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Federal Register / Vol. 61, No. 165 / Friday, August 23, 1996 / Rules and Regulations 43433

4. Paragraph (b) of § 210.76 is revised to the nonpromotion of evaluate such claims, that the claim is to read as follows: dental caries are justified. FDA is supported by such evidence (see also announcing these actions in response to § 101.14(c)). FDA considered the § 210.76 Modification or rescission of a petition filed by the National relevant scientific studies and data exclusion orders, cease and desist orders, and consent orders. Association of presented in the petition as part of its Manufacturers, Inc., and an ad hoc review of the scientific literature on * * * * * working group of sugar sugar alcohols and dental caries. The (b) Commission action upon receipt of manufacturers (hereinafter referred to as agency summarized this evidence in the petition. The Commission may the petitioners). proposed rule (60 FR 37507). thereafter institute a proceeding to DATES: Effective January 1, 1998. The The proposed rule included modify or rescind the exclusion order, qualifying and disqualifying criteria for cease and desist order, or consent order Director of the Office of the Federal Register approves the incorporation by the purpose of identifying foods eligible by issuing a notice. The Commission to bear a health claim. The proposal also may hold a public hearing and afford reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of a certain specified mandatory content and label interested persons the opportunity to information for health claims statements appear and be heard. After publication in 21 CFR 101.80(c)(2)(ii)(C), effective January 1, and provided model health claims. In its consideration of the petition, any review of sugar alcohols eligibility for a responses thereto, and any information 1998. FOR FURTHER INFORMATION CONTACT: health claim under § 101.14(b), FDA placed on the record at a public hearing discussed potential safety issues relating or otherwise, the Commission shall take Joyce J. Saltsman, Center for Food Safety and Applied Nutrition (HFS–165), Food to sugar alcohols and the petitioners’ such action as it deems appropriate. The position that the use of sugar alcohols Commission may delegate any hearing and Administration, 200 C St. SW., Washington, DC 20204, 202–205–5916. is safe and lawful. The agency also under this section to the chief discussed the potential issue that some administrative law judge for designation SUPPLEMENTARY INFORMATION: -containing foods may of a presiding administrative law judge, I. Background contain other ingredients, such as who shall certify a recommended refined flour, that may be cariogenic. determination to the Commission. In the Federal Register of July 20, Consequently, the agency proposed to By Order of the Commission. 1995 (60 FR 37507), the agency require that sugar alcohol-containing Issued: August 19, 1996. proposed to authorize the use, on food foods not lower plaque pH below 5.7, as labels and in food labeling, of health Donna R. Koehnke, determined by appropriate in vivo tests. claims on the association between sugar FDA requested written comments on the Secretary. alcohols and the nonpromotion of [FR Doc. 96–21522 Filed 8–22–96; 8:45 am] proposed rule, including comments on dental caries. In addition, FDA the agency’s tentative conclusion that BILLING CODE 7020±02±P proposed to exempt sugar alcohol- the petitioners had satisfied the containing foods from the requirement requirements regarding the safe and in § 101.14(e)(6) (21 CFR 101.14(e)(6)) of lawful use of sugar alcohols that are the DEPARTMENT OF HEALTH AND the health claims general requirements subject of the health claim and HUMAN SERVICES regulation concerning disqualification comments on the proposal to establish criteria. Section 101.14(e)(6) provides Food and Drug Administration a minimum plaque pH test for sugar that, except for dietary supplements or alcohol-containing foods. 21 CFR Part 101 where provided for in other regulations in part 101 (21 CFR part 101), subpart II. Summary of Comments and the [Docket No. 95P±0003] E, to be eligible to bear a health claim, Agency’s Responses a food must contain 10 percent or more In response to the proposal, the Food Labeling: Health Claims; Sugar of the Reference Daily Intake (RDI) or agency received approximately 20 Alcohols and Dental Caries the Daily Reference Value (DRV) for letters, each containing one or more AGENCY: Food and Drug Administration, vitamin A, vitamin C, iron, calcium, comments, from professional HHS. protein, or fiber per reference amount organizations, industry, trade ACTION: Final rule. customarily consumed before there is associations, and health care any nutrient addition. professionals. Comments that were not SUMMARY: The Food and Drug The proposed rule was issued in relevant to the sugar alcohol and dental Administration (FDA) is announcing its response to a petition filed under caries proposed rule, but that addressed decision to authorize the use, on food section 403(r)(3)(B)(i) of the Federal broader issues pertaining to health labels and in food labeling, of health Food, Drug, and Cosmetic Act (the act) claims in general, are not discussed in claims on the association between sugar (21 U.S.C. 343(r)(3)(B)(i)). Section the sections of this document that alcohols and the nonpromotion of 403(r)(3)(B)(i) of the act states that the follow.A number of comments were dental caries. The agency has concluded Secretary of Health and Human Services received that dealt generally with the that, based on the totality of the (the Secretary) (and, by delegation, questions of whether health claims need scientific evidence, there is significant FDA) shall promulgate regulations to state that the disease or health-related scientific agreement among qualified authorizing health claims only if he or condition is multifactorial, and whether experts to support the relationship she determines, based on the totality of the whole claim needs to appear in one between sugar alcohols (i.e., , publicly available scientific evidence place. These issues of broad , , , , (including evidence from well-designed applicability to health claims are being , hydrogenated studies conducted in a manner which is considered in the rulemaking entitled hydrolysates (HSH), hydrogenated consistent with generally recognized ‘‘Food Labeling: Nutrient Content syrups (HGS), or a combination scientific procedures and principles), Claims, General Principles; Health of sugar alcohols) and the nonpromotion that there is significant scientific Claims, General Requirements and of dental caries. Therefore, FDA has agreement, among experts qualified by Other Specific Requirements for concluded that claims on foods relating scientific training and experience to Individual Health Claims’’ (60 FR 43434 Federal Register / Vol. 61, No. 165 / Friday, August 23, 1996 / Rules and Regulations

66206, December 21, 1995) (hereinafter The agency does not agree that the agents (i.e., stabilizers and thickeners) referred to as ‘‘the 1995 nutrient content proposed health claim is inconsistent and are consumed for their . and health claims proposed rule’’). with health claim principles. Sugar Inasmuch as sugar alcohols are also a Therefore, FDA forwarded the alcohols are nutrients of the type source of calories, they contribute comments in question to that docket for specified in section 403(q) of the act. nutritive value to the foods, such as consideration as part of that rulemaking. FDA lists them in § 101.9(c) (21 CFR chewing gums and , in The majority of the comments 101.9(c)) as one of the nutrients that can which they are used. received in response to the sugar be listed in the nutrition label. Thus, 2. One comment stated that the alcohol proposal agreed with one or they can be the subject of a health claim. proposed claim is not a health claim in more provisions of the proposed rule The issue of whether claims about the same sense that the other authorized without providing grounds for support sugar alcohols and dental caries are claims are because the substance’s effect other than those provided by FDA in the health claims was discussed in the is largely independent of other dietary preamble to the proposal. A few of these Federal Register of July 20, 1995 (60 FR practices, i.e., sugar alcohol-sweetened comments also requested modification 37502), final rule entitled ‘‘Food will always not promote tooth of one or more provisions of the Labeling: Label Statements on Foods for decay regardless of other elements in proposed rule. A few comments Special Dietary Use; ‘Useful Only in Not the diet. Another comment stated that disagreed with the proposed rule and Promoting ’ Disclaimer’’ the idea of instituting a health claim for provided specific support for their (hereinafter referred to as ‘‘the 1995 a substance that merely replaces a positions. The agency has summarized disclaimer final rule’’). The agency nutrient that may contribute to a disease and addressed the relevant issues raised pointed out that a health claim provides or health-related condition could open in all comments in the sections of this information about how a particular type the door to questionable claims. One document that follow. of substance (sugar alcohols) can affect comment stated that the nonpromotion a person’s risk of developing a diet- claim is a product descriptor that A. General Comments related diseases (dental caries). The provides information on the absence of Some comments addressed the basic ‘‘Useful Only in Not Promoting Tooth an undesirable side effect. The agency disagrees that the claim is issue of whether FDA should permit Decay’’ statement does what a health not valid because sugar alcohols health claims about sugar alcohol and claim does in that it tells a consumer function independently of other dietary dental caries on food labeling and the that including foods sweetened with sugar alcohols in his or her diet will practices, or because the substance claim’s consistency with the general affect his or her risk of developing replaces or can substitute for another principles for health claims. dental caries. substance. The comment did not 1. One comment stated that section Thus, in the 1995 disclaimer final demonstrate that sugar alcohols affect 403(r)(1)(B) of the act, which was added rule, the agency found that the the risk of dental caries in a way that is by the Nutrition Labeling and Education statement on tooth decay is a health independent of other dietary practices, Act of 1990 (the 1990 amendments), claim because it contains both elements or why, even if the did, this fact would defines ‘‘health claims’’ as those necessary to meet the ‘‘health claim’’ render the claim invalid. In fact, as statements that characterize ‘‘the definition under 403(r)(1)(B) of the act. explained in the proposed rule (60 FR relationship of any nutrient which is of FDA concluded that ‘‘useful only in not 37507 at 37524), the association the type required [to be in nutrition promoting tooth decay’’ is not a nutrient between sugar alcohols and dental labeling] of the food to a disease or a content claim because it does not caries is related to dietary practices. The health-related condition.’’ The comment characterize the level of any nutrient. consumption of dietary and stated that in promulgating the Thus, regardless of how this claim has fermentable in the form regulations governing health claims, been used, as the law is now written, its of gums, confectioneries, and other FDA interpreted the statutory language use in food labeling would misbrand the snack foods is widespread and frequent to include any relationship of a food unless claims about sugar alcohols in the diet. There is a clear association ‘‘substance’’ to a disease or health- and dental caries are authorized by FDA between the onset of dental caries and related condition (§ 101.14(a)(2)). The under section 403(r)(3) (or section the presence in the diet of sugars and comment stated that the agency used the 403(r)(5)(D)) of the act. other fermentable carbohydrates. By term ‘‘substance’’ to make clear that Relative to the comment that a health consuming foods, such as gums, mints, health claims could be established that claim must describe the function of the , jams and jellies, and desserts, described relationships regarding either substance in question in providing in which sugar alcohols are used to particular nutrients or foods bearing nourishment or nutriment, the general replace the fermentable carbohydrates nutrients, such as fruits and vegetables, principles for health claims do not instead of the versions of those foods and a disease or health related require that the health claim, itself, that contain the fermentable condition. The comment stated that a contain such a statement. The agency carbohydrates, the consumer, the health claim must describe the function must be fully satisfied, however, that available evidence shows, reduces his or of the substance in question in the substance meets the general her risk of developing dental caries. providing nourishment or nutriment requirements for health claims under Therefore, the claim is based on dietary and how the function of that nutrient § 101.14, and under § 101.14(b)(3)(i), if practices and is relevant within the relates to a disease or health condition. the substance is consumed at other than context of the total daily diet. The comment stated that the posited decreased dietary levels, it must A claim based on the substitution or relationship between sugar alcohols and contribute taste, aroma, or nutritive replacement of one food substance for noncariogenicity is not a nutrient value, or some technical effect listed in another is not inconsistent with, or relationship and does not satisfy the 21 CFR 170.3(o), to the food and retain prohibited under, the general principles nutrient-disease relationship that attribute when consumed at levels for health claims. In fact, current dietary requirement under the act because it that are necessary to justify a claim. recommendations encourage does not address the function of a Sugar alcohols meet this requirement substitution and replacement of foods in substance in providing nourishment or (see 60 FR 37507 and 37509) because the diet, for example, the use of low-fat nutriment. they are used as sweeteners and bulking foods in place of high-fat foods. Federal Register / Vol. 61, No. 165 / Friday, August 23, 1996 / Rules and Regulations 43435

