Gluten and FDA food labeling


An estimated 3 million Americans suffer from celiac disease, a genetic autoimmune digestive disorder that damages the small intestine. The disease is triggered by consumption of a protein called gluten, which is found in wheat, barley, rye and crossbreeds of these grains. Gluten gives breads and other grain products – such as cakes, cereals, and pastas – their shape, strength and texture. For those suffering from celiac disease or preparing food for someone who does, identifying gluten-free food is critical.

Celiac symptoms in children

• abdominal bloating and pain

• chronic diarrhea

• vomiting

• constipation

• pale, foul-smelling, or fatty stool

• weight loss

• fatigue

• irritability and behavioral issues

• dental enamel defects of the permanent teeth

• delayed growth and puberty

• short stature

• failure to thrive

• Attention Deficit Hyperactivity Disorder

Celiac symptoms in adults

• unexplained iron-deficiency anemia

• fatigue

• bone or joint pain

• arthritis

• osteoporosis or osteopenia (bone loss)

• liver and biliary tract disorders (transaminitis, fatty liver, primary sclerosing cholangitis, etc.)

• depression or anxiety

• peripheral neuropathy (tingling, numbness or pain in the hands and feet)

• seizures or migraines

• missed menstrual periods

• infertility or recurrent miscarriage

• canker sores inside the mouth

• dermatitis herpetiformis (itchy skin rash)

In August 2013, the U.S. Food and Drug Administration issued a regulation that standardized what “gluten-free” means on food labels. This ensures that gluten-free claims on food products are consistent and reliable across the food industry.

Understanding GF labeling

The FDA defined the terms “Gluten-free,” “No gluten,” “Free of gluten,” “Without gluten,” and even “GF.” Foods bearing any of these terms have to meet the requirements of the gluten-free regulation. FDA encourages consumers to rely on these four terms when looking for foods that meet the FDA definition and can be used as part of a gluten-free diet. Other terms related to gluten may be used, if they are truthful and not misleading, but the food bearing the terms would not have to meet the requirements of the gluten-free regulation. Manufacturers are not required to place the voluntary gluten-free claim in any specific location on the food label.

Foods bearing a gluten-free claim must, among other things, contain less than 20 parts per million of gluten. This level is the lowest that can be reliably detected in foods using scientifically validated analytical methods. A food that is labeled as gluten-free but fails to meet the requirements of the regulation is subject to regulatory action by FDA.

Products covered

FDA’s regulation applies to all foods and beverages (including packaged foods, dietary supplements, fruits, vegetables, shell eggs and fish) except for:

• Meat, poultry, and certain egg products

• Most alcoholic beverages

Eating out

Given the public health significance of gluten-free labeling, FDA continues to encourage the restaurant industry to ensure that its use of gluten-free labeling is consistent with the federal definition. FDA also works with state and local governments, who play an important role in oversight of restaurants, and considers appropriate action as needed, alone or with other agencies, to protect consumers with respect to gluten-free labeling in restaurants.

Reporting adverse effects, labeling concerns

Individuals who become ill or experience adverse health effects that they believe are associated with having eaten a food should first seek appropriate medical care.

Afterward, individuals can report a problem with a food or its labeling in either of these ways:

• Contact the consumer complaint coordinator in their area. The list of FDA consumer complaint coordinators is available at:

• Contact MedWatch, FDA’s Safety Information and Adverse Event Reporting Program, at 1-800-332-1088, or file a MedWatch voluntary report at

• Contact: Media: 1-301-796-4540 Consumers: 1-888-SAFEFOOD (toll free)


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