October 13, 2020
Number: 2020-2
Gluten Content Statements in the Labeling and Advertising of Wine, Distilled Spirits, and Malt Beverages
Truthful, accurate, and non-misleading gluten content statements, in accordance with this ruling, are permitted on labels and in advertisements for alcohol beverage products regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB). TTB Ruling 2014–2 is superseded. This ruling does not require any changes to approved labels. Instead, it allows greater flexibility for industry members who wish to make voluntary “gluten-free” claims on labels or in advertisements of distilled spirits distilled from gluten-containing grains, subject to the conditions set forth in this ruling.
I. Introduction
In response to changes to Food and Drug Administration (FDA) regulations, TTB is updating its policy on gluten content statements on labels and in advertisements for wines, distilled spirits, and malt beverages regulated under the Federal Alcohol Administration Act (FAA Act). TTB is continuing to authorize the term “gluten-free” on labels and in advertisements if the product would be entitled to make a “gluten-free” labeling claim under the definition set forth in FDA regulations. In light of changes to FDA’s regulations, TTB is revising its policy to allow the term “gluten-free” on labels and in advertisements for distilled spirits distilled from gluten-containing grains as long as good manufacturing practices are followed that prevent the introduction of any gluten-containing material into the final product. TTB is continuing to allow labels and advertisements for products fermented from gluten-containing grains to bear a claim that the product was processed (or treated or crafted) to remove gluten, if the claim includes an appropriate qualifying statement and necessary documentation is available to substantiate the claim.
II. TTB Authority
The FAA Act authorizes the Secretary of the Treasury to issue regulations intended to prevent deception of the consumer, provide the consumer with adequate information as to the identity and quality of the product, and prohibit false or misleading statements on alcohol beverage labels or in advertisements. Additionally, the law authorizes the Secretary to prohibit, irrespective of falsity, statements relating to age, manufacturing processes, analyses, guarantees, and scientific or irrelevant matters that are likely to mislead the consumer.
TTB administers the FAA Act pursuant to section 1111(d) of the Homeland Security Act of 2002, codified at 6 U.S.C. 531(d). The Secretary has delegated, through Treasury Department Order 120–01 (Revised), various duties in the administration of this law to the TTB Administrator.
The FAA Act implementing regulations appear in 27 CFR parts 4, 5, and 7. They prohibit labeling or advertising statements that are false or untrue in any particular as well as statements that, irrespective of falsity, tend to create a misleading impression through ambiguity, omission, inference, or by the addition of irrelevant, scientific, or technical matter. See 27 CFR 4.39(a)(1), 4.64(a)(1), 5.42(a)(1), 5.65(a)(1), 7.29(a)(1), and 7.54(a)(1). Furthermore, the regulations prohibit the use of any health-related statements in the labeling or advertising of wine, distilled spirits, and malt beverages if such statements are untrue in any particular or tend to create a misleading impression. TTB evaluates such statements on a case-by-case basis and may require a disclaimer or some other qualifying statement to dispel any misleading impression created by the health-related statement. See 27 CFR 4.39(h), 4.64(i), 5.42(b)(8), 5.65(d), 7.29(e), and 7.54(e). Statements about gluten content are treated as health-related statements under TTB regulations.
This ruling provides guidance on TTB’s interpretation of the FAA Act and its implementing regulations as they apply to alcohol beverage labels or advertisements containing the claim “gluten-free” or similar claims. In cases where an alcohol beverage is not covered by the labeling provisions of the FAA Act (e.g., beers that are not saké or malt beverages, or wines that contain less than 7 percent alcohol by volume), the product is subject to the labeling requirements of the FDA under the authority of the Federal Food, Drug, and Cosmetic Act (FFDCA). Although TTB’s legal authority and regulations are separate from those of the FDA in its regulation of food labeling, TTB believes it is important in this case to adopt an approach that is as consistent as possible with the FDA regulations, given the FDA’s expertise in assessing the important consumer health considerations relating to gluten-content claims.
III. Background
A. 2013 FDA Regulations on Gluten-Related Labeling Claims
In August 2013, FDA issued a final rule on the use of “gluten-free” claims in food labeling. Under those regulations, the labeling claim “gluten-free” means that a food inherently does not contain gluten, or does not contain any of the following:
(1) An ingredient that is a gluten-containing grain (e.g., spelt wheat);
(2) An ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten (e.g., wheat flour); or
(3) An ingredient that is derived from a gluten-containing grain and 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 (i.e., 20 milligrams (mg) or more gluten per kilogram (kg) of food).
