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Decoding the FDA’s new gluten-free labeling law

September 23, 2013

This blog post was written by Dr. Karoly Horvath, pediatric gastroenterologist at the Center for Digestive Health & Nutrition at Arnold Palmer Hospital.

A few weeks ago, the federal government set a standard for gluten-free claims on food labels. Health officials report that this will help the three million Americans with celiac disease and other gluten-related disorders, and bring uniformity to the $4 billion market for gluten-free products.

What is Gluten?

Gluten is a compound of starch and proteins found in certain grassy grains, such as wheat, barley and rye. When eaten by people with celiac disease, gluten can trigger the production of antibodies that damages the lining of the small intestine. When this occurs, it can result in uncomfortable, and often painful, symptoms for those affected by celiac disease.

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New labeling for “gluten-free” foods

In 2004, the Food Allergen Labeling and Consumer Protection Act (FALCPA) was introduced. It included WHEAT among the eight most allergenic foods that had to be labeled in all food items. To protect people with celiac disease, Congress passed a law in the same year requiring the Food and Drug Administration (FDA) to set standards for how much trace gluten could be in foods whose labels said they were “gluten-free.” As consumer demand for gluten-free foods has risen, driving the rapid expansion of the gluten-free market, a standard for gluten-free foods became more urgent. The celiac community and experts expected that within two years, the Gluten Labeling Act would be passed, given the popularity of gluten-free foods. But unfortunately, it took a total of nine years to be finalized.

After much anticipation, the FDA issued a final rule defining “gluten-free” for food labeling on August 2, 2013. “The agency set a gluten limit of 20 parts per million in products labeled gluten-free,” said Michael R. Taylor, deputy commissioner for foods and veterinary medicine at the F.D.A. The limit had long been discussed, and did not come as a surprise to the industry or patient advocate groups. It was similar to the level adopted in recent years by the European Union and Canada.

What does the gluten limit of 20 parts per million (ppm) mean?

It means that only 20 molecules of gluten can be present among one million of other molecules. It is a small size of a crumb, the size of rice, in a slice of bread. How was this number decided upon? A European study in celiac volunteers showed that 20 ppm of gluten ingested daily was safe, while 50 ppm of gluten ingested per day resulted in mild intestinal injury is some patients. These volunteers had undergone intestinal biopsy prior to the study and three months after.

What the new labeling means for those affected by gluten

This FDA regulation is great news for all patients with gluten-related diseases, as well as for the medical professionals treating them. Unfortunately, the new regulation is only voluntary for companies. However, they are motivated to follow it as the gluten-free food market has grown exponentially since the 1990s, a time when only small companies produced gluten-free foods and patients needed to order them by mail.

While the FDA did set standards for labeling products as gluten-free, it did not require companies to place an easily recognizable symbol on the gluten-free foods. In other parts of the world, the picture of wheat is crossed with an “X,” a clear indication of a gluten-fee product. Even small children can find these items on the shelves of the shopping centers.

Which patients will benefit from this new regulation?

  • Patients with celiac disease, which affects approximately 1% of the US population.
  • Patients with dermatitis herpetiformis, a gluten-related skin disorder. These patients have itchy vesicles and can produce serious skin rashes if they eat foods contaminated with gluten.
  • Patients with wheat/gluten allergies. The reaction can occur within hours or a couple of days after eating foods contaminated with gluten.
  • The new (and estimated largest group) consists of people with non-celiac gluten sensitivity. This is a recently recognized category that has been confirmed through several studies. These people have various reactions to gluten, ranging from digestive complaints to "brain cloudiness,” noting that they have an inability to concentrate after gluten ingestion.
For families with kids who are affected by gluten, the new label requirements for gluten-free products initiated by the FDA is extremely important, making their trip to the grocery store a little bit easier.