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Gluten and Food Labeling: FDA's Regulation of "Gluten-Free" Claims
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In August of 2013, the U.S. Food and Drug Administration (FDA) issued a regulation that defines the term “gluten-free” for food labeling. This new definition provides consumers – especially those with celiac disease – the assurance that “gluten-free” claims on food products are consistent and reliable across the food industry, and gives them a standardized tool for managing their health and dietary intake.
“Gluten Free” Terms
Consumers may also see the terms:
- “Free of gluten”
- “No gluten”
- “Without gluten”
The new FDA regulation applies to all of these variations.
FDA’s Regulation of “Gluten-Free” Claims
FDA’s new regulation for gluten-free food labeling standardizes what “gluten-free” means on the food label. Gluten-free is a voluntary claim that manufacturers may elect to use in the labeling of their foods. However, manufacturers that label their foods gluten-free 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.
Inside the Regulation
FDA has 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 same criteria, as most people with celiac disease can tolerate foods with very small amounts of gluten.
Before the issuing of the regulation, 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.
What is Gluten?
Gluten is the protein that occurs naturally in wheat, rye, barley, and crossbreeds of these grains. Foods that typically contain gluten include breads, cakes, cereals, pastas, and many other foods. Gluten is the ingredient that gives breads and other grain products their shape, strength, and texture.
But for the estimated 3 million Americans suffering from celiac disease, an auto-immune digestive disorder, consuming gluten can have serious health consequences.
Grains: A Closer Look
Certain grains are especially likely to contain natural gluten. However, there are grains that can be made gluten-free, including:
- Crossbred hybrids like triticale
A grain can be labeled gluten-free once it is processed to remove gluten and the presence of any unavoidable gluten due to “cross-contact” is less than 20 ppm.
Foods That Can Be Labeled As “Gluten-Free”
Whether a food is manufactured to be free of gluten or by nature is free of gluten, it may bear a gluten-free labeling claim if it meets all FDA requirements for a gluten-free food. Foods/beverages like bottled spring water, fruits, vegetables, and eggs are naturally gluten free. However, because the “gluten free” claim isn’t required to be on a food package, it may not appear even if the food is, in fact, gluten-free.
What About Restaurants?
FDA recognizes that compliance with the gluten-free rule in processed foods and food served in restaurants is important for the health of people with celiac disease.
In August 2013, FDA issued final rule that established a federal definition of the term ‘”gluten-free” for food manufacturers that voluntarily label FDA-regulated foods as “gluten-free.” This definition is intended to provide a reliable way for people with celiac disease to avoid gluten, and we expect that restaurants’ use of “gluten-free” labeling will be consistent with the federal definition. The deadline for compliance with the rule is not until August 2014, although we have encouraged the food industry to bring its labeling into compliance with the new definition as soon as possible.
Given the public health significance of “gluten-free” labeling, we encourage the restaurant industry to move quickly to ensure that its use of “gluten-free” labeling is consistent with the federal definition and look forward to working with the industry to support their education and outreach to restaurants.
In addition, state and local governments play an important role in oversight of restaurants. We expect to work with our state and local government partners with respect to gluten-free labeling in restaurants. We will consider enforcement action as needed, alone or with other agencies, to protect consumers.
Gluten-Free Labeling: What It May Look Like
The new regulation doesn’t require manufacturers to place a food’s gluten-free claim in any specific location on the food label. So, manufacturers may choose where they place a gluten-free claim, as long as it doesn’t interfere with mandatory labeling information and meets the regulatory requirements.
- Some manufacturers may choose to include the logo of a gluten-free certification program on their food labels; however, FDA does not endorse, accredit, or recommend any particular third-party gluten-free certification program.
Packaging of some foods that were labeled as “gluten-free” prior to the new regulation may look the same after August 2014 because the foods already met the new definition and did not need revised packaging.
Timing of the Regulation
Many foods that were labeled as “gluten-free” prior to the new regulation may already meet the new federal definition.
For those that do not yet comply, manufacturers have until August of 2014 to bring their labels into compliance, to allow sufficient time to make whatever changes are needed in the formulation or labeling of their foods bearing a gluten-free claim. After August 2014, a food that is labeled “gluten-free” but fails to meet the requirements of the regulation will be subject to regulatory action by FDA.
Products Covered by the Gluten-Free Regulation
FDA’s new 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: Regulated by 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): Regulated by Alcohol and Tobacco Tax and Trade Bureau (TTB)
Reporting Adverse Effects and Misuse of Labeling
Health Effects: Anyone who becomes ill or experiences adverse health effects that they believe are associated with 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.
A list of FDA Consumer Complaint Coordinators is posted at FDA’s website: http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074201.htm
For more information, contact: The U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition Food Information Line at 1-888-SAFEFOOD (toll free), 10 AM to 4 PM ET, Monday through Friday. Or visit the FDA Web site at www.fda.gov.