[Federal Register Volume 61, Number 165 (Friday, August 23, 1996)]
[Rules and Regulations]
[Pages 43433-43447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-21481]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 95P-0003]


Food Labeling: Health Claims; Sugar Alcohols and Dental Caries

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
decision to authorize the use, on food labels and in food labeling, of 
health claims on the association between sugar alcohols and the 
nonpromotion of dental caries. The agency has concluded that, based on 
the totality of the scientific evidence, there is significant 
scientific agreement among qualified experts to support the 
relationship between sugar alcohols (i.e., xylitol, sorbitol, mannitol, 
maltitol, lactitol, isomalt, hydrogenated starch hydrolysates (HSH), 
hydrogenated glucose syrups (HGS), or a combination of sugar alcohols) 
and the nonpromotion of dental caries. Therefore, FDA has concluded 
that claims on foods relating sugar alcohols to the nonpromotion of 
dental caries are justified. FDA is announcing these actions in 
response to a petition filed by the National Association of Chewing Gum 
Manufacturers, Inc., and an ad hoc working group of sugar alcohol 
manufacturers (hereinafter referred to as the petitioners).

DATES: Effective January 1, 1998. The Director of the Office of the 
Federal Register approves the incorporation by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51 of a certain publication in 21 
CFR 101.80(c)(2)(ii)(C), effective January 1, 1998.

FOR FURTHER INFORMATION CONTACT: Joyce J. Saltsman, Center for Food 
Safety and Applied Nutrition (HFS-165), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-5916.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 20, 1995 (60 FR 37507), the agency 
proposed to authorize the use, on food labels and in food labeling, of 
health claims on the association between sugar alcohols and the 
nonpromotion of dental caries. In addition, FDA proposed to exempt 
sugar alcohol-containing foods from the requirement in 
Sec. 101.14(e)(6) (21 CFR 101.14(e)(6)) of the health claims general 
requirements regulation concerning disqualification criteria. Section 
101.14(e)(6) provides that, except for dietary supplements or where 
provided for in other regulations in part 101 (21 CFR part 101), 
subpart E, to be eligible to bear a health claim, a food must contain 
10 percent or more of the Reference Daily Intake (RDI) or the Daily 
Reference Value (DRV) for vitamin A, vitamin C, iron, calcium, protein, 
or fiber per reference amount customarily consumed before there is any 
nutrient addition.
    -The proposed rule was issued in response to a petition filed under 
section 403(r)(3)(B)(i) of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 343(r)(3)(B)(i)). Section 403(r)(3)(B)(i) of the 
act states that the Secretary of Health and Human Services (the 
Secretary) (and, by delegation, FDA) shall promulgate regulations 
authorizing health claims only if he or she determines, based on the 
totality of publicly available scientific evidence (including evidence 
from well-designed studies conducted in a manner which is consistent 
with generally recognized scientific procedures and principles), that 
there is significant scientific agreement, among experts qualified by 
scientific training and experience to evaluate such claims, that the 
claim is supported by such evidence (see also Sec. 101.14(c)). FDA 
considered the relevant scientific studies and data presented in the 
petition as part of its review of the scientific literature on sugar 
alcohols and dental caries. The agency summarized this evidence in the 
proposed rule (60 FR 37507).
    -The proposed rule included qualifying and disqualifying criteria 
for the purpose of identifying foods eligible to bear a health claim. 
The proposal also specified mandatory content and label information for 
health claims statements and provided model health claims. In its 
review of sugar alcohols eligibility for a health claim under 
Sec. 101.14(b), FDA discussed potential safety issues relating to sugar 
alcohols and the petitioners' position that the use of sugar alcohols 
is safe and lawful. The agency also discussed the potential issue that 
some sugar alcohol-containing foods may contain other ingredients, such 
as refined flour, that may be cariogenic. Consequently, the agency 
proposed to require that sugar alcohol-containing foods not lower 
plaque pH below 5.7, as determined by appropriate in vivo tests. FDA 
requested written comments on the proposed rule, including comments on 
the agency's tentative conclusion that the petitioners had satisfied 
the requirements regarding the safe and lawful use of sugar alcohols 
that are the subject of the health claim and comments on the proposal 
to establish a minimum plaque pH test for sugar alcohol-containing 
foods.

-II. Summary of Comments and the Agency's Responses

    -In response to the proposal, the agency received approximately 20 
letters, each containing one or more comments, from professional 
organizations, industry, trade associations, and health care 
professionals. Comments that were not relevant to the sugar alcohol and 
dental caries proposed rule, but that addressed broader issues 
pertaining to health claims in general, are not discussed in the 
sections of this document that follow.A number of comments were 
received that dealt generally with the questions of whether health 
claims need to state that the disease or health-related condition is 
multifactorial, and whether the whole claim needs to appear in one 
place. These issues of broad applicability to health claims are being 
considered in the rulemaking entitled ``Food Labeling: Nutrient Content 
Claims, General Principles; Health Claims, General Requirements and 
Other Specific Requirements for Individual Health Claims'' (60 FR

[[Page 43434]]

66206, December 21, 1995) (hereinafter referred to as ``the 1995 
nutrient content and health claims proposed rule''). Therefore, FDA 
forwarded the comments in question to that docket for consideration as 
part of that rulemaking.
    -The majority of the comments received in response to the sugar 
alcohol proposal agreed with one or more provisions of the proposed 
rule without providing grounds for support other than those provided by 
FDA in the preamble to the proposal. A few of these comments also 
requested modification of one or more provisions of the proposed rule. 
A few comments disagreed with the proposed rule and provided specific 
support for their positions. The agency has summarized and addressed 
the relevant issues raised in all comments in the sections of this 
document that follow.

A. General Comments

    -Some comments addressed the basic issue of whether FDA should 
permit health claims about sugar alcohol and dental caries on food 
labeling and the claim's consistency with the general principles for 
health claims.
    -1. One comment stated that section 403(r)(1)(B) of the act, which 
was added by the Nutrition Labeling and Education Act of 1990 (the 1990 
amendments), defines ``health claims'' as those statements that 
characterize ``the relationship of any nutrient which is of the type 
required [to be in nutrition labeling] of the food to a disease or a 
health-related condition.'' The comment stated that in promulgating the 
regulations governing health claims, FDA interpreted the statutory 
language to include any relationship of a ``substance'' to a disease or 
health-related condition (Sec. 101.14(a)(2)). The comment stated that 
the agency used the term ``substance'' to make clear that health claims 
could be established that described relationships regarding either 
particular nutrients or foods bearing nutrients, such as fruits and 
vegetables, and a disease or health related condition. The comment 
stated that a health claim must describe the function of the substance 
in question in providing nourishment or nutriment and how the function 
of that nutrient relates to a disease or health condition. The comment 
stated that the posited relationship between sugar alcohols and 
noncariogenicity is not a nutrient relationship and does not satisfy 
the nutrient-disease relationship requirement under the act because it 
does not address the function of a substance in providing nourishment 
or nutriment.
    -The agency does not agree that the proposed health claim is 
inconsistent with health claim principles. Sugar alcohols are nutrients 
of the type specified in section 403(q) of the act. FDA lists them in 
Sec. 101.9(c) (21 CFR 101.9(c)) as one of the nutrients that can be 
listed in the nutrition label. Thus, they can be the subject of a 
health claim.
    -The issue of whether claims about sugar alcohols and dental caries 
are health claims was discussed in the Federal Register of July 20, 
1995 (60 FR 37502), final rule entitled ``Food Labeling: Label 
Statements on Foods for Special Dietary Use; `Useful Only in Not 
Promoting Tooth Decay' Disclaimer'' (hereinafter referred to as ``the 
1995 disclaimer final rule''). The agency pointed out that a health 
claim provides information about how a particular type of substance 
(sugar alcohols) can affect a person's risk of developing a diet-
related diseases (dental caries). The ``Useful Only in Not Promoting 
Tooth Decay'' statement does what a health claim does in that it tells 
a consumer that including foods sweetened with sugar alcohols in his or 
her diet will affect his or her risk of developing dental caries.
    -Thus, in the 1995 disclaimer final rule, the agency found that the 
statement on tooth decay is a health claim because it contains both 
elements necessary to meet the ``health claim'' definition under 
403(r)(1)(B) of the act. FDA concluded that ``useful only in not 
promoting tooth decay'' is not a nutrient content claim because it does 
not characterize the level of any nutrient. Thus, regardless of how 
this claim has been used, as the law is now written, its use in food 
labeling would misbrand the food unless claims about sugar alcohols and 
dental caries are authorized by FDA under section 403(r)(3) (or section 
403(r)(5)(D)) of the act.
    -Relative to the comment that a health claim must describe the 
function of the substance in question in providing nourishment or 
nutriment, the general principles for health claims do not require that 
the health claim, itself, contain such a statement. The agency must be 
fully satisfied, however, that the substance meets the general 
requirements for health claims under Sec. 101.14, and under 
Sec. 101.14(b)(3)(i), if the substance is consumed at other than 
decreased dietary levels, it must contribute taste, aroma, or nutritive 
value, or some technical effect listed in 21 CFR 170.3(o), to the food 
and retain that attribute when consumed at levels that are necessary to 
justify a claim. Sugar alcohols meet this requirement (see 60 FR 37507 
and 37509) because they are used as sweeteners and bulking agents 
(i.e., stabilizers and thickeners) and are consumed for their taste. 
Inasmuch as sugar alcohols are also a source of calories, they 
contribute nutritive value to the foods, such as chewing gums and 
confectioneries, in which they are used.
    -2. One comment stated that the proposed claim is not a health 
claim in the same sense that the other authorized claims are because 
the substance's effect is largely independent of other dietary 
practices, i.e., sugar alcohol-sweetened candy will always not promote 
tooth decay regardless of other elements in the diet. Another comment 
stated that the idea of instituting a health claim for a substance that 
merely replaces a nutrient that may contribute to a disease or health-
related condition could open the door to questionable claims. One 
comment stated that the nonpromotion claim is a product descriptor that 
provides information on the absence of an undesirable side effect.
    -The agency disagrees that the claim is not valid because sugar 
alcohols function independently of other dietary practices, or because 
the substance replaces or can substitute for another substance. The 
comment did not demonstrate that sugar alcohols affect the risk of 
dental caries in a way that is independent of other dietary practices, 
or why, even if the did, this fact would render the claim invalid. In 
fact, as explained in the proposed rule (60 FR 37507 at 37524), the 
association between sugar alcohols and dental caries is related to 
dietary practices. The consumption of dietary sugars and fermentable 
carbohydrates in the form of gums, confectioneries, and other snack 
foods is widespread and frequent in the diet. There is a clear 
association between the onset of dental caries and the presence in the 
diet of sugars and other fermentable carbohydrates. By consuming foods, 
such as gums, mints, candies, jams and jellies, and desserts, in which 
sugar alcohols are used to replace the fermentable carbohydrates 
instead of the versions of those foods that contain the fermentable 
carbohydrates, the consumer, the available evidence shows, reduces his 
or her risk of developing dental caries. Therefore, the claim is based 
on dietary practices and is relevant within the context of the total 
daily diet.
    -A claim based on the substitution or replacement of one food 
substance for another is not inconsistent with, or prohibited under, 
the general principles for health claims. In fact, current dietary 
recommendations encourage substitution and replacement of foods in the 
diet, for example, the use of low-fat foods in place of high-fat foods.