However, the evidence must show that diseases. Nowhere in that document did yet they may be eaten in lieu of foods the effect of substituting one substance the agency state that the diet/disease that can contribute real nutrients to the for another is relevant to the risk of the relationships that could be the subject of diet. The comment stated that FDA disease or health-related condition that a health claim were those that involved should not be promoting products that is the subject of the claim. Here, the chronic diseases. Moreover, section are devoid of nutrition in lieu of results of long-term studies in which 403(r)(1)(B) of the act itself does not products that provide the energy and sugar alcohol-containing foods are limit the Secretary’s authority to the nutrients children need. substituted for sugar-containing foods in regulate health claims to those FDA disagrees that foods ineligible to the daily diet support the contention pertaining to chronic diseases. In fact, bear a health claim will be perceived by that sugar alcohols help reduce the risk the agency has recently authorized a consumers as bad for the health. The of developing dental caries (see, for health claim pertaining to a disease that comment did not present any evidence example, Refs. 21, 22, 23, and 25; 60 FR would generally not be considered to be to show that consumers interpret the 37507 at 37514). a chronic disease, neural tube defects. absence of a health claim on food labels The concern in one comment that As made clear in § 101.14(a)(6), the as evidence that the food is not questionable claims may occur when agency focuses on whether the disease healthful. For example, the agency has the substitution or replacement of in question, in this case dental caries, authorized a fat and heart disease claim, substances is the subject of a health constitutes damage to an organ, part, but the comment provided nothing to claim is fully addressed by the structure, or system of the body such suggest that consumers believe that a provisions of existing principles for that it does not function properly. As food product that does not bear this health claims. One of the requirements outlined in the proposal, the agency health claim will promote heart disease. for a substance to be eligible for a health tentatively concluded that dental caries FDA disagrees also that the health claim is that the substance must be meets this criterion (60 FR 37507 at claim fails to promote health objectives associated with a disease, or health- 37509 through 37510), and the and promotes consumption of a related condition, or, alternatively, the comments have presented no evidence particular nutrient rather than focusing petition must explain the prevalence of to support a different conclusion. on a balanced diet. As stated above, the disease in the U.S. population and Further, dental caries is a disease for dental caries remains a public health the relevance of the claim in context of which the general U.S. population, or an concern. Foods that meet the criteria for the total daily diet (see § 101.14(b)(1)). identified subgroup, is at risk, and the this health claim contribute to public The agency finds that this as well as the condition is prevalent in the general health objectives because they do not other eligibility requirements for health population (see § 101.14(b)(1)). promote tooth decay. claims provide protection against Although the overall incidence of The comment did not provide any questionable claims. dental caries has declined in the United 3. A comment stated that in the States, as mentioned in some comments, evidence to show that this health claim preamble to the ‘‘General Requirements dental caries is still a public health will focus the consumer’s attention on for Health Claims for Food’’ final rule issue. The disease remains one of the one nutrient rather than on a balanced (58 FR 2478, January 6, 1993), FDA most prevalent infectious diseases that diet. The claim identifies a special limited the application of the health causes substantial expense, pain, and characteristic of the food that is claims rule, based upon review of the work loss (Ref. 89). There is evidence recognized to bear on the occurrence, 1990 amendments legislative history. showing no decline in dental caries in and affect the risk, of a disease, dental The comment stated that the agency some tooth surfaces, i.e., occlusal and caries. For those interested in reducing supported limiting the type of disease proximal tooth surfaces, and a their risk of this disease, the claim relationships that would be subjected to substantial subset of children continue serves to inform them, as claims of this the health claim regime with the to exhibit a high incidence of tooth type have done for almost 20 years, of following rationale: ‘‘In the legislative decay (Ref. 95). In addition, little is this special characteristic. history, Congress focused only on those known about present trends in oral The agency also disagrees with the health claims that related to chronic health in the older population. There comment that this health claim will disease, such as cancer, heart disease, are some studies that suggest that the promote for children foods that are and osteoporosis’’ (58 FR 2478 at 2481). caries incidence in adults is devoid of nutrition. Claims for sugar The comment stated, therefore, that considerable (Ref. 95). Consequently, alcohols, unlike claims for fruits, dental caries are not the type of dental caries continues to be a disease vegetables, and grain products and heart ‘‘chronic disease’’ Congress intended to of public health concern in this country. disease authorized under 21 CFR be regulated as a health claim since 4. Three comments stated that the 101.77, for example, do not encourage dietary choices will have less of an proposed sugar alcohol health claim increased consumption of foods to help impact on tooth decay than will promotes a good food/bad food reduce disease risk. Rather, sugar numerous other factors (e.g., dichotomy, based on whether the food alcohol claims simply state that to the fluoridation of water supply). contains sugar alcohols. One comment extent these foods are consumed as Additionally, several comments alleged stated that the proposed health claim substitutes for foods that contain that dental caries is in decline in this suggests that foods not eligible to bear fermentable carbohydrates, they may country and suggested that this trend the claim will automatically contribute help reduce the risk of dental caries. justifies not finalizing the proposed to tooth decay. One comment stated that These claims in no way suggest health claim. the health claim fails to promote health adjustment in the consumption of sugar The statement within the preamble to objectives. The comment also stated that alcohol-containing foods, and to the ‘‘General Requirements for Health children should focus on a balanced extent they have such an effect, it would Claims for Food’’ final rule (58 FR 2478 diet over time for proper growth and be limited to the class of foods that at 2481) referred to in the comment was development rather than on the contain sweeteners. Given the small part of a discussion about applicability consumption of a particular ingredient. effect, if any, that the claim will have on of health claims to classical deficiency It stated that most sugar alcohol the broad range of dietary choices that nutrient diseases and was not a products contain little or no calories, people make, FDA finds no merit to this discussion on limiting claims to chronic micronutrients, or macronutrients, and comment. 43436 Federal Register / Vol. 61, No. 165 / Friday, August 23, 1996 / Rules and Regulations

5. Some comments stated that the submitted for each of the remaining pheochromocytomas. The comment focus on sugar alcohols in the proposed substances, i.e., maltitol (GRASP noted that JECFA will be reviewing claim will detract from proper dental 6G0319), maltitol syrups (HGS syrups) these issues in 1996. (The agency notes care, although they provided no (GRASP 3G0286), isomalt (GRASP that the report from the February 1996 evidence to support this contention. 6G0321), lactitol (GRASP 2G0391), HSH meeting is not yet available.) While One comment stated that a health claim (GRASP 5G0304), and HSH syrups these comments opposed indiscriminate associated with these products may (GRASP 1G0375). The agency stated that promotion or consumption of sugar result in a decrease in oral health these GRAS affirmation petitions are alcohol-sweetened foods, they did not practices of much greater importance to under consideration, and that any argue that such ingredients were not dental health than diet, i.e., brushing, positive action resulting from the safe or lawful as ordinarily used. flossing, treatments, and proposed rule should not be interpreted The agency concludes that these professional dental care, including as an indication that the agency has comments, taken together, accurately application of dental sealants and affirmed that the general food uses of reflect the current understanding of the prophylaxis. The comments stated that the sugar alcohols according to their safety of sugar alcohols. They do not, the claim should discuss the importance respective petitions are GRAS. FDA however, provide a basis for the agency of proper oral hygiene and dental care, stated that such determinations can only to reject the petitioners’ position that including the use of fluoride be made after the agency has completed the use of sugar alcohols is safe and daily. its review of each respective GRAS lawful or for invoking warnings in FDA does not agree that the proposed petition. Nonetheless, the agency stated addition to those already required. health claim will detract from proper that a preliminary review of the GRAS Therefore, the agency concludes that the dental care. As discussed in the affirmation petitions had revealed that requirements of § 101.14(b)(3)(ii) are proposed rule and as mentioned in they contain significant evidence satisfied. some of the comments, the incidence of supporting the safety of these C. Exemption from § 101.14(e)(6) dental caries has declined over the past substances, but that some concerns 20 years. Coincidentally, the claim about the safety of sugar alcohols do Under proposed § 101.80(c)(1), sugar ‘‘useful only in not promoting tooth exist. The agency also stated that two of alcohol containing foods must meet the decay’’ has been used for almost 20 the sugar alcohols that are listed in requirements in § 101.14, except that years on sugar alcohol-containing FDA’s and GRAS sugar alcohol-containing foods are chewing gums and confectioneries. regulations, i.e., mannitol (§ 180.25) and exempt from § 101.14(e)(6), the Based on the historical use of these sorbitol (§ 184.1835), require a warning requirement that foods making health products and the decline in dental label regarding laxation if daily claims contain 10 percent or more of the caries, there is no reason to conclude consumption is expected to exceed 20 RDI or the DRV for vitamin A, vitamin that the use of this claim has taken away grams (g) per day for mannitol and 50 C, iron, calcium, protein, or fiber per from proper dental care. Further, the g per day for sorbitol. FDA stated that reference amount customarily claim is consistent with public health nothing in the proposed rule would consumed before any nutrient addition. recommendations. alter these requirements. 