21 CFR 101.91(a)(3)(i) and (b)(1)–(2).
Additionally, any unavoidable presence of gluten in such a food must be below 20 ppm. 21 CFR 101.91(a)(3)(ii). FDA permits the terms “no gluten,” “free of gluten,” and “without gluten” on the same basis as the term “gluten-free.” 21 CFR 101.91(b)(2). When compliance with these rules is based on an analysis of the food, FDA stated that it would use “a scientifically valid method that can reliably detect the presence of 20 ppm gluten in a variety of food matrices, including both raw and cooked or baked products.” See 21 CFR 101.91(c). For fermented or hydrolyzed foods (or foods containing fermented or hydrolyzed ingredients), however, FDA found that there is currently no scientifically valid analytical method available that can both reliably detect and accurately quantify the equivalent of 20 ppm intact gluten.
B. TTB Ruling 2014–2
In TTB Ruling 2014–2, TTB permitted the term “gluten-free” on labels and in advertisements for alcohol beverages under the FAA Act if the product would be entitled to make such a claim under the standards set forth in § 101.91 of the FDA regulations. Under this policy, alcohol beverages could be labeled with “gluten-free” claims if they were made without ingredients containing gluten (such as wine fermented from grapes, or spirits distilled from potatoes). Industry members were expected to verify that the producer took appropriate measures to ensure that its raw materials, ingredients, production facilities, storage materials, and finished products were not subject to cross-contact with gluten.
In the 2014 ruling, TTB noted that FDA regulations disqualified foods from bearing a “gluten-free” claim if they contain an ingredient that is a gluten-containing grain, such as wheat, rye, barley, or a cross-bred hybrid of those grains. This prohibition applied regardless of the gluten content of the finished product. Consistent with FDA’s regulations, TTB stated it would continue to consider “gluten-free” label claims for TTB-regulated alcohol beverages fermented or distilled from gluten-containing grains to be misleading.
In the case of alcohol beverages made from gluten-containing ingredients but that are processed to remove gluten, TTB determined that it would be inherently misleading for such products to make a “gluten-free” claim or a claim of specific gluten content levels absent a means to verify the accuracy of that statement through scientifically validated methods or other reliable means as might be revealed through FDA rulemaking. However, TTB allowed labels and advertisements for such products to use the statement “[Processed or Treated or Crafted] to remove gluten,” together with a qualifying statement to inform consumers that: (1) the product was fermented or distilled from a grain that contains gluten; (2) the gluten content of the product cannot be verified; and (3) the product may contain gluten. TTB required that COLA applications containing such claims include a detailed description of the method used to remove gluten and, for the purpose of showing a reduction in the amount of gluten, test results indicating less than 20 ppm gluten in the product.1 Industry members were expected to be able to substantiate such claims in advertisements upon request.
TTB Ruling 2014–2 also stated that other types of claims about gluten content were prohibited if they were untrue in any particular or tended to create a misleading impression. TTB stated that it would evaluate such statements on a case-by-case basis, and may require a disclaimer or some other qualifying statement to dispel any misleading impression that any health-related statement creates. See 27 CFR 4.39(h), 4.64(i), 5.42(b)(8), 5.65(d), 7.29(e), and 7.54(e).
Finally, TTB Ruling 2014–2 noted that when FDA issued a final rule or other guidance with respect to fermented or hydrolyzed products, TTB would evaluate whether the interim policy set forth in the ruling should be revised. TTB is now revising its ruling, in light of the final rule recently issued by FDA.
C. 2020 FDA Final Rule
FDA published a proposed rule in November 2015 to establish requirements to verify “gluten-free” labeling claims for fermented or hydrolyzed foods through means other than currently available gluten testing methods. FDA published a final rule in August 2020 establishing these requirements in new 21 CFR 101.91(c)(2)–(4).2 FDA reiterated in its final rule that it knew of no scientifically valid analytical method effective in detecting and quantifying with precision the gluten protein content in fermented or hydrolyzed foods in terms of equivalent amounts of intact gluten proteins.
