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

On August 12, 2020, the U.S. Food and Drug Administration (“FDA” or “Agency”) issued a final rule to establish compliance requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and that bear the “gluten-free” claim. The rule will have an impact on foods like soy sauce, yogurt, sauerkraut, pickles, cheese, green olives, and distilled foods, such as distilled vinegars.

In the final rule, FDA noted that it knows of no scientifically valid analytical method effective in detecting and quantifying with precision the gluten protein content in fermented or hydrolyzed foods in terms of equivalent amounts of intact gluten proteins. As such, the Agency stated that it will evaluate compliance of such fermented or hydrolyzed foods that bear a ‘‘gluten-free’’ claim based on records that are made and kept by the manufacturer of the food bearing the ‘‘gluten-free’’ claim and made available to FDA.

The final rule requires manufacturers of these food products to make and keep records providing adequate assurance that (i) the food meets the definition of “gluten-free” before fermentation or hydrolysis; (ii) the manufacturer has adequately evaluated the potential for cross-contact with gluten during the manufacturing process; and if necessary, (iii) measures are in place to prevent the introduction of gluten into the food during the manufacturing process.

We note that FDA did not change the “gluten-free” definition that it established in 2013. By way of background, in addition to limiting the unavoidable presence of gluten to less than 20 parts per million, FDA allows manufacturers to label a food “gluten-free” if the food does not contain any of the following:

(i) an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains;

(ii) an ingredient derived from these grains and that has not been processed to remove gluten, or;

(iii) an ingredient derived from these grains that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten.

In an August 12, 2020 FDA news release, Department of Health and Human Services Secretary, Alex Azar, noted that the “FDA’s final rule helps to ensure common products labeled ‘gluten-free’ really are gluten-free, equipping consumers to make the best choices for their health and their families.” FDA’s final rule is effective October 13,2020.

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 226


About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...