the Bob's Red Mill Website.

I've always known that Bob's Red Mill is a top-notch company, but after visiting the mill, I'm even more convinced that they are the cream of the crop! They truly take the business of providing gluten-free food seriously and it is 100% evident as you tour their facility.

You can watch the entire webinar at the following web address:

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