New requirements for “gluten-free” labels on foods such as yogurt, pickles, cheese, green olives, soy sauce, and certain beers and wines will be established under a new final rule from the Food and Drug Administration. This rule sets forth requirements for using such labels on fermented and hydrolyzed foods or foods that contain fermented or hydrolyzed ingredients, which are often used to improve flavor or texture in processed foods such as soups, sauces, and seasonings. The regulatory change will be effective as of Oct. 13 but compliance will not be mandated until Aug. 13, 2021.


The FDA states that this rule will provide alternative means for it to verify compliance for fermented or hydrolyzed foods (or those containing fermented or hydrolyzed ingredients) labeled “gluten-free” based on records that are made and kept by the manufacturer. These records will have to provide adequate assurance that (1) the food or ingredients are gluten-free prior to fermentation or hydrolysis, (2) the manufacturer has adequately evaluated the potential for gluten cross-contact, and (3) where such potential has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process. Manufacturers will have to keep these records for at least two years after the introduction or delivery for introduction of the food into interstate commerce.


Distilled foods such as distilled vinegars are covered by this rule. The FDA will evaluate the compliance of distilled foods by verifying the absence of protein (including gluten) using scientifically valid analytical methods that can detect the presence of protein or protein fragments in the distilled food.

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