Consumers Can Now Rely on Gluten-Free Label


By Sarah Jane Schwarzenberg, MD, FAAP, Pediatric Gastroenterologist and Hepatologist at University of Minnesota Masonic
Children’s Hospital and member of AAP’s Committee on Nutrition

As of August 5, 2014, any food product manufactured in the United States that bears the “gluten-free” claim on its label must meet new and more restrictive rules. Gluten is a group of proteins that are found in wheat, rye, barley, and some other grains.

The Food and Drug Administration has now defined the “gluten-free” as having less than 20 ppm in foods that carry this label. This is the lowest level of gluten that can be detected using currently available tools. The same standard applies to foods labeled “without gluten,” “free of gluten” and “no gluten.”

This rule will be a significant help to people with celiac disease, as the previous standards allowed manufacturers to claim a product was “gluten-free” when it might contain detectable gluten.

Celiac disease is an autoimmune disease in which a component of gluten, interacting with a protein in the patient’s intestine (tissue transglutaminase, TTG), is recognized as foreign by the patient’s immune system. The immune system triggers response that attacks the patient’s intestine, gradually destroying the mucosa of the intestine.

Celiac disease is found in 1 in 200 people in the United States. There is no ethnic group at more or less risk. Although the presenting features of classic celiac disease are failure to thrive and diarrhea, recent studies show that 80% of patients with celiac disease are asymptomatic (or do not recognize their symptoms). Constipation is as frequent a presentation as diarrhea.

Untreated celiac disease carries the risk of malabsorption of macro- and micro-nutrients, resulting, for example, in osteopenia and iron-deficiency anemia. Patients may also develop other autoimmune diseases, most commonly type 1 diabetes, autoimmune thyroid disease, and Sjorgren’s syndrome. There is a small but significant increase in intestinal lymphoma in people with poorly treated celiac disease.

Screening for celiac disease is done by serum testing for TTG IgA. Because this antibody is an IgA antibody, and IgA deficiency is common, it is recommended that both IgA and IgG tTG be performed, and a total IgA be obtained as well. Because there are false positives in this screening method, it is crucial that a patient not start a gluten-free diet until the diagnosis is confirmed by small instestinal biopsy. Once on the diet, it may be impossible to obtain confirmation of the disease without a prolonged gluten challenge.

The diet must be adhered to for life, without deviation. Because of the frequency of celiac disease in our country, schools, summer camps, and religious organizations are all very familiar with managing these diets. The recent ruling by the FDA will be of help not only to families, but also to these organizations, in purchasing safe and healthy food for people with celiac disease.

As you discuss these new regulations with your patients with celiac disease, these are some details to consider.

Foods with these labels must also meet the following restrictions:

Contain no ingredient that is any type of wheat, rye, barley or crossbreeds of these grains

Contain no ingredient derived from these grains that has not been processed to remove gluten

Contain no ingredient derived from these grains that has been processed to remove gluten but contains >20 ppm gluten

These rules apply to all manufactured foods, including packaged foods sold to restaurants. The FDA does not directly oversee food in restaurants; that is the role of state and local governments. People with celiac disease are encouraged to ask in restaurants what the restaurant means by “gluten-free” and ask questions about the ingredients and preparation of the dish.

Full information on the ruling can be found at

The North American Society of Pediatric Gastroenterology and Nutrition has published evidence-based guidelines on the diagnosis and management of celiac disease, available at

The American College of Gastroenterology published Diagnosis and Management of Celiac Disease 2013

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