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Federal Register / Vol. 62, No. 131 / Wednesday, July 9, 1997 / Proposed Rules 36749

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Federal Register / Vol. 62, No. 131 / Wednesday, July 9, 1997 / Proposed Rules 36749 Federal Register / Vol. 62, No. 131 / Wednesday, July 9, 1997 / Proposed Rules 36749 Inspector, who may add comments and then I. Background not lower plaque pH below 5.7. Therefore, send it to the Manager, Los Angeles ACO. before a claim can be made for a new sugar In the Federal Register of August 23, alcohol, it must be shown to meet the Note 2: Information concerning the 1996 (61 FR 43433), the agency adopted existence of approved alternative methods of requirements for § 101.80. When this is compliance with this AD, if any, may be a final rule to authorize the use, on food demonstrated, FDA will take action to add obtained from the Los Angeles ACO. labels and in food labeling, of health the substance to the list in this regulation, (c) Special flight permits may be issued in claims on the association between sugar which has been renumbered as accordance with sections 21.197 and 21.199 alcohols and dental caries (hereinafter § 101.80(c)(2)(ii)(B). of the Federal Aviation Regulations (14 CFR referred to as the sugar alcohol final The present rulemaking is in response 21.197 and 21.199) to operate the airplane to rule) (§ 101.80 (21 CFR 101.80)). FDA to a petition to amend a location where the requirements of this AD adopted this regulation in response to a § 101.80(c)(2)(ii)(B) to include erythritol can be accomplished. petition filed under section as one of the sugar alcohols that is Issued in Renton, Washington, on July 2, 403(r)(3)(B)(i) of the Federal Food, Drug, eligible to bear the sugar alcohol and 1997. and Cosmetic Act (the act) (21 U.S.C. dental caries health claim. Darrell M. Pederson, 343(r)(3)(B)(i)). Section 403(r)(3)(B)(i) of II. Petition for Health Claim on Acting Manager, Transport Airplane the act states that the Secretary of Erythritol and the Nonpromotion of Directorate, Aircraft Certification Service. Health and Human Services (and, by Dental Caries [FR Doc. 97±17848 Filed 7±8±97; 8:45 am] delegation, FDA) shall issue regulations BILLING CODE 4910±13±U authorizing health claims only if he or A. The Petition she determines, based on the totality of On April 4, 1997, the petitioners publicly available scientific evidence submitted a petition to FDA requesting DEPARTMENT OF HEALTH AND (including evidence from well-designed that the agency amend HUMAN SERVICES studies conducted in a manner which is § 101.80(c)(2)(ii)(B) to authorize a claim consistent with generally recognized to authorize a noncariogenicity dental Food and Drug Administration scientific procedures and principles), health claim for the sugar alcohol that there is significant scientific 21 CFR Part 101 erythritol. On May 16, 1997, the agency agreement, among experts qualified by sent the petitioner a letter stating that it [Docket No. 97P±0206] scientific training and experience to had completed its initial review of the evaluate such claims, that the claim is petition, and that the petition would be Food Labeling: Health Claims; Dietary supported by such evidence (see also filed in accordance with section Sugar Alcohols and Dental Caries § 101.14(c) (21 CFR 101.14(c))). 403(r)(4) of the act (see Docket 97P± The sugar alcohol final rule sets out 0206, Letter 1). The following is a AGENCY: Food and Drug Administration, the circumstances in which a sugar HHS. review of the health claim petition and alcohol is eligible to be the subject of a of whether erythritol satisfies the ACTION: Proposed rule. health claim (§ 101.80(c)(2)(ii)). Section requirements of §§ 101.80(c)(2)(ii) and 101.80(c)(2)(ii)(A) states that the food SUMMARY: The Food and Drug 101.14(b) and (c) of FDA's regulations. must meet the requirement for a sugar Administration (FDA) is proposing to free food defined in 21 CFR B. Preliminary Requirements amend the regulation that authorized a 101.60(c)(1)(i). Section health claim on sugar alcohols and 1. The Substance That Is the Subject of 101.80(c)(2)(ii)(B) lists the sugar dental caries to include the sugar the Petition alcohols that are eligible to bear the alcohol erythritol. FDA is proposing this claim, xylitol, sorbitol, mannitol, Erythritol is a 4-carbon, action in response to a petition filed by maltitol, isomalt, lactitol, hydrogenated monosaccharide polyhydric alcohol. It the Cerestar Holding B.V., Mitsubishi starch hydrolysates, hydrogenated occurs naturally in a wide variety of Chemical Corp., and Nikken Chemicals glucose syrups, or a combination of plants (e.g., watermelons, melons, Co. The agency has tentatively these. Section 101.80(c)(2)(ii)(C) states grapes, and mushrooms) and animals concluded that, based on the totality of that: (e.g., humans, dogs, and cows). publicly available scientific evidence [W]hen fermentable carbohydrates are Erythritol is