TTB issued an extensive ruling last week that provides guidance to industry members seeking to label their products with statements about gluten-content. TTB Ruling 2012-2, available here, serves as in interim policy on the gluten-related labeling claims, until such time as the FDA, which governs labeling for all food items, and TTB finalize rules on the subject. As consumer demand for all types of gluten-free foods and beverages has risen over the last several years, proper labeling of those products has been a difficult issue for both the FDA and TTB. At its core, the problem is that testing for gluten-content remains imprecise. As a result, laws and regulations that permit labeling products as “gluten-free” or claiming a certain amount of gluten content have been slow to develop, and TTB’s practice has been to reject label applications that include gluten-based claims. TTB’s interim policy provides a means for industry members to include some gluten-related labeling information on their labels, and will likely result in the approval of more labels that claim to be gluten-free or low in gluten.

The FDA, and by extension TTB, has struggled with a definition for “gluten-free” for nearly a decade. The FDA was first tasked with issuing a rule to define “gluten-free” with the passage of the Food Allergen Labeling and Consumer Protection Act of 2004. The FDA then issued a notice of proposed rulemaking in 2007, proposing to define the term “gluten-free.” The proposed definition included that the item have no more than 20 parts gluten per million. The FDA has still not issued a final rule, and in 2011 recognized that for some food types, including fermented foods, there are no validated methods to determine if the product contains less than 20 parts gluten per million. Throughout the FDA’s process, TTB has deferred making its own rules related to gluten. The interim policy is TTB’s first effort to address the issue.

TTB regulates alcohol labeling and advertising through the Federal Alcohol Administration Act “FAA Act” and its regulations at 27 CFR parts 4, 5, and 7. At issue are regulations that: a) prohibit the use of labeling or advertising statements that are false or untrue in any particular, b) prohibit, irrespective of falsity, statements that directly, or by ambiguity, omission or inference, or by the addition of irrelevant, scientific or technical matter, tend to create a misleading impression, c) prohibit the use of any health-related statements in the labeling or advertising of wine, distilled spirits, or malt beverages if such statements are untrue in any particular or tend to create a misleading impression.

In its interim policy, TTB agrees with the FDA that “there are no scientifically valid methods for accurately measuring the gluten content of fermented products.” Up until now, this fact and the requirement that TTB prohibit misleading labels and advertising has meant that labels that include gluten-related claims have been rejected. TTB’s new guidelines provide a means for industry members to get labels approved that previously would have been rejected.

The interim policy sets forth two primary rules. First, TTB will allow the term “gluten-free” on the labels of products that are produced without any ingredients that contain gluten. For example, wines produced from grapes or vodka produced from potatoes may include the statement “gluten-free” on their labels or advertising material. No products made from gluten-containing materials may be labeled as “gluten-free.” For those products made from gluten-containing materials, including spirits and malt beverages “produced using wheat, barley, rye, or a crossbred hybrid of these grains,” TTB will allow labels that contain all of the following information: a) a statement that the product is “Processed or Treated or Crafted to remove gluten;” b) a qualifying statement to inform consumers that (i) the product was made from a grain that contains gluten, (ii) there is currently no valid test to verify the gluten content of fermented products, and (iii) the finished product may contain gluten; and c) a detailed description of the method used to remove gluten from the product. Approved statements may not contain any reference to the level of gluten in the product. Additionally, in order to evaluate the method used to remove gluten from the product, TTB will require submission of results of the “R5 Mendez Competitive ELISA assay” for the finished product for the purpose of screening the validity and effectiveness of the method used to remove gluten. Such statements may only be made on labels where the gluten content is less than 20 parts per million.

Despite the strict standard set by the TTB for gluten-related labeling, the new guidance is likely to result in numerous submissions for label-approvals based on the new rules. For additional information on labeling issues, feel free to contact one of the attorneys at Strike Kerr & Johns.

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