[Federal Register: December 2, 2002 (Volume 67, Number 231)]
[Rules and Regulations]
[Page 71461-71470]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02de02-12]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 02P-0177]
Food Labeling: Health Claims; D-tagatose and Dental Caries
AGENCY: Food and Drug Administration, HHS.
ACTION: Interim final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the
regulation authorizing a health claim on sugar alcohols and dental
caries, i.e., tooth decay, to include the sugar D-tagatose, a novel
food ingredient. Similar to the sugar alcohols currently listed in
Sec. 101.80 (21 CFR 101.80), D-tagatose is a carbohydrate sweetener
that is slowly fermented by oral microorganisms, thus producing less
acid than more fermentable carbohydrates. We (FDA) are taking this
action in response to a petition filed by Arla Foods Ingredients amba.
We previously concluded that there was significant scientific agreement
for the relationship between slowly fermented carbohydrate sugar
substitutes, specifically certain sugar alcohols, and the nonpromotion
of dental caries. Based on the totality of publicly available
scientific evidence, we now have determined that the sugar D-tagatose,
like the sugar alcohols, is not fermented by oral bacteria to an extent
sufficient to lower dental plaque pH to levels that would cause the
erosion of dental enamel. Therefore, we have concluded that D-tagatose
does not promote dental caries, and we are amending the regulation
authorizing a health claim relating certain sugar alcohols and
nonpromotion of dental caries to include D-tagatose as a substance
eligible for the claim. Moreover, because D-tagatose is a sugar, we are
denying the petitioner's request to exclude D-tagatose from the
definition of ``sugars,'' and instead are exempting foods containing D-
tagatose from the requirement that foods bearing a health claim about
nonpromotion of dental caries be sugar-free. Accordingly, although
products containing D-tagatose will not be permitted to be labeled as
``sugar-free,'' they will be authorized to say that D-tagatose sugar
does not promote, or may reduce the risk of, tooth decay.
DATES: This rule is effective December 2, 2002. Submit written or
electronic comments by February 18, 2003.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments
.
FOR FURTHER INFORMATION CONTACT: James Hoadley, Food and Drug
Administration, Center for Food Safety and Applied Nutrition (HFS-832),
Harvey W. Wiley Federal Bldg., 5100 Paint Branch Pkwy., College Park,
MD, 20740-3835, 301-436-1450.
SUPPLEMENTARY INFORMATION:
I. Introduction
The Nutrition Labeling and Education Act of 1990 (the 1990
amendments) (Public Law 101-535) amended the Federal Food, Drug, and
Cosmetic Act (the act) in a number of important ways. One aspect of the
1990 amendments was that they confirmed FDA's authority to
[[Page 71462]]
regulate health claims on food labels and in food labeling.
We issued several new regulations in 1993 that implemented the
health claim provisions of the 1990 amendments. Among these were Sec.
101.14 (21 CFR 101.14), Health Claims: General Requirements, (58 FR
2478, January 6, 1993) and Sec. 101.70 (21 CFR 101.70), Petitions for
Health Claims (58 FR 2478, January 6, 1993), which established a
process for petitioning the agency to authorize health claims about
substance-disease relationships and set out the types of information
that a health claim petition must include. These regulations became
effective on May 8, 1993.
The final rule for Sec. 101.80 (61 FR 43433, August 23, 1996),
relating sugar alcohols and the nonpromotion of dental caries (the
dental caries health claim), completed the first rulemaking that we
conducted in response to a health claim petition (Docket No. 95P-0003).
Section 101.80(a) describes the role of fermentable carbohydrates,
i.e., dietary sugars and starches, in the development of dental caries.
The fermentation of these carbohydrates by microorganisms on the
surface of teeth produces organic acids, which contribute to the
development of dental caries through erosion of tooth enamel. Section
101.80 (b) explains that sugar alcohols are fermented by oral
microorganisms more slowly than fermentable carbohydrates. Thus, the
rate of acid production is lower than that from fermentable
carbohydrates. Consequently, sugar alcohols, when used in place of
fermentable carbohydrates, are useful as sweeteners that do not promote
dental caries. Section 101.80 (c) describes the specific requirements
of the dental caries health claim, including the requirement that the
food bearing the claim be ``sugar free'' as defined by Sec.
101.60(c)(1)(i) (21 CFR 101.60(c)(1)(i)). Section 101.80 (c) also
specifies the sugar alcohols that are eligible for the claim: xylitol,
sorbitol, mannitol, maltitol, isomalt, lactitol, hydrogenated starch
hydrolysates, hydrogenated glucose syrups, erythritol, or a combination
of these (Sec. 101.80(c)(2)(ii)(B)). Section 101.80(c)(2)(ii)(C)
further states that:
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,'' * * * which is incorporated by reference * * *.
In the dental caries health claim final rule, the agency stated
that for other sugar alcohols to be listed in Sec.
101.80(c)(2)(ii)(B), a petitioner must show how the substance conforms
to the requirements of Sec. Sec. 101.14(b) and 101.80 and must provide
evidence that the new sugar alcohol will not lower dental plaque pH
below 5.7 (61 FR 43433 at 43442).
In 1997, the agency received a health claim petition (Docket No.