[[Page 43435]]

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

[[Page 43436]]

    -5. Some comments stated that the focus on sugar alcohols in the 
proposed claim will detract from proper dental care, although they 
provided no evidence to support this contention. One comment stated 
that a health claim associated with these products may result in a 
decrease in oral health practices of much greater importance to dental 
health than diet, i.e., brushing, flossing, fluoride treatments, and 
professional dental care, including application of dental sealants and 
prophylaxis. The comments stated that the claim should discuss the 
importance of proper oral hygiene and dental care, including the use of 
fluoride toothpaste daily.
    -FDA does not agree that the proposed health claim will detract 
from proper dental care. As discussed in the proposed rule and as 
mentioned in some of the comments, the incidence of dental caries has 
declined over the past 20 years. Coincidentally, the claim ``useful 
only in not promoting tooth decay'' has been used for almost 20 years 
on sugar alcohol-containing chewing gums and confectioneries. Based on 
the historical use of these products and the decline in dental caries, 
there is no reason to conclude that the use of this claim has taken 
away from proper dental care. Further, the claim is consistent with 
public health recommendations.
    -However, the agency agrees that information about proper oral 
hygiene and dental care as part of good dental health practices may be 
useful to consumers of sugar alcohol products. This information is 
consistent with information provided in ``The Surgeon General's Report 
on Nutrition and Health'' (hereinafter referred to as the Surgeon 
General's report) (Ref. 7). Therefore, the agency has been persuaded to 
include this type of information among the types of optional 
information that a manufacturer may provide as part of the health 
claim. Section 101.80(d)(3) (21 CFR 101.80(d)(3)) provides that the 
claim may state that oral hygiene and proper dental care may help to 
reduce the risk of dental caries.

B. Safety Issues

    -In its proposal, the agency noted that several of the sugar 
alcohols that are the subject of this proceeding are listed in FDA's 
food additive and generally recognized as safe (GRAS) regulations, 
i.e., xylitol (Sec. 172.395 (21 CFR 172.395)), mannitol (Sec. 180.25 
(21 CFR 180.25)), and sorbitol (Sec. 184.1835 (21 CFR 184.1835)) (see 
60 FR 37507 at 37509). In addition, it stated that GRAS affirmation 
petitions have been submitted for each of the remaining substances, 
i.e., maltitol (GRASP 6G0319), maltitol syrups (HGS syrups) (GRASP 
3G0286), isomalt (GRASP 6G0321), lactitol (GRASP 2G0391), HSH (GRASP 
5G0304), and HSH syrups (GRASP 1G0375). The agency stated that these 
GRAS affirmation petitions are under consideration, and that any 
positive action resulting from the proposed rule should not be 
interpreted as an indication that the agency has affirmed that the 
general food uses of the sugar alcohols according to their respective 
petitions are GRAS. FDA stated that such determinations can only be 
made after the agency has completed its review of each respective GRAS 
petition. Nonetheless, the agency stated that a preliminary review of 
the GRAS affirmation petitions had revealed that they contain 
significant evidence supporting the safety of these substances, but 
that some concerns about the safety of sugar alcohols do exist. The 
agency also stated that two of the sugar alcohols that are listed in 
FDA's food additive and GRAS regulations, i.e., mannitol (Sec. 180.25) 
and sorbitol (Sec. 184.1835), require a warning label regarding 
laxation if daily consumption is expected to exceed 20 grams (g) per 
day for mannitol and 50 g per day for sorbitol. FDA stated that nothing 
in the proposed rule would alter these requirements.
    -The agency stated that based on the totality of the evidence, it 
was not, at this time, challenging the petitioners' position that the 
use of the enumerated sugar alcohols is safe and lawful. Although FDA 
tentatively concluded that the petitioners satisfied the requirements 
of Sec. 101.14(b)(3)(ii), the agency requested comments on its 
tentative conclusion.
    -6. Two comments noted that the Joint Food and Agriculture 
Organization/World Health Organization (FAO/WHO) Expert Committee on 
Food Additives (JECFA) has reviewed the safety data on these sugar 
alcohols and concluded that their use is safe, with no need for 
restriction other than good manufacturing practices. One of these 
comments stated that there is sufficient documentation to support a 
general recognition of safety.
    -Three comments stated that sugar alcohols can pose health 
problems, citing specifically the well-known gastrointestinal 
disturbances, such as stomach pain and diarrhea, that can result from 
excessive consumption. One of these comments also noted safety issues 
raised regarding animal data that associate consumption of large 
amounts of sugar alcohols with adrenal medullary hyperplasia and 
pheochromocytomas. The comment noted that JECFA will be reviewing these 
issues in 1996. (The agency notes that the report from the February 
1996 meeting is not yet available.) While these comments opposed 
indiscriminate promotion or consumption of sugar alcohol-sweetened 
foods, they did not argue that such ingredients were not safe or lawful 
as ordinarily used.
    -The agency concludes that these comments, taken together, 
accurately reflect the current understanding of the safety of sugar 
alcohols. They do not, however, provide a basis for the agency to 
reject the petitioners' position that the use of sugar alcohols is safe 
and lawful or for invoking warnings in addition to those already 
required. Therefore, the agency concludes that the requirements of 
Sec. 101.14(b)(3)(ii) are satisfied.

C. Exemption from Sec. 101.14(e)(6)

    -Under proposed Sec. 101.80(c)(1), sugar alcohol containing foods 
must meet the requirements in Sec. 101.14, except that sugar alcohol-
containing foods are exempt from Sec. 101.14(e)(6), the requirement 
that foods making health claims contain 10 percent or more of the RDI 
or the DRV for vitamin A, vitamin C, iron, calcium, protein, or fiber 
per reference amount customarily consumed before any nutrient addition.
    -7. One comment asked for clarification that this exemption applied 
to all sugar alcohol-containing confectioneries, and not just to 
chewing gum, hard candies, and mints.
    -FDA notes that the exemption applies to all sugar alcohol- 
containing foods. The agency did not specifically limit the exemption 
to chewing gum and confectioneries. Because sugar alcohols function as 
sweeteners, their use has been as replacements for simple and complex 
sugars. Sugar alcohols provide a sweet taste and serve as bulking 
agents and, consequently, are used only in certain product categories. 
However, these food categories are sufficiently diverse as to make 
specific definitional criteria difficult. For this reason, FDA has not 
limited the exemption to specific foods. However, the agency wishes to 
point out that a food must still meet all of the other requirements in 
Sec. 101.80(c)(2)(ii) to be eligible to bear the claim.
    -8. Two comments that agreed with FDA's tentative decision to 
exempt sugar alcohol-containing foods from Sec. 101.14(e)(6) requested 
that sugar alcohol-containing products also be exempt from the 
requirement of Sec. 101.14(e)(3) relating to foods with disqualifying 
levels of fat, saturated fat, cholesterol, or sodium. One comment

