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.

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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. The fermentation of these that investigated the cariogenic disaccharide sugar. The petitioner carbohydrates by microorganisms potential of the substances previously identified the intended food use of produces organic acids on the surface of listed in § 101.80(c)(2)(ii)(A) and that isomaltulose as a nutritive sweetener. A teeth, which contribute to the erythritol met the requirements of 2005 generally recognized as safe development of dental caries through § 101.14(b). Therefore, erythritol was (GRAS) notification to FDA (Ref. 2) erosion of tooth enamel. Section added to the list of sugar alcohols identified use of isomaltulose as a 101.80(b) explains that some eligible as a noncariogenic carbohydrate nutritive sweetener in a variety of foods carbohydrate sweeteners, such as sugar sweetener. Section 101.80 was again to have been determined to be GRAS for alcohols, are relatively noncariogenic amended in the 2002 amendment to add food use. For the purpose of a health because they are fermented by oral D-tagatose, a non-fermentable sugar, to claim, the term ‘‘substance’’ has been microorganisms more slowly than are the list of substances eligible for the defined as ‘‘* * * a specific food or fermentable carbohydrates and health claim. This action was based component of food * * *’’ consequently, the rate of acid upon clinical evidence that ingestion of (§ 101.14(a)(2)). An ingredient added to production is lower than that from D-tagatose would not lower plaque pH a food as a sweetener is a component of fermentable carbohydrates. below 5.7 as measured by the food. As such, FDA concludes that Noncariogenic carbohydrate sweeteners, indwelling plaque pH method. Because isomaltulose is a ‘‘substance’’ as defined when used in place of fermentable D-tagatose is a sugar, not a sugar in § 101.14(a)(2) for the purpose of food sugars, are useful in that they do not alcohol, the 2002 amendment also labeling, which characterizes the promote dental caries as do the sugars changed the title of the regulation from relationship of any substance to a they replace. Section 101.80(c) describes ‘‘sugar alcohols’’ to ‘‘noncariogenic disease or health-related condition. the specific requirements of the dental carbohydrate sweeteners.’’ The most C. Review of Preliminary Requirements caries health claim, including the recent amendment of § 101.80 was to for a Health Claim requirement that the food bearing the list sucralose, a non-nutritive sweetener, claim be ‘‘sugar free’’ as an eligible noncariogenic sweetener 1. The Substance Is Associated With a (§ 101.80(c)(2)(iii)(A)). Section (71 FR 15559, March 29, 2006). Disease for Which the U.S. Population Is at Risk 101.80(c)(2)(ii) also lists 11 II. Petition and Grounds noncariogenic carbohydrate sweeteners Dental caries continues to affect a (xylitol, sorbitol, mannitol, maltitol, A. The Petition large segment of the U.S. population, isomalt, lactitol, hydrogenated starch On August 31, 2006, FDA received a notwithstanding its decline in recent hydrolysates, hydrogenated glucose health claim petition (Ref. 1) from years (Ref. 3). The U.S. Department of syrups, erythritol, D-tagatose, and Hyman, Phelps & McNamara, P.C., Health and Human Services’ Healthy sucralose) that are eligible for the claim. submitted on behalf of Cargill, Inc. People 2010 Objectives recognizes Section 101.80(c)(2)(iii)(C) further states (petitioner), under section 403(r)(4) of dental caries as the single most common that, ‘‘When carbohydrates other than the act (21 U.S.C. 343(r)(4)). The chronic disease during childhood, and those listed in paragraph (c)(2)(ii) of this petition requested that FDA amend states that 30 percent of adults have section are present in the food, the food § 101.80 to authorize a noncariogenic untreated dental decay (Ref. 4). Based

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on these facts, FDA concludes that, as isomaltulose stated in the 2005 GRAS noted in the preamble to the 1996 final required in § 101.14(b)(1), dental caries notification include use as a nutritive rule that it would take action to add is a disease for which the general U.S. sweetener in the following food additional sugar alcohols to § 101.80 population is at risk. categories: Baked goods and baking when presented, in part, with evidence mixes (§ 170.3(n)(1)); beverages that the additional sugar alcohols would 2. The Substance Is a Food (§ 170.3(n)(2) and (n)(3)); cereal-based not lower plaque pH (i.e., raise plaque When a health claim involves products (§ 170.3(n)(4)); chewing gum acidity) below 5.7 (61 FR 43433 at consumption of a substance at other (§ 170.3(n)(6)); confectionery and 43442). FDA has subsequently amended than decreased dietary levels, the frostings (§ 170.3(n)(9)); frozen dairy § 101.80 on three occasions to list substance that is the subject of the desserts and mixes (§ 