Celiac Disease

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August 15, 2014

New FDA Rules for Gluten-Free Labeling

By Margaret Shepard, Communications Specialist

Joseph Murray, M.D., discusses the new Food and Drug Administration (FDA) rules for gluten-free labeling.


Almost ten years ago congress passed a law legislating food labeling. However, part of that law required the FDA to formulate regulations defining what gluten-free is. Up until now, there was not a set definition of gluten-free in the United States.

The FDA conducted a careful study over several years analyzing all the known literature about gluten and its affect on patients with celiac disease. The goal of the study was to come up an estimation of what is a safe threshold where food is not likely to cause a problem for patients with celiac disease. The FDA came up with a level of 20-parts per million. This is a small amount and also a level possible to detect gluten.

What does this mean for patients? This means that if a food is labeled gluten-free, it has to contain less than 20-parts per million. For a great majority of patients, this means the food should not present a problem. Labeling is voluntary. If a company chooses to put a gluten-free label on its food, it'll have to meet this standard.

This is good news for patients with celiac disease as it sets standards for safety going forward.

For more information about celiac disease, visit mayoclinic.org/celiacdisease.

Dr. Murray is a gastroenterologist and celiac disease expert at Mayo Clinic.

Tags: FDA, gluten free, gluten-free labeling, Joseph Murray, News Alerts


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