7. One comment asked for However, the agency agrees that The agency stated that based on the clarification that this exemption applied information about proper oral hygiene totality of the evidence, it was not, at to all sugar alcohol-containing and dental care as part of good dental this time, challenging the petitioners’ confectioneries, and not just to chewing health practices may be useful to position that the use of the enumerated gum, hard candies, and mints. consumers of sugar alcohol products. sugar alcohols is safe and lawful. FDA notes that the exemption applies This information is consistent with Although FDA tentatively concluded to all sugar alcohol- containing foods. information provided in ‘‘The Surgeon that the petitioners satisfied the The agency did not specifically limit the General’s Report on Nutrition and requirements of § 101.14(b)(3)(ii), the exemption to chewing gum and Health’’ (hereinafter referred to as the agency requested comments on its confectioneries. Because sugar alcohols Surgeon General’s report) (Ref. 7). tentative conclusion. function as sweeteners, their use has Therefore, the agency has been 6. Two comments noted that the Joint been as replacements for simple and persuaded to include this type of Food and Agriculture Organization/ complex sugars. Sugar alcohols provide information among the types of optional World Health Organization (FAO/WHO) a sweet taste and serve as bulking agents information that a manufacturer may Expert Committee on Food Additives and, consequently, are used only in provide as part of the health claim. (JECFA) has reviewed the safety data on certain product categories. However, Section 101.80(d)(3) (21 CFR these sugar alcohols and concluded that these food categories are sufficiently 101.80(d)(3)) provides that the claim their use is safe, with no need for diverse as to make specific definitional may state that oral hygiene and proper restriction other than good criteria difficult. For this reason, FDA dental care may help to reduce the risk manufacturing practices. One of these has not limited the exemption to of dental caries. comments stated that there is sufficient specific foods. However, the agency documentation to support a general wishes to point out that a food must still B. Safety Issues recognition of safety. meet all of the other requirements in In its proposal, the agency noted that Three comments stated that sugar § 101.80(c)(2)(ii) to be eligible to bear several of the sugar alcohols that are the alcohols can pose health problems, the claim. subject of this proceeding are listed in citing specifically the well-known 8. Two comments that agreed with FDA’s food additive and generally gastrointestinal disturbances, such as FDA’s tentative decision to exempt recognized as safe (GRAS) regulations, stomach pain and , that can sugar alcohol-containing foods from i.e., xylitol (§ 172.395 (21 CFR 172.395)), result from excessive consumption. One § 101.14(e)(6) requested that sugar mannitol (§ 180.25 (21 CFR 180.25)), of these comments also noted safety alcohol-containing products also be and sorbitol (§ 184.1835 (21 CFR issues raised regarding animal data that exempt from the requirement of 184.1835)) (see 60 FR 37507 at 37509). associate consumption of large amounts § 101.14(e)(3) relating to foods with In addition, it stated that GRAS of sugar alcohols with adrenal disqualifying levels of fat, saturated fat, affirmation petitions have been medullary hyperplasia and cholesterol, or sodium. One comment Federal Register / Vol. 61, No. 165 / Friday, August 23, 1996 / Rules and Regulations 43437 stated that the agency has authority to of these claims on food products. FDA , can promote tooth decay. As grant exemptions from this requirement highlighted factors that it would stated in the recently revised Dietary when a health claim will assist consider in deciding whether to exempt Guideline for Americans (Ref. 101), both consumers in maintaining healthy a food from disqualification, including the frequency of consumption and the dietary practices. The comment stated the level of public health importance, duration of exposure of teeth to sugars that an exception is warranted because the availability of foods that qualify for and starches contribute to the risk of the health claim will assist consumers a health claim, and evidence that the dental caries. However, the agency in making decisions relating to dental population the claim targets is not at points out that, as outlined in the health in all contexts in which the claim risk for the disease associated with the proposal, the basis for the proposed is used. The comments stated that the disqualifying nutrients. It stated that claim centers around the use of sugar presence of high levels of fat, saturated exceptions to § 101.14(e)(3) should be alcohols in place of sugars. Sugar fat, cholesterol, or sodium does not granted on a case-by-case basis, using a alcohols cannot be used in place of all conflict with the health message petition process. It also proposed new fermentable carbohydrates. Rather, because these nutrients are not § 101.70(f) (21 CFR 101.70(f)) to provide sugar alcohols function as sweeteners adversely associated with dental health. guidance for petitioners requesting an and bulking agents, and their use is FDA has established different exception to the prohibition in primarily in the manufacture of gums disqualifying levels for different § 101.14(e)(3) of health claims for foods and confectioneries. Moreover, the categories of foods, depending on the exceeding the disqualifying levels significance of the claim in the context role that they play in the daily diet. identified in § 101.14(a)(5) (see 60 FR of the total daily diet is based upon: (1) Section 101.14(a)(5) defines the 66206 at 66224). The presence in the diet of foods disqualifying level for individual foods The comment did not submit any sweetened with simple and complex as 20 percent of the Daily Values (DV’s) information of the type that FDA needs sugars, and (2) the fact that sugar for total fat, saturated fat, cholesterol, as the basis for an exemption. In the alcohols, because of their very low and sodium. These levels translate to absence of such information, FDA finds fermentability, when substituted for 13.0 g of total fat, 4 g of saturated fat, that it cannot conclude that the other sugars, do not promote dental 60 milligrams (mg) of cholesterol, and population at risk for dental caries is not caries. 480 mg of sodium per reference amount at risk, for example, for heart disease. Nonetheless, the agency agrees that it customarily consumed, per labeled The agency is therefore denying the would be helpful to consumers to be serving size, and, for foods with request to exempt sugar alcohol- informed about the overall role of reference amounts customarily containing foods from the disqualifying fermentable carbohydrates in the diet consumed of 30 g or less or 2 levels established in § 101.14(a)(5). and thus is persuaded to revise tablespoons or less, per 50 g. The § 101.80(a)(2) and (a)(4) to reflect that all regulations also make additional D. Relationship Between Sugar Alcohols fermentable carbohydrates, i.e., sugars allowances for main dish products and and Dental Caries and starches, are cariogenic and to meal-type products (see § 101.14(a)(5)(i) 9. Some comments stated that in the include in these paragraphs information and (ii)). proposal the agency had correctly about dental caries provided in Dietary A food that exceeds the disqualifying identified the interaction between Guidelines for Americans (Ref. 101). In level for any of the four disqualifying sugars and other fermentable proposed § 101.80(a)(2), the agency nutrients may not bear a health claim carbohydrates and oral bacteria in the described the relationship between unless the agency has granted an development of dental caries. However, dietary sugars and tooth decay, that is exemption ‘‘based on a finding that such these comments stated that the how bacteria metabolizes sugar, causing a claim would assist consumers in proposed health claim puts undue acid and forming plaque. This was maintaining healthy dietary practices’’ emphasis on sugars and in the followed by a statement that the dental (section 403(r)(3)(A)(ii) of the act). causation of dental caries. The plaque results in more acid that The comment requesting the comments stated that the dental deminarilizes enamel after prolonged exemption of sugar alcohol-containing community is unanimous in the view exposure. The final statement was a foods from the disqualifying levels that all fermentable carbohydrates, not precaution then, that between-meal provided no evidence to demonstrate just sugars, have the potential to consumption of sugary foods would that the presence of the claim on foods contribute to tooth decay. One comment cause more tooth decay. In this containing high levels of fat, saturated stated that to the extent that dietary document, the agency is changing fat, cholesterol, or sodium will benefit factors play a role in caries, the most § 101.80(a)(2) to include the relationship consumers other than to suggest that the important factor is frequency of between consumption of fermentable claim would appear on more foods. This consumption of fermentable carbohydrates and starches, as well as rationale is not consistent with the basic carbohydrates and not consumption per dietary sugars, to tooth decay. The last notion that it makes no sense to include se. One comment quoted the report of sentence states that ongoing exposure to a health claim in the labeling of a food the Dietary Guidelines Advisory starches, as well as dietary sugars, that contains other nutrients at a level Committee on the Dietary Guidelines for increases the risk for tooth decay. that increases the risk of other diseases Americans, 1995 (Ref. 101) which states: unless a clear benefit for consumers can The agency notes that sucrose is still be demonstrated (see 58 FR 2478 at [B]oth sugars and starches can promote considered the most cariogenic sugar, tooth decay. The more often you eat foods 2489 to 2490). that contain sugars and starches, and the and that this substance has been shown In ‘‘the 1995 nutrient content and longer these foods are in your mouth before to promote the growth of plaque more health claims proposed rule,’’ FDA has you brush your teeth, the greater the risk for than other sugars (Ref. 71). Therefore, considered the instances where tooth decay. Thus, frequent eating of foods the agency is highlighting, and disclosure rather than disqualification high in sugars and starches as between-meal permitting the use of the statement may be appropriate and discussed these snacks may be more harmful to your teeth regarding, the cariogenicity of sucrose. in this proposal to amend its regulations than eating them at meals and then brushing. In addition, consistent with on nutrient content and health claims to FDA agrees that all fermentable § 101.4(b)(20), the term ‘‘sugar’’ may be provide additional flexibility in the use carbohydrates, including sugars and used as a synonym for ‘‘sucrose.’’ 43438 Federal Register / Vol. 61, No. 165 / Friday, August 23, 1996 / Rules and Regulations

The agency is also revising subjectively by the consumer, does not could be misled. In light of these § 101.80(a)(4) to state that sugar alcohols correlate with the actual retention of the changes, the agency has revised the title can be used as sweeteners to replace food on human dentition in vivo (Refs. of § 101.80(a) to more accurately reflect dietary sugars, such as sucrose and corn 92 and 93). Therefore, the agency is the contents of this paragraph. The sweeteners, in foods such as chewing deleting reference to sticky foods in revised title is ‘‘Relationship between gums and confectioneries, and that they § 101.80(a)(2). dietary carbohydrates and dental are significantly less cariogenic than 11. Several comments disagreed with caries.’’ dietary sugars and other fermentable the statements that U.S. diets tend to be 12. Some comments stated that there carbohydrates. The agency is adding the high in sugars, and that government is no indication that a sugar alcohol and statement regarding ‘‘corn sweeteners’’ organizations recommend decreased dental caries health claim will have any to reflect the fact that sugar alcohols are consumption of sugars. The comments impact on sugars consumption or on the used to replace more than sucrose in stated that FDA’s 1986 Sugars Task incidence of dental caries in the U.S. chewing gums and confectioneries, and Force report (Ref. 94) concluded that the population. The comments stated that that they are used primarily as average daily intake for added sugars sugars consumption remained stable sweeteners. The agency is deleting the accounted for 11 percent of the daily from 1977 to 1988, and that dental statement, ‘‘Thus, replacing dietary calorie intake for the total population. caries decreased during that time. One sugars with sugar alcohols helps to One comment stated that this amount comment stated that dietary counseling, maintain dental health,’’ from approximates the amount (10 percent) to the general public, on sugar § 101.80(a)(4) because it is a statement recommended by the Select Committee consumption is an ineffective caries of the significance of the relationship on Nutrition and Human Needs in its prevention technique. The comment between sugar alcohols and dental second edition of Dietary Goals for the stated that dietary guidelines do not caries which is addressed in § 101.80(b). (1977) (Ref. 100). The advocate the reduction in sugars in the Consequently, this statement is comments stated that current dietary diet as a means to lower the incidence superfluous in § 101.80(a). The agency guidelines advise that sugars be used of dental caries. concludes that, with the above only in moderation but not restriction of The intent of the health claim is to revisions, § 101.80(a)(2) and (a)(4) sugars consumption. One comment provide consumers with public health accurately reflect the relationship stated that the proposed health claim information that will enable them to between fermentable carbohydrates and implicates sugars as a diet and disease make dietary choices that can affect dental caries and are not misleading as concern, which will mislead consumers their risk of dental disease. Dental caries to the role of sugar alcohols in not as to the health significance of sugar are recognized as an important and promoting tooth decay. consumption. widespread public health problem in The agency is also deleting proposed FDA agrees that the focus of dietary the United States. Although dental § 101.80(d)(2), which permitted use of guidance for the general population is to caries among children are declining, the the term ‘‘sugar’’ or ‘‘sucrose’’ when choose a diet moderate in sugars and to overall prevalence of the condition referring to sucrose. Since § 101.80(d)(1) avoid excessive snacking (Ref. 101). imposes a substantial economic burden allows the claim to include information Therefore, FDA has modified because of the health care costs from § 101.80(a), and § 101.80(a)(2) has § 101.80(a)(3) to delete statements associated with care for this condition. been revised to include ‘‘sugar’’ as a regarding the sugars consumption in the In addition, as discussed in section II.A. synonym for ‘‘sucrose,’’ § 101.80(d)(2) is American diet and dietary of this document, there is evidence to repetitive and unnecessary. As a result recommendations to reduce sugars show that the decline in dental caries of this action, proposed § 101.80(d)(3) is intake. In their place, FDA has included may not apply to all tooth surfaces, and being redesignated as § 101.80(d)(2). information from the recent Dietary that a substantial subset of children FDA is also adding in new Guidelines for Americans (Ref. 101) in continue to exhibit a high incidence of § 101.80(d)(3) information regarding the § 101.80(a)(3), which states that dental tooth decay (Ref. 94). In addition, little importance of proper dental care in caries is still widespread in the United is known about trends in oral health in response to the comments discussed in States creating a burden on Americans. the older population. There are some comment 5 of this document. The government’s dietary guidelines studies that suggest that the caries 10. Some comments stated that the suggest selecting diets with moderation incidence in adults is considerable (Ref. agency’s emphasis in the proposal on in sugars and avoidance of excessive 95). Until means of preventing dental sticky foods as a factor in dental caries snacking. Because snacks rich in sugars caries are available to the entire U.S. was inaccurate. One comment stated and starches may result in a greater population, dietary counseling is an that more recent scientific evidence incidence of tooth decay since they are important element of dental care (Ref. does not support the relationship less likey to be followed by brushing. 