170.3(n)(20)); fruit additional noncariogenic sweeteners in health claim must contribute taste, and water ices (§ 170.3(n)(21)); gelatins, the regulation. The three added aroma, or nutritive value, or any other desserts, and puddings, etc. noncariogenic sweeteners include a technical effect listed in § 170.3(o) (21 (§ 170.3(n)(22)); jams, jellies, and sugar alcohol (erythritol), a sugar (D- CFR 170.3(o)) to the food, and must spreads (§ 170.3(n)(28)); milk products tagatose), and a non-nutritive sweetener retain that attribute when consumed at (§ 170.3(n)(31)); nuts and peanut (sucralose). Although the noncariogenic the levels that are necessary to justify a spreads (§ 170.3(n)(32)); processed fruit sweeteners that were initially the claim (§ 101.14(b)(3)(i)). The petitioner and fruit juices or vegetable juices subject of the health claim were all stated that the intended use of (§ 170.3(n)(35)) and (n)(36)); snack foods sugar alcohols, FDA has amended isomaltulose in food is as a nutritive (§ 170.3(n)(37)); sugar substitutes § 101.80 to list additional noncariogenic sweetener. Isomaltulose contributes (§ 170.3(n)(42)); and sweet sauces, sweeteners that are not sugar alcohols. taste (sweetness), nutritive value (source toppings, and syrups (§ 170.3(n)(43)). When doing so, FDA also changed the of calories), and a technical effect Other categories include nutritive title of the health claim from ‘‘Dietary (nutritive sweetener) listed in formulas at 5 to 20 percent, energy- Sugar Alcohols and Dental Caries’’ to § 170.3(o)(21) to the food and retains reduced foods at 5 to 40 percent, and ‘‘Dietary Noncariogenic Carbohydrate these attributes when consumed at meal replacements/slimming foods at 5 Sweeteners and Dental Caries.’’ levels that are necessary to justify a to 20 percent. Furthermore, FDA is not Isomaltulose, the subject of the claim. Thus, the agency concludes that aware of any scientific evidence that current petition, is a sugar. As is the the preliminary requirement of isomaltulose, under the intended case with the noncariogenic sweeteners § 101.14(b)(3)(i) is satisfied. conditions of use, would be harmful. now listed in the dental caries health 3. The Substance Is Safe and Lawful The agency has not made its own claim, the potential dental health Section 101.14(b)(3)(ii) requires that determination regarding the GRAS benefit from isomaltulose derives from for a substance to be eligible for a health status of isomaltulose, however, and its lower fermentability relative to most claim, it must be a food or a food notes that authorization of a health sugars used as food ingredients. ingredient or a component of a food claim for a substance should not be Consequently, the criteria that FDA ingredient whose use at the levels interpreted as affirmation that the use of used to evaluate the other noncariogenic necessary to justify a claim has been the substance is GRAS. FDA concludes sweeteners in the existing dental caries demonstrated by the proponent of a that the use of isomaltulose in food as health claim can be applied to assess claim, to FDA’s satisfaction, to be safe a nutritive sweetener at levels necessary whether isomaltulose also qualifies for and lawful under the applicable food to justify the claim and in accordance the health claim. with the 2005 GRAS notification safety provisions of the act. FDA B. Review of Scientific Evidence evaluates whether the substance is ‘‘safe demonstrates to FDA’s satisfaction that and lawful’’ under the applicable food such use is safe and lawful under 1. Evidence Considered in Reaching the safety provisions of the act. For applicable food safety provisions of the Decision conventional foods, this evaluation act. Therefore, FDA concludes that the The recognized role of sucrose in the involves considering whether the preliminary requirements in etiology of dental caries is related to the ingredient that is the source of the § 101.14(b)(3)(ii) are satisfied. ability of sucrose to be metabolized by substance is GRAS, approved as a food III. Review of Scientific Evidence of the oral bacteria into extracellular polymers additive, or authorized by a prior Substance-Disease Relationship that adhere firmly to the tooth surfaces sanction issued by FDA (see § 101.70(f)). (i.e., dental plaque), and at the same The petitioner asserts that there is A. Basis for Evaluating the Relationship time to form acids that can demineralize general recognition of safety, based Between Isomaltulose and Dental Caries tooth enamel (Ref. 5). FDA initially upon scientific procedures, for the use As recognized in § 101.80, certain proposed to authorize a health claim of isomaltulose as a nutritive sweetener carbohydrate sweeteners are relatively relating noncariogenic carbohydrate in food. FDA previously received a noncariogenic compared to fermentable sweeteners and nonpromotion of dental notice on November 1, 2005, informing carbohydrates such as starch and most caries (60 FR 37507, July 20, 1995), FDA that SU¨ DZUCKER AG, Mannheim/ sugars. The relationship between based on scientific evidence from Ochsenfurt, had determined through noncariogenic sweeteners and dental studies evaluating changes in human scientific procedures that use of caries involves slower fermentation by dental plaque pH, plaque acid isomaltulose as a nutritive sweetener in oral bacteria than that of the dietary production, decalcification or a variety of foods is GRAS (the 2005 sugars they replace. Noncariogenic remineralization of tooth enamel, and GRAS notification). FDA issued a letter sweeteners do not promote the the incidence of dental caries. FDA on March 20, 2006 (Ref. 2), in response development of dental caries because limited its review to these types of to this notice stating that the agency had the amount and rate of organic acids studies because previous reviews by the no questions at the time regarding resulting from their metabolism by oral Federal Government and other SU¨ DZUCKER’s conclusion that bacteria is sufficiently less than that of authorities had focused on these areas, isomaltulose is GRAS under the the fermentable carbohydrates, and they and the majority of research efforts have intended conditions of use. The do not cause the loss of minerals from also focused on these areas (60 FR intended conditions of use for tooth enamel. (§ 101.80(b)) The agency 37507 at 37523). FDA concluded that

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human studies showing sugar alcohols control procedures was known. Each effects of slowly fermentable to be associated with reduced rate of subject had a miniaturized glass pH- carbohydrates, are sufficient to enable acid production in dental plaque electrode implanted in a dental the agency to evaluate whether relative to sucrose and, in some studies, prosthesis. Once the plaque pH isomaltulose should be added to the list a reduced incidence of dental caries, telemetric prosthesis was inserted, it of substances eligible for the dental were evidence for the association of remained in place throughout the test caries health claim. sugar alcohols and a reduced risk of period. Test subjects refrained from all developing dental caries (60 FR 37507 at oral hygiene practices, except for water IV. Decision to Authorize a Health 37523). In the 1996 final rule, FDA rinses, to allow a 3 to 7 day undisturbed Claim Relating Isomaltulose to the noted that it would take action to add growth of interdental plaque to Nonpromotion of Dental Caries other sweeteners to the list of accumulate over the tips of the pH FDA previously concluded that there substances eligible for this health claim electrodes. was significant scientific agreement when presented with a petition that Baseline plaque pH was measured among qualified experts to support the included, in part, evidence that the over a 15 minute period following a 3 relationship between certain substance would not lower plaque pH minute period of chewing paraffin. Test noncariogenic carbohydrate sweeteners below 5.7 (61 FR 43433 at 43442). FDA subjects then rinsed for 2 minutes with (e.g., some sugar alcohols, D-tagatose, did not specify a specific method to be 15 milliliters (mL) of a 10 percent and sucralose) and the nonpromotion of used in measuring plaque pH for aqueous solution of isomaltulose; or dental caries. The principal evidence considering the addition of other alternatively sucking a 1.5 gram (g) that substantiates this relationship is in sweeteners to the list of eligible tablet of pressed isomaltulose. Plaque vivo data on the effects of noncariogenic substances for this health claim. pH response to isomaltulose was carbohydrate sweeteners on human However, in order for a food that recorded for 30 minutes following dental plaque pH (§ 101.80(b)). The contains both noncariogenic sweeteners isomaltulose exposure. The paraffin current petition based its assertion that and fermentable carbohydrates to chew/rinse sequence was then repeated isomaltulose is noncariogenic on qualify for this health claim, using a 10 percent sucrose rinse instead evidence from an indwelling telemetric § 101.80(c)(2)(iii)(C) specifies that an of isomaltulose. The sucrose rinse plaque pH assay of the cariogenic indwelling pH electrode method of serves as a positive control to potential of isomaltulose. As discussed measuring dental plaque pH is the demonstrate the accurate functioning of in section III of this document, the procedure that the agency will use to the pH telemetric equipment and of plaque pH assay demonstrated that verify that a food bearing the health plaque metabolism. isomaltulose did not result in decreases claim does not result in a lowering of The study report commented that in plaque pH below the critical level of dental plaque pH below 5.7. The current baseline plaque pH values measured pH 5.7, when introduced as either an petition included a report (Ref. 1, following paraffin chewing coincide aqueous solution or as a tablet, and Appendix B) from an assay of the with those found in earlier tests with