It's official. The US Government has released the Federal Register for the gluten-free labeling regulations. You can find the entire document here.
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA or we) is issuing a final rule to define the term ‘‘gluten- free’’ for voluntary use in the labeling of foods. The final rule defines the term ‘‘gluten-free’’ to mean that the food bearing the claim does not contain an ingredient that is a gluten-containing grain (e.g., spelt wheat); an ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten (e.g., wheat flour); or an ingredient that is derived from a gluten- containing grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food (i.e., 20 milligrams (mg) or more gluten per kilogram (kg) of food); or inherently does not contain gluten; and that any unavoidable presence of gluten in the food is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food). A food that bears the claim ‘‘no gluten,’’ ‘‘free of gluten,’’ or ‘‘without gluten’’ in its labeling and fails to meet the requirements for a ‘‘gluten-free’’ claim will be deemed to be misbranded. In addition, a food whose labeling includes the term ‘‘wheat’’ in the ingredient list or in a separate ‘‘Contains wheat’’ statement as required by a section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and also bears the claim ‘‘gluten-free’’ will be deemed to be misbranded unless its labeling also bears additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a ‘‘gluten-free’’ claim. Establishing a definition of the term ‘‘gluten-free’’ and uniform conditions for its use in food labeling will help ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled. We are issuing the final rule under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).
DATES: Effective date: The final rule becomes effective on September 4, 2013. Compliance date: The compliance date of this final rule is August 5, 2014. See section II.B.4 (comment 35 and response 35) for an additional explanation of the compliance date and implementation of this final rule.
FOR FURTHER INFORMATION CONTACT: Felicia B. Billingslea, Center for Food Safety and Applied Nutrition (HFS– 820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–2371, FAX: 301– 436–2636, email: GlutenFreeFinalRule Questions@fda.hhs.gov.
READ THE ENTIRE REPORT FROM THE FEDERAL REGISTER HERE
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA or we) is issuing a final rule to define the term ‘‘gluten- free’’ for voluntary use in the labeling of foods. The final rule defines the term ‘‘gluten-free’’ to mean that the food bearing the claim does not contain an ingredient that is a gluten-containing grain (e.g., spelt wheat); an ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten (e.g., wheat flour); or an ingredient that is derived from a gluten- containing grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food (i.e., 20 milligrams (mg) or more gluten per kilogram (kg) of food); or inherently does not contain gluten; and that any unavoidable presence of gluten in the food is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food). A food that bears the claim ‘‘no gluten,’’ ‘‘free of gluten,’’ or ‘‘without gluten’’ in its labeling and fails to meet the requirements for a ‘‘gluten-free’’ claim will be deemed to be misbranded. In addition, a food whose labeling includes the term ‘‘wheat’’ in the ingredient list or in a separate ‘‘Contains wheat’’ statement as required by a section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and also bears the claim ‘‘gluten-free’’ will be deemed to be misbranded unless its labeling also bears additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a ‘‘gluten-free’’ claim. Establishing a definition of the term ‘‘gluten-free’’ and uniform conditions for its use in food labeling will help ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled. We are issuing the final rule under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).
DATES: Effective date: The final rule becomes effective on September 4, 2013. Compliance date: The compliance date of this final rule is August 5, 2014. See section II.B.4 (comment 35 and response 35) for an additional explanation of the compliance date and implementation of this final rule.
FOR FURTHER INFORMATION CONTACT: Felicia B. Billingslea, Center for Food Safety and Applied Nutrition (HFS– 820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–2371, FAX: 301– 436–2636, email: GlutenFreeFinalRule Questions@fda.hhs.gov.
READ THE ENTIRE REPORT FROM THE FEDERAL REGISTER HERE
Labels: FDA, Food Allergen Labeling and Consumer Protection Act, gluten-free, labeling
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