[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.
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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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synthesis by S. mutans and change of enamel hardness,'' Nihon
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Brown, D. A. M. Geddes, and A. F. Hall, ``The effect of chewing gum
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sweeteners,'' Journal of Dental Research, 64:1130-1133, 1985.
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G. Frostell, ``Acid production from sorbitol in human dental
plaque,'' Archives of Oral Biology, 23:971-975, 1978.
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carbohydrate products,'' Acta Odontologica Scandanavia, 27:3-29,
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a nonsugar licorice and different sugar substitutes in Streptococcus
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[[Page 43445]]
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Technology, Academic Press, 22:46-53, 1989.
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-91. Joint FAO/WHO Expert Committee on Food Additives,
``Evaluation of Certain Food Additives and Contaminants,'' Geneva,
Switzerland, pp. 16-17, 1993.
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``Lack of correlation between food retention on the human dentition
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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.
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World Review of Nutrition and Dietetics, 65:1-37, 1991.
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sugar substitutes on oral microorganisms,'' in Developments in
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Science, New York, pp. 151-188, 1987.
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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