therefore, would be considered to not cariogenic potential of isomaltulose the same test subjects. The study report promote demineralization of dental which used the indwelling pH electrode also commented that the observed enamel. The results of the isomaltulose method of measuring dental plaque pH decrease of plaque pH subsequent to the plaque pH assay are consistent with the specified in § 101.80(c)(2)(iii)(C). This is sucrose rinse (lowest pH value range evidence relied upon by the agency the same type of evidence FDA was 4.40 to 4.90) demonstrates the when adding other noncariogenic considered previously in its decisions to accurate functioning of the pH sweeteners to the list of sweeteners amend § 101.80 to list D-tagatose (67 FR telemetric equipment and of plaque eligible for this health claim. Therefore, 71461) and sucralose (71 FR 15559). metabolism on the telemetric prosthesis. based on the totality of publicly The lowest interdental plaque pH available evidence pertaining to the 2. Review of Isomaltulose recorded among the six test subjects Noncariogenic Assay Data cariogenic potential of isomaltulose and during the 30 minutes following the to the relationship between dental The petition included a report (Ref. 1, isomaltulose rinse ranged from 6.00 to plaque pH and dental caries, FDA Appendix B) of an in vivo assay of the ± ± 6.35 (6.19 0.12, mean standard concludes that there is significant cariogenic potential of isomaltulose. deviation, n=6). The lowest interdental scientific agreement that isomaltulose This assay was conducted following the plaque pH recorded among the six test does not promote dental caries. protocol described in ‘‘Identification of subjects during the 30 minutes Accordingly, FDA is amending § 101.80 Low Caries Risk Dietary Components,’’ following the isomaltulose tablet ranged to authorize extending the dental caries by T. Imfield, vol. 11, Monographs in from 5.80 to 6.65 (6.38 ± 0.39, mean ± health claim to include isomaltulose. Oral Science, 1983, which is standard deviation, n=4). The study incorporated by reference in the dental report concluded that no critical V. Description of Modifications to caries health claim decrease (i.e., below pH 5.7) in the § 101.80 (§ 101.80(c)(2)(iii)(C)). This protocol interdental plaque pH due to bacterial A. Requirements provides for the continuous telemetric fermentation of isomaltulose occurred recording of plaque pH in vivo. The test following either the rinsing with 15 mL Specific requirements for use of the was conducted for Cerestar R & D of a 10 percent solution of isomaltulose dental caries health claim are provided Center, Vilvoorde, Belgium, by the nor the sucking of a 1.5 g tablet of in § 101.80(c)(2). Section 101.80(c)(2)(ii) University of Zurich, Dental Institute, pressed isomaltulose. Although this lists noncariogenic carbohydrate Clinic of Preventive Dentistry, report of an in vivo dental plaque pH sweeteners eligible for the health claim. Periodontology and Cariology, test of isomaltulose constitutes a limited Eligible sugar alcohols, sugars, and non- Bioelectric Unit. body of scientific evidence on the nutritive sweeteners are listed in The plaque pH telemetry assays were cariogenic potential of isomaltulose, § 101.80(c)(2)(ii)(A), (B), and (C), performed with six test subjects in good FDA is satisfied that this report, in respectively. FDA is amending general health. All test subjects had conjunction with the information § 101.80(c)(2)(ii)(B) to include previously participated in similar previously considered by the agency on isomaltulose as an additional eligible studies and their response to positive the etiology of dental caries and the noncariogenic sugar. Section

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101.80(c)(2)(iii) specifies eligibility between-meal consumption of foods all noncariogenic carbohydrate criteria for a food to bear the health high in sugars and starches and the sweeteners. FDA concludes that claim on its label. The first criterion in promotion of dental caries authorizing the petition by adding only this paragraph is that the food be ‘‘sugar (§ 101.80(c)(2)(i)(A)), and (2) isomaltulose to the dental caries health free,’’ as defined in § 101.60(c)(1)(i), identification of the substance by name claim is the best option of those except that the food may contain D- or as a sugar alcohol identified. tagatose (§ 101.80(c)(2)(iii)(A)). FDA is (§ 101.80(c)(2)(i)(C)). The ‘‘shortened Option One: Deny the Petition amending § 101.80(c)(2)(iii)(A) to claim’’ version, however, does not omit The agency can only define costs and include isomaltulose, in addition to D- the requirement that when a benefits relative to a baseline, and FDA tagatose, in the exception to the ‘‘sugar noncariogenic sugar is the subject of the usually selects the option of taking no free’’ criterion of eligible foods. claim, the substance be identified in the action as the baseline because it helps claim statement as a sugar. As such, the readers identify the costs and