INTERIM POLICY ON GLUTEN CONTENT STATEMENTS IN THE LABELING AND ADVERTISING OF WINE, DISTILLED SPIRITS, AND MALT BEVERAGES
This serves as a reminder of our policy on gluten content statements. Truthful, accurate, and non-misleading gluten content statements, in accordance with TTB Ruling 2014-2, are permitted on labels and in advertisements for alcohol beverage products regulated by TTB.
When FDA issues further guidance or a final rule with regard to gluten-free statements on labels of foods that are fermented or contain fermented ingredients, TTB will evaluate whether the interim policy in TTB Ruling 2014-2 should be revised.
The key points of TTB Ruling 2014-2 are shown below. Please read the full ruling for additional information.
- The term "gluten-free" 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.
- Any industry member making a "gluten-free" claim on a label or in an advertisement to describe a product that is not made with gluten-containing grains, or any ingredient derived from these grains, is expected to verify 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. 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.
- 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 to describe an alcohol beverage that 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.
- Labels or advertisements that state or imply, without an appropriate basis or the necessary qualification, that gluten testing methodologies are scientifically valid or validated for use in fermented products or that gluten testing methodologies can accurately measure the specific level of gluten in a fermented or distilled finished product (such as "contains x ppm") will be considered misleading pending the establishment of a scientifically valid method of measuring gluten levels in such products that appropriately measures the amount of gluten and relates the quantified amounts of fermented material to 20 ppm intact gluten.
- 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 produced using an ingredient that is a gluten-containing grain, or an ingredient that is 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:
- One of the following qualifying statements must also appear legibly and conspicuously on the label or in the advertisement as part 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."
"This product was distilled from grains containing gluten, which removed some or all of the gluten. The gluten content of this product cannot be verified, and this product may contain gluten."
- TTB will not approve labels containing the above claims unless the label application includes a detailed description of the method used to remove gluten from the product and appropriate gluten assay results for the finished product (and the name and manufacturer of the assay). Industry members should also be prepared to substantiate advertising claims with the same information, upon request.
- TTB will approve labels with the statements described above only if TTB concludes, based on the totality of the information submitted, that the statement is truthful, accurate, and not likely to mislead consumers.
- 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).
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).
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