95). between foods that easily stick to teeth The agency disagrees with the The sugar alcohol-containing foods and dental caries. The comment comment that the health claim will that have used this dental caries claim included a study to support this mislead consumers as to the health over the past 20 years have primarily assertion. The comment stated that the significance of sugars consumption. been snack foods, i.e., chewing gums high starch and low sugar foods are Sugars consumption has long been and confectioneries. Snack foods are a retained on teeth longer than high sugar associated with risk of dental caries, and part of the diets of many Americans. As and low starch foods. One comment information reflecting this fact is a stated in the recent Dietary Guidelines stated that a health claim statement common component of public health for Americans (Ref. 101), frequent about foods that easily stick to teeth is education efforts. Moreover, as a result between-meal snacks that are high in misleading and could drive consumers of the changes that FDA has made, sugars and starches may be more towards erroneous food choices in the § 101.80(a)(2), (a)(3), and (a)(4) harmful to teeth than eating the same interest of avoiding what they think are accurately reflect the relationship that foods at meals and then brushing. sticky foods. exists among sugar alcohols, dietary Therefore, chewing gums and The agency concurs that the evidence sugars and other fermentable confectioneries that contain sugar submitted suggests that the degree of carbohydrates, and dental caries. Thus, alcohols but no fermentable stickiness of a food, as perceived there is less chance that consumers carbohydrates provide an alternative Federal Register / Vol. 61, No. 165 / Friday, August 23, 1996 / Rules and Regulations 43439 food choice for those consumers who showed acid production from sorbitol The agency concludes, based on the enjoy sweetened snack foods yet are after a prolonged period of incubation evidence, that frequent or long-term use interested in dental health. (22 hours) have little relevance to the in of sugar alcohols, especially in the The comments incorrectly suggest this vivo situation. In vivo studies have context of a daily diet that contains health claim is intended to imply that shown that plaque pH drops only other carbohydrates that are sugar alcohol-containing foods will marginally after consumption of preferentially metabolized by oral prevent dental caries. The agency sorbitol-containing foods (Ref. 95). bacteria, may result in some adaptation wishes to highlight the difference Moreover, plaque pH telemetry tests by the bacteria in plaque to these between a prophylactic effect and a have been used to assess the acidogenic substances. The effect, however, would nonpathologic effect. The proposed potential of sorbitol on plaque in situ not be such that consumption of sugar claim does not state that sugar alcohols (Ref. 95). These tests have demonstrated alcohols would contribute in any way to provide a prophylactic benefit, i.e., the consistently that the consumption of the risk of dental caries in the general claim is not that they will prevent tooth sorbitol is not associated with an population. decay. Rather, the claim states that sugar acidification of dental plaque that alcohols do not promote dental caries. F. Nature of Claim and Optional would suggest cariogenic risk. Information The evidence supports a beneficial role As discussed in the proposed rule (60 of sugar alcohols in the absence of other FR 37507 at 37523), there is evidence In § 101.80(c)(2)(i), the agency carbohydrates in maintaining plaque pH that suggests that long-term, proposed specific requirements on the above a level that promotes enamel uninterrupted consumption of sorbitol nature of the claim, including the use of demineralization. results in adaptation by oral bacteria statements such as ‘‘does not promote,’’ and, therefore, in more acid production. ‘‘useful in not promoting,’’ or ‘‘expressly E. Significance of the Relationship for not promoting’’ dental caries. In However, microbiological studies have Between Sugar Alcohols and Dental § 101.80(c)(2)(i)(C), FDA proposed, that shown that the final pH obtained after Caries for packages with a total surface area long-term exposure to sorbitol remained Under proposed § 101.80(b), the available for labeling of 15 or more above a plaque pH level associated with agency stated that sugar alcohols do not square inches, the claim state that cariogenic risk (Ref. 96, 98, 99, and 102), promote dental caries because they are dental caries depends on many factors. and that pre- and post-adaptation rates slowly metabolized by bacteria to form 14. Several comments stated that the of acid production from sorbitol in vitro some acid. The rate and amount of acid proposed regulation should require that are very similar and very low compared production from sugar alcohols is the labeled claim identify other dietary to glucose (Ref. 102). Additionally, significantly less than that from sucrose, factors that are associated with dental adaptation is inhibited in the presence and therefore consumption of sugar caries. One comment stated that the of glucose, as bacterial alcohols does not cause the loss of claim should allude to the role of all preferentially switches to the metabolic minerals from . fermentable carbohydrates in the 13. Some comments argued that there substrate that is more readily used as an development of dental caries, although is scientific evidence to show that oral energy source (Refs. 46, 95, and 60 FR the comment did not provide data to bacteria can adapt to sorbitol, thus 37507 at 37512). At the same time that show that the term ‘‘fermentable making it cariogenic. One comment bacteria switch to glucose as the carbohydrates’’ is meaningful to stated that there is considerable debate preferred energy source, the mechanism consumers. Other comments over the potential for an adaptive shift that enables them to metabolize sorbitol emphasized the importance of in the oral ecology in response to the is repressed (Ref. 95). addressing issues related to frequent consumption of sugar alcohols, Bacteria in plaque may also show consumption of fermentable specifically that plaque bacteria may some level of adaptation to long-term carbohydrates. adapt to xylitol, thus making it exposure to mannitol (Ref. 97). As with Issues related to providing potentially cariogenic. sorbitol, however, the amount of acid information about dietary factors are FDA notes that the fermentability of produced from bacterial metabolism of relevant to the requirement that the sorbitol and other sugar alcohols, in mannitol is small and very slow claim enable the public to understand human and animal models and in vitro, compared to bacterial metabolism of the significance of the information in was discussed in the proposed rule (60 glucose. The study results showed that the context of a total daily diet (section FR 37507) and has been reviewed in a final plaque pH levels in situ did not 403(r)(3)(B)(iii) of the act). Therefore, in number of published articles (Refs. 95 to drop to levels that demineralized dental considering these comments, the agency 99 and 102). This information shows enamel (Ref. 97). reviewed the dietary context in which that of sorbitol proceeds at In response to the comment that the claim would be presented. While the a slow rate, with a final pH remaining plaque bacteria may adapt to xylitol, claim for sugar alcohols is about the above the low pH levels achieved with thus making it potentially cariogenic, effect of using them to replace dietary glucose or sucrose. the agency notes that some in vitro sugars, the agency is persuaded that the In vitro studies have shown that studies have isolated plaque claim should include information to set dental plaque, when incubated with microorganisms capable of metabolizing the message within the broader context sorbitol, did not produce enough acid to xylitol. Incubating certain strains of of fermentable carbohydrates so as to cause enamel decalcification. Some bacteria over prolonged time showed provide overall dietary information investigators note, however, that it may increased acid production from xylitol potentially beneficial to consumers. It is be very misleading to extrapolate from (Ref. 97). The amount of acid produced, well accepted that the relationship an in vitro pure culture situation to that however, was very small and has not between diet and the development of of a mixed microbial community in vivo been shown to promote dental enamel dental caries is based on the interaction (Ref. 102). demineralization. There is no evidence between oral bacteria and the presence In addition to the fact that the use of to show that adaptation to xylitol is of substances that support the growth a purified culture does not reflect a maintained when plaque bacteria are and development of these bacteria, normal mix of the types of oral bacteria, exposed to other fermentable especially the bacteria in plaque, and on the results of in vitro studies that carbohydrates in the daily diet. the production of acid in dental plaque. 43440 Federal Register / Vol. 61, No. 165 / Friday, August 23, 1996 / Rules and Regulations

As noted in several of the comments, it document) may reduce the risk of tooth 16. One comment stated that the is also well accepted that dietary decay (§ 101.80(c)(2)(i)(B)). elements of the claim for small packages carbohydrates, such as dietary sugars Further, to assist consumers in do not adequately explain the and starches, are readily fermented by comprehending the information specific significance to a person’s diet of oral bacteria and can promote the to this claim within the context of the including the particular food product growth and development of these total daily diet, and to avoid confusion bearing the claim. bacteria. about sugar alcohols’ role in the diet As discussed in the proposed rule (see Further, in its review of the scientific given the inclusion of information about 60 FR 37507 at 37525), the claim evidence in the proposal (60 FR 37507), starches, FDA is providing in ‘‘useful in not promoting tooth decay’’ the agency tentatively concluded that, § 101.80(d)(4) that the claim may state has been used on a limited number of in the absence of other fermentable that the sugar alcohol serves as a foods, primarily chewing gums and -containing foods, sugar sweetener. This information will clarify confectioneries, for 20 years. This claim alcohol-containing foods did not that the sweetener used in the product has a history of being used by promote dental caries because they do does not promote tooth decay. consumers without particular not lower plaque pH to the level Additionally, the agency recognized confusion. Thus, the agency concludes associated with enamel in preparing the final rule that it had that it is not necessary to include demineralization. The agency received inadvertently failed to provide for the additional information as part of this no comments or additional data to cause declaration of the nutrient in proposed claim when it appears on small it to change this tentative finding. § 101.80(c)(2)(i). Therefore, FDA is packages to prevent it from being Therefore, the agency now concludes adding § 101.80(c)(2)(i)(C) which states misleading. that, for the public to understand fully, that in specifying the nutrient, the claim 17. Some comments stated that it was in the context of other dietary shall state ‘‘sugar alcohol,’’ ‘‘sugar important that label statements of the components, the relationship between alcohols,’’ or use the name of the claim include reference to nondietary consumption of sugar alcohols and the specific sugar