Federal Register/Vol. 72, No. 179/Monday, September 17, 2007

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Federal Register/Vol. 72, No. 179/Monday, September 17, 2007 Federal Register / Vol. 72, No. 179 / Monday, September 17, 2007 / Rules and Regulations 52783 § 181.74 [Amended] place it appears and, in its place, adding • Federal eRulemaking Portal: http:// the term ‘‘CBP’’. www.regulations.gov. Follow the I 8. In § 181.74: instructions for submitting comments. Jayson P. Ahern, I a. Paragraph (a) is amended by • Agency Web site: http:// removing the citation to Acting Commissioner, U.S. Customs and www.fda.gov/dockets/ecomments. Border Protection. ‘‘181.72(a)(2)(iii)’’ and adding in its Follow the instructions for submitting place the citation to ‘‘181.72(a)(3)(iii)’’, Approved: September 10, 2007. comments on the agency Web site. and by removing the word ‘‘Customs’’ Timothy E. Skud, Written Submissions and, in its place, adding the term Deputy Assistant Secretary of the Treasury. Submit written submissions in the ‘‘CBP’’. [FR Doc. 07–4551 Filed 9–14–07; 8:45 am] following ways: • I BILLING CODE 9111–14–P FAX: 301–827–6870. b. Paragraphs (b) and (c) are amended • Mail/Hand delivery/Courier [For by removing the term ‘‘Customs’’ each paper, disk, or CD–ROM submissions]: place it appears and, in its place, adding Division of Dockets Management (HFA– the term ‘‘CBP’’. DEPARTMENT OF HEALTH AND 305), Food and Drug Administration, I c. In paragraph (d) introductory text, HUMAN SERVICES 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. the reference to ‘‘Customs officer’’ is Food and Drug Administration removed and the term ‘‘CBP officer’’ is To ensure more timely processing of comments, FDA is no longer accepting added in its place; and the two 21 CFR Part 101 references to ‘‘Customs’’ which follow comments submitted to the agency by e- mail. FDA encourages you to continue are removed and in each instance the [Docket No. 2006P–0487] term ‘‘CBP’’ is added in its place. to submit electronic comments by using I Food Labeling; Health Claims; Dietary the Federal eRulemaking Portal or the d. Paragraph (e)(1) is amended, in the agency Web site, as described second sentence following the heading, Noncariogenic Carbohydrate Sweeteners and Dental Caries previously, in the ADDRESSES portion of by removing the word ‘‘Customs’’ and, this document under Electronic in its place, adding the term ‘‘CBP’’, and AGENCY: Food and Drug Administration, Submissions. by removing the address citation HHS. Instructions: All submissions received ‘‘Project North Star Coordination Center, ACTION: Interim final rule. must include the agency name and P.O. Box 400, Buffalo, New York 14225– Docket No. 2006P–0487 for this 0400’’, and, in its place, adding the SUMMARY: The Food and Drug rulemaking. All comments received may address citation ‘‘U.S. Customs and Administration (FDA) is issuing this be posted without change to http:// Border Protection, Office of interim final rule to amend the www.fda.gov/ohrms/dockets/ International Trade, Commercial regulation authorizing a health claim on default.htm, including any personal Targeting and Enforcement, 1300 noncariogenic carbohydrate sweeteners information provided. For additional Pennsylvania Ave., NW., Washington, and dental caries, i.e., tooth decay, to information on submitting comments, DC 20229’’. include isomaltulose, a noncariogenic see the ‘‘Comments’’ heading of the sugar. FDA is taking this action in I e. Paragraph (e)(2) is amended by SUPPLEMENTARY INFORMATION section of response to a health claim petition this document. removing the phrase ‘‘Customs may’’, submitted on behalf of Cargill, Inc. Docket: For access to the docket to and adding in its place the phrase ‘‘CBP Based on the totality of publicly read background documents or may’’. available scientific evidence, FDA now comments received, go to http:// § 181.93 [Amended] has determined that the nutritive www.fda.gov/ohrms/dockets/ sweetener isomaltulose, like other default.htm and insert the docket I 9. In § 181.93: noncariogenic carbohydrate sweeteners number, found in brackets in the I a. In paragraph (a), the two references listed in the dental caries health claim heading of this document, into the to ‘‘Commissioner of Customs’’ are regulation, is not fermented by oral ‘‘Search’’ box and follow the prompts bacteria to an extent sufficient to lower removed and in each instance references and/or go to the Division of Dockets dental plaque pH to levels that would to ‘‘Commissioner of U.S. Customs and Management, 5630 Fishers Lane, rm. contribute to the erosion of dental Border Protection’’ are added in its 1061, Rockville, MD 20852. enamel. Therefore, FDA has concluded place, and the address citation FOR FURTHER INFORMATION CONTACT: that isomaltulose does not promote Jillonne Kevala, Center for Food Safety ‘‘National Commodity Specialist dental caries, and it is amending the Division, United States Customs and Applied Nutrition (HFS–830), Food regulation authorizing a health claim and