By Allergen Bureau

Gluten free claims on fermented and hydrolyzed foods: FDA Final Rule

Compliance with US Food and Drug Administration final rule for gluten free claims on fermented and hydrolyzed foods came into effect on August 13, 2021. The final rule affects foods such as yogurt, sauerkraut, pickles, cheese, green olives, vinegar, beers, wine and hydrolyzed plant proteins.

In both fermented and hydrolyzed foods, protein strands have been broken down into smaller strands or individual amino acids. Because of this, currently available test methods cannot reliably detect and quantify gluten in fermented or hydrolyzed foods.

The FDA final rule provides alternative means for the agency to verify compliance with the requirements for fermented or hydrolyzed foods labelled ‘gluten-free’ based on records that are made and kept by the manufacturer. These records need to provide adequate assurance that the food or ingredients used in the food are free from gluten before fermentation or hydrolysis. Once analytical methods are developed and validated to reliably detect gluten in these products, the FDA will no longer require manufacturers to keep such records.

The final rule also provides for using scientifically valid analytical methods to verify the absence of gluten in distilled foods.

The rule is designed to protect individuals with coeliac disease who are advised to avoid all sources of gluten in their diet to prevent adverse health effects, and aims to ensure consumers are not misled. The rule became effective on August 13, 2020 with a 12 month timeframe for compliance.

See the FDA website for further details about the Final Rule on Gluten-Free Labelling of Fermented and Hydrolyzed Foods.