Questions and Answers on the Gluten-Free Food Labeling Final Rule (2024)

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) directed the Department of Health and Human Services (HHS) to define and permit the use of the term "gluten-free" in the labeling of FDA-regulated foods.

Regulating the "gluten-free" labeling claim benefits 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. It also benefits the food industry by establishing a level playing field among manufacturers of products labeled "gluten-free" and gives a clear understanding of the requirements for a food to bear a "gluten-free" claim.

On August 5, 2013, FDA issued a final rule defining the term "gluten-free" for voluntary use in the labeling of foods (2013 final rule). In addition, on June 25, 2014, FDA issued a guide for small food businesses to help them comply with the final rule's requirements.

On August 13, 2020, FDApublished a final rule establishing compliance methods for fermented, hydrolyzed, and distilled foods or ingredients that are labeled as "gluten-free" (2020 final rule). The 2020 final rule covers foods such as yogurt, sauerkraut, pickles, cheese, green olives, FDA-regulated beers and wines, and hydrolyzed plant proteins used to improve flavor or texture in processed foods such as soups, sauces, and seasonings. The 2020 final rule also pertains to distilled foods such as distilled vinegar. This rule does not change the definition of "gluten-free" but establishes compliance requirements for these foods. We refer to the requirements of the 2013 and 2020 final rules as "the regulation" or "21 CFR 101.91" for the remainder of this document.

If or when a scientifically valid method to detect and quantify the presence of gluten in fermented or hydrolyzed foods becomes available, we will identify this change through a guidance document or other appropriate means. In addition, FDA may consider changing our regulations if warranted. We will continue to educate and monitor industry on the requirements for the use of the "gluten-free" claim and consider regulatory action for products found to be misbranded on a case-by-case basis.

The regulation applies to FDA-regulated packaged foods, including dietary supplements and fermented, hydrolyzed, or distilled foods, which are described below:

• A fermented food is one that has undergone a process that typically involves the conversion of complex organic compounds, especially sugars and other carbohydrates, to simpler compounds such as lactic acid and ethyl alcohol. This process is referred to as fermentation. During fermentation, proteins are broken apart into smaller groups of amino acids known as peptides.Fermentation is not considered as a process to remove gluten and conventional analytical methods may not accurately detect and quantify gluten in fermented foods. Examples of fermented foods include beer and yogurt.
• A hydrolyzed food is one in which a food’s chemical components—such as proteins—are broken into smaller organic compounds by reaction with water. These reactions are often accelerated by enzymes.Hydrolysis is not considered as a process to remove gluten and just as with fermentation, conventional analytical methods may not accurately detect and quantify gluten in hydrolyzed foods. Examples of hydrolyzed foods include hydrolyzed soy protein and hydrolyzed wheat protein.
• Distilled foods are formed as a result of a purification process that involves heating a liquid such that volatile components with lower boiling points are vaporized and recovered separately from nonvolatile components with higher boiling points. The remaining nonvolatile compounds, whose boiling points were too high to undergo vaporization, are removed from the distilled food. Examples of distilled foods include some vinegars and distilled water.

The regulation does not apply to those foods whose labeling is regulated by the U.S. Department of Agriculture (USDA) or 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.

Yes. FDA continues to work with USDA and TTB to harmonize the requirements as much as possible, taking into consideration our different statutory authorities.

Beer is a fermented beverage derived from fermented malted cereal grains, most commonly malted barley or wheat, which are gluten-containing grains. Beers that meet the definition of "malt beverages" in the Federal Alcohol Administration Act (27 U.S.C. 211(a)(7)) are subject to TTB's labeling requirements. Certain other beers that do not meet the definition of "malt beverage" are subject to FDA's labeling requirements. An example of a beer subject to FDA labeling requirements is sorghum beer.

