GIA Physicians applaud FDA’s Definition of ‘Gluten Free’

Imagine if eating a certain food ingredient would not only make you sick, but also threaten your health or possibly even your life? What if you couldn’t trust that foods labeled free of this ingredient were accurate?

That’s been the situation faced by millions of people who have celiac disease or gluten sensitivity. The only treatment for these conditions is a 100-percent gluten-free diet. In 2004, Congress called on the Food and Drug Administration (FDA) to set standards for foods that claim to be gluten free.  Nearly a decade later, the FDA issued its final rule in August that defines what characteristics a food has to have to bear a label that proclaims it “gluten- free.” The rule also holds foods labeled “without gluten,” “free of gluten,” and “no gluten” to the same standard.

This rule has been eagerly awaited by advocates for people with celiac disease, including the specialists at Gastrointestinal Associates who treat patients with these conditions daily.

As one of the criteria for using the claim “gluten-free,” FDA is setting a gluten limit of less than 20 ppm (parts per million) in foods that carry this label. This is the lowest level that can be consistently detected in foods using valid scientific analytical tools. Also, most people with celiac disease can tolerate foods with very small amounts of gluten. This level is consistent with those set by other countries and international bodies that set food safety standards.

“This standard ‘gluten-free’ definition will eliminate uncertainty about how food producers label their products and will assure people with celiac disease that foods labeled ‘gluten-free’ meet a clear standard established and enforced by FDA,” said Michael R. Taylor, J.D., deputy FDA commissioner for foods and veterinary medicine in a statement on the FDA’s website.

Celiac disease is not a food allergy, but an inherited, autoimmune disease that damages the lining of the small intestine when gluten is ingested. Gluten is a composite of starch and proteins found in many common food items, including breads, cakes, candy, cereal, condiments, cookies, pasta, pizza, pretzels and soups. It is also found in such unlikely products as makeup, lipstick, perfume and medications.

“Without proper food labeling regulation, celiac patients cannot know what the words ‘gluten free’ mean when they see them on a food label,” said Allessio Fasano, M.D. in the FDA report. Fasano is director of the Center for Celiac Research at MassGeneral Hospital for Children, visiting professor of pediatrics at Harvard Medical School and member of the American Celiac Disease Alliance.

If you suspect you may have celiac disease or gluten sensitivity, see a GIA physician before beginning a gluten-free diet before seeing your GIA physician. Doing so will obscure the test results.

Fast Facts about Celiac Disease:

•     Celiac disease is known as the great masquerader because it presents in so many different ways. Patients often go years before getting a correct diagnosis.

•     Celiac disease causes inflammation of the intestines, which prevents the body from absorbing  vitamins A, D, E and K, which can lead to: drastic weight loss, brittle bones, osteoporosis, skin lesions, problems with eyesight, iron deficiency/anemia,  bruising and even diabetes and intestinal cancer.

How Does FDA Define ‘Gluten-Free’?

In addition to limiting the unavoidable presence of gluten to less than 20 ppm, FDA will allow manufacturers to label a food “gluten-free” if the food does not contain any of the following:

  1. an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains
  2. an ingredient derived from these grains and that has not been processed to remove gluten
  3. an ingredient derived from these grains and that has been processed to remove gluten, if

it results in the food containing 20 or more parts per million (ppm) gluten

Foods such as bottled spring water, fruits and vegetables, and eggs can also be labeled “gluten-free” if they inherently don’t have any gluten.

The regulation was published Aug. 5, 2013 in the Federal Register, and manufacturers have one year from the publication date to bring their labels into compliance. Many products are already in compliance with these requirements.

Under the new rule, a food label that bears the claim “gluten-free,” as well as the claims “free of gluten,” “without gluten,” and “no gluten,” but fails to meet the requirements of the rule would be considered misbranded and subject to regulatory action by FDA.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

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