[[Page 43437]]

stated that the agency has authority to grant exemptions from this 
requirement when a health claim will assist consumers in maintaining 
healthy dietary practices. The comment stated that an exception is 
warranted because the health claim will assist consumers in making 
decisions relating to dental health in all contexts in which the claim 
is used. The comments stated that the presence of high levels of fat, 
saturated fat, cholesterol, or sodium does not conflict with the health 
message because these nutrients are not adversely associated with 
dental health.
    -FDA has established different disqualifying levels for different 
categories of foods, depending on the role that they play in the daily 
diet. Section 101.14(a)(5) defines the disqualifying level for 
individual foods as 20 percent of the Daily Values (DV's) for total 
fat, saturated fat, cholesterol, and sodium. These levels translate to 
13.0 g of total fat, 4 g of saturated fat, 60 milligrams (mg) of 
cholesterol, and 480 mg of sodium per reference amount customarily 
consumed, per labeled serving size, and, for foods with reference 
amounts customarily consumed of 30 g or less or 2 tablespoons or less, 
per 50 g. The regulations also make additional allowances for main dish 
products and meal-type products (see Sec. 101.14(a)(5)(i) and (ii)).
     -A food that exceeds the disqualifying level for any of the four 
disqualifying nutrients may not bear a health claim unless the agency 
has granted an exemption ``based on a finding that such a claim would 
assist consumers in maintaining healthy dietary practices'' (section 
403(r)(3)(A)(ii) of the act).
    -The comment requesting the exemption of sugar alcohol-containing 
foods from the disqualifying levels provided no evidence to demonstrate 
that the presence of the claim on foods containing high levels of fat, 
saturated fat, cholesterol, or sodium will benefit consumers other than 
to suggest that the claim would appear on more foods. This rationale is 
not consistent with the basic notion that it makes no sense to include 
a health claim in the labeling of a food that contains other nutrients 
at a level that increases the risk of other diseases unless a clear 
benefit for consumers can be demonstrated (see 58 FR 2478 at 2489 to 
2490).
    -In ``the 1995 nutrient content and health claims proposed rule,'' 
FDA has considered the instances where disclosure rather than 
disqualification may be appropriate and discussed these in this 
proposal to amend its regulations on nutrient content and health claims 
to provide additional flexibility in the use of these claims on food 
products. FDA highlighted factors that it would consider in deciding 
whether to exempt a food from disqualification, including the level of 
public health importance, the availability of foods that qualify for a 
health claim, and evidence that the population the claim targets is not 
at risk for the disease associated with the disqualifying nutrients. It 
stated that exceptions to Sec. 101.14(e)(3) should be granted on a 
case-by-case basis, using a petition process. It also proposed new 
Sec. 101.70(f) (21 CFR 101.70(f)) to provide guidance for petitioners 
requesting an exception to the prohibition in Sec. 101.14(e)(3) of 
health claims for foods exceeding the disqualifying levels identified 
in Sec. 101.14(a)(5) (see 60 FR 66206 at 66224).
    -The comment did not submit any information of the type that FDA 
needs as the basis for an exemption. In the absence of such 
information, FDA finds that it cannot conclude that the population at 
risk for dental caries is not at risk, for example, for heart disease. 
The agency is therefore denying the request to exempt sugar alcohol-
containing foods from the disqualifying levels established in 
Sec. 101.14(a)(5).

D. Relationship Between Sugar Alcohols and Dental Caries

    -9. Some comments stated that in the proposal the agency had 
correctly identified the interaction between sugars and other 
fermentable carbohydrates and oral bacteria in the development of 
dental caries. However, these comments stated that the proposed health 
claim puts undue emphasis on sugars and sucrose in the causation of 
dental caries. The comments stated that the dental community is 
unanimous in the view that all fermentable carbohydrates, not just 
sugars, have the potential to contribute to tooth decay. One comment 
stated that to the extent that dietary factors play a role in caries, 
the most important factor is frequency of consumption of fermentable 
carbohydrates and not consumption per se. One comment quoted the report 
of the Dietary Guidelines Advisory Committee on the Dietary Guidelines 
for Americans, 1995 (Ref. 101) which states:

    -[B]oth sugars and starches can promote tooth decay. The more 
often you eat foods that contain sugars and starches, and the longer 
these foods are in your mouth before you brush your teeth, the 
greater the risk for tooth decay. Thus, frequent eating of foods 
high in sugars and starches as between-meal snacks may be more 
harmful to your teeth than eating them at meals and then brushing.

    -FDA agrees that all fermentable carbohydrates, including sugars 
and starches, can promote tooth decay. As stated in the recently 
revised Dietary Guideline for Americans (Ref. 101), both the frequency 
of consumption and the duration of exposure of teeth to sugars and 
starches contribute to the risk of dental caries. However, the agency 
points out that, as outlined in the proposal, the basis for the 
proposed claim centers around the use of sugar alcohols in place of 
sugars. Sugar alcohols cannot be used in place of all fermentable 
carbohydrates. Rather, sugar alcohols function as sweeteners and 
bulking agents, and their use is primarily in the manufacture of gums 
and confectioneries. Moreover, the significance of the claim in the 
context of the total daily diet is based upon: (1) The presence in the 
diet of foods sweetened with simple and complex sugars, and (2) the 
fact that sugar alcohols, because of their very low fermentability, 
when substituted for other sugars, do not promote dental caries.
    -Nonetheless, the agency agrees that it would be helpful to 
consumers to be informed about the overall role of fermentable 
carbohydrates in the diet and thus is persuaded to revise 
Sec. 101.80(a)(2) and (a)(4) to reflect that all fermentable 
carbohydrates, i.e., sugars and starches, are cariogenic and to include 
in these paragraphs information about dental caries provided in Dietary 
Guidelines for Americans (Ref. 101). In proposed Sec. 101.80(a)(2), the 
agency described the relationship between dietary sugars and tooth 
decay, that is how bacteria metabolizes sugar, causing acid and forming 
plaque. This was followed by a statement that the dental plaque results 
in more acid that deminarilizes enamel after prolonged exposure. The 
final statement was a precaution then, that between-meal consumption of 
sugary foods would cause more tooth decay. In this document, the agency 
is changing Sec. 101.80(a)(2) to include the relationship between 
consumption of fermentable carbohydrates and starches, as well as 
dietary sugars, to tooth decay. The last sentence states that ongoing 
exposure to starches, as well as dietary sugars, increases the risk for 
tooth decay.
    -The agency notes that sucrose is still considered the most 
cariogenic sugar, and that this substance has been shown to promote the 
growth of plaque more than other sugars (Ref. 71). Therefore, the 
agency is highlighting, and permitting the use of the statement 
regarding, the cariogenicity of sucrose. In addition, consistent with 
Sec. 101.4(b)(20), the term ``sugar'' may be used as a synonym for 
``sucrose.''

[[Page 43438]]