Beers that are not made from gluten-containing grains or that are made from gluten-containing grains that have been processed to remove gluten in accordance with the definition of "gluten-free" before the fermentation process may bear the term “gluten-free” if they meet the applicable requirements in 21 CFR 101.91. (See question 6.)

The regulation 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.

What other terms are permitted in addition to “Gluten-free”?

The gluten-free regulation identifies three additional claims that are considered to be equivalent to “gluten-free”: “free of gluten”, “without gluten”, and “no gluten” (21 CFR 101.91(b)(2). Use of any of these 4 terms would mean that the food would have to meet the requirements of the gluten-free claim. Other terms regarding the absence of gluten will be evaluated under FDA’s general misbranding provisions on a case-by case basis.

No. The regulation establishes requirements for the voluntary use of "gluten-free" claims.

Yes. If distilled properly, distillation is capable of removing all proteins, including gluten, it would be considered a process to remove gluten.Thus, an ingredient that is derived from a gluten containing grain that has been properly distilled would be allowed to be used in a food bearing the "gluten-free" claim because the ingredient would meet the requirements of 21 CFR 101.91.

The 2020 final rule clarifies that, in most cases, it is unlikely that gluten will be present in a distilled ingredient because distillation is a purification process that separates volatile components like alcohol and flavors from nonvolatile materials like proteins and sugars. However, this would depend on the adequacy of the distillation process (e.g., transfer of gluten into the distillate may occur under poor manufacturing practices).Protein testing using scientifically valid methods to measure the protein content can be done to confirm that no detectable protein (intact protein or protein fragments) is present and thus no gluten in distilled ingredients.

Yes. All foods imported into the United States must meet the same federal requirements as foods domestically produced. Therefore, if the label of an imported food subject to FDA regulations makes a "gluten-free" claim, that food must comply with the "gluten-free" labeling requirements.

Yes. Whether a food is manufactured to be free of gluten or by nature is free of gluten (e.g., bottled spring water), it may bear a "gluten-free" labeling claim if it complies with our regulation for a "gluten-free" food. The claim is voluntary.

No. However, as with any other non-gluten-containing grain, oats that are labeled "gluten-free" must contain 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."

Any grain other than the gluten-containing grains of wheat, rye, barley, or their crossbred hybrids like triticale can be labeled "gluten-free" if the presence of any unavoidable gluten due to cross-contact situations is less than 20 ppm.

While not defined in the regulation, cross-contact, in the context of § 101.91, generally refers to the unavoidable presence of gluten in a food due to contact with a gluten-containing food (wheat, rye, barley, or their crossbred hybrids like triticale). The U.S. Grain Standards allow commodity grains, legumes, and seeds to contain a small percentage of another commodity grain as a result of commingling during production. The presence of gluten in a grain, legume, or seed that is naturally free of gluten from this type of commingling is an example of cross-contact. The typical practice of crop rotation, as well as the shared use of harvesting and transport equipment and storage silos, often results in gluten-containing grains coming into contact with other grains, legumes, and seeds that are naturally free of gluten. Furthermore, manufacturing facilities that use shared production equipment to produce foods both with and without gluten could result in gluten cross-contact. Any grain other than the gluten-containing grains of wheat, rye, barley, or their crossbred hybrids like triticale can be labeled "gluten-free" if it meets the definition, including that the presence of any unavoidable gluten due to cross-contact situations is less than 20 ppm.

The regulation does not require manufacturers to place the voluntary "gluten-free" claim in any specific location on the food label. Manufacturers may choose where they place a "gluten-free" claim on their food labels, provided that the claim does not interfere with other FDA-required labeling information and meets all other applicable statutory and regulatory requirements.

Manufacturers may include the logo of a "gluten-free" certification program on their food labels, provided that its use is truthful and not misleading. FDA does not endorse, accredit, or recommend any particular third-party "gluten-free" certification program.

The regulation does not address the use of a logo of a third-party "gluten-free" certification program.

