Labeling Your Beverages – “Gluten-free”

The TTB has recently weighed in with an interim policy on how brewers, distillers and vintners can advertise the “gluten-free” beverages they produce.  Interestingly, TTB Ruling 2012-2 takes into account both the federal regulations governing gluten-free advertising that are currently being considered by the FDA and the scientific uncertainty that currently plagues the ability to regulate and determine the exact gluten-free nature of a product.  The lack of a full determination by the FDA and the TTB’s concurrence that at present, a scientific test that has been peer reviewed and approved for gluten-content testing, were considerations in offering this interim guidance.

These issues are particularly of interest to those of you seeking to produce or advertise gluten-free products marketed to those suffering from celiac disease or consumers participating in gluten-free diets.

For now, the TTB is provisionally stating that products seeking to advertise the gluten-free nature of their products must follow some strict procedures and labeling guidelines:

[A]ny industry member making a “gluten-free” claim on a label or in an advertisement to describe a product that is not made with wheat, barley, rye, or a crossbred hybrid of these grains, or any ingredient derived from these grains, is responsible for verifying that the producer has used good manufacturing practices to ensure that its raw materials, ingredients, production facilities, storage materials, and finished products are not cross-contaminated 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 may request samples to be submitted to TTB’s Beverage Alcohol Laboratory to analyze the finished product.

[L]abels and advertisements may include truthful and accurate statements that a product was “[Processed or Treated or Crafted] to remove gluten” for products that were produced from wheat, barley, rye, or a crossbred hybrid of these grains, or any ingredient derived from these grains, and then processed or treated or crafted to remove some or all of the gluten under the following conditions:

(1) 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.”

OR,

• “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.”

(2) TTB will not approve labels containing the above claims unless the label application contains a detailed description of the method used to remove gluten from the product and R5 Mendez Competitive ELISA assay results for the finished product showing a response of less than 20 ppm gluten (and the name and manufacturer of the assay). Industry members should also be prepared to substantiate advertising claims with the same information, upon request.

Industry members are responsible for verifying the accuracy of any gluten claim on labels and in advertisements. TTB may request the submission of samples of the finished product to the Beverage Alcohol Laboratory to verify any claim and test results.

The TTB expounds on the statement of purpose behind these interim regulations and a detailed description of what is required to achieve label approval in the regulation.  Given that those suffering from celiac disease have been estimated at 1% of the U.S. population and that there are plenty of individuals on gluten-free diets who may otherwise want to consume alcohol, this guidance is welcomed, but strict compliance may be more of a pain while the industry awaits final determination on the issue.