On April 15, three representatives from an Oregon-based beer company called the Craft Brew Alliance and a lobbyist from the Patton Boggs firm met with two White House officials to push their case.
The Craft Brew Alliance is the only major brewery to use a method that removes gluten from finished beer, which it does for its Omission Beer, instead of starting with grains that don't contain gluten. Company executives wanted to make sure their method, which is newer but boasts a more traditional beer taste, could use the "gluten-free" label.
"For reasons that are really not at all explained in the rulemaking, FDA proposed to say if you start with a prohibited grain … you can't under any circumstances have a gluten-free end result," said Stuart Pape, the Patton Boggs partner who attended the meeting at the White House's Office of Management and Budget. "You can start with barley and process the barley to make another ingredient and then go on, but you can't take barley, brew the beer and then process the food."
The company claims that foreign companies recognize its method of removing gluten from beer, and American regulators should too. "We just want commonsense regulations that align FDA with the global market," said Mary Rait, Craft Brew Alliance's regulatory specialist.
"The ironic thing is we're selling in Canada and Europe now as gluten-free and we really want our gluten-free consumers [in the United States] to have the same opportunity," said Craft Beer Alliance chief executive Terry Michaelson.
Gluten-free products are popular among individuals with celiac disease, a condition that causes gluten to trigger an immune reaction and can result in pain and diarrhea. The disease affects at least 3 million Americans, according to the Children's Hospital and Research Center Oakland.
"We wanted the taste profile and the experience to be something that really matches up with what non-celiacs experience, and this was the only way to kind of deliver that flavor," said Michaelson, who noted that some gluten-free beers can have an untraditional taste.
Michaelson, who has celiac disease, added that scientific methods of gluten detection have advanced to accurately detect the amount of gluten removed by the process.
The company also makes the Kona, Widmer Brothers and Redhook beer brands.
In May, 2012, the Alcohol and Tobacco Tax and Trade Bureau, an arm of the Treasury Department, announced in an interim rule that "it would be inherently misleading for products produced from grains containing gluten or their derivatives to make a 'gluten-free' claim or a claim of specific gluten content levels," since the FDA does not recognize a scientific method to test a fermented beverage's gluten content.
The agency asserted instead that beer producers could use the label “Processed or Treated or Crafted to remove gluten."
The FDA's proposed rule has been labeled "economically significant," which means it is predicted to impact the economy by at least $100 million.