Yes. Neither our "gluten-free" food labeling regulation nor our general food labeling regulations prohibit the use of a statement like "made with no gluten-containing ingredients" or "not made with gluten-containing ingredients" on any food products, provided that the statement is truthful and not misleading. However, unless the label of the food including such a statement also bears a "gluten-free" claim, consumers should not assume that the food meets all FDA requirements for the use of the "gluten-free" claim.

Yes. The regulation does not prohibit the inclusion of a voluntary advisory label statement, such as “made in a facility that also processes wheat,” on foods labels that also contain a voluntary “gluten-free” claim, provided that the statement is truthful and not misleading. FDA evaluates food labels on a case-by-case basis to determine whether a specific advisory statement included along with a “gluten-free” claim would be potentially misleading to the consumer. However, any food whose label bears a “gluten-free” claim, regardless of whether it also has an advisory statement, must comply with 21 CFR 101.91.

At the time the regulation was written, FDA used an analytical methods-based approach to define the term “gluten-free” and adopted less than 20 ppm gluten as one criterion for a food labeled “gluten-free” because we rely on scientifically validated methods for enforcing 21 CFR 101.91. Analytical methods that were scientifically validated to reliably detect gluten at a level lower than 20 ppm were not available at that time. 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.

The regulation 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.

We will use our routine post-market monitoring activities to enforce the gluten-free food labeling regulation. These activities include sampling; periodic inspections of food manufacturing facilities; food label reviews; follow-up on consumer and industry complaints reported to us; and, when needed, gluten analyses of food samples.

No. The regulation does not require manufacturers to test for the presence of gluten in their starting ingredients or finished foods labeled “gluten-free.” However, manufacturers are responsible for ensuring that foods bearing a “gluten-free” claim comply with 21 CFR 101.91. Among other requirements, this means that any unavoidable gluten present in a food labeled “gluten-free” is less than 20 ppm. Manufacturers may choose to use effective quality control tools to ensure that any foods they label “gluten-free” do not contain 20 ppm or more gluten, such as:

• conducting in-house gluten testing of starting ingredients or finished foods,
• employing a third-party laboratory to conduct in-house gluten testing,
• requesting certificates of gluten analysis from ingredient suppliers, or
• participating in a third-party “gluten-free” certification program.

Additional record-keeping requirements may exist if the food is hydrolyzed or fermented or contains hydrolyzed or fermented ingredients (see 21 CFR 101.91(c)(2)-(4)).

Manufacturers who elect to analyze their foods for gluten can select the test methods most appropriate for them, considering the type of foods they manufacture. Manufacturers are not obligated to use any one specific method to check for gluten in their foods. FDA recommends the use of scientifically valid methods in order for the gluten test results obtained to be reliable and consistent. Conducting gluten testing using a scientifically valid method is an effective tool manufacturers can use to ensure that their foods labeled “gluten-free” do not contain 20 ppm or more gluten.

FDA routinely uses scientifically valid methods that have undergone an independent multi-laboratory performance evaluation where the results have been published in the peer-reviewed scientific literature to ensure that the results obtained are accurate and reliable. We have currently identified two sandwich enzyme-linked immunosorbent assays (ELISA)-based methods (see R-Biopharm: Food & Feed Analysis and Morinaga Institute of Biological Science, Inc.: Wheat Protein ELISA Kit (Gliadin)) that, when necessary, the agency will use in tandem to determine compliance with 21 CFR 101.91. However, as discussed in the the 2013 final rule, FDA is aware that sandwich ELISA methods do not adequately detect gluten in fermented and hydrolyzed foods. Because there are no currently available scientifically valid methods that can do so, we issued a rule in 2020 to address this issue.

The 2020 final rule states that we will verify compliance with 21 CFR 101.91 for distilled foods by verifying the absence of protein in the distilled component using a scientifically valid analytical method that can reliably detect the presence or absence of protein or protein fragments in the food. However, the 2020 final rule does not require manufacturers to test distilled foods for the presence of gluten in their starting ingredients or finished foods labeled “gluten-free.” If a manufacturer elects to analyze their distilled foods for gluten, FDA recommends using a scientifically valid method to measure protein content. Protein testing can be done to confirm that protein is absent in the distilled product, and no detectable level of protein would indicate an absence of gluten.

