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 Rules and Regulations D09002ee1c80a46f5 D09002ee1c80a4786 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 issuing this interim final rule to amend the regulation authorizing a health claim on noncariogenic carbohydrate sweeteners and dental caries, i.e., tooth decay, to include isomaltulose, a noncariogenic sugar. FDA is taking this action in response to a health claim petition submitted on behalf of Cargill, Inc. Based on the totality of publicly available scientific evidence, FDA now has determined that the nutritive sweetener isomaltulose, like other noncariogenic carbohydrate sweeteners listed in the dental caries health claim regulation, is not fermented by oral bacteria to an extent sufficient to lower dental plaque pH to levels that would contribute to the erosion of dental enamel. Therefore, FDA has concluded that isomaltulose does not promote dental caries, and it is amending the regulation authorizing a health claim relating certain noncariogenic sweeteners and the nonpromotion of dental caries to include isomaltulose as a substance eligible for the claim. 72 FR 52783 https://www.govinfo.gov/app/details/FR-2007-09-17/E7-18196 E7-18196 fr17se07-5 4160-01-S Docket No. 2006P-0487 https://www.govinfo.gov/app/details/FR-2007-09-17/E7-18196 https://www.govinfo.gov/content/pkg/FR-2007-09-17/html/E7-18196.htm https://www.govinfo.gov/content/pkg/FR-2007-09-17/pdf/E7-18196.pdf 7 p. 52783 52789 72 FR 52783 Title 21 Part 101 21 CFR Part 101 Food Labeling; Health Claims; Dietary Noncariogenic Carbohydrate Sweeteners and Dental Caries; Federal Register Vol. 72, Issue RULE E7-18196 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2007-09-17 2007-12-03 Docket No. 2006P-0487 4160-01-S E7-18196 Interim final rule.

The Food and Drug Administration (FDA) is issuing this interim final rule to amend the regulation authorizing a health claim on noncariogenic carbohydrate sweeteners and dental caries, i.e., tooth decay, to include isomaltulose, a noncariogenic sugar. FDA is taking this action in response to a health claim petition submitted on behalf of Cargill, Inc. Based on the totality of publicly available scientific evidence, FDA now has determined that the nutritive sweetener isomaltulose, like other noncariogenic carbohydrate sweeteners listed in the dental caries health claim regulation, is not fermented by oral bacteria to an extent sufficient to lower dental plaque pH to levels that would contribute to the erosion of dental enamel. Therefore, FDA has concluded that isomaltulose does not promote dental caries, and it is amending the regulation authorizing a health claim relating certain noncariogenic sweeteners and the nonpromotion of dental caries to include isomaltulose as a substance eligible for the claim.

This interim final rule is effective September 17, 2007. Submit written or electronic comments by December 3, 2007. Jillonne Kevala, 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 Dietary noncariogenic carbohydrate sweeteners and dental caries; health claims, http://www.cfsan.fda.gov/˜rdb/opa-g184.html http://www.fda.gov/dockets/ecomments http://www.fda.gov/ohrms/dockets/default.htm http://www.healthypeople.gov/document/html/volume2/21oral.htm http://www.nlm.nih.gov/medlineplus/ency/article/001055.htm http://www.regulations.gov http://www2.nidcr.nih.gov/sgr/execsumm.htm Vol. 72, no. 179 Office of the Federal Register, National Archives and Records Administration 2007-09-17 continuing daily deposited born digital 363 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2007-09-17 P0b002ee180954683 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr17se07 https://www.govinfo.gov/app/details/FR-2007-09-17 https://www.govinfo.gov/content/pkg/FR-2007-09-17/pdf/FR-2007-09-17.pdf https://www.govinfo.gov/content/pkg/FR-2007-09-17/xml/FR-2007-09-17.xml fdlp 52749 53100 DGPO 2010-09-22 2024-06-05 FR-2007-09-17 machine generated eng FR FR-2007-09-17 72 179