The U.S. Food and Drug Administration issued a final rule, effective October 13, 2020, to establish compliance requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and that are labeled “gluten-free.” The rule pertains to foods such as: soy sauce, yogurt, sauerkraut, pickles, cheese, green olives, FDA-regulated beer and wine, and hydrolyzed plant proteins used to improve flavor or texture in processed foods such as soups, sauces, and seasonings.

The rule requires manufacturers of the fermented and hydrolyzed food products to make and keep records providing adequate assurance that:

  • The food meets the definition of “gluten-free” before fermentation or hydrolysis;
  • The manufacturer has adequately evaluated the potential for cross-contact with gluten during the manufacturing process; and
  • If necessary, measures are in place to prevent the introduction of gluten into the food during the manufacturing process.

FDA chose a recordkeeping approach for “gluten free” claims on these products because currently available analytical methods cannot be used to determine, with precision, if these products meet the “gluten-free” definition codified at 21 C.F.R. § 101.91. Once a scientifically valid method has been developed that can accurately detect and quantify gluten in fermented or hydrolyzed foods or ingredients, it will no longer be necessary for the manufacturer of foods bearing the “gluten-free” claim to make and keep these records. FDA believes that this approach will ensure that individuals with celiac disease are not misled and receive truthful and accurate information because gluten breaks down during fermentation and hydrolysis.

The rule also discusses that the FDA will monitor compliance of distilled foods, such as vinegar, by verifying the absence of protein using scientifically valid analytical methods that can reliably detect the presence of protein or protein fragments in the distilled food.

The definition of “gluten-free” for other foods, established in 2013, is not changed by this new final rule. As a reminder, the FDA defines “gluten-free” as food that is either inherently gluten free; or does not contain an ingredient that is:

(1) A gluten-containing grain (e.g., spelt wheat);

(2) Derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or

(3) Derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food.

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Our FDA attorneys have the technical and legal knowledge to assist clients with reviewing labels and determining if a claim is appropriate on foods and dietary supplements. If you have questions or require assistance on FDA matters, contact Seth Mailhot, Emily Lyons or your Husch Blackwell attorney.

Written with the assistance of Natalie Sobierajski, a summer associate in the Husch Blackwell LLP Milwaukee, Wisconsin office.