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NewsRegulatoryFDA

Fast Approaching: FDA Compliance Date for Final Rule on Gluten-Free Labeling of Fermented and Hydrolyzed Foods

gluten-free foods
August 5, 2021

The U.S. Food and Drug Administration (FDA) released a final rule on August 13, 2020 to establish compliance requirements for fermented and hydrolyzed foods that use the "gluten-free" claim on their labeling. This rule is designed to protect those who have celiac disease and are advised to avoid all gluten in their diet. The compliance date for the rule is August 13, 2021. 

The final rule, entitled "Gluten-Free Labeling of Fermented or Hydrolyzed Foods," can be applied 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 part of the final rule.

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

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KEYWORDS: gluten-free

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