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 substance 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.
Regulation:Â
FDA established, among other criteria, 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 these same criteria, as most people with celiac disease can tolerate foods with very small amounts of gluten. Before the regulation was issued in 2013, there were no U.S. standards or definitions for the food industry to use in labeling products as “gluten-free.†This left many consumers, especially those with a health concern, unsure of a food’s gluten content.
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. Some foods and beverages, such as bottled spring water, fruits, vegetables, and eggs, are naturally gluten-free. However, because a “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 is Celiac disease?
Celiac disease is an autoimmune disorder that can occur in genetically predisposed people where the ingestion of gluten leads to damage in the small intestine. Â It is estimated to affect 1 in 100 people worldwide. Â Two and one-half million Americans are undiagnosed and are at risk for long-term health complications.
When people with celiac disease eat gluten (a protein found in wheat, rye and barley), their body mounts an immune response that attacks the small intestine. These attacks lead to damage on the villi, small fingerlike projections that line the small intestine, that promote nutrient absorption. When the villi get damaged, nutrients cannot be absorbed properly into the body.
Frequently Asked questions
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What has FDA done regarding gluten-free labeling?
On August 5, 2013, FDA issued a final rule defining the term “gluten-free†for voluntary use in the labeling of foods. The compliance date for the final rule was August 5, 2014. Food products bearing a gluten-free claim labeled on or after that date must meet the rule’s requirements. In addition, on June 25, 2014, FDA issued a guide for small food businesses to help them comply with the final rule’s requirements. FDA will continue to educate and monitor industry on the gluten-free claim.
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Who does the rule benefit?
These actions benefit people with celiac disease, an inherited chronic inflammatory auto-immune disorder that is estimated to affect up to 3 million Americans. For people who have celiac disease, consumption of gluten results in the destruction of the lining of the small intestine and the risk of other serious health conditions. The definition also benefits the food industry by establishing a level playing field among manufacturers of products labeled “gluten-free.â€
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How is “gluten-free†defined in the rule?
In general, foods may be labeled “gluten-free†if they meet the definition and otherwise comply with the final rule’s requirements. More specifically, the final rule defines “gluten-free” as meaning that the food either is inherently gluten free; or does not contain an ingredient that is: 1) a gluten-containing grain (e.g., spelt wheat); 2) derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or 3) derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food. Also, any unavoidable presence of gluten in the food must be less than 20 ppm.
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Why is the FDA regulating gluten labeling on food?
The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) directed HHS to define and permit the use of the term “gluten-free” in the labeling of foods. FDA published a proposed rule in January 2007. The proposal defined the term “gluten-free” and announced FDA’s intent to conduct a safety assessment for gluten exposure for people with celiac disease. In August 2011, FDA reopened the comment period on the proposal, and announced the availability of the gluten safety assessment, as well as its tentative conclusion to follow the approach in the proposed rule.
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What products are covered by the final rule?
The final rule applies to all FDA-regulated packaged foods, including dietary supplements. The rule excludes those foods whose labeling is regulated by the U.S. Department of Agriculture (USDA) and the Alcohol and Tobacco Tax and Trade Bureau (TTB). Generally, USDA regulates the labeling of meats, poultry, and certain egg products (FDA regulates the labeling of shell eggs). TTB regulates the labeling of most alcoholic beverages, including all distilled spirits, wines that contain 7 percent or more alcohol by volume, and malted beverages that are made with both malted barley and hops.
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Are all FDA-regulated foods that meet the definition of “gluten-free†required to be labeled gluten-free?
No. The final rule establishes requirements for the voluntary use of gluten-free claims. The Food Allergen Labeling and Consumer Protection Act of 2004directed the Secretary of Health and Human Services to issue federal regulations that “define†and “permit use of†the term “gluten-free†on the labeling of foods.
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Can a food be labeled gluten-free if it is made with small amounts of a gluten-containing grain or ingredients derived from such grains that were not processed to remove gluten, if the food contains less than 20 ppm gluten?
No. A food labeled gluten-free cannot be intentionally made with any amount of a gluten-containing grain (wheat, rye, barley, or their crossbred hybrids like triticale) or an ingredient derived from such grain that was not processed to remove gluten. The goal of manufacturing any food labeled gluten-free should be for the food to not contain any gluten or to contain the lowest amount possible that is less than 20 ppm gluten. One goal of FDA’s regulatory definition of the term “gluten-free†is to limit consumer confusion when reading ingredient lists of foods labeled gluten-free.
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Why didn’t FDA adopt zero ppm gluten rather than less than 20 ppm gluten as one of the criteria for a food labeled gluten-free?
FDA used an analytical methods-based approach to define the term gluten-free and adopted < 20 ppm gluten as one of the criteria for a food labeled gluten-free because the agency relies upon scientifically validated methods for enforcing its regulations. Analytical methods that are scientifically validated to reliably detect gluten at a level lower than 20 ppm are not currently available.
In addition, some celiac disease researchers and some epidemiological evidence suggest that most individuals with celiac disease can tolerate variable trace amounts and concentrations of gluten in foods (including levels that are less than 20 ppm gluten) without causing adverse health effects.
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A manufacturer’s foods labeled gluten-free are certified by a third-party organization to contain either less than 5 or 10 ppm gluten, which is lower than the final rule’s criterion of less than 20 ppm for a food labeled gluten-free. May manufacturers state on the label that their foods contain less than 5 or 10 ppm gluten?
The final rule does not prohibit manufacturers from stating any truthful and non-misleading information on their food labels, including declaring the maximum amount of gluten the food may contain. However, doing so would mean that each food bearing the label statement does not contain gluten at a level that exceeds the amount declared
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Would foods labeled gluten-free be a better choice for persons with celiac disease and others sensitive to gluten than foods not labeled gluten-free?
Not necessarily. Gluten-free is a voluntary claim that manufacturers may elect to use in the labeling of their foods, provided that those foods meet all final rule requirements for a gluten-free food. Some manufacturers may have to specially process, or reformulate foods in order for them to be free of gluten and to be eligible to bear a gluten-free labeling claim. Producers of foods that are by nature free of gluten (e.g., bottled spring water, fresh fruits and vegetables, and fresh seafood) may choose not to label these foods as gluten-free even though the foods could be consumed as part of a gluten-free diet. For foods that are by nature free of gluten, but are at high risk of gluten cross-contact (e.g., products made from grains, legumes, and seeds), the appearance of a gluten-free claim on the labels would provide consumers with the expectation that any gluten present is less than 20 ppm. Persons with celiac disease or who are otherwise sensitive to gluten should seek the advice of their health care providers for selecting appropriate foods they can consume following a gluten-free diet.
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