The new FDA requirements, which are effective October 13, 2020, provide that when a scientifically valid method pursuant to 21 CFR 101.91(c)(1) is not available because the food is fermented or hydrolyzed, the manufacturer who wishes to make a “gluten-free” claim about a fermented or hydrolyzed food must maintain records that demonstrate that the fermented or hydrolyzed food is “gluten-free,” i.e., that it meets the definition of “gluten-free” in 21 CFR 101.91(a)(3), before fermentation or hydrolysis occurs. 21 CFR 101.91(c)(2). Likewise, for foods with a “gluten-free” claim that contain one or more fermented or hydrolyzed ingredients, FDA mandated that manufacturers must make and keep records demonstrating adequate assurance that such ingredients are “gluten-free” before fermentation or hydrolysis. 21 CFR 101.91(c)(3).
The FDA final rule also requires manufacturers of such fermented or hydrolyzed foods, or foods which contain fermented or hydrolyzed ingredients, to ensure that the manufacturer has adequately evaluated the processing of the food for any potential for gluten cross-contact, and where such a potential is identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process. 21 CFR 101.91(c)(2)–(3).
FDA’s August 2020 final rule also specified how FDA will determine compliance with FDA’s “gluten-free” labeling requirements for distilled products.3 FDA explained in the final rule that distillation removes all protein (including gluten) if good manufacturing practices are followed (such as avoiding the introduction of any initial gluten-containing material into the distillate). As a result, protein testing can confirm the absence of protein or protein fragments (and thus gluten) in the distillate, regardless of whether it was distilled from fermented or hydrolyzed gluten-containing ingredients. 85 FR 49248. FDA therefore finalized at 21 CFR 101.91(c)(5) a provision stating that it would verify the absence of gluten in distilled foods bearing a “gluten-free” claim by using scientifically valid analytical methods that can reliably detect the presence or absence of protein or protein fragments (and thus gluten) in the food.
IV. Revisions to TTB Policy
In light of FDA’s recent final rule concerning the verification of “gluten-free” claims on the labeling of foods that are fermented, hydrolyzed, or distilled, or contain fermented, hydrolyzed, or distilled ingredients, TTB is revising its policy for gluten content claims in labeling and advertising under the FAA Act. The revised policy is described below and set forth in the holdings at the end of this ruling. Consistent with previous rulings, industry members are responsible for verifying the accuracy of any gluten-related claim on labels or in advertisements. This ruling does not require any changes to approved labels. Instead, it allows greater flexibility for industry members who wish to make voluntary “gluten-free” claims on labels or in advertisements of distilled spirits distilled from gluten-containing grains, subject to the conditions set forth in the ruling. The ruling does not change TTB’s policy with regard to malt beverages fermented from gluten-containing grains.
A. Products that Meet the FDA Regulatory Definition of “Gluten-Free”
TTB continues to permit the term “gluten-free” on labels and in advertisements for alcohol beverages produced without gluten-containing grains or other ingredients containing gluten, provided the industry member takes appropriate measures to ensure that its raw materials, ingredients, production facilities, storage materials, and finished products were not subject to cross-contact with gluten.
In light of FDA’s findings pertaining to distilled products, TTB is revising its policy on “gluten-free” claims for distilled spirits distilled from gluten-containing grains. Because distillation removes protein if good manufacturing practices are followed, and because it is possible to verify the absence of protein or protein fragments (and thus gluten) in these products using scientifically valid analytical methods, TTB will permit “gluten-free” claims on distilled spirits products distilled from gluten-containing grains as long as good manufacturing practices are followed that prevent the introduction of any gluten-containing material into the final product. If a distilled spirits product is comprised of a distillate distilled from gluten-containing grains and of one or more protein-containing ingredients added after distillation, the finished product label may bear a “gluten-free” claim if the manufacturer is prepared to substantiate, upon request, the absence of protein in the distillate, the absence of gluten in the added ingredients, and the precautions taken to prevent cross-contact, including from storage materials that may contain gluten.
