FDA Finalizes Requirements for ‘Gluten-Free’ Labeling of Fermented or Hydrolyzed Foods

On August 12, 2020, the Food and Drug Administration (FDA) issued a final rule, “Gluten-Free Labeling of Fermented or Hydrolyzed Foods,” to establish compliance requirements for fermented and hydrolyzed foods, as well as foods that contain fermented and hydrolyzed ingredients, and that bear a “gluten-free,” “no gluten,” “free of gluten” or “without gluten” claim. The final rule was published in the Federal Register on August 13, 2020, and does not change the definition of “gluten-free” established by the FDA in 2013. Examples of foods covered by the final rule are cheese, yogurt, sauerkraut, pickles, 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.

Since gluten breaks down during fermentation and hydrolysis, currently available analytical methods are not able to adequately detect and quantify gluten proteins in foods manufactured through these processes. Thus, it is not possible to determine through testing if fermented or hydrolyzed foods/ingredients meet the “gluten-free” requirements under 21 CFR 101.91. Accordingly, the final rule establishes alternative means for the FDA to verify compliance with the “gluten-free” labeling requirements. Specifically, manufacturers of fermented or hydrolyzed foods, or foods containing one or more fermented or hydrolyzed ingredients, that bear the “gluten-free” label or a similar claim must make and keep records providing adequate assurance that:

• Fermented or hydrolyzed foods/ingredients meet 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.
• Measures are in place to prevent the introduction of gluten into the food during the manufacturing process (if there is a potential for gluten cross-contact).

The records required by the final rule may include test results, certificates of analysis, or other verification documentation for the ingredients used in the food or the food itself before fermentation or hydrolysis. The records should be retained for at least two years after the fermented or hydrolyzed food is introduced or delivered for introduction into interstate commerce. The records must also be made available during FDA inspections.

With respect to distilled foods such as distilled vinegar, the FDA notes that distillation should remove all protein (and thus gluten) if good manufacturing practices are followed. However, poor manufacturing practices may result in the transfer of gluten into the distillate. Thus, the final rule provides that the FDA will evaluate compliance with the “gluten-free” labeling requirements for distilled foods by verifying the absence of protein or protein fragments and, therefore, gluten through scientifically valid analytical methods.

There appears to be a discrepancy regarding the effective date of the final rule. The Federal Register notice summary indicates that the final rule will be effective on October 13, 2020, but Section VI of the rule instead states that the effective date is September 14, 2020. Irrespective of the effective date of the final rule, the compliance date is set for next year, August 13, 2021, which allows affected manufacturers time to review their products for compliance with the new final rule or remove “gluten-free” or similar claims for non-complying products.