benefits of B. Model Health Claims model ‘‘shortened claims’’ provided by actions that change the status quo. In Section 101.80(e) provides examples FDA in § 101.80(e)(2) identify by name this case, denying the petition would of statements that meet the requirements either tagatose or isomaltulose. correspond to taking no action because to make a health claim about it would imply no change in the dental nonpromotion of dental caries. FDA VI. Analysis of Impacts caries health claim and thus the emphasizes that these ‘‘model health FDA has examined the impacts of the continuation of the status quo. By claims’’ are illustrative only. These interim final rule under Executive Order definition, the baseline itself has no model claims illustrate both the 12866 and the Regulatory Flexibility Act costs or benefits. This does not mean elements of the health claim statement (5 U.S.C. 601–612), and the Unfunded that FDA ignores the costs and benefits required under § 101.80(c)(2)(i) and Mandates Reform Act of 1995 (Pub. L. of the baseline. Instead, it means that some of the optional elements permitted 104–4). Executive Order 12866 directs the agency expresses the costs and under § 101.80(d). FDA is amending agencies to assess all costs and benefits benefits of the baseline in how it § 101.80 to add isomaltulose as an of available regulatory alternatives and, calculates the costs and benefits of the additional noncariogenic carbohydrate when regulation is necessary, to select other regulatory options. sweetener eligible for the health claim, regulatory approaches that maximize Option Two: Authorize the Petition and is not approving specific wording of net benefits (including potential (Add Only Isomaltulose to § 101.80) claim statements. Manufacturers economic, environmental, public health This option would allow producers continue to be free to design their own and safety, and other advantages; who use isomaltulose to use the dental claim so long as it is consistent with distributive impacts; and equity). The caries health claim on their product agency regulations. agency believes that this interim final labels under certain conditions. Under § 101.80(c)(2)(i)(H), there is a rule is not a significant regulatory action Producers would only choose to change requirement that when the substance as defined by the Executive order. product labels or reformulate products if that is the subject of the claim is a The Regulatory Flexibility Act they believe that doing so will increase noncariogenic sugar, the claim shall requires agencies to analyze regulatory profits more than the costs of making identify the substance as a sugar that, options that would minimize any those changes. Providing this unlike other sugars, does not promote significant impact of a rule on small information may increase profits for the development of dental caries. This entities. Because this interim final rule some producers because some requirement was added to § 101.80, concerns voluntary claims, the agency consumers may find this information along with the addition of the sugar D- certifies that the interim final rule will valuable when choosing products. Some tagatose as a sweetener eligible for the not have a significant economic impact consumers may find this information claim, to address the potential on a substantial number of small valuable because it may allow them to incongruity arising from a sugar- entities. reduce their risk of dental carries. FDA containing food bearing a dental caries Section 202(a) of the Unfunded has determined that this information health claim stating that foods high in Mandates Reform Act of 1995 requires has sufficient scientific support and, sugars promote tooth decay. The model that agencies prepare a written when provided in labeling under certain health claim examples in statement, which includes an conditions, is truthful and not § 101.80(e)(1)(iii) and (iv) and assessment of anticipated costs and misleading to consumers. Therefore, § 101.80(e)(2)(iii) and (iv) are examples benefits, before proposing ‘‘any rule that using the claims will not generate of health claim statements for use with includes any Federal mandate that may offsetting costs for consumers. The D-tagatose-containing foods. FDA is result in the expenditure by State, local, agency does not know how many revising these model health claims to and tribal governments, in the aggregate, producers will find it worthwhile to use change from the specific sugar or by the private sector, of $100,000,000 this claim. However, if this interim final ‘‘tagatose’’ to ‘‘name of a sugar from or more (adjusted annually for inflation) rule is finalized without change, it is paragraph (c)(2)(ii)(B) of this section’’ to in any one year.’’ The current threshold sure that to whatever extent producers be inclusive of either tagatose or after adjustment for inflation is $122 use the claim, both producers and isomaltulose, or other noncariogenic million, using the most current (2005) consumers will be made better off under sugars that may be added to the rule in Implicit Price Deflator for the Gross option two than under option one. The the future. Domestic Product. FDA does not expect agency can conclude that adding Current § 101.80(e)(1) consists of this interim final rule to result in any 1- isomaltulose to the dental caries health examples of the full claim, and year expenditure that would meet or claim will generate either a net increase § 101.80(e)(2) consists of examples of exceed this amount. in social benefits or, if no producers the shortened claim for use on packages FDA identified the following three find it worthwhile to use the claims, no with less than 15 square inches of options regarding this petition: (1) Deny impact on social welfare. surface area available for labeling. The the petition, (2) authorize the petition Option Three: Add Isomaltulose to ‘‘shortened claim’’ version provided for (add only isomaltulose to § 101.80), or § 101.80 and Also Expand the Scope of in § 101.80(c)(2)(i)(G) may omit: (1) (3) add isomaltulose to § 101.80 and also the Claim to Include All Noncariogenic Stating the relationship of frequent expand the scope of the claim to include Carbohydrate Sweeteners

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This option would allow producers supported by the totality of publicly those required by this interim final rule, who use isomaltulose and all other available scientific evidence. this preemptive effect is consistent with noncariogenic carbohydrate sweeteners what Congress set forth in section 403A VII. Environmental Impact to use the dental caries health claim on of the act. Section 403A(a)(5) of the act their product labels under certain The agency has determined under 21 displaces both State legislative conditions rather than just listing CFR 25.32(p) that this action is of a type requirements and State common law specific individual sweeteners. Similar that does not individually or duties. Medtronic v. Lohr, 518 U.S. 470, to option two, producers would only cumulatively have a significant effect on 503 (1996) (Breyer, J., concurring in part choose to change product labels or the human environment. Therefore, and concurring in judgment); id. at 510 reformulate products if they believe that neither an environmental assessment (O’Connor, J., joined by Rehnquist, C. J., the benefits that they will derive from nor an environmental impact statement Scalia, J., and Thomas, J., concurring in doing so are at least as great as the costs is required. part and dissenting in part); Cipollone v. of making those changes. In addition, VIII. Paperwork Reduction Act Liggett Group, Inc., 505 U.S. 504, 521 this option would reduce the future (1992) (plurality opinion); id. at 548–49 burden on manufacturers of petitioning FDA concludes that the labeling (Scalia, J., joined by Thomas, J., FDA to use the dental caries health provisions of this interim final rule are concurring in judgment in part and claim for additional noncariogenic not subject to review by the Office of dissenting in part). carbohydrate sweeteners, and it would Management and Budget because they FDA believes that the preemptive also reduce FDA’s burden of evaluating do not constitute a ‘‘collection of effect of this interim final rule is each petition for each individual information’’ under the Paperwork consistent with Executive Order 13132. noncariogenic carbohydrate sweetener. Reduction Act of 1995 (44 U.S.C. 3501– Section 4(e) of the Executive order 3520). Rather, the food labeling health However, FDA does not know the provides that ‘‘when an agency proposes claim on the association between identity of all the sweeteners that may to act through adjudication or consumption of isomaltulose and the fall under the category of ‘‘all rulemaking to preempt State law, the nonpromotion of dental caries is a noncariogenic carbohydrate agency shall provide all affected State ‘‘public disclosure of information sweeteners.’’ Thus, FDA would have to and local officials notice and an originally supplied by the Federal extrapolate the data applicable to the opportunity for appropriate Government to the recipient for the known noncariogenic carbohydrate participation in the proceedings.’’ FDA purpose of disclosure to the public’’ (see sweeteners to unknown noncariogenic provided the States with an opportunity 5 CFR 1320.3(c)(2)). carbohydrate sweeteners in that for appropriate participation in this category, even though the science may IX. Federalism rulemaking on August 1, 2007, when not support such an extrapolation. By FDA’s Division of Federal and State FDA has analyzed this interim final Relations provided notice via fax and e- expanding the use of the claim to all rule in accordance with the principles mail transmission to State health noncariogenic carbohydrate sweeteners set forth in Executive Order 13132. FDA commissioners, State agriculture without reviewing the scientific data on has determined that the rule has a commissioners, food program directors, each