alcohol. This approach is factors, particularly oral hygiene, that promotion of dental caries, information consistent with the approach that the are associated with dental caries. One about other carbohydrates needs to be agency has taken in § 101.9(c)(6)(iii) on comment stated that dental care and the declaration of sugar alcohols within oral hygiene are more important factors included as part of the claim. the Nutrition Facts panel. in the nonpromotion of dental caries In addition, the agency acknowledges In light of these revisions, FDA has than the substitution of sugar alcohol- the comments’ emphasis on issues redesignated proposed containing foods for sugar-containing related to frequency of consumption. § 101.80(c)(2)(i)(A) (see 60 FR 37507 at foods. The importance of this factor is 37530) as § 101.80(c)(2)(i)(B) and One comment, however, stated that supported by the Dietary Guidelines for redesignated proposed the requirement that a claim state that Americans (Ref. 101). FDA addressed § 101.80(c)(2)(i)(B), in which the agency tooth decay depends on many factors this aspect of the diet-disease stated that the terms ‘‘dental caries’’ or (for larger packages) does not add to an relationship when it included a ‘‘tooth decay’’ be used to specify the understanding of the claim and would statement concerning frequent between disease, as § 101.80(c)(2)(i)(D). There only confuse the message that sugar meal consumption in an example of a were no comments on the latter alcohol-containing products do not model health claim. provision. promote tooth decay. Other comments Therefore, in response to the 15. One comment agreed with the supported an abbreviated claim and comments, FDA is adding abbreviated claim and stated that it asserted that reference to the § 101.80(c)(2)(i)(A), which provides that carries the necessary consumer message. multifactorial etiology of dental caries the claim must include the information The comment further stated that, as a does not add information needed by that frequent between-meal result, package size should not consumers. consumption of foods high in sugars determine the length of the health As discussed in the proposal, the and starches can promote tooth decay. claim. agency acknowledges that the This information is consistent with the The agency disagrees. As discussed in development of dental caries involves a information provided to consumers in the agency’s response to comment 14., complex interplay of many factors, both the Dietary Guidelines for Americans issues related to providing information dietary and nondietary. Nonetheless, (Ref. 101), which states that frequent about dietary factors are relevant to the while there is an important role for eating of foods high in sugars and requirement that the claim enable the dental care and oral hygiene in reducing starches as between-meal snacks can public to understand the significance of the incidence of dental caries, the promote tooth decay. The agency is the information in the context of a total agency notes that current and well using the phrase ‘‘sugars and starches,’’ daily diet (section 403(r)(3)(B)(iii) of the recognized recommendations also stress which is used by the Dietary Guidelines act). While the claim for sugar alcohols the role of diet. for Americans (a document intended for is about the effect of using them to In response to comments described the general public), because it is replace dietary sugars, the agency is above, the agency has considered the apparently more familiar to consumers, persuaded by other comments that the need for the inclusion of statements and thus likely to be better understood claim should include information to set within the label claim concerning the by them, than is the phrase the message within the broader context multifactorial nature of dental caries ‘‘fermentable carbohydrates.’’ of fermentable carbohydrates and their and information on nondietary factors to Consistent with the proposal, the frequency of consumption so as to help reduce the risk of this disease. information that FDA is requiring on provide overall dietary information that The agency notes that comments that packages with a total surface area is useful to consumers. The importance requested that the agency require that available for labeling of 15 or more of fermentable carbohydrates and of the nondietary factors be included in the square inches must include a statement frequency of consuming such foods health claim provided no evidence that that the sugar alcohols present in the between meals is supported by the claims about the relationship among food do not promote tooth decay or (as Dietary Guidelines for Americans (Ref. sugar alcohols, fermentable discussed in comment 17 of this 101). carbohydrates, and dental caries are Federal Register / Vol. 61, No. 165 / Friday, August 23, 1996 / Rules and Regulations 43441 misleading if a reference to nondietary superiority of certain sugar alcohols in stated that the pH of 5.7 is an factors is not included in the claim. affecting the occurrence of dental caries. appropriate threshold value for the pH Given the unique history of this claim, The proposal on sugar alcohols when measured at the inner plaque i.e., that it has been used for focused on the nonpromotion of dental surface (i.e., at the interface between approximately 20 years, and the fact caries, but it was not the agency’s intent plaque and dental enamel) at that the incidence of dental caries has to specifically exclude the concept of interproximal sites. The comment stated decreased over that period, the agency risk reduction from the claim. In that a different threshold pH value is is not persuaded that the absence of response to this comment, the agency appropriate for plaque pH reference to specific nondietary factors considered the coverage of the claim measurements obtained with other in this claim has had adverse effects that and noted that, in proposed techniques and at other sites. would suggest that the claim is § 101.80(d)(3), it had listed risk factors In the proposed rule, the agency also misleading. for dental caries. One factor listed was stated that the acidogenicity of HSH and Moreover, FDA has decided not to the frequent consumption of sucrose or other sugar alcohol mixtures is related require that the statement ‘‘depends on other fermentable carbohydrates. The to the manufacturing process, and that many factors’’ be included as part of the substitution of sugar alcohols in diets the process may vary among claim on products with 15 or more for foods containing sucrose or other manufacturers. The agency asked for square inches of space available for fermentable carbohydrates reduces comments on how to determine whether labeling. The fact that the incidence of exposure to one risk factor for dental sugar alcohol mixtures, such as HSH, dental caries has declined over the past caries. Thus, FDA has concluded that it when used in a food whose label bears 20 years strongly suggests that public is appropriate to characterize the a dental caries health claim, are in health education, including information relationship as ‘‘may reduce the risk.’’ compliance with any final rule resulting in preventive dental measures, that has To make this finding explicit, the from the proposal (60 FR 37507 at been available to consumers during this agency has inserted the phrase ‘‘may 37524). One comment stated that the period has been effective (Ref. 95). reduce the risk’’ in § 101.80(c)(2)(i)(B). agency’s concern regarding the potential Moreover, as stated above, FDA is aware As for claims of superiority, the acidogenicity of HSH is covered with of the unique history of this claim. agency notes that the provision of the the plaque pH test. Given the history of this claim and the act that authorizes health claims focuses When FDA asked for comments in the public education that has been on diet/disease relationships. Once a proposal about establishing a minimum available, FDA has reconsidered its relationship is established, there is no plaque pH requirement, it was tentative view that the statement further provision within the health addressing concerns that a sugar ‘‘depends on many factors’’ is necessary claim regime for claims of superiority in alcohol-containing food might also to the consumer understanding of the affecting the disease in question. A contain a fermentable carbohydrate that claim. FDA concludes that the available manufacturer who makes a statement on would render the food cariogenic (60 FR evidence demonstrates that the claim is the label or in labeling of a food 37507 at 37526). The application of the complete without this information, and, concerning the superiority of the effect plaque pH test is thus predicated on the therefore, that this information need not of one substance compared to another inclusion of fermentable carbohydrates be made a required element of this does so at the risk that FDA will find the in a food that contains sugar alcohols. health claim. However, the agency is claim to be false and misleading and Consequently, there is no need to providing that the information may be thus subject to regulatory action under exempt certain sugar alcohol-containing included in the health claims. section 403(a) of the act. foods from the plaque pH test. Rather, Thus, in this document, the agency is if sugar alcohols are used as sweeteners G. Plaque pH Test deleting proposed paragraphs in a food, and there are no fermentable § 101.80(c)(2)(i)(C) and (c)(2)(i)(D). It is In § 101.80(c)(2)(ii)(C), FDA proposed carbohydrates in the food, testing is not modifying § 101.80(d)(2) to provide that to provide that to qualify to bear a necessary. the claim may state that the claim, the sugar alcohol-containing food In response to the comment development of dental caries depends not lower plaque pH below 5.7 by concerning the need for manufacturers on many factors and list those risk bacterial fermentation either during to have flexibility in selecting the factors. In place of proposed consumption or up to 30 minutes after method for measuring plaque pH, the § 101.80(c)(2)(i)(C), the agency is consumption, as measured by in vivo agency points out that it does not requiring in § 101.80(c)(2)(i)(F) that the tests. The agency asked for comments require manufacturers who wish to claim not imply that consumption of on this approach. make the health claim to perform the foods containing sugar alcohols is the 19. Two comments asked that FDA plaque pH test, nor does it require that only recognized means of achieving clarify that sugar alcohol-containing a specific procedure be used when the reduced risk of dental caries. Consistent chewing gums and confectioneries will test is performed. However, the agency with these changes, FDA has deleted the be exempt from any plaque pH test is specifying in § 101.80(c)(2)(ii)(C) the model claim in proposed § 101.80(e)(2) requirement. One comment stated that method that it will use to determine that illustrated a claim with the the plaque pH requirement should be whether a food complies with the statement ‘‘depends on many factors.’’ specific to sugar alcohol-containing plaque pH requirement in this 18. One comment suggested since the foods that also contain fermentable regulation. In doing so, FDA is agency had proposed to authorize a carbohydrates. One comment stated that responding to the comment that claim using the terminology ‘‘does not manufacturers can tell from the requested that the agency specify the promote,’’ then a claim relative to composition of the food if the plaque pH procedure. Manufacturers are free to reducing the risk for dental caries was test is needed. One comment stated that decide for themselves whether and how a separate claim that would not be the agency should give manufacturers to test their products to satisfy authorized by a final rule in this flexibility in selecting the best protocol themselves that the foods comply with proceeding. The comment suggested for testing plaque pH. One comment § 101.80(c)(2)(ii)(C)). If they fail to do so, that it would be necessary to obtain requested that the agency be more they risk that FDA will find in its separate authorization for such a claim specific as to the type of test used to compliance testing of their food that the as a means of conveying the relative determine plaque pH. The comment food does not comply with the plaque 43442 Federal Register / Vol. 61, No. 165 / Friday, August 23, 1996 / Rules and Regulations pH standard and thus is subject to (§ 101.14(b)(3)(ii)). Moreover, the agency substance in question, e.g., regulatory action. would expect, in the case of a new sugar polydextrose, meets the entire set of The plaque pH test that the agency alcohol, to see evidence that the criteria for a health claim, the will use to determine whether a food is substance will not lower plaque pH authorization for the claim cannot be in compliance with this final rule is the below 5.7. If such showing is made, broadened to include other substances. indwelling plaque pH method, an FDA will take action to add the In response to the comment as to why intraoral telemetry method. The Swiss substance to the list in this regulation, the claim is being allowed on foods that have used this method since 1969 for which has been renumbered as contain sugar alcohols (and meet other regulatory purposes, and it has been § 101.80(c)(2)(ii)(B). criteria) and is not limited to only gums shown to be very reliable (Ref. 75). The 21. Two comments requested that and confectioneries, the agency points indwelling plaque pH method is FDA make provision in this regulation out that the claim is based upon the considered by many as the benchmark for additional FDA