February 2017 Update: A peer-reviewed study published in the Journal of AOAC International indicates that gluten-reduced beer may not be safe for people with celiac disease. Article on study | Journal publication
Analysis of the Gluten-Free Labeling Rule
By Jennifer Iscol
The Food and Drug Administration’s gluten-free labeling rule, announced August 2, 2013, was written to clear up confusion about which products are gluten-free by establishing a federal standard, but it appears that there will be a period of adjustment for both consumers and the food industry as the full implications of the rule are analyzed and absorbed.
Almost immediately after the rule was announced, the gluten-free labeling status of Omission beer, produced by Craft Brew Alliance in Oregon, became a source of confusion.
The FDA’s rule will impact the TTB’s approach
Under the new rule, products that are regulated by the FDA and labeled gluten-free must contain less than 20 parts per million (ppm) of gluten. The FDA’s rule also will have an impact on products regulated by the USDA and the U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB), which will work with the FDA to harmonize their approach.
Like other beers made with barley, Omission is regulated by the TTB, not the FDA. In accordance with an interim TTB policy statement issued last year, Omission beer cannot be labeled gluten-free at this time, and the FDA ruling does not change that.
However, because government departments plan to coordinate their approach to gluten-free labeling, the FDA’s new rule will affect Omission’s future chances for gluten-free labeling under the TTB. In addition, the FDA plans to propose a separate rule at a later date that will regulate fermented and hydrolyzed products, and that rule also is expected to have an impact on TTB’s approach.
Setback for Craft Brew Alliance
The FDA denied a request by Craft Brew Alliance to revise the definition of gluten-free to accommodate products processed in the way that Omission beer is made, which involves using gluten-containing ingredients, producing the product, and then removing the gluten.
In its guidance on the rule in the Federal Register, the FDA also rejected Craft Brew Alliance’s use of a new test to back the claim that Omission beer is gluten-free, stating that the method, known as the R5 competitive ELISA, is not “scientifically valid” for analyzing the gluten content of fermented foods for the purpose of determining compliance with the rule.
The rule is a setback for Craft Brew Alliance, which is the ninth largest brewer in the country and 32% owned by Anheuser-Busch. But the company is continuing a public relations effort to persuade gluten-free consumers that Omission beer is safe to drink.
Press release leads to confusion
In a press release issued immediately after news of the FDA announcement broke on August 2nd, Terry Michaelson, CEO of Craft Brew Alliance, stated, “At Omission Beer, we applaud the FDA for bringing U.S. rules in alignment with the global standard for gluten-free. Our beer tests well below the 20 ppm standard.” The press release described the scientific validation of the R5 competitive ELISA, the test that Omission uses to determine its gluten content.
The press release does not explain that Omission’s labeling status is unchanged by the new rule, nor does it acknowledge that the FDA turned down the two key requests that would have helped pave the way to label Omission beer gluten-free: (1) the request to revise the definition of gluten-free to allow products made with gluten-containing ingredients when the gluten is later removed, and (2) to accept the R5 competitive ELISA for the purpose of testing whether gluten-free beer complies with the rule.
Apparently misinterpreting the press release, some online media outlets erroneously trumpeted the news that Omission can now be labeled gluten-free. Food Republic wrote, “[thanks] to a new ruling this past Friday, Omission is allowed to label their products as gluten-free because they contain less than 20 parts per million of gluten.” Within hours, syndication of the Food Republic article had spread the news to other websites and social media platforms. First We Feast described how the FDA rule gave Omission “the gluten-free stamp of approval.”
Questions about the safety of Omission beer
The production of Omission beer is unusual; it is made with gluten-containing ingredients and then treated with an enzyme that Omission claims renders it safe for people on a gluten-free diet. Craft Brew Alliance acknowledges that fragments of gluten remain in Omission after processing, but insists that the fragments are too small to be toxic.
After brewing, Craft Brew Alliance tests the gluten content of every batch of Omission with the R5 competitive ELISA and posts the results on its website. Consumers can check the test results of the bottle of Omission in their hand by entering the code on its label onto the website and viewing the original lab report for that batch.
However, some experts state that the R5 competitive ELISA is not an appropriate test for Omission beer and that its results cannot indicate whether the product is safe for people with celiac disease. In guidance on the new labeling rule, the FDA agreed, stating,” [W]e do not consider [competitive ELISA-based] methods scientifically valid for the purposes of analyzing fermented or hydrolyzed foods to determine compliance with this rule…”
According to Stephen Taylor, Ph.D., co-director of the Food Allergy Research and Resource Program at the University of Nebraska, while R5 ELISAs are well accepted for testing the gluten content of most foods, they can only detect intact proteins. The process that Craft Brew Alliance uses to remove the gluten from Omission beer breaks down the gluten proteins into fragments. “The enzyme that they use in this process defeats the R5 competitive ELISA test,” explained Dr. Taylor.
