Gluten and Food Labeling: FDA's New Regulation

Sep 25, 2013, 10:00 ET from U.S. Food and Drug Administration

SILVER SPRING, Md., Sept. 25, 2013 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration (FDA) has issued a regulation that defines the term "gluten-free" for food labeling. This new standard, which is voluntary for use by food manufacturers, provides consumers the assurance that "gluten-free" claims on food products are reliable and consistent across the food industry.


For those consumers seeking a gluten-free diet, the new regulation also eliminates uncertainty by providing a standardized tool for managing their health and dietary intake.

"Gluten-Free" Labeling is Critical for Some Consumers

What is Gluten?  Gluten is a protein that occurs naturally in wheat, rye, barley, and crossbreeds of these grains.  Foods that typically contain gluten include breads, cakes, cereals, and pastas. Gluten is the ingredient that gives breads and other grain products their shape, strength, and texture. But for someone suffering from celiac disease, consuming gluten can have serious health consequences.

Celiac Disease is a Chronic Illness: As many as 3 million Americans may have celiac disease – an inherited, chronic, inflammatory auto-immune digestive disorder.  It is often silent, latent or misdiagnosed.  When someone afflicted with celiac disease consumes gluten, his/her body's natural defense system triggers the production of antibodies that attack and damage the lining of the small intestine.  This damage limits the ability to absorb nutrients and can lead to other very serious health problems.

Definition of "Gluten-Free": FDA has set a gluten limit of less than 20 parts per million (ppm) for foods that carry the label "gluten-free."  This level is the lowest that can be reliably detected in foods, and most people with celiac disease can tolerate foods with very small amounts of gluten.  The new regulation also applies to foods labeled with the terms "no gluten," "free of gluten," and "without gluten."

Timing for Label Compliance is One Year: Many foods that were labeled as "gluten-free" prior to the new regulation may already meet the federal definition. For those that do not yet comply, manufacturers have until August of 2014 to make whatever changes are needed in the formulation or labeling of the foods bearing a gluten-free claim in order to legally market them in the United States.

For more information visit:

Gluten and Food Labeling: FDA's Regulation of "Gluten-Free" Claims

What is Gluten-Free? FDA Has an Answer

Reporting Health Effects:  Anyone who becomes ill or experiences adverse health effects that they believe are associated with having eaten a particular food should first seek appropriate medical care.  Afterward, individuals can report the incident by calling FDA's report line: 240-402-2405.

Reporting Labeling Issues:  Consumers and manufacturers can report potential misuse of gluten-free claims on food labels to an FDA Consumer Complaint Coordinator in the state where the food was purchased. 

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

SOURCE U.S. Food and Drug Administration