As many know, on August 5, 2013, FDA issued a final rule regarding the labeling of gluten-free foods. See 78 FR 47178, Food Labeling; Gluten-Free Labeling of Foods. As noted by On Reserve previously, TTB announced on August 22, 2013 that the agency would review its policy on the use of the term “gluten-free” on alcohol beverage labels and advertising that are regulated by TTB. See TTB to Review its Policy on the Term “Gluten-Free” for Alcohol Beverage Labeling. While FDA’s final rule does, in fact, define the term “gluten-free,” the finalized definition only applies to food products that fall within the labeling jurisdiction of the FDA. On its Questions and Answers page, FDA specifically noted that the final rule does not apply to food and beverage products regulated by the United States Department of Agriculture (“USDA”) and the TTB. The agency clarified that, “USDA regulates the labeling of meats, poultry, and certain egg products (FDA regulates the labeling of shell eggs). TTB regulates the labeling of most alcoholic beverages, including all distilled spirits, wines that contain 7 percent or more alcohol by volume, and malted beverages that are made with both malted barley and hops.” Questions and Answers: Gluten-Free Food Labeling Final Rule. FDA’s final rule on gluten-free allows a food product to be labeled as free from gluten unless the product contains any of the following:
- An ingredient that is a gluten-containing grain (e.g., wheat, rye, barley, or cross-bred hybrid of these grains);
- An ingredient that derives from a gluten-containing grain but has not been processed to remove gluten (e.g., wheat flour); or
- An ingredient that derives from a gluten-containing grain but where the ingredient been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in 20 parts per million (ppm) or more gluten in the food. 21 C.F.R. 101.91(a)(3), 78 FR 47178.
Effectively, a food can bare a gluten-free claim on the label if that food product is inherently free of gluten or if the presence of a gluten-containing ingredient in the food product is processed to contain less than 20 ppm. If the food label contains a gluten-free claim but does not meet the aforementioned standards, the FDA would consider the food to be misbranded. (This standard applies to the claim regardless of whether the claim is “Gluten-Free” or “Free of Gluten,” “No Gluten,” “Without Gluten,” or similar.)
On February 11, 2014, TTB issued a revised interim policy on gluten content statements on the labels of wine, spirits, and malt beverages that fall within TTB’s labeling and advertising jurisdiction. See Ruling 2014-2 Revised Interim Policy on Gluten Content Statements in the Labeling and Advertising of Wine, Distilled Spirits, and Malt Beverages. In TTB’s interim policy for gluten-free labeling, the Agency concluded that the term “gluten-free” may be used on TTB-regulated beverages for labeling and advertising if the product meets the standards determined by the new FDA regulation for gluten-free at 21 C.F.R. 101.91. The Agency goes on to clarify this by reasserting its prior determination in Ruling 2012-2 that products that inherently do not contain gluten, such as wine fermented from grapes and do not include any gluten-containing ingredients, may continue to use gluten-free claims on their labels and advertisements. TTB noted that “this revision only clarifies the standards for these products and should not require any changes to TTB-approved labels for wines and distilled spirits that are made from ingredients that do not contain gluten and currently are labeled or advertised as ‘gluten-free.’” Revised Interim Policy on Gluten Content Statements in the Labeling and Advertising of Wine, Distilled Spirits, and Malt Beverages.
TTB recognized FDA’s allowance of gluten-free claims on food products where gluten-containing ingredients (i.e., not the food) are processed to removed gluten and the use of the ingredient in the food does not result in 20 ppm or more of gluten in the food. In its interim policy, TTB asserted that it generally does not believe this standard will be relevant to malted beverages fermented from malted barley or other gluten-containing grains or to distilled spirits distilled from gluten-containing grains because “these products are usually made from the grains themselves, not from ingredients such as wheat starch or barley starch.” Id. The difference here, from TTB’s point of view, is to claim gluten-free, the product must contain ingredients that derive from a gluten-containing grain and were processed to remove gluten, not where the product derives from the actual gluten-containing grains themselves.
TTB further rules in its interim policy that foods containing a gluten-containing grain, such as wheat, rye, barley, or a cross-bred hybrid of those grains, are disqualified from containing a gluten-free claim, regardless of the amount of gluten in the finished product. Id. “TTB will continue to consider ‘gluten-free’ label claims for TTB-regulated alcohol beverages made from gluten-containing grains to be misleading.” Id. Moreover, TTB noted that because of FDA’s determination that there is no scientifically valid way to evaluate claims that a beer made from gluten-containing grains can be processed in a way to remove gluten, and there is no current method to determine if such evidence is valid or effective, TTB maintains its position that it would be misleading for such products to claim “gluten-free” on their labels or advertisements. “Accordingly, consistent with FDA’s decision to maintain the status quo for the labeling of beers subject to its regulations pending further rulemaking, TTB has decided that . . . TTB will also maintain its current policy . . . with regard to alcohol beverages made from gluten-containing grains.” Id. The Agency will continue to allow products made from gluten-containing grains to bear claims such that the product was “Processed” or “Treated” or “Crafted” to remove gluten, along with an appropriate qualifying statement as spelled out in Ruling 2012-2, but such products cannot bear a gluten-free claim. See Ruling 2012-2, Interim Policy on Gluten Content Statements in the Labeling and Advertising of Wines, Distilled Spirits, and Malt Beverages. (The qualifying statement noted in 2012-2 informs consumers that: (1) the product was fermented or distilled from a gluten-containing grain; (2) the exact gluten content of the product cannot be confirmed; and (3) the product may contain gluten.)
In its 2012-2 ruling, TTB noted that some of the alcohol beverages that fall within its labeling jurisdiction generally do not contain gluten if manufactured under good manufacturing processes (e.g., wine fermented from grapes or vodka distilled from potatoes) and reminded industry members that the bottler or importer was responsible for ensuring the accuracy and truthfulness of a gluten-free claim. In the 2012-2 ruling, brewers also asked TTB to consider allowing “gluten-free” claims on beverage products (e.g., malt beverages fermented from malted barley and other gluten-containing grains) that were crafted, processed, or treated to remove gluten if the product contained low amounts of gluten (e.g., 10 ppm). In its prior ruling, TTB determined in that it would be misleading to state “gluten-free” on products produced using wheat, barley, rye, or a cross-bred hybrid of gluten-containing grains, but would allow the label to claim that the product was “[Processed or Treated or Crafted] to remove gluten,” along with an appropriate qualifying statement. In its 2014-2 ruling, TTB noted that it will continue to allow such claims (i.e., Processed, Treated, or Crafted with an appropriate qualifying statement) pending any subsequent rulemaking on behalf of the FDA.
In this new policy, TTB noted that:
Although TTB labeling regulations for alcohol beverages are not always identical to FDA labeling regulations for foods, given the important consumer health considerations relating to “gluten-free” claims, TTB believes that it is important to adopt an approach on this issue that is as consistent as possible with the regulations issued by FDA, while taking into consideration the differences in the statutes administered by TTB and FDA, respectively. Ruling 2014-2 Revised Interim Policy on Gluten Content Statements in the Labeling and Advertising of Wine, Distilled Spirits, and Malt Beverages
This is an important consideration given the consumer reliance on the term “gluten-free” on food products. For a claim like gluten-free, it is greatly important for there to be a particular level of congruence between agencies in determining and agreeing to a definition, especially given the use of the term on a wide variety of food and beverage products that fall into the labeling jurisdiction of multiple agencies. TTB’s declaration is also another demonstration of the workmanship between agencies, particularly TTB and FDA, especially with respect to food and beverage products.