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Gluten-Free Brewers Group Responds to FDA Final Rule on Gluten-Free Claims on Fermented Foods

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In August 2020, the federal Food & Drug Administration (FDA) finalized the definition and labeling requirements of gluten-free fermented and hydrolyzed foods (including beer and other alcoholic beverages).  The ruling provides a clear delineation between products that are truly gluten-free and products that are not and how product labels communicate those differences to consumers.  In the case of beer, the distinction is between naturally gluten-free beers and barley-based beers processed in an attempt to reduce the gluten.

On September 23rd the world’s dedicated gluten-free breweries gathered for a 2nd annual conference, held virtually this year due to COVID-19. Holidaily Brewing Company in Golden, Colorado hosted brewery owners, brewers and staff to share ideas and discuss technical brewing techniques specific to gluten-free brewing. A portion of the conference was dedicated to discussion of the FDA ruling, how it should be interpreted and what consumer risks still exist. 

Traditionally, beer is brewed utilizing four main ingredients – grain, water, yeast and hops. While water and hops are gluten-free and yeast can be created and/or propagated gluten-free with general ease, the grain can be a challenge for brewers who aim to brew a truly gluten-free beer. The most common grains found in beer are barley and wheat, both of which contain gluten.

In an attempt to find an easy way to provide a safe product for celiac or gluten-sensitive consumers, breweries have tried “reducing” or “removing” gluten from traditional beers.  In this case, brewers produce beer with gluten-containing ingredients (barley and/or wheat, etc.) and treat the liquid to “remove” gluten with an enzyme. The product must test at 20 ppm of gluten or lower before packaging and even so, labels cannot reflect “gluten-free.” The Alcohol and Tobacco Tax and Trade Bureau (TTB) created a puzzling labeling option for these beers, calling them gluten-removed.

Why did the TTB not allow these beers to be labeled as gluten-free?

Further research was needed due to two concerns – consumer complaints and, well…science. Thirsty, gluten-free beer drinkers trying these “gluten reduced” beers with the promise that they were testing below 20 ppm were having negative gluten reactions.

According to a February 2018 study published in The American Journal of Clinical Nutrition,

“The average inadvertent exposure to gluten by CD individuals on a GFD was estimated to be ∼150–400 (mean) and ∼100–150 (median) mg/d using the stool test and ∼300–400 (mean) and ∼150 (median) mg/d using the urine test. The analyses of the latiglutenase data for CD individuals with moderate to severe symptoms indicate that patients ingested significantly >200 mg/d of gluten.” (Syage, Kelly, Dickason, Ramirez, Leon, Dominguez, Sealey-Voyksner (2018) Determination of gluten consumption in celiac disease patients on a gluten-free diet.  The American Journal of Clinical Nutrition, Vol. 107, Issue 2, February 2018, Pages 201-207)

The study concludes, “these surrogate biomarkers of gluten ingestion indicate that many individuals following a GFD regularly consume sufficient gluten to trigger symptoms and perpetuate intestinal histologic damage.” (Syage et. Al., 2018). The study was provided to the Gluten-Free Brewer’s Group by Tricia Thompson, MS, RD, of GlutenFreeWatchdog.com.

Additionally, there are entire groups and pages on social media with people from all over the world asking why they are getting sick from gluten-removed beers. One particular group on Facebook is actually called “We Got Sick Drinking Gluten-Reduced Beers”. These are the consumers who, when the FDA opened up a call for comments by interested members of the public regarding labeling beer, responded. The cry by consumers was heard.

Michelle Colgrave, Professor of Food & Agriculture at Csiro & Cowan University in Australia conducted a study on fragments of gluten left behind after utilizing the enzyme. Testing with liquid chromatography-mass spectrometry, Colgrave found that hydrolyzed gluten was left behind after the enzyme was added. (Colgrave et al (2017) Liquid chromatography-mass spectrometry analysis reveals hydrolyzed gluten in beers crafted to remove gluten. J. Agric. & Food Chem. 65, 9715)

In other words, when beer is created with gluten containing grains and treated with an enzyme, the gluten protein that was once one large protein is now broken into smaller fragments. What consumers were reporting and studies are now showing is that while the gluten tests available may report the beer is less than 20 ppm, the components left in the liquid continue to make sensitive consumers sick. (Akeroyd et al (2017) Journal of American Society of Brewing Chemists, 74, 91; Allred et al, 2017, Journal of AOAC International, 100, 485) “To utilize the word ‘removed’ is actually quite deceiving. The gluten is still in the beer, it’s just in smaller pieces than before,” says Laura Ukowich, VP of Operations at Holidaily Brewing in Golden, Colorado. “This is why sensitive consumers are still getting sick.” The testing that occurs now has room for improvement. The FDA claims “we know of no scientifically valid analytical method effective in detection and quantifying with precision to the protein content in fermented or hydrolyzed food in terms of equivalent amounts of intact proteins.”

Despite maintaining high standards for quality control as an industry, individual breweries are still prone to mistakes.  According to the results of a 2016 TTB Alcohol Beverage Sampling Program conducted by the federal alcohol regulating body a random selection of 53 malt beverages were tested for adherence labeling compliance regulations. One of the tests checked to see if the alcohol by volume (ABV) of the liquid inside fell within regulatory tolerance (+/- 0.3% ABV) of what was claimed on the label.    29 of the 53 products – 54 % – fell outside of the allowed variance.  (https://www.ttb.gov/images/pdfs/2017-03-01-fy2016-results.pdf)

Ultimately, the final ruling by the FDA is that in order for a beer to be labeled as gluten-free, only gluten-free ingredients must go into the beer.  “A solution to all of this confusion already exists,” Doug Foster of Aurochs Brewing in Pittsburgh, PA discussed. “These dedicated gluten-free breweries address any issues by creating craft beer made out of naturally gluten-free ingredients. It eliminates the need to even worry about gluten-reduced, unsafe products and labeling.”

There are not shortcuts by the members of the Gluten-Free Brewer’s Group. These breweries are dedicated to making safe, quality gluten-free beers for consumers to feel completely safe drinking. If you see the label gluten-free on a beer, know that it was made with gluten-free ingredients. If you are sensitive, be aware that gluten-reduced or gluten-removed may be a risk.

“Just as the only treatment for celiac disease is a completely gluten-free diet, the only truly safe beer products to consume are those that are made with 100% gluten free ingredients,” JP Bierly Founder of Bierly Brewing in McMinnville, Oregon. “Agreed,” said Karen Hertz of Holidaily Brewing  “we are glad there is a difference between the gluten-free and gluten-removed labeling for beers but ultimately there shouldn’t even be a gluten-removed category. It’s either gluten-free or it’s not. We will keep advocating for that as a group.”

About the Gluten-free Brewers Group

Members of the Gluten-Free Brewers Group are passionate about crafting high-quality beer that is accessible to all including those with Celiac Disease and other gluten-related disorders.

There are currently 15 dedicated gluten-free breweries in the United States. Follow along with the hashtag #getbeercurious to learn more about gluten-free beer. Breweries interested in joining the Gluten-free Brewers Group can reach out to Kaitlyn Gipple at kgipple@holidailybrewing.com.