    -The agency is also revising Sec. 101.80(a)(4) to state that sugar 
alcohols can be used as sweeteners to replace dietary sugars, such as 
sucrose and corn sweeteners, in foods such as chewing gums and 
confectioneries, and that they are significantly less cariogenic than 
dietary sugars and other fermentable carbohydrates. The agency is 
adding the statement regarding ``corn sweeteners'' to reflect the fact 
that sugar alcohols are used to replace more than sucrose in chewing 
gums and confectioneries, and that they are used primarily as 
sweeteners. The agency is deleting the statement, ``Thus, replacing 
dietary sugars with sugar alcohols helps to maintain dental health,'' 
from Sec. 101.80(a)(4) because it is a statement of the significance of 
the relationship between sugar alcohols and dental caries which is 
addressed in Sec. 101.80(b). Consequently, this statement is 
superfluous in Sec. 101.80(a). The agency concludes that, with the 
above revisions, Sec. 101.80(a)(2) and (a)(4) accurately reflect the 
relationship between fermentable carbohydrates and dental caries and 
are not misleading as to the role of sugar alcohols in not promoting 
tooth decay.
     -The agency is also deleting proposed Sec. 101.80(d)(2), which 
permitted use of the term ``sugar'' or ``sucrose'' when referring to 
sucrose. Since Sec. 101.80(d)(1) allows the claim to include 
information from Sec. 101.80(a), and Sec. 101.80(a)(2) has been revised 
to include ``sugar'' as a synonym for ``sucrose,'' Sec. 101.80(d)(2) is 
repetitive and unnecessary. As a result of this action, proposed 
Sec. 101.80(d)(3) is being redesignated as Sec. 101.80(d)(2). FDA is 
also adding in new Sec. 101.80(d)(3) information regarding the 
importance of proper dental care in response to the comments discussed 
in comment 5 of this document.
    -10. Some comments stated that the agency's emphasis in the 
proposal on sticky foods as a factor in dental caries was inaccurate. 
One comment stated that more recent scientific evidence does not 
support the relationship between foods that easily stick to teeth and 
dental caries. The comment included a study to support this assertion. 
The comment stated that the high starch and low sugar foods are 
retained on teeth longer than high sugar and low starch foods. One 
comment stated that a health claim statement about foods that easily 
stick to teeth is misleading and could drive consumers towards 
erroneous food choices in the interest of avoiding what they think are 
sticky foods.
    -The agency concurs that the evidence submitted suggests that the 
degree of stickiness of a food, as perceived subjectively by the 
consumer, does not correlate with the actual retention of the food on 
human dentition in vivo (Refs. 92 and 93). Therefore, the agency is 
deleting reference to sticky foods in Sec. 101.80(a)(2).
    -11. Several comments disagreed with the statements that U.S. diets 
tend to be high in sugars, and that government organizations recommend 
decreased consumption of sugars. The comments stated that FDA's 1986 
Sugars Task Force report (Ref. 94) concluded that the average daily 
intake for added sugars accounted for 11 percent of the daily calorie 
intake for the total population. One comment stated that this amount 
approximates the amount (10 percent) recommended by the Select 
Committee on Nutrition and Human Needs in its second edition of Dietary 
Goals for the United States (1977) (Ref. 100). The comments stated that 
current dietary guidelines advise that sugars be used only in 
moderation but not restriction of sugars consumption. One comment 
stated that the proposed health claim implicates sugars as a diet and 
disease concern, which will mislead consumers as to the health 
significance of sugar consumption.
    -FDA agrees that the focus of dietary guidance for the general 
population is to choose a diet moderate in sugars and to avoid 
excessive snacking (Ref. 101). Therefore, FDA has modified 
Sec. 101.80(a)(3) to delete statements regarding the sugars consumption 
in the American diet and dietary recommendations to reduce sugars 
intake. In their place, FDA has included information from the recent 
Dietary Guidelines for Americans (Ref. 101) in Sec. 101.80(a)(3), which 
states that dental caries is still widespread in the United States 
creating a burden on Americans. The government's dietary guidelines 
suggest selecting diets with moderation in sugars and avoidance of 
excessive snacking. Because snacks rich in sugars and starches may 
result in a greater incidence of tooth decay since they are less likey 
to be followed by brushing.
    -The agency disagrees with the comment that the health claim will 
mislead consumers as to the health significance of sugars consumption. 
Sugars consumption has long been associated with risk of dental caries, 
and information reflecting this fact is a common component of public 
health education efforts. Moreover, as a result of the changes that FDA 
has made, Sec. 101.80(a)(2), (a)(3), and (a)(4) accurately reflect the 
relationship that exists among sugar alcohols, dietary sugars and other 
fermentable carbohydrates, and dental caries. Thus, there is less 
chance that consumers could be misled. In light of these changes, the 
agency has revised the title of Sec. 101.80(a) to more accurately 
reflect the contents of this paragraph. The revised title is 
``Relationship between dietary carbohydrates and dental caries.''
    -12. Some comments stated that there is no indication that a sugar 
alcohol and dental caries health claim will have any impact on sugars 
consumption or on the incidence of dental caries in the U.S. 
population. The comments stated that sugars consumption remained stable 
from 1977 to 1988, and that dental caries decreased during that time. 
One comment stated that dietary counseling, to the general public, on 
sugar consumption is an ineffective caries prevention technique. The 
comment stated that dietary guidelines do not advocate the reduction in 
sugars in the diet as a means to lower the incidence of dental caries.
    -The intent of the health claim is to provide consumers with public 
health information that will enable them to make dietary choices that 
can affect their risk of dental disease. Dental caries are recognized 
as an important and widespread public health problem in the United 
States. Although dental caries among children are declining, the 
overall prevalence of the condition imposes a substantial economic 
burden because of the health care costs associated with care for this 
condition. In addition, as discussed in section II.A. of this document, 
there is evidence to show that the decline in dental caries may not 
apply to all tooth surfaces, and that a substantial subset of children 
continue to exhibit a high incidence of tooth decay (Ref. 94). In 
addition, little is known about trends in oral health in the older 
population. There are some studies that suggest that the caries 
incidence in adults is considerable (Ref. 95). Until means of 
preventing dental caries are available to the entire U.S. population, 
dietary counseling is an important element of dental care (Ref. 95).
    -The sugar alcohol-containing foods that have used this dental 
caries claim over the past 20 years have primarily been snack foods, 
i.e., chewing gums and confectioneries. Snack foods are a part of the 
diets of many Americans. As stated in the recent Dietary Guidelines for 
Americans (Ref. 101), frequent between-meal snacks that are high in 
sugars and starches may be more harmful to teeth than eating the same 
foods at meals and then brushing. Therefore, chewing gums and 
confectioneries that contain sugar alcohols but no fermentable 
carbohydrates provide an alternative

[[Page 43439]]

food choice for those consumers who enjoy sweetened snack foods yet are 
interested in dental health.
    -The comments incorrectly suggest this health claim is intended to 
imply that sugar alcohol-containing foods will prevent dental caries. 
The agency wishes to highlight the difference between a prophylactic 
effect and a nonpathologic effect. The proposed claim does not state 
that sugar alcohols provide a prophylactic benefit, i.e., the claim is 
not that they will prevent tooth decay. Rather, the claim states that 
sugar alcohols do not promote dental caries. The evidence supports a 
beneficial role of sugar alcohols in the absence of other carbohydrates 
in maintaining plaque pH above a level that promotes enamel 
demineralization.

E. Significance of the Relationship Between Sugar Alcohols and Dental 
Caries

    -Under proposed Sec. 101.80(b), the agency stated that sugar 
alcohols do not promote dental caries because they are slowly 
metabolized by bacteria to form some acid. The rate and amount of acid 
production from sugar alcohols is significantly less than that from 
sucrose, and therefore consumption of sugar alcohols does not cause the 
loss of minerals from tooth enamel.
    -13. Some comments argued that there is scientific evidence to show 
that oral bacteria can adapt to sorbitol, thus making it cariogenic. 
One comment stated that there is considerable debate over the potential 
for an adaptive shift in the oral ecology in response to the 
consumption of sugar alcohols, specifically that plaque bacteria may 
adapt to xylitol, thus making it potentially cariogenic.
    -FDA notes that the fermentability of sorbitol and other sugar 
alcohols, in human and animal models and in vitro, was discussed in the 
proposed rule (60 FR 37507) and has been reviewed in a number of 
published articles (Refs. 95 to 99 and 102). This information shows 
that fermentation of sorbitol proceeds at a slow rate, with a final pH 
remaining above the low pH levels achieved with glucose or sucrose.
    -In vitro studies have shown that dental plaque, when incubated 
with sorbitol, did not produce enough acid to cause enamel 
decalcification. Some investigators note, however, that it may be very 
misleading to extrapolate from an in vitro pure culture situation to 
that of a mixed microbial community in vivo (Ref. 102).
    -In addition to the fact that the use of a purified culture does 
not reflect a normal mix of the types of oral bacteria, the results of 
in vitro studies that showed acid production from sorbitol after a 
prolonged period of incubation (22 hours) have little relevance to the 
in vivo situation. In vivo studies have shown that plaque pH drops only 
marginally after consumption of sorbitol-containing foods (Ref. 95). 
Moreover, plaque pH telemetry tests have been used to assess the 
acidogenic potential of sorbitol on plaque in situ (Ref. 95). These 
tests have demonstrated consistently that the consumption of sorbitol 
is not associated with an acidification of dental plaque that would 
suggest cariogenic risk.
    -As discussed in the proposed rule (60 FR 37507 at 37523), there is 
evidence that suggests that long-term, uninterrupted consumption of 
sorbitol results in adaptation by oral bacteria and, therefore, in more 
acid production. However, microbiological studies have shown that the 
final pH obtained after long-term exposure to sorbitol remained above a 
plaque pH level associated with cariogenic risk (Ref. 96, 98, 99, and 
102), and that pre- and post-adaptation rates of acid production from 
sorbitol in vitro are very similar and very low compared to glucose 
(Ref. 102). Additionally, adaptation is inhibited in the presence of 
glucose, as bacterial metabolism preferentially switches to the 
metabolic substrate that is more readily used as an energy source 
(Refs. 46, 95, and 60 FR 37507 at 37512). At the same time that 
bacteria switch to glucose as the preferred energy source, the 
mechanism that enables them to metabolize sorbitol is repressed (Ref. 
95).
    -Bacteria in plaque may also show some level of adaptation to long-
term exposure to mannitol (Ref. 97). As with sorbitol, however, the 
amount of acid produced from bacterial metabolism of mannitol is small 
and very slow compared to bacterial metabolism of glucose. The study 
results showed that final plaque pH levels in situ did not drop to 
levels that demineralized dental enamel (Ref. 97).
    -In response to the comment that plaque bacteria may adapt to 
xylitol, thus making it potentially cariogenic, the agency notes that 
some in vitro studies have isolated plaque microorganisms capable of 
metabolizing xylitol. Incubating certain strains of bacteria over 
prolonged time showed increased acid production from xylitol (Ref. 97). 
The amount of acid produced, however, was very small and has not been 
shown to promote dental enamel demineralization. There is no evidence 
to show that adaptation to xylitol is maintained when plaque bacteria 
are exposed to other fermentable carbohydrates in the daily diet.
    -The agency concludes, based on the evidence, that frequent or 
long-term use of sugar alcohols, especially in the context of a daily 
diet that contains other carbohydrates that are preferentially 
metabolized by oral bacteria, may result in some adaptation by the 
bacteria in plaque to these substances. The effect, however, would not 
be such that consumption of sugar alcohols would contribute in any way 
to the risk of dental caries in the general population.