individual sweetener, FDA would preemptive effect on State law. Section and drug program directors as well as not be able to verify that the claim was 4(a) of the Executive order requires FDA field personnel of FDA’s intent to being used under circumstances where agencies to ‘‘construe * * * a Federal amend the health claim regulation it is truthful and not misleading to statute to preempt State law only where authorizing health claims for consumers. If producers used the the statute contains an express noncariogenic carbohydrate sweeteners expanded claim on a product that was, preemption provision or there is some and dental caries (§ 101.80). It advised in fact, not noncariogenic, then the other clear evidence that the Congress the States of FDA’s possible action and expanded claim could actually result in intended preemption of State law, or encouraged the States and local an increase in the number of dental where the exercise of State authority governments to review the notice and to caries. conflicts with the exercise of Federal provide any comments to the docket Based on these considerations, FDA authority under the Federal statute.’’ (Docket No. 2006P–0487), until cannot conclude that the potential cost Section 403A of the act (21 U.S.C. 343– September 1, 2007. FDA received no savings of option three would 1) is an express preemption provision. comments from any States in response necessarily outweigh the increased risk Section 403A(a)(5) of the act provides to the fax and e-mail transmission. FDA of producers making a false or that: is also providing an opportunity for misleading claim under the expanded * * * no State or political subdivision of State and local officials to comment on claim. Therefore, FDA cannot conclude a State may directly or indirectly establish this interim final rule. that option three would be better for under any authority or continue in effect as In conclusion, the agency has to any food in interstate commerce—*** social welfare than option two. determined that the preemptive effects In addition, the agency notes that it (5) any requirement respecting any claim of the type described in section 403(r)(1) made of this interim final rule are consistent does not believe this option is legally in the label or labeling of food that is not with Executive Order 13132. feasible. FDA believes that expanding identical to the requirement of section 403(r) the dental caries health claim to all *** X. Issuance of an Interim Final Rule carbohydrate sweeteners without This interim final rule amends and Immediate Effective Date reviewing the scientific data supporting existing food labeling regulations to add FDA is issuing this rule as an interim such a claim of noncariogenicity for isomaltulose to the authorized health final rule, effective immediately, with each individual carbohydrate sweetener claim for noncariogenic carbohydrate an opportunity for public comment. would be a failure to carry out FDA’s sweeteners and dental caries. Although Section 403(r)(7) of the act authorizes us statutory responsibility under section this rule has a preemptive effect in that to make proposed regulations issued 403(r)(3)(B) of the act to issue health it precludes States from issuing any under section 403(r) of the act effective claim regulations only when FDA health claim labeling requirements for upon publication pending consideration determines that there is significant isomaltulose and the nonpromotion of of public comment and publication of a scientific agreement that the claim is dental caries that are not identical to final regulation, if the agency

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determines that such action is confirm or amend the interim final rule Authority: 15 U.S.C. 1453, 1454, 1455; 21 necessary. This authority enables the in a final rule. U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. agency to act promptly on petitions that 243, 264, 271. XI. Comments provide for information that is necessary I 2. Section 101.80 is amended by to: (1) Enable consumers to develop and Interested persons may submit to the revising paragraphs (c)(2)(ii)(B), maintain healthy dietary practices, (2) Division of Dockets Management (see (c)(2)(iii)(A), (e)(1)(iii), (e)(1)(iv), enable consumers to be informed ADDRESSES) written or electronic promptly and effectively of important (e)(2)(iii), and (e)(2)(iv) to read as comments regarding this document. follows: new knowledge regarding nutritional Submit a single copy of electronic and health benefits of food, or (3) ensure comments or two paper copies of any § 101.80 Health claims: dietary that scientifically sound nutritional and mailed comments, except that noncariogenic carbohydrate sweeteners health information is provided to individuals may submit one paper copy. and dental caries. consumers as soon as possible. Comments are to be identified with the * * * * * Proposed regulations made effective docket number found in brackets in the (c) * * * upon publication under this authority