B. Products that Do Not Meet the FDA Regulatory Definition of “Gluten-Free”
For products that do not meet the above definition of “gluten-free” (such as malt beverages fermented from ingredients that are gluten-containing grains), TTB will continue to permit industry members to state that a product is “[Processed or Treated or Crafted] to remove gluten” under its FAA Act authority as described in TTB Ruling 2014–2 and as restated below. We note that FDA’s August 2020 final rule explicitly states that beer manufacturers whose products are subject to FDA’s labeling requirements and do not meet FDA’s “gluten-free” definition are not precluded from using other statements on the label, such as the “[Processed or Treated or Crafted] to remove gluten” statement previously described in TTB Ruling 2014–2, if they are truthful and not misleading in accordance with FDA general labeling requirements. Because this ruling allows for “gluten-free” claims on labels of distilled spirits distilled from gluten-containing grains as described above, there is no longer any need to specifically provide for the use of the “[Processed or Treated or Crafted] to remove gluten” statement for new labels of distilled spirits distilled from gluten-containing grains. If an industry member wishes to use any gluten-related statements (other than a claim that the product is “gluten-free” in accordance with the policy set forth in this ruling), TTB would evaluate such statements on a case-by-case basis to determine if they are truthful and non-misleading.
TTB will not approve a label containing the statement that a product is “[Processed or Treated or Crafted] to remove gluten” unless the label application contains a detailed description of the method used to remove gluten from the product. TTB Ruling 2014–2 also required the submission of the results of an appropriate gluten assay for the finished product. The ruling noted that because there are not yet scientifically valid assays that can accurately quantify the gluten content of fermented products, TTB would use these results for the limited purpose of determining whether there was any change in the amount of gluten detected in the product and the direction and magnitude of that change, but not for the purpose of quantifying the amount of gluten in the finished product. TTB also clarified that this requirement did not imply that any results from an assay used for this limited purpose could be used to support a “gluten-free” claim. Based on TTB’s experience evaluating the gluten removal methodology submitted with the label applications since issuing Ruling 2014–2, TTB is no longer requiring such results to be submitted, except upon request.
It remains TTB’s policy that any other explicit or implicit claims about gluten content are prohibited if they are untrue in any particular or tend to create a misleading impression. TTB will evaluate such statements on a case-by-case basis, and may require a disclaimer or some other qualifying statement to dispel any misleading impression created by any health-related statements. See 27 CFR 4.39(h), 4.64(i), 5.42(b)(8), 5.65(d), 7.29(e), and 7.54(e).
TTB continues to agree with FDA that there is currently no scientifically valid method to quantify the amount of gluten in fermented or hydrolyzed foods in terms of equivalent amounts of intact gluten protein. Accordingly, it remains TTB’s policy that, pending the establishment of such a method, labels or advertisements are misleading if they state or imply, without an appropriate basis or the necessary qualifications, a specific level of gluten in the finished product (such as “contains x ppm”) or that a gluten testing methodology used for fermented products is scientifically valid and can accurately measure the specific level of gluten in the finished product. TTB continues to encourage industry members to facilitate the development of the necessary methods and reference standards to meet the needs for quantitative analysis of gluten in fermented foods. TTB will provide guidance to industry members interested in pursuing development and validation of such methods, where appropriate.
Industry members are reminded that statements, symbols, vignettes, or other forms of labeling or advertising claims that expressly, or by implication, characterize the relationship of the product, or any substance within the product, to a disease or health-related condition (such as celiac disease) are prohibited unless such statements comply with the requirements for specific health claims as set forth in the TTB regulations. See 27 CFR 4.39(h)(2)(ii), 4.64(i)(2)(ii), 5.42(b)(8)(ii)(B), 5.65(d)(2)(ii), 7.29(e)(2)(ii), and 7.54(e)(2)(ii).
V. TTB Determination
Held, the term “gluten-free” or any other explicit or implicit claim that the product contains no gluten (such as “no gluten,” “free of gluten,” or “without gluten”) may be used in the labeling and advertising of any wine, distilled spirits, or malt beverages where the product would be entitled to make a “gluten-free” labeling claim under the standards set forth in the FDA regulations at 21 CFR 101.91(a)(3).
Held further, TTB will consider the use of the term “gluten-free” or any other explicit or implicit claim that the product contains no gluten (such as “no gluten,” “free of gluten,” or “without gluten”) to be misleading when used in the labeling or advertising of alcohol beverages if the alcohol beverage would not be entitled to make a “gluten-free” labeling claim under the standards set forth in the FDA regulations at 21 CFR 101.91(a)(3).
