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  1. CFSAN Constituent Updates

FDA Issues Final Rule on Gluten-Free Labeling of Fermented and Hydrolyzed Foods

Constituent Update

August 12, 2020

The U.S. Food and Drug Administration today released a final rule to establish compliance requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, that bear the “gluten-free” claim.  The final rule, titled “Gluten-Free Labeling of Fermented or Hydrolyzed Foods,” covers foods such as yogurt, sauerkraut, pickles, cheese, green olives, FDA-regulated beers and wines, and hydrolyzed plant proteins used to improve flavor or texture in processed foods such as soups, sauces, and seasonings.

Because gluten proteins in hydrolyzed and fermented foods are no longer intact and, currently, cannot be adequately detected and quantified through testing, the final rule states that FDA will determine compliance based on records kept by the manufacturer to show that their foods are gluten-free before fermentation or hydrolysis.   It also includes a discussion of compliance for distilled foods such as vinegar. The rule does not change the definition of “gluten-free” established by FDA in 2013.

The “gluten-free” definition 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 the disease.

The FDA issued a proposed rule regarding the compliance requirements for fermented and hydrolyzed foods on November 18, 2015.

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