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Volume XI, Number 266

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Compliance Date for Final Rule on Gluten-Free Labeling of Fermented and Hydrolyzed Foods Approaches

As we have previously reported on, the FDA issued a final rule regarding gluten-free labeling of fermented and hydrolyzed foods on August 12, 2020. The rule established a compliance date of August 13, 2021.

The rule does not alter the definition of gluten-free that was established in a 2013 final rule, which essentially requires foods bearing gluten-free claims to be made without gluten containing ingredients or processed such that no more than 20 ppm of gluten remain in the final food product. However, the FDA determined that additional regulation of fermented and hydrolyzed foods was required to ensure compliance with the 2013 final rule because currently the “FDA 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.”

Therefore, the 2020 rule established a records-based system to ensure that fermented and hydrolyzed foods are gluten-free consistent with the definition established in 2013. Specifically, food manufacturers of foods that bear gluten-free claims are required to keep records that demonstrate that (1) the food is gluten-free before fermentation or hydrolysis; (2) the manufacturer has adequately evaluated the potential for cross-contact with gluten during the manufacturing process; and (3) if necessary, measures are in place to prevent the introduction of gluten into the food during the manufacturing process. The records requirement only applies to food ingredients for which adequate analytical methods to test for gluten content are not available (i.e., hydrolyzed and fermented foods) and the records must be kept for at least 2 years after introduction of the food into interstate commerce and must be reasonably accessible to FDA during inspection at each manufacturing facility. We also note that the rule applies to enzymes that are grown on growth media containing gluten (e.g., wheat) because gluten from the growth media may be carried over and may be hydrolyzed due to fermentation, thus making it undetectable based on current methodologies.

As the compliance date approaches, food manufacturers of gluten-free products should be collecting and reviewing documentation from suppliers of any hydrolyzed or fermented food ingredients to ensure compliance with the rule.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 194
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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...

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