How FDA Regulates Gluten-Free Labeling of Fermented Foods

As of August 2021, finalized rules are in effect for gluten-free claims on fermented and hydrolyzed foods regulated by FDA. If a fermented or hydrolyzed food (or a food containing fermented or hydrolyzed ingredients) bears a gluten-free label, the manufacturer must maintain records demonstrating that the food or ingredient met the FDA definition of gluten free prior to fermentation or hydrolysis and that gluten cross-contact was controlled after fermentation or hydrolysis. While this regulation seems straightforward on paper, challenges remain for food manufacturers trying to interpret the rule for their products. This article reviews the development of the current gluten-free regulations and the impact of the recently finalized rule for fermented and hydrolyzed foods. 

Gluten and Celiac Disease

Celiac disease, also known as gluten-sensitive enteropathy, a lifelong condition affecting an estimated 1% of the U.S. population, is characterized by a chronic immune-mediated inflammatory response to the gluten proteins found in certain cereal grains, including wheat, rye, barley, and sometimes oats. The inflammatory process in celiac disease primarily impacts the intestinal tract, creating a chronic malabsorption syndrome unless treated. The symptoms of celiac disease, which are reflective of an inability to absorb nutrients including weight loss, anemia (iron deficiency), bone loss (calcium deficiency), and growth retardation in children, along with nausea, abdominal cramping, and diarrhea.

Gluten is a complex mixture of different individual proteins and includes two major fractions—prolamins (also referred to as gliadins) and glutelins. Individuals affected by celiac disease must strictly avoid gluten-containing foods to prevent serious adverse health outcomes, making establishment of regulatory criteria for the use of gluten-free claims critical to their ability to make safe food choices.

For many years, food manufacturers catering to celiac consumers had been labeling products as gluten free, but there was no established regulatory definition in the U.S. prior to 2013. The development of the current regulatory structure started with the Food Allergen Labeling and Consumer Protection Act of 2004, which required the Secretary of Health and Human Services to issue regulations to define and permit use of the term “gluten-free” for food labels. The final rule for gluten-free labeling of foods under FDA jurisdiction was published in August 2013, with a compliance date of August 5, 2014.

Gluten-Free Regulatory Definition

The gluten-free labeling regulation finalized by FDA and incorporated as 21 CFR 101.91 defines gluten-containing grains as wheat (any species belonging to the genus Triticum), rye (any species belonging to the genus Secale), barley (any species belonging to the genus Hordeum), or any of their crossbred hybrids (e.g., triticale). As illustrated in Table 1, this definition can encompass many different individual species, particularly when it comes to wheat. The rule also defines gluten as “the proteins that naturally occur in gluten-containing grains that may cause adverse health effects in persons with celiac disease (e.g., prolamins and glutelins).”

Table 1: Examples of gluten-containing grains.

     With respect to the definition of gluten-free, the rule stipulates that a product bearing a gluten-free label may not contain any of the following:

1. An ingredient that is a gluten-containing grain;
2. An ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten; or
3. An ingredient that is derived from a gluten-containing grain and that has been processed to remove gluten, if the use of that ingredient results in the presence of 20 ppm or more gluten in the food.

Foods that inherently do not contain gluten may be labeled as gluten free if the presence of any unavoidable gluten is less than 20 ppm gluten.

Failure to meet these requirements for a product labeled as gluten free would result in a misbranded product. In addition, the terms “no gluten,” “free of gluten,” and “without gluten” must meet the same requirements as products labeled “gluten free.”