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 2002_register executive 2010-09-23 article Rules and Regulations D09002ee1c818d894 D09002ee1c818d934 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 amending the regulation authorizing a health claim on the relationship between beta- glucan soluble fiber from whole oat sources and reduced risk of coronary heart disease (CHD). The amendment adds as an additional eligible source of whole oat beta-glucan soluble fiber, the soluble fraction of alpha-amylase hydrolyzed oat bran or whole oat flour with a beta-glucan soluble fiber content of up to 10 percent on a dry weight basis (dwb) and not less than that of the starting material (dwb). We (FDA) are taking this action in response to a petition jointly filed by the Quaker Oats Co. and Rhodia, Inc. (the petitioners). We concluded previously that there was significant scientific agreement that a relationship exists between the beta-glucan soluble fiber of certain whole oat sources and the reduction of risk of CHD by lowering blood cholesterol levels. We now have concluded, based on the publicly available scientific evidence that, in addition to rolled oats, oat bran, and whole oat flour, the soluble fraction of alpha-amylase hydrolyzed oat bran or whole oat flour with a beta-glucan content up to 10 percent (dwb) and not less than that of the starting material (dwb) is an appropriate source of beta-glucan soluble fiber for the health claim. Therefore, we are amending the regulation that authorizes a health claim on the relationship between soluble fiber from whole oats and reduced risk of CHD to include this additional source of beta- glucan soluble fiber. 67 FR 61773 https://www.govinfo.gov/app/details/FR-2002-10-02/02-25067 02-25067 fr02oc02-7 4160-01-S Docket No. 01Q-0313 https://www.govinfo.gov/app/details/FR-2002-10-02/02-25067 https://www.govinfo.gov/content/pkg/FR-2002-10-02/html/02-25067.htm https://www.govinfo.gov/content/pkg/FR-2002-10-02/pdf/02-25067.pdf 11 p. 61773 61783 67 FR 61773 Title 21 Part 101 21 CFR Part 101 Food Labeling: Health Claims; Soluble Dietary Fiber From Certain Foods and Coronary Heart Disease; Federal Register Vol. 67, Issue RULE 02-25067 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2002-10-02 2002-12-16 Docket No. 01Q-0313 4160-01-S 02-25067 Interim final rule.

The Food and Drug Administration (FDA) is amending the regulation authorizing a health claim on the relationship between beta- glucan soluble fiber from whole oat sources and reduced risk of coronary heart disease (CHD). The amendment adds as an additional eligible source of whole oat beta-glucan soluble fiber, the soluble fraction of alpha-amylase hydrolyzed oat bran or whole oat flour with a beta-glucan soluble fiber content of up to 10 percent on a dry weight basis (dwb) and not less than that of the starting material (dwb). We (FDA) are taking this action in response to a petition jointly filed by the Quaker Oats Co. and Rhodia, Inc. (the petitioners). We concluded previously that there was significant scientific agreement that a relationship exists between the beta-glucan soluble fiber of certain whole oat sources and the reduction of risk of CHD by lowering blood cholesterol levels. We now have concluded, based on the publicly available scientific evidence that, in addition to rolled oats, oat bran, and whole oat flour, the soluble fraction of alpha-amylase hydrolyzed oat bran or whole oat flour with a beta-glucan content up to 10 percent (dwb) and not less than that of the starting material (dwb) is an appropriate source of beta-glucan soluble fiber for the health claim. Therefore, we are amending the regulation that authorizes a health claim on the relationship between soluble fiber from whole oats and reduced risk of CHD to include this additional source of beta- glucan soluble fiber.

This interim final rule is effective October 2, 2002. Submit written or electronic comments by December 16, 2002. James E. Hoadley, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD, 20740-3835, 301-436-1450. Food for human consumption: Food labeling Soluble dietary fiber and coronary heart disease; health claims, http://www.fda.gov/dockets/ecomments Vol. 67, no. 191 Office of the Federal Register, National Archives and Records Administration 2002-10-02 continuing daily deposited born digital 226 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2002-10-02 P0b002ee18099fcc3 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr02oc02 https://www.govinfo.gov/app/details/FR-2002-10-02 https://www.govinfo.gov/content/pkg/FR-2002-10-02/pdf/FR-2002-10-02.pdf https://www.govinfo.gov/content/pkg/FR-2002-10-02/xml/FR-2002-10-02.xml fdlp 61761 61974 DGPO 2010-09-23 2024-06-07 FR-2002-10-02 machine generated eng FR FR-2002-10-02 67 191