F. Nature of Claim and Optional Information

    -In Sec. 101.80(c)(2)(i), the agency proposed specific requirements 
on the nature of the claim, including the use of statements such as 
``does not promote,'' ``useful in not promoting,'' or ``expressly for 
not promoting'' dental caries. In Sec. 101.80(c)(2)(i)(C), FDA 
proposed, that for packages with a total surface area available for 
labeling of 15 or more square inches, the claim state that dental 
caries depends on many factors.
    -14. Several comments stated that the proposed regulation should 
require that the labeled claim identify other dietary factors that are 
associated with dental caries. One comment stated that the claim should 
allude to the role of all fermentable carbohydrates in the development 
of dental caries, although the comment did not provide data to show 
that the term ``fermentable carbohydrates'' is meaningful to consumers. 
Other comments emphasized the importance of addressing issues related 
to frequent consumption of fermentable carbohydrates.
    -Issues related to providing information about dietary factors are 
relevant to the requirement that the claim enable the public to 
understand the significance of the information in the context of a 
total daily diet (section 403(r)(3)(B)(iii) of the act). Therefore, in 
considering these comments, the agency reviewed the dietary context in 
which the claim would be presented. While the claim for sugar alcohols 
is about the effect of using them to replace dietary sugars, the agency 
is persuaded that the claim should include information to set the 
message within the broader context of fermentable carbohydrates so as 
to provide overall dietary information potentially beneficial to 
consumers. It is well accepted that the relationship between diet and 
the development of dental caries is based on the interaction between 
oral bacteria and the presence of substances that support the growth 
and development of these bacteria, especially the bacteria in plaque, 
and on the production of acid in dental plaque.

[[Page 43440]]

As noted in several of the comments, it is also well accepted that 
dietary carbohydrates, such as dietary sugars and starches, are readily 
fermented by oral bacteria and can promote the growth and development 
of these bacteria.
    -Further, in its review of the scientific evidence in the proposal 
(60 FR 37507), the agency tentatively concluded that, in the absence of 
other fermentable carbohydrate-containing foods, sugar alcohol-
containing foods did not promote dental caries because they do not 
lower plaque pH to the level associated with enamel demineralization. 
The agency received no comments or additional data to cause it to 
change this tentative finding. Therefore, the agency now concludes 
that, for the public to understand fully, in the context of other 
dietary components, the relationship between consumption of sugar 
alcohols and the promotion of dental caries, information about other 
carbohydrates needs to be included as part of the claim.
    -In addition, the agency acknowledges the comments' emphasis on 
issues related to frequency of consumption. The importance of this 
factor is supported by the Dietary Guidelines for Americans (Ref. 101). 
FDA addressed this aspect of the diet-disease relationship when it 
included a statement concerning frequent between meal consumption in an 
example of a model health claim.
    - Therefore, in response to the comments, FDA is adding 
Sec. 101.80(c)(2)(i)(A), which provides that the claim must include the 
information that frequent between-meal consumption of foods high in 
sugars and starches can promote tooth decay. This information is 
consistent with the information provided to consumers in the Dietary 
Guidelines for Americans (Ref. 101), which states that frequent eating 
of foods high in sugars and starches as between-meal snacks can promote 
tooth decay. The agency is using the phrase ``sugars and starches,'' 
which is used by the Dietary Guidelines for Americans (a document 
intended for the general public), because it is apparently more 
familiar to consumers, and thus likely to be better understood by them, 
than is the phrase ``fermentable carbohydrates.''
    -Consistent with the proposal, the information that FDA is 
requiring on packages with a total surface area available for labeling 
of 15 or more square inches must include a statement that the sugar 
alcohols present in the food do not promote tooth decay or (as 
discussed in comment 17 of this document) may reduce the risk of tooth 
decay (Sec. 101.80(c)(2)(i)(B)).
    -Further, to assist consumers in comprehending the information 
specific to this claim within the context of the total daily diet, and 
to avoid confusion about sugar alcohols' role in the diet given the 
inclusion of information about starches, FDA is providing in 
Sec. 101.80(d)(4) that the claim may state that the sugar alcohol 
serves as a sweetener. This information will clarify that the sweetener 
used in the product does not promote tooth decay.
    -Additionally, the agency recognized in preparing the final rule 
that it had inadvertently failed to provide for the declaration of the 
nutrient in proposed Sec. 101.80(c)(2)(i). Therefore, FDA is adding 
Sec. 101.80(c)(2)(i)(C) which states that in specifying the nutrient, 
the claim shall state ``sugar alcohol,'' ``sugar alcohols,'' or use the 
name of the specific sugar alcohol. This approach is consistent with 
the approach that the agency has taken in Sec. 101.9(c)(6)(iii) on the 
declaration of sugar alcohols within the Nutrition Facts panel.
    -In light of these revisions, FDA has redesignated proposed 
Sec. 101.80(c)(2)(i)(A) (see 60 FR 37507 at 37530) as 
Sec. 101.80(c)(2)(i)(B) and redesignated proposed 
Sec. 101.80(c)(2)(i)(B), in which the agency stated that the terms 
``dental caries'' or ``tooth decay'' be used to specify the disease, as 
Sec. 101.80(c)(2)(i)(D). There were no comments on the latter 
provision.
    -15. One comment agreed with the abbreviated claim and stated that 
it carries the necessary consumer message. The comment further stated 
that, as a result, package size should not determine the length of the 
health claim. -
    -The agency disagrees. As discussed in the agency's response to 
comment 14., issues related to providing information about dietary 
factors are relevant to the requirement that the claim enable the 
public to understand the significance of the information in the context 
of a total daily diet (section 403(r)(3)(B)(iii) of the act). While the 
claim for sugar alcohols is about the effect of using them to replace 
dietary sugars, the agency is persuaded by other comments that the 
claim should include information to set the message within the broader 
context of fermentable carbohydrates and their frequency of consumption 
so as to provide overall dietary information that is useful to 
consumers. The importance of fermentable carbohydrates and of the 
frequency of consuming such foods between meals is supported by the 
Dietary Guidelines for Americans (Ref. 101).
    -16. One comment stated that the elements of the claim for small 
packages do not adequately explain the significance to a person's diet 
of including the particular food product bearing the claim.
    -As discussed in the proposed rule (see 60 FR 37507 at 37525), the 
claim ``useful in not promoting tooth decay'' has been used on a 
limited number of foods, primarily chewing gums and confectioneries, 
for 20 years. This claim has a history of being used by consumers 
without particular confusion. Thus, the agency concludes that it is not 
necessary to include additional information as part of this claim when 
it appears on small packages to prevent it from being misleading.
    -17. Some comments stated that it was important that label 
statements of the claim include reference to nondietary factors, 
particularly oral hygiene, that are associated with dental caries. One 
comment stated that dental care and oral hygiene are more important 
factors in the nonpromotion of dental caries than the substitution of 
sugar alcohol-containing foods for sugar-containing foods.
    -One comment, however, stated that the requirement that a claim 
state that tooth decay depends on many factors (for larger packages) 
does not add to an understanding of the claim and would only confuse 
the message that sugar alcohol-containing products do not promote tooth 
decay. Other comments supported an abbreviated claim and asserted that 
reference to the multifactorial etiology of dental caries does not add 
information needed by consumers.
    -As discussed in the proposal, the agency acknowledges that the 
development of dental caries involves a complex interplay of many 
factors, both dietary and nondietary. Nonetheless, while there is an 
important role for dental care and oral hygiene in reducing the 
incidence of dental caries, the agency notes that current and well 
recognized recommendations also stress the role of diet.
    -In response to comments described above, the agency has considered 
the need for the inclusion of statements within the label claim 
concerning the multifactorial nature of dental caries and information 
on nondietary factors to help reduce the risk of this disease.
    -The agency notes that comments that requested that the agency 
require that nondietary factors be included in the health claim 
provided no evidence that claims about the relationship among sugar 
alcohols, fermentable carbohydrates, and dental caries are