heading of this document. Received are deemed to be final agency action for comments may be seen in the Division (2) * * * purposes of judicial review. The of Dockets Management between 9 a.m. (ii) * * * legislative history indicates that such and 4 p.m., Monday through Friday. regulations should be issued as interim (B) The sugars D-tagatose and final rules (H. Conf. Rept. No. 105–399, XII. References isomaltulose. at 98 (1997)). * * * * * The petitioner requested the agency to The following references have been consider making any proposed placed on display in the Division of (iii) * * * regulation on the petitioned health Dockets Management (see ADDRESSES) (A) The food shall meet the claim effective upon publication of an and may be seen by interested persons requirement in § 101.60(c)(1)(i) with interim final rule. FDA acknowledges between 9 a.m. and 4 p.m., Monday respect to sugars content, except that the that all three of the criteria in section through Friday. food may contain D-tagatose or 403(r)(7)(A) of the act have been met in 1. Cargill, Inc., ‘‘Petition to Amend 21 CFR isomaltulose. 101.80 to Authorize a Noncariogenicity the petition submitted by Hyman, * * * * * Phelps & McNamara, P.C. on behalf of Dental Health Claim for Isomaltulose,’’ Docket No. 2006P–0487, August 31, 2006. (e) * * * Cargill, Inc. The health claim will 2. Agency Response Letter to GRAS Notice enable consumers to develop and No. GRN 000184, Food and Drug (1) * * * maintain healthy dietary practices, such Administration, Center for Food Safety and (iii) Frequent eating of foods high in as limiting snacks that contain Applied Nutrition, Office of Food Additive sugars and starches as between-meal fermentable sugars. The health claim Safety, March 20, 2006. Available at: http:// snacks can promote tooth decay. [Name also will provide consumers with www.cfsan.fda.gov/~rdb/opa-g184.html. important knowledge regarding the 3. U.S. Department of Health and Human of sugar from paragraph (c)(2)(ii)(B) of reduced cariogenic potential of Services, Oral Health in America: A Report this section], the sugar used to sweeten isomaltulose relative to that of other of the Surgeon General—Executive Summary, this food, unlike other sugars, may sugars, and will provide consumers Rockville, MD, National Institute of Dental reduce the risk of dental caries. and Craniofacial Research, National Institutes with scientifically sound information on of Health, May 2000. Available at: http:// (iv) Frequent between-meal the dental health benefits of foods www2.nidcr.nih.gov/sgr/execsumm.htm. consumption of foods high in sugars containing isomaltulose. Therefore, FDA 4. U.S. Department of Health and Human and starches promotes tooth decay. is using the authority given to us in Services, ‘‘Oral Health,’’ chapter 21, Healthy [Name of sugar from paragraph section 403(r)(7)(A) of the act to issue an People 2010, vol. II, part B, 2d ed., (c)(2)(ii)(B) of this section], the sugar in interim final rule authorizing a health Washington, DC., U.S. Government Printing [name of food], unlike other sugars, does Office, November 2000. Available at: http:// claim for isomaltulose and the not promote tooth decay. nonpromotion of dental caries, effective www.healthypeople.gov/document/html/ immediately. volume2/21oral.htm. * * * * * FDA invites public comment on this 5. Medline Plus Medical Encyclopedia, (2) * * * interim final rule. The agency will ‘‘Dental Cavities.’’ Available at U.S. National Library of Medicine and the National (iii) [Name of sugar from paragraph consider modifications to this interim Institutes of Health MedlinePlus: http:// (c)(2)(ii)(B) of this section] sugar does final rule based on comments made www.nlm.nih.gov/medlineplus/ency/article/ not promote tooth decay. during the comment period. Interested 001055.htm. persons may submit to the Division of (iv) [Name of sugar from paragraph Dockets Management, in any of the List of Subjects in 21 CFR Part 101 (c)(2)(ii)(B) of this section] sugar may ways noted in the ADDRESSES section at reduce the risk of tooth decay. Food labeling, Nutrition, Reporting the beginning of this document, and recordkeeping requirements. Dated: September 6, 2007. comments regarding this interim final Jeffrey Shuren, rule by December 3, 2007. Comments I Therefore, under the Federal Food, are to be identified with the docket Drug, and Cosmetic Act and under Assistant Commissioner for Policy. number found in brackets in the authority delegated to the Commissioner [FR Doc. E7–18196 Filed 9–14–07; 8:45 am] heading of this document. Received of Food and Drugs, 21 CFR part 101 is BILLING CODE 4160–01–S comments may be seen in the Division amended as follows: of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. PART 101—FOOD LABELING This regulation is effective upon publication in the Federal Register. The I 1. The authority citation for 21 CFR agency will address comments and part 101 continues to read as follows:

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