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Celiac.com 11/15/2010 - Fermentation of wheat flour with sourdough lactobacilli and fungal proteases decreases the concentration of gluten in wheat. Depending on the level of hydrolyzation, gluten levels can be reduced as low as 8 parts per million. A team of researchers recently conducted a small study to assess whether people with celiac disease can eat baked goods made with wheat flour that is hydrolyzed via sourdough lactobacilli and fungal proteases during food processing. The team included L. Greco, M. Gobbetti, R. Auricchio, R. Di Mase, F. Landolfi, F. Paparo, R. Di Cagno, M. De Angelis, C. G. Rizzello, A. Cassone, G. Terrone, L. Timpone, M. D'Aniello, M. Maglio, R. Troncone, S. Auricchio. They are affiliated with the Department of Pediatrics and European Laboratory for the Study of Food Induced Diseases, University of Naples, Federico II in Naples Italy. The team evaluated the safety of daily administration of baked goods made from this hydrolyzed form of wheat flour for patients with celiac disease. Patients who volunteered for the study were assigned at random to consume 200 grams per day of baked goods from one of three groups. The did so every day for 60 days. The first group of six patients ate natural flour baked goods (NFBG), with a gluten content of 80,127 ppm gluten. The second group of 2 patients ate baked goods made from extensively hydrolyzed flour (S1BG), with a residual gluten content of 2,480 ppm. The third group of patients ate baked goods made from fully hydrolyzed flour (S2BG), with just 8 ppm residual gluten. In the first group, two of the six patients consuming baked goods made with natural flour (NFBG) discontinued the challenge because of adverse symptoms. All six patients in this group showed increased levels of anti-tissue transglutaminase (tTG) antibodies and small bowel deterioration. The two patients who ate baked goods made from extensively hydrolyzed flour (S1BG) had no clinical complaints, but biopsy showed intestinal damage in the form of subtotal villous atrophy. The five patients who ate baked goods made with made from fully hydrolyzed flour (S2BG), at just 8 ppm residual gluten had no clinical complaints. Also, they showed no increase in anti-tTG antibodies, and Marsh grades of their small intestinal mucosa showed no adverse change. Evidence with this small 60-day dietary study shows that people with celiac disease can safely consume baked goods made from fully hydrolyzed wheat flour, manufactured with sourdough lactobacilli and fungal proteases. This flour shows no toxicicity to patients with celiac disease. The team notes that a combined analysis of serologic, morphometric, and immunohistochemical parameters is the most accurate method to assess new therapies for this disorder. The results need to be borne out by further study, but, in the future, baked goods made with fully hydrolyzed wheat flour, manufactured with sourdough lactobacilli and fungal proteases may become another option for people with celiac disease. Source: Clin Gastroenterol Hepatol. 2010 Oct 15. doi:10.1016/j.cgh.2010.09.025
Celiac.com 03/22/2016 - The US Food and Drug Administration (FDA) has extended the period for public comments on a proposed rule for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and bear a "gluten-free" claim. FDA is extending the comment period for the proposed rule on gluten-free labeling for fermented or hydrolyzed foods by 60 days. The agency originally introduced the Proposed Rule for Gluten-Free Labeling of Fermented or Hydrolyzed Foods on November 18, 2015. The original public comment period was set to end on February 16, 2016. The new closure date for public comments will be 60 days after a notice appears in the Federal Register. The new rule's Federal Register Docket Number is FDA-2014-N-1021, and the relevant Federal Register Docket Name is: "Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods." The proposed rule does not require or establish standards for "gluten-free" labeling. Instead, it establishes compliance methods for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients that bear a voluntary "gluten-free" labeling claim. Source: Lexology.com
"The U.S. Food and Drug Administration today released a proposed rule to establish requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and bear the “gluten-free” claim. The proposed rule, titled “Gluten-Free Labeling of Fermented or Hydrolyzed Foods,” pertains to foods such as yogurt, sauerkraut, pickles, cheese, green olives, vinegar, and FDA regulated beers....." http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm472778.htm
Celiac.com 12/15/2015 - The FDA is proposing a new rule for naming and labeling fermented and hydrolyzed foods, or foods with these ingredients, claiming to be gluten-free. Called "Gluten-Free Labeling of Fermented or Hydrolyzed Foods," the rule covers gluten-free labeling of foods like yogurt, sauerkraut, pickles, cheese, green olives, vinegar, and FDA-regulated beers. This is a follow-up to the FDA's final 2013 gluten-free foods rule, which highlighted uncertainty in gluten test results when dealing with intact gluten. This new rule is meant to serve as an alternative method for the FDA to vet compliance through records from manufacturers. The agency will accept comments starting Wednesday. Under the new rule, the FDA proposes the following manufacturer requirements: The food meets the requirements of the gluten-free food labeling final rule prior to fermentation or hydrolysis; The manufacturer has adequately evaluated its process for any potential gluten cross-contact, and where a potential for gluten cross-contact has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process. The agency says the proposed rule will address distilled foods compliance through scientific methods that confirm protein's absence (including gluten).