[[Page 43441]]

misleading if a reference to nondietary factors is not included in the 
claim. Given the unique history of this claim, i.e., that it has been 
used for approximately 20 years, and the fact that the incidence of 
dental caries has decreased over that period, the agency is not 
persuaded that the absence of reference to specific nondietary factors 
in this claim has had adverse effects that would suggest that the claim 
is misleading.
    -Moreover, FDA has decided not to require that the statement 
``depends on many factors'' be included as part of the claim on 
products with 15 or more square inches of space available for labeling. 
The fact that the incidence of dental caries has declined over the past 
20 years strongly suggests that public health education, including 
information in preventive dental measures, that has been available to 
consumers during this period has been effective (Ref. 95). Moreover, as 
stated above, FDA is aware of the unique history of this claim. Given 
the history of this claim and the public education that has been 
available, FDA has reconsidered its tentative view that the statement 
``depends on many factors'' is necessary to the consumer understanding 
of the claim. FDA concludes that the available evidence demonstrates 
that the claim is complete without this information, and, therefore, 
that this information need not be made a required element of this 
health claim. However, the agency is providing that the information may 
be included in the health claims.
    -Thus, in this document, the agency is deleting proposed paragraphs 
Sec. 101.80(c)(2)(i)(C) and (c)(2)(i)(D). It is modifying 
Sec. 101.80(d)(2) to provide that the claim may state that the 
development of dental caries depends on many factors and list those 
risk factors. In place of proposed Sec. 101.80(c)(2)(i)(C), the agency 
is requiring in Sec. 101.80(c)(2)(i)(F) that the claim not imply that 
consumption of foods containing sugar alcohols is the only recognized 
means of achieving reduced risk of dental caries. Consistent with these 
changes, FDA has deleted the model claim in proposed Sec. 101.80(e)(2) 
that illustrated a claim with the statement ``depends on many 
factors.''
    -18. One comment suggested since the agency had proposed to 
authorize a claim using the terminology ``does not promote,'' then a 
claim relative to reducing the risk for dental caries was a separate 
claim that would not be authorized by a final rule in this proceeding. 
The comment suggested that it would be necessary to obtain separate 
authorization for such a claim as a means of conveying the relative 
superiority of certain sugar alcohols in affecting the occurrence of 
dental caries.
    -The proposal on sugar alcohols focused on the nonpromotion of 
dental caries, but it was not the agency's intent to specifically 
exclude the concept of risk reduction from the claim. In response to 
this comment, the agency considered the coverage of the claim and noted 
that, in proposed Sec. 101.80(d)(3), it had listed risk factors for 
dental caries. One factor listed was the frequent consumption of 
sucrose or other fermentable carbohydrates. The substitution of sugar 
alcohols in diets for foods containing sucrose or other fermentable 
carbohydrates reduces exposure to one risk factor for dental caries. 
Thus, FDA has concluded that it is appropriate to characterize the 
relationship as ``may reduce the risk.'' To make this finding explicit, 
the agency has inserted the phrase ``may reduce the risk'' in 
Sec. 101.80(c)(2)(i)(B).
    -As for claims of superiority, the agency notes that the provision 
of the act that authorizes health claims focuses on diet/disease 
relationships. Once a relationship is established, there is no further 
provision within the health claim regime for claims of superiority in 
affecting the disease in question. A manufacturer who makes a statement 
on the label or in labeling of a food concerning the superiority of the 
effect of one substance compared to another does so at the risk that 
FDA will find the claim to be false and misleading and thus subject to 
regulatory action under section 403(a) of the act.

G. Plaque pH Test

    -In Sec. 101.80(c)(2)(ii)(C), FDA proposed to provide that to 
qualify to bear a claim, the sugar alcohol-containing food not lower 
plaque pH below 5.7 by bacterial fermentation either during consumption 
or up to 30 minutes after consumption, as measured by in vivo tests. 
The agency asked for comments on this approach.
    -19. Two comments asked that FDA clarify that sugar alcohol-
containing chewing gums and confectioneries will be exempt from any 
plaque pH test requirement. One comment stated that the plaque pH 
requirement should be specific to sugar alcohol-containing foods that 
also contain fermentable carbohydrates. One comment stated that 
manufacturers can tell from the composition of the food if the plaque 
pH test is needed. One comment stated that the agency should give 
manufacturers flexibility in selecting the best protocol for testing 
plaque pH. One comment requested that the agency be more specific as to 
the type of test used to determine plaque pH. The comment stated that 
the pH of 5.7 is an appropriate threshold value for the pH when 
measured at the inner plaque surface (i.e., at the interface between 
plaque and dental enamel) at interproximal sites. The comment stated 
that a different threshold pH value is appropriate for plaque pH 
measurements obtained with other techniques and at other sites.
    -In the proposed rule, the agency also stated that the 
acidogenicity of HSH and other sugar alcohol mixtures is related to the 
manufacturing process, and that the process may vary among 
manufacturers. The agency asked for comments on how to determine 
whether sugar alcohol mixtures, such as HSH, when used in a food whose 
label bears a dental caries health claim, are in compliance with any 
final rule resulting from the proposal (60 FR 37507 at 37524). One 
comment stated that the agency's concern regarding the potential 
acidogenicity of HSH is covered with the plaque pH test.
    -When FDA asked for comments in the proposal about establishing a 
minimum plaque pH requirement, it was addressing concerns that a sugar 
alcohol-containing food might also contain a fermentable carbohydrate 
that would render the food cariogenic (60 FR 37507 at 37526). The 
application of the plaque pH test is thus predicated on the inclusion 
of fermentable carbohydrates in a food that contains sugar alcohols. 
Consequently, there is no need to exempt certain sugar alcohol-
containing foods from the plaque pH test. Rather, if sugar alcohols are 
used as sweeteners in a food, and there are no fermentable 
carbohydrates in the food, testing is not necessary.
    -In response to the comment concerning the need for manufacturers 
to have flexibility in selecting the method for measuring plaque pH, 
the agency points out that it does not require manufacturers who wish 
to make the health claim to perform the plaque pH test, nor does it 
require that a specific procedure be used when the test is performed. 
However, the agency is specifying in Sec. 101.80(c)(2)(ii)(C) the 
method that it will use to determine whether a food complies with the 
plaque pH requirement in this regulation. In doing so, FDA is 
responding to the comment that requested that the agency specify the 
procedure. Manufacturers are free to decide for themselves whether and 
how to test their products to satisfy themselves that the foods comply 
with Sec. 101.80(c)(2)(ii)(C)). If they fail to do so, they risk that 
FDA will find in its compliance testing of their food that the food 
does not comply with the plaque

[[Page 43442]]

pH standard and thus is subject to regulatory action.
    -The plaque pH test that the agency will use to determine whether a 
food is in compliance with this final rule is the indwelling plaque pH 
method, an intraoral telemetry method. The Swiss have used this method 
since 1969 for regulatory purposes, and it has been shown to be very 
reliable (Ref. 75). The indwelling plaque pH method is considered by 
many as the benchmark for plaque pH testing (Ref. 46). It is not the 
agency's intent to use this method of plaque pH testing as a means to 
rank the relative cariogenicity of foods; rather, the agency will use 
this method to determine whether foods that contain both sugar alcohols 
and fermentable carbohydrates qualify to bear this health claim.
    -With regard to the agency's request for comments about the 
potential acidogenicity of HSH and other sugar alcohol mixtures, the 
agency agrees with the comment that stated that the agency's concern 
regarding the potential acidogenicity of HSH is covered with the plaque 
pH test. Manufacturers who produce HSH will be responsible to ensure 
that their product, when used in a food that bears a dental caries 
health claim, is in compliance with the Sec. 101.80. If sugar alcohol 
mixtures, such as HSH, are used as sweeteners in a food, and there are 
no fermentable carbohydrates contributed by the sugar alcohol mixture 
or in the food, plaque pH testing is not necessary. If fermentable 
carbohydrates are present, manufacturers will need to ensure that the 
mixture does not lower plaque pH below 5.7.

