An estimated 3 million Americans suffer from celiac disease, an auto-immune digestive disorder, that can have serious health consequences. For them, FDA’s standard for the claim “gluten-free” on food labels is critical. This regulation provides consumers with the assurance that “gluten-free” claims on food products are consistent and reliable across the food industry, and gives them – especially those with celiac disease – a standardized tool for managing their health and dietary intake.
What is Gluten?
Gluten is a protein that occurs naturally in wheat, rye, barley, and crossbreeds of these grains, like triticale. Foods that typically contain gluten include breads, cakes, cereals, pastas, and many others. Gluten is the ingredient that gives breads and other grain products their shape, strength, and texture. However, many of these grains can be made gluten-free.
FDA’s Regulation for “Gluten-Free” Claims
Gluten-free is a voluntary claim that food manufacturers may choose to use in the labeling of their products. If manufacturers label their foods gluten-free, however, they are accountable for using the claim in a truthful and not misleading manner, and for complying with all requirements established by the regulation and enforced by FDA.
Before the regulation was issued, there were no U.S. standards or definitions for the food industry to use in labeling products “gluten-free.” This left many consumers, especially those with a health concern, unsure of a food’s gluten content.
FDA set a gluten limit of less than 20 parts per million (ppm) for foods that carry the label “gluten-free,” “no gluten,” “free of gluten,” or “without gluten.” This level is the lowest that can be reliably detected in foods using scientifically validated analytical methods. Other countries and international bodies use this standard because most people with celiac disease can tolerate foods with such very small amounts of gluten.
Foods That Can Be Labeled Gluten-Free
Whether a food is manufactured to be free of gluten or is free of gluten by nature, it may bear a gluten-free labeling claim if it meets all FDA requirements for a gluten-free food. Foods and beverages like bottled spring water, fruits, vegetables, and eggs are naturally gluten-free. However, even though a food may be gluten-free, the claim might not appear on the label because the regulation allows, but does not require, a gluten-free claim to be on the package.
Gluten-Free Labeling: What Does It Look Like?
A gluten-free claim doesn’t have to be in any specific location on the food label. Manufacturers may choose where they place it, as long as it doesn’t interfere with mandatory labeling information and meets the regulatory requirements.
Some manufacturers may decide to use the logo of a gluten-free certification program on their food labels, but FDA does not endorse, accredit, or recommend any third-party gluten-free certification program.
Products Covered by the Gluten-Free Regulation
The regulation applies to all foods and beverages (including packaged foods, dietary supplements, fruits and vegetables, shell eggs, and fish) except for:
- Meat, poultry, and certain egg products that are regulated by the U.S. Department of Agriculture (USDA)
- Most alcoholic beverages (all distilled spirits, wines with 7 percent or more alcohol by volume, and beverages made with malted barley and hops) which are regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB) of the U.S. Department of the Treasury
Reporting Adverse Effects and Misuse of Labeling
- Health Effects: Anyone who becomes ill or experiences adverse health effects that they think resulted from having eaten a particular food, including individuals with food allergies and those with celiac disease, should first seek appropriate medical care.
- Afterward, FDA encourages individuals to report the incident to the Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System by calling 240-402-2405.
- Labeling Issues: Consumers and manufacturers can report any complaint they may have, such as potential misuse of gluten-free claims on food labels, to an FDA Consumer Complaint Coordinator in the state where the food was purchased. The list of FDA Consumer Complaint Coordinators is posted on FDA’s website.