FDA Issues Final Rule for Gluten-Free Fermented, Hydrolyzed Foods

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Gluten free

Silver Spring, MD—FDA has issued a final rule to establish compliance requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and that bear the “gluten-free” claim, according to a press release. This includes foods such as soy sauce, yogurt, sauerkraut, pickles, cheese, green olives, and distilled foods, such as distilled vinegars.

The rule adds compliance requirements, which are necessary because gluten breaks down during hydrolysis and fermentation, and cannot be measured by current analytical methods, according to the press release. Manufacturers will be required to make and keep records providing adequate assurance that the food meets 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, and measures are in place to prevent gluten from being introduced into the food during the manufacturing process.

“These new compliance requirements for labeling a product ‘gluten-free’ will protect individuals with celiac disease, an incurable, hereditary disorder that millions of Americans, including myself, live with,” said Health and Human Services Secretary Alex Azar, in the press release. “The FDA’s final rule helps to ensure common products labeled ‘gluten-free’ really are gluten-free, equipping consumers to make the best choices for their health and their families.”

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“The FDA continues to work to protect people with celiac disease, which impacts at least 3 million Americans,” added FDA Commissioner Stephen M. Hahn, M.D. “The agency has taken a number of steps on this front by first establishing a standardized definition of ‘gluten-free,’ and now by continuing to work to ensure manufacturers are keeping the products that are labeled with this claim gluten-free.”

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