H. Applicability of Claim to Other Substances

    -In proposed Sec. 101.80(c)(2)(ii)(B), the agency specified the 
substances (i.e., sugar alcohols) that are the subject of the sugar 
alcohol and dental caries proposed regulation.
    -20. Two comments requested that proposed Sec. 101.80(c)(2)(ii)(B) 
be modified to allow any sugar alcohol that may be developed in the 
future to fall under this health claim without amending the regulation.
    -FDA is denying this request. Under the general requirements for 
health claims, the petitioner must show how the substance that is the 
subject of the health claim conforms to the requirements of 
Sec. 101.14(b). For those substances that are to be consumed at other 
than decreased dietary levels, the petitioner must demonstrate to FDA's 
satisfaction that the substance is safe and lawful under the applicable 
food safety provisions of the act (Sec. 101.14(b)(3)(ii)). Moreover, 
the agency would expect, in the case of a new sugar alcohol, to see 
evidence that the substance will not lower plaque pH below 5.7. If such 
showing is made, FDA will take action to add the substance to the list 
in this regulation, which has been renumbered as 
Sec. 101.80(c)(2)(ii)(B).
    -21. Two comments requested that FDA make provision in this 
regulation for additional FDA approved ingredients, e.g., polydextrose, 
that satisfy the requirement that they do not lower plaque pH below 
5.7. The comments stated that this would obviate the need to amend the 
regulation as additional ingredients become available in the future. 
One comment stated that the plaque pH test serves as the true marker of 
noncariogenicity, not the presence of sugar alcohols or the absence of 
sugars. The comment suggested that the plaque pH test is the only 
critical endpoint necessary to justify use of this health claim.
    -One comment noted that the agency suggested that this claim will 
apply primarily to snack foods that do not play a fundamental role in 
structuring a healthy diet. The comment stated that other food products 
could be designed to not lower plaque pH below the required level of 
5.7. The comment stated that products widely known to be noncariogenic 
and to have a role in a healthy diet, e.g., cheese, would be unable to 
bear this claim. The comment suggested that the claim be limited to 
chewing gums and confectioneries, although the comment provided no 
background on how to differentiate confectioneries from snack foods, 
nor did it provide evidence as to how this limitation would advance the 
purposes of the health claim provisions of the act.
    -FDA is denying the requests to make provision in this final rule 
for other ingredients, such as polydextrose, that do not lower plaque 
pH below 5.7. The requirement that the food not lower plaque pH below 
5.7 is not the only criterion that must be satisfied for a food to bear 
the health claim. The agency recognizes that there may be scientific 
evidence to show that foods that do not contain sugar alcohols would 
qualify to bear a nonpromotion of dental caries health claim. However, 
the health claim petition that is the subject of this rulemaking (Ref. 
1), which was filed in accordance with the requirements of Sec. 101.70, 
addressed only certain sugar alcohols and presented the scientific 
evidence pertaining to those substances. The agency did not review the 
totality of publicly available evidence on the cariogenicity of other 
ingredients or other foods. Without assurances that the substance in 
question, e.g., polydextrose, meets the entire set of criteria for a 
health claim, the authorization for the claim cannot be broadened to 
include other substances.
    -In response to the comment as to why the claim is being allowed on 
foods that contain sugar alcohols (and meet other criteria) and is not 
limited to only gums and confectioneries, the agency points out that 
the claim is based upon the substitution of sugar alcohols for 
fermentable carbohydrates, not on the use of certain foods. To the 
extent that consumers can select foods that contain fewer fermentable 
carbohydrates, their chances of reducing their risk of developing 
dental caries are increased. Limiting the claim to certain categories 
of foods would limit the significance of the claim and not serve the 
interests of the consumer.

I. Other Issues

    -The agency proposed that any final rule that may issue based upon 
the proposal become effective 30 days following its publication.
    -22. Two comments requested that FDA change the effective date of 
the final rule to 6 months following its publication. The comments 
stated that this change would allow time for industry to change labels 
on products that may need changing if wording changes on the claim are 
needed.
    -FDA has considered the issue of the compliance date and has 
concluded that the compliance date for this regulation will be January 
1, 1998. This date is consistent with that proposed by FDA in the 
``Uniform Compliance Date for Food Labeling Regulations'' proposal rule 
(hereinafter referred to as the ``uniform compliance date'' proposed 
rule) (61 FR 16422, April 15, 1996). In that document, the agency 
stated that it periodically has announced uniform compliance dates for 
new food labeling requirements. It stated that use of a uniform 
compliance date provides for an orderly and economical industry 
adjustment to new labeling requirements by allowing sufficient lead 
time to plan for the use of existing label inventories and the 
development of new labeling materials. FDA stated that this policy also 
serves consumers' interests because the increased cost of multiple 
short-term label revisions that would otherwise occur would likely be 
passed on to consumers in the form of higher food prices. Although FDA 
is adopting January 1, 1998, as the compliance date, the agency is 
encouraging firms to begin voluntary compliance as early as possible 
after publication of this rule and to begin making changes when they 
reprint their labels.

[[Page 43443]]

-III. Decision to Authorize a Health Claim Relating Sugar Alcohols 
to Dental Caries

    -FDA has considered all of the comments that it received in 
response to the sugar alcohol and dental caries health claim proposal. 
The agency concludes that the relationship between sugar alcohols and 
dental caries is truthful, not misleading, and scientifically valid in 
that there is significant scientific agreement based on the totality of 
publicly available scientific evidence that sugar alcohols do not 
promote dental caries. Therefore, FDA is authorizing this claim, 
although based on some of the comments, the agency has been persuaded 
to make a number of editorial changes in the proposed codified material 
of the health claim.

-IV. Environmental Impact

    -The agency has previously considered the environmental effects of 
this rule as announced in the proposed rule (60 FR 37507). At that 
time, the agency determined under 21 CFR 25.24(a)(11) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. No new information or 
comments have been received that would affect the agency's previous 
determination that there is no significant impact on the human 
environment and that an environmental impact statement is not required.

-V. Analysis of Impacts

    -FDA has examined the economic implications of the final rule 
establishing a health claim for sugar alcohols and dental caries as 
required by Executive Order 12866 and the Regulatory Flexibility Act 
(Pub. Law 96-354) as amended by the Small Business Regulatory 
Enforcement Fairness Act of 1996. Executive Order 12866 directs 
agencies to assess all costs and benefits of available regulatory 
alternatives and, when regulation is necessary, to select regulatory 
approaches that maximize net benefits (including potential economic, 
environmental, public health and safety effects; distributive impacts; 
and equity). FDA finds that this final rule is not a significant rule 
as defined by Executive Order 12866.
    -In response to the proposal, FDA received two comments suggesting 
that the costs of the proposed health claim exceed the benefits. One 
comment suggested that parents who substitute sugar alcohol containing 
snacks for other snack foods will be trading dental caries for gastric 
problems in their young children. The second comment stated that, 
because gums and candies that contain sugar alcohols are more expensive 
than other sweets, some consumers may purchase them with funds that 
otherwise would be used for preventive dental health measures.
    -The agency is unconvinced by these comments. Because the claim is 
already being used on many products in ways that would satisfy the 
conditions for use as approved by this regulation, the agency does not 
agree that the claim will cause consumers to switch from sugar-
containing products to existing products containing sugar alcohols. 
Therefore, it is unlikely that this regulation will result in any 
significant changes in consumer behavior. In fact, any change in 
consumer behavior because of sugar alcohols most likely has already 
taken place. This regulation is thus not expected to cause an increase 
in gastric problems.
    -The agency also does not agree that this regulation is likely to 
result in a decrease in preventive dental health measures. Consumers of 
sugar alcohol containing foods purchase the products either because of 
their dietetic attributes or because of their role in preventive dental 
health. The majority of sugar alcohol containing foods that would 
qualify for the health claim currently have sugar-free claims which are 
required to be accompanied by a statement that the product is not a 
low-calorie food. Therefore, it is unlikely that these products are 
being consumed by calorie-conscious individuals.
    -The health claim should have no impact on the purchases of 
consumers who consume these products for the dietetic properties 
because neither sugary foods nor preventive dental health measures are 
substitutes for dietetic foods. The agency is aware of no evidence that 
sugar alcohol containing foods and preventive dental health measures 
are substitutes for dentally concerned consumers. In fact, it is more 
likely that these consumers view the two categories as complementary 
products working together as a part of a dental health regime. It is 
likely that the cross elasticity of demand, a numerical measure of the 
connection between two goods, for sugar alcohol containing foods and 
preventive dental health measures is either not significantly different 
from zero, or negative. In other words, the two product categories are 
either not close substitutes or are complementary products. Therefore, 
the agency rejects the assertion that the use of preventive dental 
health measures will decline as a result of this rule.
    -Although the benefits of this rule are minimal, the costs of this 
regulation are also anticipated to be small. FDA is aware that some 
firms are already using similar claims on product labels. It is likely 
that most of these claims satisfy the criteria described in this 
rulemaking. However, because FDA is requiring er claims for larger 
package sizes, some product labels may need to be revised. To the 
extent that labels need revision, this final rule will impose costs. On 
average, the administrative, redesign, and inventory disposal costs of 
revising a label for the affected product categories within a six month 
compliance period are between $800 and $1525 per label depending on the 
location of the claim. Because FDA does not know the number of sugar 
alcohol claims currently being made nor the proportion of existing 
claims that do not meet FDA's criteria, the agency cannot estimate the 
total costs of this regulation.
    -The Regulatory Flexibility Act as amended requires analyzing 
options for regulatory relief for small businesses. According to the 
information currently available to the agency, of the relatively small 
number of products that would require relabeling as a result of this 
final rule, none are produced by small firms. Therefore, the agency 
certifies that this rule will not have a significant impact on a 
substantial number of small businesses.

-VI. Paperwork Reduction Act

    -This final rule contains no information collection or 
recordkeeping requirements under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq.).

-VII. References

    -The following references have been placed on display in the 
Dockets Management Branch (address above) and may be seen by interested 
persons between 9 a. m. and 4 p. m., Monday through Friday.

    -1. Drozen, Melvin S., ``Health claim petition regarding the 
noncariogenicity of sugar alcohols,'' August 31, 1994.
    - 2. Drozen, Melvin S., ``Objections and request for a hearing 
by Working Group of sugar alcohol manufacturers to the revocation of 
21 C.F.R. section 105.66(f),'' Docket No. 91N-384L, Dockets 
Management Branch, FDA, Rockville, MD.
    -3. Saltsman, Joyce J., CFSAN, FDA, Letter to Melvin S. Drozen, 
September 15, 1994.
    -4. Saltsman, Joyce J., CFSAN, FDA, Letter to Melvin S. Drozen, 
October 7, 1994.
    -5. Drozen, Melvin S., Letter to FDA, November 15, 1994.
    -6. Saltsman, Joyce J., CFSAN, FDA, Memorandum of telephone 
conversation, December 8, 1994.