Drug Administration, 5100 Paint Service, 6 World Trade Center, New relating certain noncariogenic York, NY 10048’’ is removed and the Branch Pkwy., College Park, MD 20740– sweeteners and the nonpromotion of 3835, 301–436–1450. address citation ‘‘National Commodity dental caries to include isomaltulose as SUPPLEMENTARY INFORMATION: Specialist Division, U.S. Customs and a substance eligible for the claim. Border Protection, One Penn Plaza, 10th DATES: This interim final rule is I. Background Floor, New York, NY 10119’’ is added effective September 17, 2007. Submit The Nutrition Labeling and Education in its place. written or electronic comments by Act of 1990 (the 1990 amendments) I b. Paragraphs (b)(1)(i), (b)(1)(ii), (b)(3), December 3, 2007. (Pub. L. 101–535) amended the Federal (b)(4), (b)(5)(i)(A), and (d) are amended ADDRESSES: You may submit comments, Food, Drug, and Cosmetic Act (the act) by removing the word ‘‘Customs’’ each identified by Docket No. 2006P–0487, in a number of important respects. One by any of the following methods: aspect of the 1990 amendments was that Electronic Submissions they clarified FDA’s authority to Submit electronic comments in the regulate health claims on food labels following ways: and in food labeling. VerDate Aug<31>2005 15:49 Sep 14, 2007 Jkt 211001 PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 E:\FR\FM\17SER1.SGM 17SER1 mstockstill on PROD1PC66 with RULES 52784 Federal Register / Vol. 72, No. 179 / Monday, September 17, 2007 / Rules and Regulations In 1993, FDA issued a regulation to shall not lower plaque pH below 5.7 by dental health claim for isomaltulose. implement the health claim provisions bacterial fermentation either during FDA notified the petitioner on of the 1990 amendments entitled ‘‘Food consumption or up to 30 minutes after December 8, 2006, that the initial review Labeling: General Requirements for consumption, as measured by the of the petition had been completed and Health Claims for Food’’ (58 FR 2478, indwelling plaque pH test found in that the petition had been filed for January 6, 1993), which established a ‘Identification of Low Caries Risk further action in accordance with process for petitioning the agency to Dietary Components,’ ***.’’ section 403(r)(4) of the act. If the agency authorize health claims about FDA noted in the 1996 final rule that does not act, by either denying the substance-disease relationships and set it would consider adding other petition or issuing a proposed regulation out the types of information that a noncariogenic carbohydrate sweeteners to authorize the health claim, within 90 health claim petition must include (21 in the list of sweeteners eligible for the days of the date of filing for further CFR 101.70). This regulation became health claim based on a petition to action, the petition is deemed to be effective on May 8, 1993. amend the regulation that would show denied unless an extension is mutually The final rule that established how the substance conforms to the agreed upon by the agency and the § 101.80 (21 CFR 101.80) (61 FR 43433, requirements of §§ 101.14(b) (21 CFR petitioner (section 403(r)(4)(A)(i) of the August 23, 1996) (the 1996 final rule), 101.14(b)) and 101.80 and that provides act and 21 CFR 101.70(j)(3)(iii)). On relating sugar alcohols to the evidence that the additional March 5, 2007, FDA and the petitioner nonpromotion of dental caries, noncariogenic carbohydrate sweetener mutually agreed to extend the deadline completed the first rulemaking that FDA will not lower dental plaque pH below for the agency’s decision on the petition conducted in response to a health claim 5.7 (61 FR 43433 at 43442). Section until September 5, 2007. The petitioner petition (Docket No. 1995P–0003). 101.80 was first amended in 1997 to list requested that FDA consider exercise of Section 101.80 (the dental caries health the sugar alcohol erythritol as an its authority under section 403(r)(7) of claim) was subsequently amended, to additional noncariogenic carbohydrate the act to make the amendment to expand the substances which are the sweetener eligible for the claim (62 FR § 101.80 effective upon publication. 63653, December 2, 1997). The petition subject of the claim, to include B. Nature of the Substance noncariogenic carbohydrate sweeteners to list erythritol in § 101.80 (Docket No. other than sugar alcohols (67 FR 71461, 1997P–0206) presented scientific data The petitioner identified the December 2, 2002) (the 2002 from a rodent cariogenicity study and substance, which is the subject of the amendment). Section 101.80(a) from a human in vivo indwelling plaque petitioned health claim, to be describes the role of fermentable pH test of erythritol. The agency was isomaltulose. Isomaltulose (CAS Reg. carbohydrates, (i.e., most dietary sugars satisfied that this evidence was No. 13718–94–0) (6-O-a-D- and starches), in the development of consistent with the results of the studies glucopyranosyl-D-fructose) is a dental caries.
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