FDA Taking Comments on New Gluten Free Regulation


In an effort to improve the labeling requirements of certain gluten-free products, the U.S. Food and Drug Administration has proposed new rules on the designation for producers of fermented, distilled or hydrolyzed foods, including beer.

The proposed compliance stipulations build on a 2013 ruling that defined the term “gluten-free” for voluntary use in labeling.

The new set of requirements is being considered as an increasing number of breweries are rolling out gluten-free as well as “gluten-reduced” products into the market. The announcement also came on the same day that New Belgium Brewing announced plans to introduce its own gluten-reduced beer offerings.

In a release, the FDA said it intends to establish specific requirements for products that “contain fermented or hydrolyzed ingredients and bear the ‘gluten-free’ claim.”

Proposed requirements, according to the FDA, include:

  • The food (and beer) must meet the requirements of the gluten-free food labeling final rule prior to fermentation or hydrolysis.
  • The manufacturer must adequately evaluate its process for any potential gluten cross-contact.
  • If a potential for gluten cross-contact has been identified, the manufacturer would need to implement measures to prevent the introduction of gluten into the food during the manufacturing process.

It should be noted, however, that the proposed ruling would not force manufacturers to label their gluten-free products as such — it simply adds another layer of evaluation requirements.

Under that ruling, manufacturers could label their products as “gluten-free” if it was “inherently gluten-free” or did NOT contain an ingredient that was itself a gluten-containing grain; derived from a gluten-containing grain that had not been processed to remove gluten; or derived from a gluten-containing grain that had been processed to remove gluten, if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food.

Producers are vying for the attention of nearly 3 million Americans, the FDA estimates, who have Celiac disease. Those individuals, as well as other health-conscious shoppers seeking out these products will spend upwards of $6.6 billion on gluten-free food and beverage products in 2017, according to a report from Packaged Facts.

So, in order to help those individuals more safely purchase packaged items, the FDA currently allows manufacturers to voluntarily label their food and beverage products as “gluten-free.”

But the 2013 ruling didn’t properly address the “uncertainty” of interpreting results of current gluten test methods for fermented and hydrolyzed foods, the agency said.

“Due to this uncertainty, the FDA has issued this proposed rule to provide alternative means for the agency to verify compliance for fermented or hydrolyzed foods labeled ‘gluten-free’ based on records that are made and kept by the manufacturer,” it wrote in a statement.

The FDA is currently accepting public comments on the issue. More details and instructions on how to comment directly can be found on the FDA website.

Gluten Reduced vs. Gluten Free Roils Beer Producers


The 2013 ruling also stated that “any unavoidable presence of gluten in the food must be less than 20 ppm.”

That 20-ppm threshold is significant because many beer producers — including Craft Brew Alliance, Stone Brewing and, most recently, New Belgium Brewing — routinely point to it as the “FDA standard.”

In doing so, Celiac patients could be led to believe that gluten-reduced products are safe for consumption — a sticking point for Brian Thiel, the co-founder of Ghostfish Brewing, a gluten-free craft brewery based in Seattle, Wash.

“The marketing of gluten-reduced beers — the way they are categorized within retail stores and referred to within media outlets — creates confusion in the marketplace,” he said.

Celiac disease, an autoimmune disorder that prevents the digestion of gluten proteins and attacks the small intestines, causes those who ingest gluten to experience fatigue, flushed red face, irritable bowel syndrome and depression, among other symptoms.

But Thiel, whose wife was diagnosed with celiac disease and was the inspiration for his brewery, believes even those with mild gluten allergies could be damaging their bodies by consuming gluten-reduced products.

For people that do have medical issues, whether it is celiac disease or just an allergy to gluten, those people look for products that are in that category. If they don’t do their research, there could be an assumption that they are drinking gluten-free beer when the beer still has some level of gluten in it.”

Gluten-reduced beers, he said, are creating marketplace confusion and greater separation between the two products, both in the way they are labeled and stocked on retailer shelves, is needed.