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In an effort to ensure that individuals with celiac disease are not misled by “gluten-free” labels, FDA has established a final rule to establish compliance requirements for fermented and hydrolyzed foods—or those foods that contain fermented or hydrolyzed ingredients—that bear the “gluten-free” claim. With more than three million people in the U.S. afflicted with celiac disease, this is a vital rule to ensure their health and safety.

FDA’s rule, “Gluten-Free Labeling of Fermented or Hydrolyzed Foods,” impacts foods such as cheese, yogurt, pickles, beer and wine, and any hydrolyzed plant proteins that are used to improve flavor or texture in processed foods such as soups, sauces, and seasonings.

The new rule requires manufacturers to show that their foods are gluten-free before fermentation or hydrolysis. This is important, as gluten proteins in hydrolyzed and fermented foods are no longer intact and, currently, cannot be adequately detected and quantified through testing.

Therefore, a main component of the rule requires manufacturers of any foods that contain fermented or hydrolyzed ingredients that claim they are “gluten-free” to keep impeccable records to prove with “adequate assurance” that the fermented or hydrolyzed ingredients are truly “gluten-free” as designated by the 2013 gluten-free food labeling final rule. That rule stated that when a manufacturer utilizes the “gluten-free” label on food packaging, the product must have fewer than 20 parts per million of gluten to be classified correctly.

Examples of record keeping that will be accepted to prove food is gluten-free include test results, certificates of analysis, or verification documentation for each ingredient in the food.

FDA will continue to evaluate the compliance of distilled foods by verifying any absence of protein using scientifically valid analytical methods that can reliably detect the presence of protein or protein fragments in the distilled food.

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