Because the current gluten tests do not adequately detect and quantify gluten in fermented and hydrolyzed foods or ingredients, 21 CFR 101.91(c)(2)-(4) requires that, to make a “gluten-free” claim, manufacturers of these foods must make and keep records that provide adequate assurance that:

• The food meets the definition for “gluten-free” in 21 CFR 101.91(a)(3), including that the food had less than 20 ppm gluten, before fermentation or hydrolysis.
• The manufacturer adequately evaluated the processing for any potential for gluten cross-contact.
• Where a potential for gluten cross-contact has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process.

These records could include test results conducted by the manufacturer or an ingredient supplier, a certificate of analysis, or other appropriate verification documentation for the food or each ingredient used in the food.

For hydrolyzed and fermented foods labeled as “gluten-free,” the manufacturer must keep the records described above for at least 2 years after the food is introduced or delivered for introduction into interstate commerce (21 CFR 101.91(c)(4)). Manufacturers must provide these records to us for examination and copying during an inspection upon request.

Yes. The requirements are the same. However, the specific types of records that would provide adequate assurance for hydrolyzed or fermented ingredients with a high likelihood of gluten cross-contact, such as grains and legumes, may vary from those expected for ingredients with a lower likelihood of gluten cross-contact, such as dairy.

Yes. Any manufacturer of a hydrolyzed or fermented food, or a food containing hydrolyzed or fermented ingredients, must follow the applicable requirements even if the food was inherently “gluten-free”—that is, it does not contain a gluten-containing grain or an ingredient derived from a gluten-containing grain (21 CFR 101.91(b)(1)). (See next question.) For the recordkeeping requirement, the extent of the records necessary will depend on the food, the ingredients, the manufacturing process, and other foods processed in the plant.

Fermented or hydrolyzed food products made from gluten-containing grains would not be permitted to bear a “gluten-free” claim unless the grains were processed to remove gluten and the use of the ingredient resulted in the presence of less than 20 ppm gluten in the food before hydrolysis or fermentation.

Currently, FDA does not have plans to authorize third-parties to inspect facilities of manufacturers that label foods “gluten-free” or to verify if such foods meet the regulatory definition of “gluten-free.”

In December 2017, the FDA’s Center for Drug Research and Evaluation (CDER) issued a Federal Register notice (82 FR 58618) announcing the availability of a draft guidance for industry entitled “Gluten in Drug Products and Associated Labeling recommendations.”This draft guidance, when finalized, will represent the agency’s current thinking on how certain oral drug products should be labeled regarding gluten to help individuals with celiac disease limit gluten exposure from consumption of drug products.

It depends on the ingredients and processing of the soy sauce. Soy sauce is a food ordinarily made by fermenting a mixture of soybeans and wheat. However, some soy sauces are not made using wheat. In general, when soy sauce is made from soybeans and wheat, or any other gluten-containing grain, it may not bear a “gluten-free” claim. If soy sauce is not made using wheat or any other gluten-containing grain then it can bear a “gluten-free’ claim. Also, if the soy sauce is made using a gluten-containing grain that is processed to remove gluten resulting in the presence of less than 20 ppm gluten prior to the fermentation process, then it can bear a “gluten-free” claim. Soy sauce produced in this manner could also be used as an ingredient in a food bearing a “gluten-free” claim, provided that the use of the soy sauce does not result in the presence of 20 ppm or more gluten in the food.

As with other foods, if the soy sauce is made using wheat that has been processed to remove gluten, bears a “gluten-free” claim, and declares “wheat” in the ingredient list or in a separate “Contains wheat” statement, then it must also comply with the disclaimer statement requirement in 21 CFR 101.91(b)(3) indicating that the wheat has been processed to allow the food to meet FDA requirements for “gluten-free” foods.

