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FDA releases information on gluten-free labeling for Celiac disease patients

08 May 2019 | News

In August 2013, the U.S. Food and Drug Administration (FDA) issued a regulation that standardized the meaning of the voluntary claim "gluten-free" on food labels.

Representative Image

Representative Image

May is Celiac Awareness Month. An estimated 3 million Americans suffer from celiac disease, a genetic autoimmune digestive disorder that damages the small intestine. Celiac 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 choosing/preparing food for someone who does), identifying gluten-free food is critical.

In August 2013, the U.S. Food and Drug Administration (FDA) issued a regulation that standardized the meaning of the voluntary claim "gluten-free" on food labels. This ensures that gluten-free claims on food products are consistent and reliable across the food industry.

Understanding Gluten-Free Labeling

FDA defined the terms "Gluten-free," "No gluten," "Free of gluten," and "Without gluten." Manufacturers are not required to label gluten-free products—the use of the claim is voluntary. Foods with any of these terms in their labeling have to meet the requirements of the gluten-free regulation. FDA encourages consumers to rely on these four terms when looking for foods that can be used as part of a gluten-free diet. 

Foods bearing a gluten-free claim must, among other things, contain less than 20 parts per million of gluten. 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 by the Gluten-Free Regulation

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

Gluten-Free When 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 and 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.

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