United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2007_register executive 2010-09-22 article Proposed Rules D09002ee1c80c9abb D09002ee1c80c9b7b United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is proposing to define the term "gluten-free" for voluntary use in the labeling of foods, to mean that the food does not contain any of the following: An ingredient that is any species of the grains wheat, rye, barley, or a crossbred hybrid of these grains (all noted grains are collectively referred to as "prohibited grains"); an ingredient that is derived from a prohibited grain and that has not been processed to remove gluten (e.g., wheat flour); an ingredient that is derived from a prohibited 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; or 20 ppm or more gluten. A food that bears the claim "gluten-free" or similar claim in its labeling and fails to meet the conditions specified in the proposed definition of "gluten-free" would be deemed misbranded. FDA also is proposing to deem misbranded a food bearing a gluten-free claim in its labeling if the food is inherently free of gluten and if the claim does not refer to all foods of that same type (e.g., "milk, a gluten-free food" or "all milk is gluten-free"). In addition, a food made from oats that bears a gluten-free claim in its labeling would be deemed misbranded if the claim suggests that all such foods are gluten-free or if 20 ppm or more gluten is present in the food. Establishing a definition of the term "gluten-free" and uniform conditions for its use in the labeling of foods is needed to ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled. This proposed action is in response to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). 72 FR 2795 https://www.govinfo.gov/app/details/FR-2007-01-23/E7-843 E7-843 fr23ja07-10 RIN 0910-ZA26 4160-01-S Docket No. 2005N-0279 https://www.govinfo.gov/app/details/FR-2007-01-23/E7-843 https://www.govinfo.gov/content/pkg/FR-2007-01-23/html/E7-843.htm https://www.govinfo.gov/content/pkg/FR-2007-01-23/pdf/E7-843.pdf Food Labeling Nutrition Reporting and Recordkeeping Requirements 23 p. 2795 2817 72 FR 2795 Title 21 Part 101 21 CFR Part 101 RIN 0910-ZA26 Food Labeling; Gluten-Free Labeling of Foods; Federal Register Vol. 72, Issue PRORULE E7-843 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2007-04-23 Docket No. 2005N-0279 4160-01-S E7-843 Proposed rule.

The Food and Drug Administration (FDA) is proposing to define the term "gluten-free" for voluntary use in the labeling of foods, to mean that the food does not contain any of the following: An ingredient that is any species of the grains wheat, rye, barley, or a crossbred hybrid of these grains (all noted grains are collectively referred to as "prohibited grains"); an ingredient that is derived from a prohibited grain and that has not been processed to remove gluten (e.g., wheat flour); an ingredient that is derived from a prohibited 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; or 20 ppm or more gluten. A food that bears the claim "gluten-free" or similar claim in its labeling and fails to meet the conditions specified in the proposed definition of "gluten-free" would be deemed misbranded. FDA also is proposing to deem misbranded a food bearing a gluten-free claim in its labeling if the food is inherently free of gluten and if the claim does not refer to all foods of that same type (e.g., "milk, a gluten-free food" or "all milk is gluten-free"). In addition, a food made from oats that bears a gluten-free claim in its labeling would be deemed misbranded if the claim suggests that all such foods are gluten-free or if 20 ppm or more gluten is present in the food. Establishing a definition of the term "gluten-free" and uniform conditions for its use in the labeling of foods is needed to ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled. This proposed action is in response to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

Submit written or electronic comments by April 23, 2007. Rhonda R. Kane, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD, 301-436-2371, FAX: 301-436- 2636, e-mail: rhonda.kane@fda.hhs.gov. Food Labeling Nutrition Reporting and Recordkeeping Requirements Food for human consumption: Food labeling Gluten-free; voluntary nutrition labeling, rhonda.kane@fda.hhs.gov http://151.121.3.117/reference-library/standards/810101.pdf http://consensus.nih.gov/2004/2004CeliacDisease118html.htm http://consensus.nih.gov/2004/2004CeliacDisease118Program.pdf http://digestive.niddk.nih.gov/ddiseases/pubs/celiac/ http://precis.preciscentral.com/files/source/67/html/45832.htm http://wheat.pw.usda.gov/ggpages/topics/celiac.html http://wheat.pw.usda.gov/ggpages/topics/Celiac.vs.grains.html http://www.aaic.org/02progrm.htm http://www.census.gov/population/www/popclockus.html http://www.cfsan.fda.gov/˜dms/alrgcom.html http://www.cfsan.fda.gov/˜dms/alrgn.html http://www.cfsan.fda.gov/˜dms/alrgn2.html http://www.efsa.europa.eu http://www.fda.gov/dockets/ecomments http://www.fda.gov/ohrms/dockets/ac/05/minutes/2005-4160m1_summary%20minutes.pdf http://www.fda.gov/ohrms/dockets/ac/cfsan05.html http://www.fda.gov/ohrms/dockets/default.htm http://www.fda.gov/ohrms/dockets/dockets/05n0231/05N-0231-EC4.htm http://www.fda.gov/ohrms/dockets/dockets/05n0231/05n-0231-rpt0001.pdf http://www.fda.gov/ohrms/dockets/dockets/05n0279/05n-0279-EC1482-Attach-1.pdf http://www.fda.gov/ohrms/dockets/dockets/05n0279/05n-0279-tr00001-01-vol16.doc http://www.fda.gov/ohrms/dockets/dockets/05n0279/05n-0279-tr00001-02-erratta-vol16.doc http://www.fda.gov/ohrms/dockets/dockets/05n0279/05n-0279_emc-000299-03.pdf http://www.foodstandards.gov.au/foodstandardscode http://www.gipsa.usda.gov/GIPSA/webapp?area=home&subject=grpi&topic=sq-ous http://www.regulations.gov www.nutritioncaremanual.org Vol. 72, no. 14 Office of the Federal Register, National Archives and Records Administration 2007-01-23 continuing daily deposited born digital 272 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2007-01-23 P0b002ee18095c73a 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr23ja07 https://www.govinfo.gov/app/details/FR-2007-01-23 https://www.govinfo.gov/content/pkg/FR-2007-01-23/pdf/FR-2007-01-23.pdf https://www.govinfo.gov/content/pkg/FR-2007-01-23/xml/FR-2007-01-23.xml fdlp 2763 3024 DGPO 2010-09-22 2024-06-05 FR-2007-01-23 machine generated eng FR FR-2007-01-23 72 14