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Not long ago, gluten-free foods on the grocery shelves could be hard to find. Not so much, now. The U.S. Food and Drug Administration wants you to know that foods labeled as "gluten-free" and with similar terms such as "without gluten," "free of gluten," and "no gluten" must meet specific criteria set by the FDA in August 2013 and August 2020.

These requirements are important for people with celiac disease, who face serious, and even potentially life-threatening illnesses if they eat gluten, typically found in breads, cakes, cereals, pastas, and many other foods. Some individuals may not have celiac disease but may still be sensitive to gluten.

There is no cure for celiac disease and the only way to manage the disease is to avoid eating gluten. Without a standardized definition of “gluten-free,” these consumers could never really be sure if their body would tolerate a food with that label.

As one of the criteria for using the claim “gluten-free,” the FDA set a limit of less than 20 ppm (parts per million) for the unavoidable presence of gluten in foods that carry this label. That 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 internationally.

“This standard ‘gluten-free’ definition eliminates uncertainty about how food producers label their products. People with celiac disease can rest assured that foods labeled ‘gluten-free’ meet a clear standard established and enforced by the FDA,” says Carol D'Lima, food technologist with the Office of Nutrition and Food Labeling in the FDA's Center for Food Safety and Applied Nutrition.

What Is Gluten?

Gluten is a mixture of proteins that occur naturally in wheat, rye, barley, and crossbreeds of these grains.

As many as 3 million people in the U.S. have celiac disease. It occurs when the body's natural defense system reacts to gluten by attacking the lining of the small intestine. Without a Healthy intestinal lining, the body cannot absorb the nutrients it needs. Delayed growth and nutrient deficiencies can result in, and may lead to conditions such as anemia (a lower-than-normal number of red blood cells) and osteoporosis, a disease in which bones become fragile and more likely to break. Other serious Health problems associated with celiac disease may include diabetes, autoimmune thyroid disease, and intestinal cancers.

How Does the FDA Define "Gluten-Free?"

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

• an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains,
• an ingredient derived from these grains and that has not been processed to remove gluten, or
• an ingredient derived from these grains that has been processed to remove gluten, if it results in the food containing 20 or more ppm gluten

Foods that are inherently gluten-free, for example bottled spring water, fruits and vegetables, and eggs can also be labeled “gluten-free” provided any gluten that came in contact with the food is less than 20 ppm.

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 FDA requirements for use of these terms is considered misbranded and subject to regulatory action by the FDA.

Currently, there are no valid tests to detect gluten in foods that are hydrolyzed and fermented, like cheese and yogurt. So if they display a "gluten-free" claim, manufacturers must keep certain records to show that the foods meet gluten-free standards.  

If you have any doubts about a product’s ingredients and whether or not the product is gluten-free, the FDA recommends that you should contact the manufacturer or check its website for more information. 

What About in Restaurants?

Some restaurants use the term “gluten-free” in their menus. The gluten-free final rule applies to packaged foods, which may be sold in some retail and food-service establishments such as carry-out restaurants. Given the public Health significance of gluten-free labeling, restaurants making a gluten-free claim on their menus should be consistent with the FDA’s definition.

D'Lima suggests that consumers who are concerned about gluten-free claims in restaurants ask the following questions when ordering foods described as gluten-free.

• What does the restaurant mean by the term “gluten-free?”
• What ingredients are used in this item?
• How is the item prepared?

State and local governments play an important role in oversight of restaurants. The FDA will continue to work with partners in state and local governments to encourage appropriate gluten-free labeling in restaurants.

Reporting Adverse Reactions and Labeling Concerns 

If you think that you or a family member has had a reaction or injury that might be associated with having eaten a gluten-free labeled food product, talk with your Health care professional. If a product has unclear labeling or you believe is mislabeled as gluten-free, the FDA would like to know. Keep any food packages because they may contain important information. You may want to contact the manufacturer about the problem. Also, report the problem to the FDA. 

Consumers and manufacturers can submit reports detailing product reactions or labeling concerns to an FDA Consumer Complaint Coordinator for the state where the food was purchased. You can also call the FDA at 1-888-SAFEFOOD. 

Consumers can submit a report using FDA’s MedWatch Online reporting form for consumers. Please include as much information as possible, as noted in the "Reporting Adverse Reactions and Labeling Concerns" section on the FDA's Food Allergies webpage. 

For more information on gluten, please see the FDA's Gluten-Free Labeling of Foods webpage.