[[Page 43444]]

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[[Page 43445]]

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caries,'' In: Progress in Sweeteners, editor: T. H. Grenby, Elsevier 
Science, Inc., pp. 311-328, 1989.
    -86. Loesche, W. J., ``The rationale for caries prevention 
through use of sugar substitutes,'' International Dental Journal, 
35:1-8, 1985.
    -87. Mandel, I. D., ``Dental caries,'' American Scientist, 
67:680-688, 1979.
    -88. Koulourides, T., R. Bodden, S. Keller, L. Manson-Hing, J. 
Lastra, and T. Housch, ``Cariogenicity of nine sugars tested with an 
intraoral device in man,'' Caries Research 10:427-441, 1976.
    -89. Baer, A., ``Significance and promotion of sugar 
substitution for the prevention of dental caries,'' Lben.-Wiss U. 
Technology, Academic Press, 22:46-53, 1989.
    -90. LSRO, FASEB, ``Health Aspect of Sugar Alcohols and 
Lactose,'' Bethesda, MD, September, 1986.
    -91. Joint FAO/WHO Expert Committee on Food Additives, 
``Evaluation of Certain Food Additives and Contaminants,'' Geneva, 
Switzerland, pp. 16-17, 1993.
    -92. Kashket, S., J. van Houte, L. R. Lopez, and S. Stocks, 
``Lack of correlation between food retention on the human dentition 
and consumer perception of food stickiness,'' Journal of Dental 
Research, 70:1314-1319, 1991.
    -93. S. Kashket, J. Zhang, and J. van Houte, ``Accumulation of 
fermentable sugars and metabolic acids in food particles that become 
entrapped on the dentition,'' unpublished manuscript.
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from FDA's Sugars Task Force, 1986--Evaluation of health aspects of 
sugars contained in carbohydrate sweeteners,'' Journal of Nutrition, 
116(11S):S1-S9, S39-S43, 1986.
    -95. Birkhed, D., and A. Bar, ``Sorbitol and dental caries,'' 
World Review of Nutrition and Dietetics, 65:1-37, 1991.
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International Dental Journal, 35:9-17, 1985.
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    -101. USDA and DHHS, ``Nutrition and Your Health: Dietary 
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List of Subjects in 21 CFR Part 101

     Food labeling, Incorporation by reference, Nutrition, Reporting 
and recordkeeping requirements.
     Therefore, under the Federal Food, Drug, and Cosmetic Act and 
under authority delegated to the Commissioner of Food and Drugs, 21 CFR 
part 101 is amended as follows:

[[Page 43446]]

PART 101--FOOD LABELING

     1. The authority citation for 21 CFR part 101 is revised to read 
as follows:

     Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act 
(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342, 
343, 348, 371).

     2. New Sec. 101.80 is added to subpart E to read as follows:

Sec. 101.80   Health claims: dietary sugar alcohols and dental caries.

     (a) Relationship between dietary carbohydrates and dental caries. 
(1) Dental caries, or tooth decay, is a disease caused by many factors. 
Both environmental and genetic factors can affect the development of 
dental caries. Risk factors include tooth enamel crystal structure and 
mineral content, plaque quantity and quality, saliva quantity and 
quality, individual immune response, types and physical characteristics 
of foods consumed, eating behaviors, presence of acid producing oral 
bacteria, and cultural influences.
    -(2) The relationship between consumption of fermentable 
carbohydrates, i.e., dietary sugars and starches, and tooth decay is 
well established. Sucrose, also known as sugar, is one of the most, but 
not the only, cariogenic sugars in the diet. Bacteria found in the 
mouth are able to metabolize most dietary carbohydrates, producing acid 
and forming dental plaque. The more frequent and longer the exposure of 
teeth to dietary sugars and starches, the greater the risk for tooth 
decay.
    -(3) Dental caries continues to affect a large proportion of 
Americans. Although there has been a decline in the prevalence of 
dental caries among children in the United States, the disease remains 
widespread throughout the population, imposing a substantial burden on 
Americans. Recent Federal government dietary guidelines recommend that 
Americans choose diets that are moderate in sugars and avoid excessive 
snacking. Frequent between-meal snacks that are high in sugars and 
starches may be more harmful to teeth than eating such foods at meals 
and then brushing.-
     (4) Sugar alcohols can be used as sweeteners to replace dietary 
sugars, such as sucrose and corn sweeteners, in foods such as chewing 
gums and certain confectioneries. Dietary sugar alcohols are 
significantly less cariogenic than dietary sugars and other fermentable 
carbohydrates.
     (b) Significance of the relationship between sugar alcohols and 
dental caries. Sugar alcohols do not promote dental caries. Sugar 
alcohols are slowly metabolized by bacteria to form some acid. The rate 
and amount of acid production is significantly less than that from 
sucrose and other fermentable carbohydrates and does not cause the loss 
of important minerals from tooth enamel.
     (c) Requirements. (1) All requirements set forth in Sec. 101.14 
shall be met, except that sugar alcohol-containing foods are exempt 
from section Sec. 101.14(e)(6).
     (2) Specific requirements. (i) Nature of the claim. A health claim 
relating sugar alcohols, compared to other carbohydrates, and the 
nonpromotion of dental caries may be made on the label or labeling of a 
food described in (c)(2)(ii) of this section, provided that:
    -(A) The claim shall state that frequent between-meal consumption 
of foods high in sugars and starches can promote tooth decay.
    -(B) The claim shall state that the sugar alcohol present in the 
food ``does not promote,'' ``may reduce the risk of,'' ``useful [or is 
useful] in not promoting,'' or ``expressly [or is expressly] for not 
promoting'' dental caries;
    -(C) In specifying the nutrient, the claim shall state ``sugar 
alcohol,'' ``sugar alcohols,'' or the name or names of the sugar 
alcohols, e.g., ``sorbitol.''
    -(D) In specifying the disease, the claim uses the following terms: 
``dental caries'' or ``tooth decay.''
     (E) The claim shall not attribute any degree of the reduction in 
risk of dental caries to the use of the sugar alcohol-containing food.
    -(F) The claim shall not imply that consuming sugar alcohol-
containing foods is the only recognized means of achieving a reduced 
risk of dental caries.
    -(G) Packages with less than 15 square inches of surface area 
available for labeling are exempt from paragraphs (A) and (C) of this 
section.
     (ii) Nature of the food. (A) The food shall meet the requirement 
in Sec. 101.60(c)(1)(i) with respect to sugars content.
     (B) The sugar alcohol in the food shall be xylitol, sorbitol, 
mannitol, maltitol, isomalt, lactitol, hydrogenated starch 
hydrolysates, hydrogenated glucose syrups, or a combination of these.
     (C) When fermentable carbohydrates are present in the sugar 
alcohol-containing food, the food shall not lower plaque pH below 5.7 
by bacterial fermentation either during consumption or up to 30 minutes 
after consumption, as measured by the indwelling plaque pH test found 
in ``Identification of Low Caries Risk Dietary Components,'' T. N. 
Imfeld, Volume 11, Monographs in Oral Science, 1983, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies may be obtained from Karger AG Publishing Co., P. O. 
Box, Ch-4009 Basel, Switzerland, or may be examined at the Center for 
Food Safey and Applied Nutrition's Library, 200 C St. SW., rm. 3321, 
Washington, DC, or at the Office of the Federal Register, 800 North 
Capitol St. NW., suite 700, Washington, DC.
     (d) Optional information. (1) The claim may include information 
from paragraphs (a) and (b) of this section, which describe the 
relationship between diets containing sugar alcohols and dental caries.
     (2) The claim may indicate that development of dental caries 
depends on many factors and may identify one or more of the following 
risk factors for dental caries: Frequent consumption of fermentable 
carbohydrates, such as dietary sugars and starches; presence of oral 
bacteria capable of fermenting carbohydrates; length of time 
fermentable carbohydrates are in contact with the teeth; lack of 
exposure to fluoride; individual susceptibility; socioeconomic and 
cultural factors; and characteristics of tooth enamel, saliva, and 
plaque.

[[Page 43447]]

    -(3) The claim may indicate that oral hygiene and proper dental 
care may help to reduce the risk of dental disease.
    -(4) The claim may indicate that the sugar alcohol serves as a 
sweetener.
     (e) Model health claim. The following model health claims may be 
used in food labeling to describe the relationship between sugar 
alcohol-containing foods and dental caries.
    -(1) Example of the full claim:
    -(i) Frequent eating of foods high in sugars and starches as 
between-meal snacks can promote tooth decay. The sugar alcohol [name, 
optional] used to sweeten this food may reduce the risk of dental 
caries.
    -(ii) Frequent between-meal consumption of foods high in sugars and 
starches promotes tooth decay. The sugar alcohols in [name of food] do 
not promote tooth decay.-
    -(2) Example of the shortened claim for small packages:
    -(i) Does not promote tooth decay.
    -(ii) May reduce the risk of tooth decay.

    Dated: August 16, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-21481 Filed 8-20-96; 8:53 am]
BILLING CODE 4160-01-F