No. Malt syrup and malt extract are interchangeable terms for a viscous concentrate of a water extract of germinated barley, with or without a preservative. The terms barley malt or barley malt extract are used also. Malt extract and malt syrup are ingredients derived from a gluten-containing grain, barley, that has not been processed to remove gluten. Food and ingredient manufacturers should be aware that malt extract and other similar malt-derived ingredients are ingredients derived from gluten-containing grains that have not been processed to remove gluten and, therefore, cannot be used in foods that bear a “gluten-free” labeling claim.The terms "malt extract" or "malt syrup" unqualified should be applied only to products prepared from barley. See FDA Compliance Policy Guide Sec 515.200 Malt Extract; Malt Syrup; Malted Cereal Syrup; Liquid Malt; Dried Malt.

Can Malt vinegar be used in foods bearing a “gluten-free” claim?

Malt vinegar is a product made by the alcoholic and subsequent acidic fermentation without distillation, of an infusion of barley malt (CPG 525.825). Since it is an ingredient derived from a gluten-containing grain, barley, undergoes fermentation, and has not been processed to remove gluten, it cannot be used in foods that bear a “gluten-free” labeling claim.

Not necessarily. Consumers with celiac disease should read and scrutinize labels to avoid gluten ingredients. “Gluten-free” is a voluntary claim that manufacturers can use in food labeling, provided that those foods meet all requirements for a “gluten-free” food. Some manufacturers may specially process or reformulate foods to be free of gluten and to be eligible to bear a “gluten-free” labeling claim. However, 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 higher 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, if any gluten were present, it would be present at less than 20 ppm in final product. Persons with celiac disease, especially those who may be sensitive to these low levels of gluten, and persons 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.

If you think that you or a family member has an injury or illness that you believe is associated with having eaten a particular food, including individuals with food allergies and those with celiac disease, contact your healthcare provider immediately. Keep any food packages because they may contain important information. Also, suspected foodborne illness or labeling concerns may be reported to FDA in either of these ways:

• Consumers can submit a report using FDA’s MedWatch Online reporting form for consumers, which can be found here: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Consumers and manufacturers can submit reports detailing product reactions to an FDA Consumer Complaint Coordinator for the state where the food was purchased. A list of FDA Consumer Complaint Coordinators is available, or search for “consumer complaint coordinator” at https://www.fda.gov. You can also call FDA at 1-888-SAFEFOOD.

Reports submitted to FDA should include as much information as possible, such as:

• Who is reporting the incident and who was affected? Please provide names, addresses, and phone numbers.
• The name and address of the place where the product was purchased.
• A clear description of the reaction, including:
  • Date the reaction occurred.
  • All symptoms experienced.
  • How long after you ate or drank the product that the reaction occurred.
  • Medications used to treat symptoms.
  • Whether the reaction required further medical care, and if so, what kind. Please provide contact information for the doctor or hospital.
• A complete description of the product, including:
  • Date of purchase.
  • Any codes or identifying marks on the label or container, such as lot number, expiration date, and UPC code.
  • Photos of the product, label, ingredient statement, and lot code.

FDA’s regulation applies to packaged foods. FDA will monitor any reported information related to unpackaged food and share any complaints received about unpackaged foods, such as those served in restaurants, with state and local government partners.

No. A manufacturer may make a wide variety of foods, including those that are “gluten-free” and those that contain gluten. Manufacturers can voluntarily use the “gluten-free” claim to clearly inform consumers about which of their foods complies with FDA’s gluten-free regulation.

The regulation applies to packaged foods, which may be sold in some retail and food-service establishments such as some carry-out restaurants. However, given the public health significance of “gluten-free” labeling, we recommend restaurants making a “gluten-free” claim on their menus to be consistent with our “gluten-free” definition.