approved substitution of sugar alcohols for for plaque pH testing (Ref. 46). It is not ingredients, e.g., polydextrose, that fermentable carbohydrates, not on the the agency’s intent to use this method satisfy the requirement that they do not use of certain foods. To the extent that of plaque pH testing as a means to rank lower plaque pH below 5.7. The consumers can select foods that contain the relative cariogenicity of foods; comments stated that this would obviate fewer fermentable carbohydrates, their rather, the agency will use this method the need to amend the regulation as chances of reducing their risk of to determine whether foods that contain additional ingredients become available developing dental caries are increased. both sugar alcohols and fermentable in the future. One comment stated that Limiting the claim to certain categories carbohydrates qualify to bear this health the plaque pH test serves as the true of foods would limit the significance of claim. marker of noncariogenicity, not the the claim and not serve the interests of With regard to the agency’s request for presence of sugar alcohols or the the consumer. comments about the potential absence of sugars. The comment I. Other Issues acidogenicity of HSH and other sugar suggested that the plaque pH test is the alcohol mixtures, the agency agrees with only critical endpoint necessary to The agency proposed that any final the comment that stated that the justify use of this health claim. rule that may issue based upon the agency’s concern regarding the potential One comment noted that the agency proposal become effective 30 days acidogenicity of HSH is covered with suggested that this claim will apply following its publication. the plaque pH test. Manufacturers who primarily to snack foods that do not 22. Two comments requested that produce HSH will be responsible to play a fundamental role in structuring a FDA change the effective date of the ensure that their product, when used in healthy diet. The comment stated that final rule to 6 months following its a food that bears a dental caries health other food products could be designed publication. The comments stated that claim, is in compliance with the to not lower plaque pH below the this change would allow time for § 101.80. If sugar alcohol mixtures, such required level of 5.7. The comment industry to change labels on products as HSH, are used as sweeteners in a stated that products widely known to be that may need changing if wording food, and there are no fermentable noncariogenic and to have a role in a changes on the claim are needed. carbohydrates contributed by the sugar healthy diet, e.g., cheese, would be FDA has considered the issue of the alcohol mixture or in the food, plaque unable to bear this claim. The comment compliance date and has concluded that pH testing is not necessary. If suggested that the claim be limited to the compliance date for this regulation fermentable carbohydrates are present, chewing gums and confectioneries, will be January 1, 1998. This date is manufacturers will need to ensure that although the comment provided no consistent with that proposed by FDA in the mixture does not lower plaque pH background on how to differentiate the ‘‘Uniform Compliance Date for Food below 5.7. confectioneries from snack foods, nor Labeling Regulations’’ proposal rule did it provide evidence as to how this (hereinafter referred to as the ‘‘uniform H. Applicability of Claim to Other limitation would advance the purposes compliance date’’ proposed rule) (61 FR Substances of the health claim provisions of the act. 16422, April 15, 1996). In that In proposed § 101.80(c)(2)(ii)(B), the FDA is denying the requests to make document, the agency stated that it agency specified the substances (i.e., provision in this final rule for other periodically has announced uniform sugar alcohols) that are the subject of ingredients, such as polydextrose, that compliance dates for new food labeling the sugar alcohol and dental caries do not lower plaque pH below 5.7. The requirements. It stated that use of a proposed regulation. requirement that the food not lower uniform compliance date provides for 20. Two comments requested that plaque pH below 5.7 is not the only an orderly and economical industry proposed § 101.80(c)(2)(ii)(B) be criterion that must be satisfied for a food adjustment to new labeling modified to allow any sugar alcohol that to bear the health claim. The agency requirements by allowing sufficient lead may be developed in the future to fall recognizes that there may be scientific time to plan for the use of existing label under this health claim without evidence to show that foods that do not inventories and the development of new amending the regulation. contain sugar alcohols would qualify to labeling materials. FDA stated that this FDA is denying this request. Under bear a nonpromotion of dental caries policy also serves consumers’ interests the general requirements for health health claim. However, the health claim because the increased cost of multiple claims, the petitioner must show how petition that is the subject of this short-term label revisions that would the substance that is the subject of the rulemaking (Ref. 1), which was filed in otherwise occur would likely be passed health claim conforms to the accordance with the requirements of on to consumers in the form of higher requirements of § 101.14(b). For those § 101.70, addressed only certain sugar food prices. Although FDA is adopting substances that are to be consumed at alcohols and presented the scientific January 1, 1998, as the compliance date, other than decreased dietary levels, the evidence pertaining to those substances. the agency is encouraging firms to begin petitioner must demonstrate to FDA’s The agency did not review the totality voluntary compliance as early as satisfaction that the substance is safe of publicly available evidence on the possible after publication of this rule and lawful under the applicable food cariogenicity of other ingredients or and to begin making changes when they safety provisions of the act other foods. Without assurances that the reprint their labels. Federal Register / Vol. 61, No. 165 / Friday, August 23, 1996 / Rules and Regulations 43443

III. Decision to Authorize a Health young children. The second comment Although the benefits of this rule are Claim Relating Sugar Alcohols to stated that, because gums and candies minimal, the costs of this regulation are Dental Caries that contain sugar alcohols are more also anticipated to be small. FDA is FDA has considered all of the expensive than other sweets, some aware that some firms are already using comments that it received in response to consumers may purchase them with similar claims on product labels. It is the sugar alcohol and dental caries funds that otherwise would be used for likely that most of these claims satisfy health claim proposal. The agency preventive dental health measures. the criteria described in this concludes that the relationship between The agency is unconvinced by these rulemaking. However, because FDA is sugar alcohols and dental caries is comments. Because the claim is already requiring er claims for larger package truthful, not misleading, and being used on many products in ways sizes, some product labels may need to scientifically valid in that there is that would satisfy the conditions for use be revised. To the extent that labels significant scientific agreement based on as approved by this regulation, the need revision, this final rule will the totality of publicly available agency does not agree that the claim impose costs. On average, the scientific evidence that sugar alcohols will cause consumers to switch from administrative, redesign, and inventory do not promote dental caries. Therefore, sugar-containing products to existing disposal costs of revising a label for the FDA is authorizing this claim, although products containing sugar alcohols. affected product categories within a six based on some of the comments, the Therefore, it is unlikely that this month compliance period are between agency has been persuaded to make a regulation will result in any significant $800 and $1525 per label depending on number of editorial changes in the changes in consumer behavior. In fact, the location of the claim. Because FDA proposed codified material of the health any change in consumer behavior does not know the number of sugar claim. because of sugar alcohols most likely alcohol claims currently being made nor has already taken place. This regulation the proportion of existing claims that do IV. Environmental Impact is thus not expected to cause an increase not meet FDA’s criteria, the agency The agency has previously considered in gastric problems. cannot estimate the total costs of this the environmental effects of this rule as The agency also does not agree that regulation. announced in the proposed rule (60 FR this regulation is likely to result in a The Regulatory Flexibility Act as 37507). At that time, the agency decrease in preventive dental health amended requires analyzing options for determined under 21 CFR 25.24(a)(11) measures. Consumers of sugar alcohol regulatory relief for small businesses. that this action is of a type that does not containing foods purchase the products According to the information currently individually or cumulatively have a either because of their dietetic attributes available to the agency, of the relatively significant effect on the human or because of their role in preventive small number of products that would environment. No new information or dental health. The majority of sugar require relabeling as a result of this final comments have been received that alcohol containing foods that would rule, none are produced by small firms. would affect the agency’s previous qualify for the health claim currently Therefore, the agency certifies that this determination that there is no have sugar-free claims which are rule will not have a significant impact significant impact on the human required to be accompanied by a on a substantial number of small environment and that an environmental statement that the product is not a low- businesses. impact statement is not required. calorie food. Therefore, it is unlikely VI. Paperwork Reduction Act that these products are being consumed V. Analysis of Impacts by calorie-conscious individuals. This final rule contains no FDA has examined the economic The health claim should have no information collection or recordkeeping implications of the final rule impact on the purchases of consumers requirements under the Paperwork establishing a health claim for sugar who consume these products for the Reduction Act of 1995 (44 U.S.C. 3501 alcohols and dental caries as required dietetic properties because neither et seq.). by Executive Order 12866 and the sugary foods nor preventive dental VII. References Regulatory Flexibility Act (Pub. Law health measures are substitutes for The following references have been 96–354) as amended by the Small dietetic foods. The agency is aware of no placed on display in the Dockets Business Regulatory Enforcement evidence that sugar alcohol containing Management Branch (address above) Fairness Act of 1996. Executive Order foods and preventive dental health and may be seen by interested persons 12866 directs agencies to assess all costs measures are substitutes for dentally between 9 a. m. and 4 p. m., Monday and benefits of available regulatory concerned consumers. In fact, it is more through Friday. alternatives and, when regulation is likely that these consumers view the necessary, to select regulatory two categories as complementary 1. Drozen, Melvin S., ‘‘Health claim approaches that maximize net benefits products working together as a part of petition regarding the noncariogenicity of sugar alcohols,’’ August 31, 1994. (including potential economic, a dental health regime. It is likely that 2. Drozen, Melvin S., ‘‘Objections and environmental, public health and safety the cross elasticity of demand, a request for a hearing by Working Group of effects; distributive impacts; and numerical measure of the connection sugar alcohol manufacturers to the revocation equity). FDA finds that this final rule is between two goods, for sugar alcohol of 21 C.F.R. section 105.66(f),’’ Docket No. not a significant rule as defined by containing foods and preventive dental 91N–384L, Dockets Management Branch, Executive Order 12866. health measures is either not FDA, Rockville, MD. In response to the proposal, FDA significantly different from zero, or 3. Saltsman, Joyce J., CFSAN, FDA, Letter received two comments suggesting that negative. In other words, the two to Melvin S. Drozen, September 15, 1994. the costs of the proposed health claim product categories are either not close 4. Saltsman, Joyce J., CFSAN, FDA, Letter to Melvin S. Drozen, October 7, 1994. exceed the benefits. One comment substitutes or are complementary 5. Drozen, Melvin S., Letter to FDA, suggested that parents who substitute products. Therefore, the agency rejects November 15, 1994. sugar alcohol containing snacks for the assertion that the use of preventive 6. Saltsman, Joyce J., CFSAN, FDA, other snack foods will be trading dental dental health measures will decline as Memorandum of telephone conversation, caries for gastric problems in their a result of this rule. December 8, 1994. 43444 Federal Register / Vol. 61, No. 165 / Friday, August 23, 1996 / Rules and Regulations

