By: T. Daniel Logan
On October 13, 2020, the Alcohol and Tobacco Tax and Trade Bureau (TTB) issued an updated ruling entitled “Gluten Content Statements in the Labeling and Advertising of Wine, Distilled Spirits, and Malt Beverages.” TTB 2020-2. This ruling follows on the August 2020 finalization of the Food and Drug Administration (FDA) rule which sets forth the requirements for making “gluten-free” claims for food products.[1] Generally, TTB regulations prohibit the use of false or misleading “health-related statements” in the labeling and advertising of wine, distilled spirits, and malt beverages.[2] Per the ruling, TTB considers claims about gluten content to be “health related statements.”
TTB’s updated ruling largely tracks the FDA rule, with particular focus on fermented, hydrolyzed, and distilled products. Specifically, the ruling provides the guidelines for making claims related to gluten, as set forth below.
- “Gluten-free” and similar claims may be used on labels of TTB-regulated alcohol products if such products could otherwise make a claim under FDA’s regulations at 21 CFR 101.91.
- TTB places the onus on industry members to ensure that any “gluten-free” claim is truthful and not misleading. Entities must be prepared to provide substantiating evidence on request.
- Producers of distilled spirits making a gluten-free claim for a product distilled from gluten-containing grains and “other protein-containing ingredients” must be prepared to demonstrate the absence of protein in the distillate, the absence of gluten in any added ingredients, and measures sufficient to prevent the product or any ingredients from any cross-contact with gluten following distillation.
- TTB will consider any claims about the specific level of gluten, such as “contains 5 ppm,” in a fermented product (including beer and wine) as misleading unless appropriately qualified, until FDA or TTB specifies a scientifically valid analytical method for gluten determinations in such products. To date, neither FDA nor TTB have stated such a method exists.
- Companies may continue to use claims that fermented products were “[Processed/Treated/Crafted] to remove gluten,” where such products were fermented from one or more ingredients that are gluten-containing grains or derived therefrom and subsequently processed to remove some or all gluten. In order to make such claim: 1) the industry member must submit a description of the method used to remove gluten along with an application for label approval; and 2) any labeling and advertising bearing such a claim must conspicuously bear the following qualifying 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.”
- Distilled spirits bearing an approved “[Processed/Treated/Crafted] to remove gluten” claim may now bear a “gluten-free” claim without a new Certificate of Label Approval (COLA) application, 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.
- Any 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.[3]
[1] Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods, 85 Fed. Reg. 49240 (Aug. 13, 2020).
[2] 27 C.F.R. §§ 4.39(h), 4.64(i), 5.42(b)(8), 5.65(d), 7.29(e), 7.54(e).
[3] See 27 C.F.R. §§ 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), 7.54(e)(2)(ii).