Constituent Update

August 5, 2021

On August 13, 2020, the U.S. Food and Drug Administration released a final rule to establish compliance requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and bear the “gluten-free” claim. In both fermented and hydrolyzed foods, protein strands have been broken down into smaller strands or individual amino acids. The rule is designed to protect individuals with celiac disease -- a hereditary, chronic inflammatory disorder of the small intestine -- who are advised to avoid all sources of gluten in their diet to protect against adverse health effects associated with consumption of gluten for those with the disease. The compliance date for the rule is August 13, 2021.

The final rule, titled “Gluten-Free Labeling of Fermented or Hydrolyzed Foods,” pertains to foods such as yogurt, sauerkraut, pickles, cheese, green olives, vinegar, beers, wine and hydrolyzed plant proteins used to improve flavor or texture in processed foods such as soups, sauces, and seasonings. Distilled foods, such as distilled vinegars, are also discussed in the final rule.

The final rule does not change the definition of “gluten-free” established in 2013, but only adds compliance requirements for hydrolyzed or fermented foods and compliance information for distilled foods. Currently available test methods cannot reliably detect and quantify gluten in fermented or hydrolyzed foods because gluten proteins are no longer intact as a result of these processes. Thus, the final rule provides alternative means for the agency to verify compliance with the requirements for fermented or hydrolyzed foods labeled “gluten-free” based on records that are made and kept by the manufacturer. The final rule also provides for using scientifically valid analytical methods to verify the absence of gluten in distilled foods, as appropriate.

For more information:

• Final Rule on Gluten-Free Labeling of Fermented or Hydrolyzed Foods (August 13, 2020)
• Final Rule on Gluten-Free Labeling of Foods (August 5, 2013)
• FDA's Gluten-Free Labeling of Foods Main Page