FDA’s final rule on gluten-free labeling of fermented and hydrolyzed foods

The FDA released a final rule that establishes criteria for “gluten-free” labeling for fermented and hydrolyzed foods, as well as goods that include fermented or hydrolyzed components. According to the publication, these standards are necessary to guarantee that people with celiac disease are not deceived and that they receive correct information about fermented or hydrolyzed foods branded as "gluten-free."    

Currently, FDA is unaware of any scientifically viable analytical approach that can accurately identify and quantify gluten protein concentration in fermented or hydrolyzed foods in terms of equal quantities of intact gluten proteins. As a result, FDA intends to assess compliance of fermented or hydrolyzed foods with a "gluten-free" claim based on documents created and maintained by the maker of the "gluten-free" claim and made available to them for examination and copying. Before fermentation or hydrolysis, the records must give reasonable evidence that the food or components utilized in the product are "gluten-free". Once FDA determines that a scientifically viable technique for correctly detecting and quantifying gluten in fermented or hydrolyzed foods has been established, the maker of gluten-free goods will no longer be required to compile and retain these records.    

Furthermore, this final regulation specifies that the absence of protein in distilled foods will be verified using scientifically valid analytical procedures capable of consistently detecting the presence of protein or protein fragments in the distilled food.    

The regulation came into effect on August 13th, 2021, with a 12-month compliance period.