Held further, the types of products for which a “gluten-free” labeling or advertising claim may be made include products produced without any ingredients that contain gluten (such as wines fermented from grapes or spirits distilled from potatoes) as well as distilled spirits distilled from gluten-containing grains if good manufacturing practices are followed that prevent the introduction of any gluten-containing material into the final product.
Held further, industry members are responsible for ensuring that any “gluten-free” claim is truthful and accurate and should be prepared to substantiate such claims upon request, including by verifying that the producer has taken appropriate measures to ensure that its raw materials, ingredients, production facilities, storage materials, and finished products are not subject to cross-contact with gluten. Any industry member making a “gluten-free” claim on a label or in an advertisement to describe a product that is comprised of a distillate distilled from gluten-containing grains and of other protein-containing ingredients should be prepared to substantiate, upon request, the absence of protein in the distillate and the absence of gluten in any added ingredients, and to verify that the producer has taken appropriate measures to ensure that the product or its ingredients is not subject to cross-contact with gluten after distillation.
Held further, labels or advertisements that make statements, without an appropriate basis or necessary qualification, about the specific level of gluten in a fermented finished product (such as “contains x ppm”), or about the validity of gluten testing methodologies for fermented products, will be considered misleading pending the establishment of a scientifically valid analytical method of measuring gluten levels in such products.
Held further, labels and advertisements may include truthful and accurate statements that the product was “[Processed or Treated or Crafted] to remove gluten” for products that were fermented from one or more ingredients that are, or are derived from, a gluten-containing grain, where the product is then processed or treated or crafted to remove some or all of the gluten, under the following conditions:
(1) The following qualifying statement must also appear legibly and conspicuously on the label or in the advertisement as part of (i.e., immediately adjacent to or as a continuation of) the above statement:
“Product fermented from grains containing gluten and [processed or treated or crafted] to remove gluten. The gluten content of this product cannot be verified, and this product may contain gluten.”
(2) The industry member must submit, along with the application for label approval, a detailed description of the method used to remove gluten from the product. Industry members must also be prepared to substantiate advertising claims with the same information, upon request. TTB expects industry members to be able to verify, upon request, that any product labeled or advertised using the above claim was not subject to cross-contact with gluten after it was processed or treated or crafted to remove gluten.
Held further, a distilled spirits label for which an industry member has already obtained a certificate of label approval (COLA) may be revised to replace a “[Processed or Treated or Crafted] to remove gluten” statement with a “gluten-free” statement, provided the product is entitled to such a claim under the guidance contained in this ruling and the industry member is prepared to substantiate the claim upon request. The submission of a new COLA application is not necessary to make such a revision.
Held further, statements, symbols, vignettes, or other forms of labeling or advertising claims that expressly, or by implication, characterize the relationship of the product, or any substance within the product, to a disease or health-related condition (such as celiac disease) are prohibited unless such statements comply with the requirements for specific health claims as set forth in the TTB regulations. See 27 CFR 4.39(h)(2)(ii), 4.64(i)(2)(ii), 5.42(b)(8)(ii)(B), 5.65(d)(2)(ii), 7.29(e)(2)(ii), and 7.54(e)(2)(ii).
Held further, the use of any other explicit or implicit claims about the gluten content of the product is prohibited if such statements are untrue in any particular or tend to create a misleading impression. TTB will evaluate such statements on a case-by-case basis, and may require a disclaimer or some other qualifying statement to dispel any misleading impression created by any health-related statements. See 27 CFR 4.39(h), 4.64(i), 5.42(b)(8), 5.65(d), 7.29(e), and 7.54(e).
Industry members are responsible for verifying the accuracy of any gluten claim on labels and in advertisements. TTB may request samples to be submitted for laboratory analysis, if necessary, to evaluate a label or advertising claim.
Mary G. Ryan
Administrator
Alcohol and Tobacco Tax and Trade Bureau
1 As described in Section IV.B. below, this testing requirement no longer applies upon issuance of this ruling.
2 Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods, 85 FR 49240 (Aug. 13, 2020).
3 Paragraph (c) of 21 CFR 101.91 contains FDA’s provisions for verifying compliance when different types of foods, including those that are fermented or distilled, are labeled as “gluten-free.”