also a product of the presented in the petition, erythritol does present in the sugar alcohol-containing food, fermentation by yeasts and molds of not promote dental caries. Therefore, the food shall not lower plaque pH below 5.7 sugars (Ref. 1, p. 27). FDA is proposing to amend the sugar by bacterial fermentation either during alcohol and dental caries health claim to consumption, or up to 30 minutes after 2. The Substance Is Associated With a include erythritol. consumption as measured by the indwelling Disease for Which the U.S. Population plaque pH test found in ``Identification of DATES: Written comments by September Is at Risk Low Caries Risk Dietary Components,'' * * * 22, 1997. The agency is proposing that which is incorporated by reference * * *. In the preamble to the proposed sugar any final rule that may issue based upon In the sugar alcohol final rule, the alcohol and dental caries rule (60 FR this proposal become effective upon its agency stated that for other sugar 37507 at 37509, July 20, 1995) and in publication in the Federal Register. alcohols to be included in the regulation authorizing the claim on ADDRESSES: Written comments to the § 101.80(c)(2)(ii)(B), a petitioner must sugar alcohols and dental caries Dockets Management Branch (HFA± show how the substance conforms to the (§ 101.80(a)(3)), FDA established that 305), Food and Drug Administration, requirements of §§ 101.14(b) and 101.80 dental caries is a disease for which the 12420 Parklawn Dr., rm. 1±23, (61 FR 43433 at 43442). FDA stated: U.S. population is at risk. The agency Rockville, MD 20857. For those substances that are to be stated: FOR FURTHER INFORMATION CONTACT: consumed at other than decreased dietary Dental caries is recognized in The Surgeon Joyce J. Saltsman, Center for Food Safety levels, the petitioner must demonstrate to General's Report on Nutrition and Health * * * as a disease or health-related condition and Applied Nutrition (HFS±165), Food FDA's satisfaction that the substance is safe and lawful under the applicable food safety for which the United States population is at and Drug Administration, 200 C St. SW., provisions of the act (§ 101.14(b)(3)(ii)). risk * * *. The overall prevalence of dental Washington, DC 20204, 202±205±5483. Likewise, the petitioner would need to caries imposes a substantial burden on SUPPLEMENTARY INFORMATION: provide evidence that the sugar alcohol will Americans. Of the 13 leading health 36750 Federal Register / Vol. 62, No. 131 / Wednesday, July 9, 1997 / Proposed Rules problems in the United States, dental The large body of published data supports a 15-minute period after the subjects diseases rank second in direct costs * * *. the conclusion that the intake of erythritol chewed a piece of paraffin for 3 Dental caries continues to affect a large would not be expected to cause adverse minutes. The subjects then sucked on proportion of Americans. Although there has effects in humans under the conditions of use the sugar-free throat lozenge containing been a decline in the prevalence of dental in food and that other qualified food safety caries among children in the United States, experts would agree that erythritol is erythritol, followed by plaque pH the disease remains widespread throughout generally recognized as safe (GRAS) under measurements over a 30-minute period. the population * * *. the conditions of its intended use in food. The same test procedure was then Based on these facts, FDA concludes The petitioner also asserted that repeated using a 10-percent sucrose that, as required in § 101.14(b)(1), dental erythritol occurs endogenously and rinse as the control substance in place caries is a disease for which the U.S. naturally in the diet, and that it has a of the erythritol lozenge. population is at risk. history of safe use in foods. The The results of this test showed that petitioner further argued that the safety after the first paraffin chew, baseline 3. The Substance Is a Food of erythritol is supported by its plaque pH measured between 6.9 to 7.0, In the preamble to the sugar alcohols chemical structure, i.e., it is positioned values that were similar to earlier tests proposed rule (60 FR 37507 at 37509) in the homologous series of sugar with the same subjects and plaque ages and in the final regulation itself alcohols, between glycerol and xylitol, a (Ref. 1, Appendix B-2). Following (§ 101.80(a)(4)), the agency states that series that also includes other common consumption of erythritol, plaque pH sugar alcohols can be used as food ingredients such as sorbitol and measured 6.0 to 6.65. The sucrose rinse sweeteners to replace dietary sugars, mannitol. caused plaque pH to drop to a range of such as sucrose and corn sweeteners, in Based on the totality of the evidence, 4.25 to 4.9, levels that were significantly foods such as chewing gums and certain the agency is not prepared, at this time, lower than pH of plaque during the confectioneries.
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