Omission beer “may still contain pieces of gluten that are large enough to be hazardous to celiacs. No one knows for sure,” stated Dr. Taylor. Gluten is a protein composed of chains of amino acids called peptides. Dr. Taylor maintained that key safety questions remain: for example, whether all toxic peptides are detected by the R5 and whether all toxic peptides have been identified. Dr. Taylor emphasized that he is not certain that Omission beer is unsafe for celiacs, but rather that he is unsure that it is safe.
Alessio Fasano, MD, director of the Center for Celiac Research and Treatment at MassGeneral Hospital for Children, agrees with Dr. Taylor that negative results on the R5 competitive ELISA do not prove Omission beer’s safety for people with celiac disease. Dr. Fasano noted that “the purpose of the R5 ELISA is to test for cross contamination with naturally occurring gluten, not gluten that is artificially manipulated or degraded by an enzyme.”
Omission beer must follow TTB policy
Spurred by the popularity of alcoholic beverages developed for the gluten-free market, the TTB issued its 2012 interim policy statement that does not allow a “gluten-free” claim on the label of alcoholic beverages made from gluten ingredients. The TTB does allow such beverages to be labeled as “[Processed or Treated or Crafted] to remove gluten,” as long as they also include a qualifying statement.
The required qualifying statement must inform consumers that: (1) the product was made from a grain that contains gluten; (2) there is currently no valid test to verify the gluten content of fermented products; and (3) the finished product may contain gluten.
Until the FDA works with the TTB to harmonize their respective labeling requirements, and TTB issues new guidance, the TTB interim policy is still in effect and governs the labeling of Omission beer.
Safety disclaimer virtually absent in social media marketing
Craft Brew Alliance appears to follow TTB policy in labeling Omission beer, but in social media the company seems to send a conflicting message: that Omission beer is scientifically proven to be safe for people with celiac disease.
On its website and in its Facebook and Twitter campaigns, Craft Brew Alliance encourages consumers to check the lab results of their bottle of Omission beer, and frequently refers to the company’s “transparency” in posting the test results of every batch, tweeting: “We’re the only US food/beverage company that makes #gluten test results for all batches available/searchable for consumers.”
One Twitter user asked the company last summer, “Is it safe for celiacs?” Omission tweeted in reply: “[Our] CEO and brewmaster’s wife are celiac,” and referred the consumer to their promotional video and test results. The video, posted on Omission’s website, describes the beer as one that “everyone can enjoy,” and explains that the beer is not shipped out until independent lab test results come back showing that it contains less than 20 parts per million gluten.
According to the TTB ruling, the required qualifying statement must appear “legibly and conspicuously” on the label and in advertisements. The Omission promotional video includes the qualifying statement in small type at the bottom of the final frame: “Product fermented from grains containing gluten and crafted to remove gluten. The gluten content of this product cannot be verified, and this product may contain gluten.”
The qualifying statement does not appear in the company’s August 2nd press release. On its Facebook page on August 2nd, the day the FDA ruling was released, Omission posted, “Let’s raise a glass to the U.S. Food and Drug Administration and all of you for the new US standard on Gluten Free labeling!” There was no reference to the fact that Omission beer still cannot be labeled gluten-free, and, five days later, the brand had not corrected comments on the post like this one, “Woo-hoo! My favorite beer is now officially gluten free!!!!!”
Is it the label or the media message that’s getting through?
With the FDA’s new rule defining “gluten-free” in a way that appears to exclude products like Omission beer, and the method that Craft Brew Alliance uses to test Omission’s gluten content not accepted for this purpose by the FDA, the company may face new hurdles in its goal to label Omission as gluten-free.
In its well-distributed social media message that Omission beer is safe for gluten-free consumers, however, the brand’s actual labeling seems to fade into the background behind the impact of its public relations strategy.
What is a consumer to make of this regulatory push and pull? The FDA is encouraging companies to come into compliance with the new definition of gluten-free as soon as possible, but gives them until August 2014 to do so. The confusion over Omission beer’s labeling status may be the first of other instances that will require some clarification or adjustment over the next year as the full ramifications of the new rule, and subsequent related rules or guidance, are understood and put into practice. Until then, gluten-free buyers beware.
More resources: FDA gluten-free labeling rule
Jennifer Iscol is president of the Celiac Community Foundation of Northern California