On February 11, 2014, TTB released a Revised Interim Policy on Gluten Content Statements in the Labeling and Advertising of Wine, Distilled Spirits, and Malt Beverages (the 2014 Interim Policy). The 2014 Policy updates the 2012 Interim Policy in the wake of FDA’s final rule on the use of the term “gluten-free” for products under their labeling jurisdiction. (Note: FDA has labeling jurisdiction over certain alcoholic beverages, including certain beers that are not sake, certain malt beverages and wine with less than 7% ABV.) TTB issued the 2014 Policy in order to parallel FDA’s requirements and reduce confusion for consumers. Ultimately, as it pertains to beverages, nothing much has changed, and confusion remains.
For FDA and TTB, items can still be labeled “gluten-free” if they do not contain an ingredient that is a gluten-containing grain or inherently does not contain gluten (i.e. wine and vodka distilled from ingredients that do not contain gluten). TTB requires anyone making such claims in an advertisement or on a label to be responsible for verifying that the producer has taken proper measures to avoid cross-contamination, and they should be prepared to substantiate such claims.
Things get trickier when trying to use a “gluten-free” label with a food or beverage that was made with a gluten-containing ingredient and processed to remove the gluten. According to FDA, such items may be entitled to a “gluten-free” designation if the gluten-containing ingredient itself, and not the finished product, was treated to remove gluten such that 20 parts per million or less of gluten remains. However, “gluten-free” is not appropriate where the finished product has been processed. TTB does not anticipate this distinction to matter for malt beverages or distilled spirits made with gluten-containing grains, as the finished product is treated to remove the gluten. Problematically, FDA admits that there is still no scientifically valid way to determine the gluten content in fermented and hydrolyzed foods (including beer), and they are going to issue a proposed rule to address the “gluten-free” labeling of beers subject to its labeling requirements given this quandary. In the interim, FDA will exercise enforcement discretion with respect to FDA-regulated beer.
Therefore, beverage manufacturers seeking to alert consumers to the fact that their finished product has been processed to remove gluten may not use a “gluten-free” designation. However, TTB will approve statements about gluten they conclude are not misleading, which will be evaluated on a case by case basis and may require a disclaimer. This language can be wordy, making label compliance burdensome for producers. As with the 2012 Interim Policy, labels can contain “[processed or treated or crafted] to remove gluten” if they have certain qualifying statements and are not likely to mislead consumers. On the other hand, TTB will consider statements such as “contains x ppm gluten” to be misleading given the lack of scientific validity. Despite this fact, they will still require label applications to include a detailed description of the method used to remove gluten and the submission of results of a gluten assay for the finished product only to confirm there was some change in the gluten level. As with the 2012 Policy, anything that characterizes the relationship of the product to a health condition (such as celiac) is prohibited unless in compliance with TTB regulations.
When FDA issues further guidance or a final rule with respect to gluten-free statements on foods that contain fermented ingredients, TTB will evaluate again whether its own policy should be revised.