7. DHHS, Public Health Service (), of the trial and the control of the dietary 38. Bibby, B. G., and J. Fu, ‘‘Changes in ‘‘The Surgeon General’s Report on Nutrition regimen,’’ Acta Odontologica Scandanavia, plaque pH in vitro by sweeteners,’’ Journal of and Health,’’ U.S. Government Printing 33:105–127, 1975. Dental Research, 64:1130–1133, 1985. Office, Washington, DC, 1988. 25. Rekola, M., ‘‘Approximal caries 39. Birkhed, D., and S. Edwardsson, ‘‘Acid 8. Harper, D. S., D. C. Abelson, and M. E. development during 2-year total substitution production from sucrose substitutes in Jensen, ‘‘Human plaque acidity models,’’ of dietary sucrose with xylitol,’’ Caries human dental plaque,’’ Proceedings of Journal of Dental Research, 65(Special Research, 21:87–94, 1987. ERGOB Conference, pp. 211–217, 1978. Issue):1503–1510, 1986. 26. Scheinin, A., J. Banoczy, J. Szoke, I. 40. Birkhed, D., S. Edwardsson, B. 9. Ten Cate, J. M., ‘‘Demineralization Eszta˙ri, K. Pieniha¨kkinen, U. Scheinin, J. 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Pienih¨ kkinen, Odontologica Scandinavica, 37:103–115, Research, 65(Special Issue):1520–1524, 1986. ‘‘Collaborative WHO xylitol field studies in 11. Stookey, G. K., ‘‘Considerations in 1979. Hungary. II. General background and control 42. Frostell, G., ‘‘Dental plaque pH in determining the cariogenic potential of foods: of the dietary regimen,’’ Acta Odontologica How should existing knowledge be relation to intake of carbohydrate products,’’ Scandinavica, 43:349–357, 1985. combined?,’’ Journal of Dental Research, Acta Odontologica Scandanavia, 27:3–29, 28. Scheinin, A., K. Pieniha¨kkinen, J. 65(Special Issue):1525–1527, 1986. 1969. Tiekso, J. Ba˙no˙czy, J. Szo¨ke, I. Eszta˙ri, P. 12. Working Group Consensus Report, 43. Toors, F. A., and J. I. B. Herczog, ‘‘Acid Zimmerman, and E. Hadas, ‘‘Collaborative ‘‘Integration of methods,’’ Journal of Dental production from a nonsugar licorice and WHO xylitol field studies in Hungary. VII. Research, 65(Special Issue):1537–1539, 1986. different sugar substitutes in Streptococcus Two-year caries incidence in 976 13. DePaola, D. P., ‘‘Executive summary,’’ mutans monoculture and pooled plaque- institutionalized children,’’ Acta Scientific Consensus Conference on Methods saliva mixtures,’’ Caries Research, 12:60–68, Odontologica Scandinavica, 43:381–387, for Assessment of the Cariogenic Potential of 1978. 1985. Foods, Journal of Dental Research, 65(Special 44. Gallagher, I. H., and S. J. Fussell, 29. Barmes, D., J. Barnaud, S. Issue)1540–1543, 1986. ‘‘Acidogenic fermentation of alcohols by human dental plaque 14. Life Science Research Organization, Khambonanda, and J. Sardo Infirri, ‘‘Field microorganisms,’’ Archives of Oral Biology, Federation of America Societies for trials of preventive regimes in Thailand and 24:673–679, 1979. Experimental Biology (LSRO, FASEB), French Polynesia,’’ International Dental 45. Gehring, F., and H. D. Hufnagel, ‘‘Intra- ‘‘Dietary Sugars in Health and Disease, II. Journal, 35:66–72, 1985. and extraoral pH measurements on human Xylitol,’’ Bethesda, MD, July, 1978. 30. Kandelman, D., A. Ba¨r, and A. Hefti, ‘‘Collaborative WHO xylitol field study in dental plaque after rinsing with some sugar 15. LSRO, FASEB, ‘‘Dietary Sugars in and sucrose substitute solutions,’’ Health and Disease, III. Sorbitol,’’ Bethesda, French Polynesia. I. Baseline Prevalence and 32-month caries increment,’’ Caries Oralprophylaxe, 5:13–19, 1983. MD, July, 1978. 46. Havenaar, R., J. H. J. Huis In’t Veld, O. 16. LSRO, FASEB, ‘‘Dietary Sugars in Research, 22:1–10, 1988. 31. Frostell, G., L. Blo¨mlof, I. Blomqvist, G. Backer Dirks, and J. D. de Stoppelaar, ‘‘Some Health and Disease, IV. Mannitol,’’ Bethesda, bacteriological aspects of sugar substitutes,’’ MD, July, 1978. M. Dahl, S. Edward, A. Fjellstrom, C. O. Henrikson, O. Larje, C. E. Nord, and K. J. Proceedings from ERGOB Conference, pp. 17. Working Group Consensus Report, 192–196, 1978. ‘‘Animal caries,’’ Journal of Dental Research, Nordenvall, ‘‘Substitution of sucrose by Lycasin in candy. ‘The Roslagen study’,‘‘ 47. Jensen, M. E., ‘‘Human plaque 65:1528–1529, 1986. acidogenicity studies with hydrogenated 18. Working Group Consensus Report, Acta Odontologica Scandinavica, 32:235– 253, 1974. starch hydrolysates,’’ unpublished. ‘‘Human plaque acidity,’’ Journal of Dental 48. Maki, Y., K. Ohta, I. Takazoe, Y. Research, 65:1530–1531, 1986. 32. Glass, R. L., ‘‘A two year clinical trial of sorbitol gum,’’ Caries Research, 17:365– Matsukubo, Y. Takaesu, V. Topitsoglou, and 19. Working Group Consensus Report, G. Frostell, ‘‘Acid production from 368, 1983. ‘‘Demineralization/remineralization,’’ Journal isomaltulose, sucrose, sorbitol, xylitol in 33. Ikeda, T., K. Ochiai, Y. Doi, T. Mukasa, of Dental Research, 65:1532–1536, 1986. suspensions of human dental plaque,’’ Caries and S. Yagi, ‘‘Maltitol and SE58 in and 20. Mo¨ller, I. J., and S. Poulsen, ‘‘The effect Research, 17:335–339, 1983. decalcification as human intraoral substrate’’, of sorbitol-containing chewing gum on the 49. Park, K. K., B. R. Schemehorn, J. W. Nihon University Journal of Oral Science, incidence of dental caries, plaque and Bolton, and G. K. Stookey, ‘‘Comparative gingivitis,’’ Community Dental and Oral 25:1–5, 1975. effect of sorbitol and xylitol mints on plaque Epidemiology, 1:58–67, 1973. 34. Yagi, S., ‘‘Effects of maltitol on acidogenicity,’’ presented at the International 21. Ba˙no˙czy, J., E. Hadas, I. Eszta˙ry, I. insoluble glucan synthesis by S. mutans and Association for Dental Research, April 17–21, Marosi, and J. Nemes, ‘‘Three-year results change of enamel hardness,’’ Nihon 1991. with sorbitol in clinical itudinal University Journal of Oral Science, 4:136– 50. So¨derling, E., K. K. Ma¨kinen, C.-Y. experiments,’’ Journal of the International 144, 1978. Chen, H. R. Pape, and P.-L. Ma¨kinen, ‘‘Effect Association of Dentistry in Children, 12:59– 35. Leach, S. A., G. T. R. Lee, and W. M. of sorbitol, xylitol and xylitol/sorbitol gums 63, 1981. Edgar, ‘‘Remineralization of artificial caries- on dental plaque,’’ Caries Research, 23:378– 22. Kandelman, D., and G. Gagnon, like lesions in human enamel in situ by 384, 1989. ‘‘Clinical results after 12 months from a study chewing sorbitol gum,’’ Journal of Dental 51. Birkhed, D., and G. Skude, ‘‘Relation of of the incidence and progression of dental Research, 68:1064–1068, 1989. amylase to starch and Lycasin metabolism in caries in relation to consumption of chewing- 36. Rundegren, J., T. Koulourides, and T. human dental plaque in vitro,’’ Scandinavian gum containing xylitol in school preventive Ericson, ‘‘Contribution of maltitol and Journal of Dental Research, 86:248–258, programs,’’ Journal of Dental Research, Lycasin to experimental enamel 1978. 66:1407–1411, 1987. demineralized in the human mouth,’’ Caries 52. Havenaar, R., J. S. Drost, J. D. de 23. Rekola, M., ‘‘Changes in buccal white Research, 14:67–74, 1980. Stoppelaar, J. H. J. Huis in’t Veld, and O. spots during two-year total substitution of 37. Creanor, S. L., R. Strang, W. H. Backer Dirks, ‘‘Potential cariogenicity of dietary sucrose with xylitol,’’ Acta Gilmour, R. H. Foye, J. Brown, D. A. M. Lycasin 80/55 in comparison to starch, Odontologica Scandinavica, 44:285–290, Geddes, and A. F. Hall, ‘‘The effect of sucrose, xylitol, sorbitol and L-sorbose in 1986. chewing gum use on in situ enamel lesion rats,’’ Caries Research, 18:375–384, 1984. 24. Makinen, K. K., and A. Scheinin, remineralization,’’ Journal of Dental 53. Havenaar, R., J. S. Drost, J. H. J. Huis ‘‘Turku sugar studies. VI. The administration Research, 71:1895–1900, 1992. in’t Veld, O. Backer Dirks, and J. D. de Federal Register / Vol. 61, No. 165 / Friday, August 23, 1996 / Rules and Regulations 43445

Stoppelaar,, ‘‘Potential cariogenicity of utilization by for ‘‘Cariogenicity of nine sugars tested with an Lycasin 80/55 before and after repeated insoluble glucan synthesis and experimental intraoral device in man,’’ Caries Research transmissions of the dental plaque flora in dental caries in rats,’’ Nihon University 10:427–441, 1976. rats,’’ Archives of Oral Biology, 29:993–999, Journal of Oral Science, 3:266–275, 1977. 89. Baer, A., ‘‘Significance and promotion 1984. 70. Hoeven, J. S. van der, ‘‘Cariogenicity of of sugar substitution for the prevention of 54. Havenaar, R., J. H. J. Huis In’t Veld, J. alcohols in rats,’’ Caries dental caries,’’ Lben.-Wiss U. Technology, D. de Stoppelaar, and O. Backer Dirks, ‘‘A Research, 14:61–66, 1980. Academic Press, 22:46–53, 1989. purified cariogenic diet for rats to test sugar 71. Burt, B. A., and A. I. Ismail, ‘‘Diet, 90. LSRO, FASEB, ‘‘Health Aspect of Sugar substitutes with special emphasis on general nutrition, and food cariogenicity,’’ Journal of Alcohols and ,’’ Bethesda, MD, health,’’ Caries Research, 17:340–352, 1983. Dental Research, 65(Special Issue):1475– September, 1986. 55. Havenaar, R., J. D. Huis in’t Veld, J. D. 1484, 1986. 91. Joint FAO/WHO Expert Committee on J. de Stoppelaar, and O. B. Dirks, ‘‘Anti- 72. National Research Council, National Food Additives, ‘‘Evaluation of Certain Food cariogenic and remineralizing properties of Academy of Sciences, ‘‘Diet and Health,’’ Additives and Contaminants,’’ Geneva, xylitol in combination with sucrose in rats National Academy Press, Washington, DC, Switzerland, pp. 16–17, 1993. inoculated with Streptococcus mutans,’’ 1989. 92. Kashket, S., J. van Houte, L. R. Lopez, Caries Research, 18:269–277, 1984. 73. Hoeven, J.S. van der, ‘‘Cariogenicity of and S. Stocks, ‘‘Lack of correlation between 56. Grenby, T. H., and J. Colley, ‘‘Dental lactitol in program-fed rats,’’ Caries Research, food retention on the human dentition and effects of xylitol compared with other 20:441–443, 1986. consumer perception of food stickiness,’’ carbohydrates and in the diet of 74. Imfeld, T., and H. R. Mu¨ hlemann, Journal of Dental Research, 70:1314–1319, laboratory rats,’’ Archives of Oral Biology, ‘‘Cariogenicity and acidogenicity of food, 1991. 28:745–758, 1983. and beverages,’’ Pharmacology 93. S. Kashket, J. Zhang, and J. van Houte, 57. Karle, E. J., and F. Gehring, and Therapeutic Dentistry, 3:53–68, 1978. ‘‘Accumulation of fermentable sugars and ‘‘Kariogenita¨tsuntersuchungen von 75. Imfeld, T., ‘‘Identification of Low metabolic acids in food particles that become zuckeraustauschstoffen an xerostomierlen Caries Risk Dietary Components,’’ entrapped on the dentition,’’ unpublished ratten. (Studies on the cariogenesis of sugar Monographs in Oral Science, vol. 11, Karger, manuscript. substitutes in xerostomized rats),’’ Deutsche Basel, Switzerland, pp. 1–8 and 117–144, 94. Glinsmann, W. H., H. Irausquin, and Y. Zahnarztliche Zeitschrift, 34:551–554, 1979. 1983. K. Park, ‘‘Report from FDA’s Sugars Task 58. Mu¨ hlemann, H. R., R. Schmid, T. 76. Grenby, T. H., A. Phillips, and M. Noguchi, T. Imfeld, and R. S. Hirsch, ‘‘Some Force, 1986—Evaluation of health aspects of Mistry, ‘‘Studies of the dental properties of sugars contained in carbohydrate dental effects of xylitol under laboratory and lactitol compared with five other bulk in vivo conditions,’’ Caries Research, 11:263– sweeteners,’’ Journal of Nutrition, sweeteners in vitro,’’ Caries Research, 276, 1977. 116(11S):S1–S9, S39–S43, 1986. 23:315–319, 1989. 59. Shyu, K.-W., and M.-Y Hsu, ‘‘The 95. Birkhed, D., and A. Ba¨r, ‘‘Sorbitol and 77. Grenby, T. H., and A. Phillips, ‘‘Dental cariogenicity of xylitol, mannitol, sorbitol dental caries,’’ World Review of Nutrition and metabolic effects of lactitol in the diet of and sucrose,’’ Proceedings of the National and Dietetics, 65:1–37, 1991. laboratory rats,’’ British Journal of Nutrition, Science Council ROC, 4:21–26, 1980. 96. Birkhed, D., S. Kalfas, G. Svensater, and 60. Bramstedt, F., F. Gehring, and E. J. 61:17–24, 1989. S. Edwardsson, ‘‘Microbiological aspects of Karle, ‘‘Comparative study of the cariogenic 78. Edgar, W. M., and D. A. M. Geddes, some caloric sugar substitutes,’’ International effects of Palatinit, xylitol and saccharose in ‘‘Plaque acidity models for cariogenicity Dental Journal, 35:9–17, 1985. animals,’’ unpublished, 1976. testing—some theoretical and practical 97. Linke, H., ‘‘Sweeteners and dental 61. Izumiya, A., T. Ohshima, and S. Sofue, observations,’’ Journal of Dental Research, health: the influence of sugar substitutes on ‘‘Caries inducibility of various sweeteners,’’ 65(Special Issue):1498–1502, 1986. oral microorganisms,’’ in Developments in Academy of Pedodontia, p. 65, May 1984. 79. Birkhed, D., S. Kalfas, G. Svensa¨ter, and Sweeteners, vol. 3, edited by T. H. Grenby, 62. Gehring, F., and E. J. Karle, ‘‘The sugar S. Edwardsson, ‘‘Microbiological aspects of Elsevier Applied Science, New York, pp. substitute Palatinit with special emphasis on some caloric sugar substitutes,’’ International 151–188, 1987. microbiological and caries-preventing Dental Journal, 35:9–17, 1985. 98. Triller, M., ‘‘Sugars, sweeteners, and aspects,’’ Zeitschrift Ernahrungswiss, 20:96– 80. Schrotenboer, G. H., ‘‘In the Matter of dental caries prevention,’’ in Sugarless—the 106, 1981. Revising the Regulation for Foods for Special Way Forward, edited by A. J. Rugg-Gunn, 63. Karle, E. J., and F. Gehring, ‘‘Palatinit Dietary Uses,’’ Docket No. FDC–78, March 4, Elsevier Applied Science, New York, pp. 70– -A New and its 1970 at 6–7. 84, 1990. Carioprophylactic Assessment,’’ Deutsche 81. Saltsman, Joyce J., CFSAN, FDA, 99. Scheinin, A., and E. So¨derling, Zalnarztliche Zeitschrift 33:189–191, 1978. Memorandum to file—Environmental ‘‘Carbohydrate sweeteners and dental caries,’’ 64. Larje, O., and R. H. Larson, ‘‘Reduction Assessment of Health Claim Petition, Proceedings of the Finnish Dental Society, of dental caries in rats by intermittent feeding December 23, 1994. 