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 1997_register executive 2010-09-24 article Part III Rules and Regulations D09002ee1be3662f7 D09002ee1be3663fc United States Rule originator org United States Government Agency or Subagency 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 announcing its decision to authorize the use, on food labels and in food labeling, of health claims on the association between soluble fiber from whole oats and a reduced risk of coronary heart disease (CHD). Based on its review of evidence submitted with comments to the proposal, as well as of the evidence described in the proposal, the agency has concluded that the type of soluble fiber found in whole oats, i.e., beta (<greek-b>)- glucan soluble fiber, is primarily responsible for the association between consumption of whole oats, including oat bran, rolled oats, and whole oat flour, and an observed lowering of blood cholesterol levels. The agency has concluded that, based on the totality of the scientific evidence, there is significant scientific agreement among qualified experts to support the relationship between soluble fiber in whole oats and CHD. Therefore, FDA has decided to make the subject of the health claim ``soluble fiber from whole oats'' and has concluded that claims on foods relating the onsumption of soluble fiber from whole oats to reduced risk of heart disease are justified. FDA is announcing this action in response to a petition filed by the Quaker Oats Company (the petitioner). 62 FR 3584 https://www.govinfo.gov/app/details/FR-1997-01-23/97-1598 97-1598 fr23ja97-18 RIN 0910-AA19 4160-01-F Docket No. 95P-0197 https://www.govinfo.gov/app/details/FR-1997-01-23/97-1598 https://www.govinfo.gov/content/pkg/FR-1997-01-23/html/97-1598.htm https://www.govinfo.gov/content/pkg/FR-1997-01-23/pdf/97-1598.pdf 18 p. 3584 3601 62 FR 3584 Title 21 Part 101 21 CFR Part 101 RIN 0910-AA19 Food Labeling: Health Claims; Oats and Coronary Heart Disease; Federal Register Vol. 62, Issue RULE 97-1598 III Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 1997-01-23 Docket No. 95P-0197 4160-01-F 97-1598 Final rule.

The Food and Drug Administration (FDA) is announcing its decision to authorize the use, on food labels and in food labeling, of health claims on the association between soluble fiber from whole oats and a reduced risk of coronary heart disease (CHD). Based on its review of evidence submitted with comments to the proposal, as well as of the evidence described in the proposal, the agency has concluded that the type of soluble fiber found in whole oats, i.e., beta (<greek-b>)- glucan soluble fiber, is primarily responsible for the association between consumption of whole oats, including oat bran, rolled oats, and whole oat flour, and an observed lowering of blood cholesterol levels. The agency has concluded that, based on the totality of the scientific evidence, there is significant scientific agreement among qualified experts to support the relationship between soluble fiber in whole oats and CHD. Therefore, FDA has decided to make the subject of the health claim ``soluble fiber from whole oats'' and has concluded that claims on foods relating the onsumption of soluble fiber from whole oats to reduced risk of heart disease are justified. FDA is announcing this action in response to a petition filed by the Quaker Oats Company (the petitioner).

The regulation is effective January 23, 1997. The Director of the Office of the Federal Register approves the incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of a certain publication in 21 CFR 101.81(c)(2)(ii)(A), effective January 23, 1997. Joyce J. Saltsman, Center for Food Safety and Applied Nutrition (HFS-165), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-5916. Vol. 62, no. 15 Office of the Federal Register, National Archives and Records Administration 1997-01-23 continuing daily deposited born digital 170 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-1997-01-23 P0b002ee180a44474 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr23ja97 https://www.govinfo.gov/app/details/FR-1997-01-23 https://www.govinfo.gov/content/pkg/FR-1997-01-23/pdf/FR-1997-01-23.pdf fdlp 3441 3601 DGPO 2010-09-24 2023-05-17 FR-1997-01-23 machine generated eng FR FR-1997-01-23 62 15