82:276–289, 1986. with sucrose substitutes,’’ Archives of Oral 82. Ayers, C. S., and R. A. Abrams, 100. Select Committee on Nutrition and Biology, 15:805–816, 1970. ‘‘Noncariogenic sweeteners, sugar substitutes Human Needs, ‘‘Dietary Goals for the United 65. Mu¨ hlemann, H. R., ‘‘Effect of topical for caries control,’’ Dental Hygiene, April, States,’’ 2d ed., U.S. Government Printing application of sugar substitutes on bacterial 162–167:1987. Office, pp. 27–34, 1977. agglomerate formation, caries incidence and 83. Rugg-Gunn, A. J., and W. M. Edgar, 101. USDA and DHHS, ‘‘Nutrition and solution rates of molars in the ,’’ ‘‘Sweeteners and dental health,’’ Community Your Health: Dietary Guidelines for unpublished, 1978. Dental Health, 2:213–223, 1985. Americans,’’ Home and Garden Bulletin No. 66. Ooshima, T., A. Izumitani, T. Minami, 84. Grenby, T. H., ‘‘Nutritive sucrose 232, U.S. Government Printing Office, 4th T. Yoshida, S. Sobue, T. Fujiwari, and substitutes and dental health,’’ In: ed., 1995. S.Hamada, ‘‘Non-cariogenicity of maltitol in Developments in Sweeteners, editors: T. H. 102. Hogg, S. D., and A. J. Rugg-Gunn, SPF rats infected with mutans streptococci,’’ Grenby, K. J. Parker, and M. G. Lindley, ‘‘Can the oral flora adapt to sorbitol?,’’ submitted for publication. Elsevier Science, Inc., 2:51–88, 1983. Journal of Dentistry, 19:263–271, 1991. 67. Tate, N., S. Wada, H. Tani, and K. 85. Rugg-Gunn, A. J., ‘‘Lycasin and the Oikawa, ‘‘Experimental studies on prevention of dental caries,’’ In: Progress in List of Subjects in 21 CFR Part 101 correlations between progressive caries and Sweeteners, editor: T. H. Grenby, Elsevier Food labeling, Incorporation by sugar intake,’’ unpublished. Science, Inc., pp. 311–328, 1989. reference, Nutrition, Reporting and 68. Leach, S. A., and R. M. Green, ‘‘Effect 86. Loesche, W. J., ‘‘The rationale for caries prevention through use of sugar substitutes,’’ recordkeeping requirements. of xylitol-supplemented diets on the Therefore, under the Federal Food, progression and regression of fissure caries in International Dental Journal, 35:1–8, 1985. the albino rat,’’ Caries Research, 14:16–23, 87. Mandel, I. D., ‘‘Dental caries,’’ Drug, and Cosmetic Act and under 1980. American Scientist, 67:680–688, 1979. authority delegated to the Commissioner 69. Mukasa, T., ‘‘The possibility of maltitol 88. Koulourides, T., R. Bodden, S. Keller, of Food and , 21 CFR part 101 is and SE 58 as non-cariogenic sweeteners: their L. Manson-Hing, J. Lastra, and T. Housch, amended as follows: 43446 Federal Register / Vol. 61, No. 165 / Friday, August 23, 1996 / Rules and Regulations

PART 101ÐFOOD LABELING than eating such foods at meals and (G) Packages with less than 15 square then brushing. inches of surface area available for 1. The authority citation for 21 CFR (4) Sugar alcohols can be used as labeling are exempt from paragraphs (A) part 101 is revised to read as follows: sweeteners to replace dietary sugars, and (C) of this section. Authority: Secs. 4, 5, 6 of the Fair such as sucrose and corn sweeteners, in (ii) Nature of the food. (A) The food Packaging and Labeling Act (15 U.S.C. 1453, foods such as chewing gums and certain shall meet the requirement in 1454, 1455); secs. 201, 301, 402, 403, 409, confectioneries. Dietary sugar alcohols § 101.60(c)(1)(i) with respect to sugars 701 of the Federal Food, Drug, and Cosmetic are significantly less cariogenic than content. Act (21 U.S.C. 321, 331, 342, 343, 348, 371). dietary sugars and other fermentable carbohydrates. (B) The sugar alcohol in the food shall 2. New § 101.80 is added to subpart E be xylitol, sorbitol, mannitol, maltitol, to read as follows: (b) Significance of the relationship between sugar alcohols and dental isomalt, lactitol, hydrogenated starch caries. Sugar alcohols do not promote hydrolysates, hydrogenated glucose § 101.80 Health claims: dietary sugar syrups, or a combination of these. alcohols and dental caries. dental caries. Sugar alcohols are slowly metabolized by bacteria to form some (C) When fermentable carbohydrates (a) Relationship between dietary acid. The rate and amount of acid are present in the sugar alcohol- carbohydrates and dental caries. (1) production is significantly less than that containing food, the food shall not Dental caries, or tooth decay, is a from sucrose and other fermentable lower plaque pH below 5.7 by bacterial disease caused by many factors. Both carbohydrates and does not cause the fermentation either during consumption environmental and genetic factors can loss of important minerals from tooth or up to 30 minutes after consumption, affect the development of dental caries. enamel. as measured by the indwelling plaque Risk factors include tooth enamel (c) Requirements. (1) All requirements pH test found in ‘‘Identification of Low crystal structure and mineral content, set forth in § 101.14 shall be met, except Caries Risk Dietary Components,’’ T. N. plaque quantity and quality, saliva that sugar alcohol-containing foods are Imfeld, Volume 11, Monographs in Oral quantity and quality, individual exempt from section § 101.14(e)(6). Science, 1983, which is incorporated by immune response, types and physical (2) Specific requirements. (i) Nature reference in accordance with 5 U.S.C. characteristics of foods consumed, of the claim. A health claim relating 552(a) and 1 CFR part 51. Copies may eating behaviors, presence of acid sugar alcohols, compared to other be obtained from Karger AG Publishing producing oral bacteria, and cultural carbohydrates, and the nonpromotion of Co., P. O. Box, Ch-4009 Basel, influences. dental caries may be made on the label Switzerland, or may be examined at the (2) The relationship between or labeling of a food described in Center for Food Safey and Applied consumption of fermentable (c)(2)(ii) of this section, provided that: Nutrition’s Library, 200 C St. SW., rm. carbohydrates, i.e., dietary sugars and (A) The claim shall state that frequent 3321, Washington, DC, or at the Office starches, and tooth decay is well between-meal consumption of foods of the Federal Register, 800 North established. Sucrose, also known as high in sugars and starches can promote Capitol St. NW., suite 700, Washington, sugar, is one of the most, but not the tooth decay. DC. only, cariogenic sugars in the diet. (B) The claim shall state that the sugar Bacteria found in the mouth are able to alcohol present in the food ‘‘does not (d) Optional information. (1) The metabolize most dietary carbohydrates, promote,’’ ‘‘may reduce the risk of,’’ claim may include information from producing acid and forming dental ‘‘useful [or is useful] in not promoting,’’ paragraphs (a) and (b) of this section, plaque. The more frequent and longer or ‘‘expressly [or is expressly] for not which describe the relationship between the exposure of teeth to dietary sugars promoting’’ dental caries; diets containing sugar alcohols and and starches, the greater the risk for (C) In specifying the nutrient, the dental caries. tooth decay. claim shall state ‘‘sugar alcohol,’’ ‘‘sugar (2) The claim may indicate that (3) Dental caries continues to affect a alcohols,’’ or the name or names of the development of dental caries depends large proportion of Americans. sugar alcohols, e.g., ‘‘sorbitol.’’ on many factors and may identify one Although there has been a decline in the (D) In specifying the disease, the or more of the following risk factors for prevalence of dental caries among claim uses the following terms: ‘‘dental dental caries: Frequent consumption of children in the United States, the caries’’ or ‘‘tooth decay.’’ fermentable carbohydrates, such as disease remains widespread throughout (E) The claim shall not attribute any dietary sugars and starches; presence of the population, imposing a substantial degree of the reduction in risk of dental oral bacteria capable of fermenting burden on Americans. Recent Federal caries to the use of the sugar alcohol- carbohydrates; length of time government dietary guidelines containing food. fermentable carbohydrates are in contact recommend that Americans choose diets (F) The claim shall not imply that with the teeth; lack of exposure to that are moderate in sugars and avoid consuming sugar alcohol-containing fluoride; individual susceptibility; excessive snacking. Frequent between- foods is the only recognized means of socioeconomic and cultural factors; and meal snacks that are high in sugars and achieving a reduced risk of dental characteristics of tooth enamel, saliva, starches may be more harmful to teeth caries. and plaque. Federal Register / Vol. 61, No. 165 / Friday, August 23, 1996 / Rules and Regulations 43447

(3) The claim may indicate that oral (dextrose) to utilizing one of comprehensive safety review of corn hygiene and proper dental care may several glucose isomerase enzyme sugar, , invert sugar, and help to reduce the risk of dental disease. preparations, is GRAS as a direct human sucrose. (4) The claim may indicate that the food ingredient. This action is in In the 1983 final rule, the agency gave sugar alcohol serves as a sweetener. response to six petitions filed by notice to all interested parties that when (e) Model health claim. The following members of the food industry. the agency completed its comprehensive model health claims may be used in DATES: Effective August 23, 1996. The safety review of corn sugar (dextrose), food labeling to describe the Director of the Office of the Federal corn syrup, invert sugar, and sucrose, it relationship between sugar alcohol- Register approves the incorporation by would examine the data on these containing foods and dental caries. reference in accordance with 5 U.S.C. substances to determine whether those (1) Example of the full claim: 552(a) and 1 CFR part 51 of a certain data provide an adequate basis to affirm (i) Frequent eating of foods high in publication in 21 CFR 184.1866, that HFCS is GRAS. In the Federal sugars and starches as between-meal effective August 23, 1996. Register of November 7, 1988 (53 FR snacks can promote tooth decay. The FOR FURTHER INFORMATION CONTACT: 44862), the agency published a final sugar alcohol [name, optional] used to James C. Wallwork, Center for Food rule affirming that the use of corn sugar, sweeten this food may reduce the risk Safety and Applied Nutrition (HFS– corn syrup, invert sugar, and sucrose in of dental caries. 217), Food and Drug Administration, food is GRAS. (ii) Frequent between-meal 200 C St. SW., Washington, DC 20204– consumption of foods high in sugars 0001, 202–418–3078. II. The Safety Review of High Fructose and starches promotes tooth decay. The SUPPLEMENTARY INFORMATION: Corn Syrup sugar alcohols in [name of food] do not promote tooth decay. I. Background In the Federal Register of November (2) Example of the shortened claim for In the Federal Register of February 8, 7, 1988 (53 FR 44904), FDA proposed to small packages: 1983 (48 FR 5716), FDA published a affirm that the use of HFCS in food is (i) Does not promote tooth decay. document that listed HFCS as GRAS for GRAS (hereinafter referred to as the (ii) May reduce the risk of tooth use in food (§ 182.1866 (21 CFR 1988 HFCS proposal). Included in the decay. 182.1866)) and also affirmed that certain 1988 HFCS proposal was the agency’s: Dated: August 16, 1996. insoluble glucose isomerase enzyme (1) Evaluation of the data contained in the petitions and of their relationship to William K. Hubbard, preparations are GRAS for use in the manufacture of HFCS (§ 184.1372 (21 the safety of HFCS; (2) discussion of the Associate Commissioner for Policy relevancy of reports by the Select Coordination. CFR 184.1372)) (hereinafter referred to as the 1983 final rule). The agency Committee on GRAS Substances of the [FR Doc. 96–21481 Filed 8–20–96; 8:53 am] Federation of American Societies for BILLING CODE 4160±01±F published this final rule in response to six industry petitions that requested Experimental Biology entitled GRAS affirmation for certain insoluble ‘‘Evaluation of the Health Aspects of Corn Sugar (Dextrose), Corn Syrup, and 21 CFR Parts 182 and 184 glucose isomerase enzyme preparations used to make HFCS and for the Invert Sugar as Food Ingredients’’ (Ref. [Docket No. 85N±0548] manufactured product itself. 1) and ‘‘Evaluation of the Health The basis for listing HFCS in 21 CFR Aspects of Sucrose as a Food Direct Food Substances Affirmed as part 182 was that HFCS is made with Ingredient’’ (Ref. 2) to the safety Generally Recognized as Safe; High enzyme preparations that FDA has assessment of HFCS; and (3) discussion Fructose Corn Syrup affirmed as GRAS; the saccharide of the relevancy of FDA’s Sugars Task Force Report ‘‘Evaluation of the Health AGENCY: Food and Drug Administration, composition (glucose to fructose ratio) Aspects of Sugars Contained in HHS. of HFCS is approximately the same as Carbohydrate Sweeteners’’ (Ref. 3) to the ACTION: Final rule. that of , invert sugar, and the disaccharide sucrose; and the minor safety evaluation of HFCS. SUMMARY: The Food and Drug components (primarily higher The agency made it clear during its Administration (FDA) is amending its saccharides of glucose) of HFCS are also safety evaluation of corn sugar, corn regulations for substances that are found at similar levels in corn syrup syrup, invert sugar, and sucrose that its generally recognized as safe (GRAS) to and corn sugar which are already on the exposure estimate for HFCS included affirm that high fructose corn syrup GRAS list. Therefore, FDA concluded exposure to HFCS containing 55 percent (HFCS), prepared from high dextrose that it was appropriate to list HFCS as fructose (HFCS–55) (Ref. 3). equivalent corn starch hydrolysate by GRAS for use in food while the agency Furthermore, FDA noted that most of partial enzymatic conversion of glucose fully evaluated it during the the components found in HFCS