97P-0206) requesting that we amend the dental caries health claim
regulation to include erythritol among the sugar alcohols listed in
Sec. 101.80(c)(2)(ii)(B). The petition met the requirements in
Sec. Sec. 101.14(b) and 101.80, including evidence from clinical
studies using the indwelling plaque pH test cited in Sec.
101.80(c)(2)(ii)(C), demonstrating that erythritol-containing foods do
not lower plaque pH below 5.7. Therefore, we amended Sec.
101.80(c)(2)(ii)(B) to include erythritol as one of the sugar alcohols
that is eligible to bear a dental caries health claim (62 FR 63653,
December 2, 1997).
II. Petition for Health Claim on D-tagatose and the Nonpromotion of
Dental Caries
A. The Petition
On January 9, 2002, Arla Foods Ingredients amba, DK-8260 Viby,
Denmark, (the petitioner) submitted a petition under section 403(r)(4)
of the act (21 U.S.C. 343(r)(4)). The petition requested that we: (1)
Amend Sec. 101.80 to include the sugar D-tagatose as one of the
substances eligible to bear the dental caries health claim; (2) amend
Sec. 101.9 (21 CFR 101.9), the nutrition labeling regulation, to
exclude D-tagatose from the definition of ``sugars'' (Sec.
101.9(c)(6)(ii)), thereby allowing a ``sugar free'' nutrient content
claim; and (3) modify the wording of Sec. 101.80 because D-tagatose is
not a sugar alcohol. On April 19, 2001, we notified the petitioner that
we had completed our initial review of the petition and that the
petition had been filed for further action (Docket No. 02P-0177, Let 1)
in accordance with section 403(r)(4) of the act. The April 19, 2001,
letter stated that consistent with our strategy for implementation of
the 1999 Pearson court decision (see 65 FR 59855, October 6, 2000), the
agency would consider using its interim final rule authority under
section 403(r)(7)(A)(iii) of the act to allow use of the health claim
immediately upon publication of the proposal. If the agency does not
act, by either denying the petition or issuing a proposed regulation to
authorize the health claim, within 90 days of the date of filing, the
petition is deemed to be denied unless an extension is mutually agreed
upon by the agency and the petitioner (Section 403(r)(4)(A)(i) of the
act and Sec. 101.70(j)(3)(iii)). On July 11, 2002, FDA and the
petitioner agreed to extend the deadline to publish a proposed
regulation until December 2, 2002 (Docket No. 02P-0177, Let 2).
B. Nature of the Substance
As noted by the petition, D-tagatose, the subject of this health
claim, is a sugar (see Ref. 1 at page 2). D-tagatose is a
monosaccharide ketohexose sugar.\1\ There are four different ketohexose
sugars, differing only in the orientation of the hydroxyl groups
attached to the carbon atoms in positions 3, 4, and 5; the other three
ketohexoses are D-fructose, D-sorbose, and D-psicose. D-fructose is the
only abundant ketohexose in nature; D-tagatose occurs naturally in the
human food supply at only trace amounts. D-tagatose and D-fructose
differ in the orientation of the hydroxyl group at the carbon atom at
position 4. The Chemical Abstracts Service Registry Number (CAS No.)
for D-tagatose is 87-81-0. It has a sweetness of about 75-92 percent
that of sucrose.
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\1\ All of the common monosaccharides are six-carbon sugars,
i.e., hexoses. All sugars have a carbon-oxygen double bond at either
the carbon atom in position 1 (aldose) or at the carbon atom in
position 2 (ketose). Sugar alcohols differ from sugars in that the
double-bonded oxygen of sugars is reduced to a hydroxyl group (-OH)
in the sugar alcohols.
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C. Review of Preliminary Requirements for a Health Claim
1. The Substance Is Associated With a Disease for Which the U.S.
Population Is at Risk
At the time that the dental caries health claim initially was
proposed, the agency recognized that, although the prevalence of dental
caries among children in the United States had been declining since the
early 1970s, the overall prevalence of dental caries remained a
substantial burden throughout the U.S. population (60 FR 37507 at
37509, July 20, 1995). Currently, the Department of Health and Human
Services' Healthy People 2010 Objectives recognizes dental caries as
the single most common chronic disease of childhood, and states that 30
percent of adults have untreated dental decay (Ref. 2). Based on these
facts, FDA concludes that, as required in Sec. 101.14(b)(1), dental
caries is a disease for which the U.S. population is at risk.
2. The Substance Is a Food
Under Sec. 101.14(b)(3)(i), the substance that is the subject of a
health claim must contribute taste, aroma, or nutritive value, or any
other technical effect
[[Page 71463]]
listed in Sec. 170.3(o) (21 CFR 170.3(o)), to the food and must retain
that attribute when consumed at the levels that are necessary to
justify a claim. The petition states that the intended use of D-
tagatose in foods is as a nutritive sweetener, humectant, texturizer or
stabilizer (Sec. 170.3(o)(16), (o)(21), (o)(28), (o)(32)). D-tagatose
used as a sweetener contributes taste to the food. Existing Sec.
101.80 does not specify the levels in foods of sugar alcohols necessary
to justify the health claim and the current petition does not propose a
qualifying level for D-tagatose. As a substitute for dietary sugars, D-
tagatose will be used in foods at levels necessary to provide the
desired level of sweetness in the finished product. Because D-tagatose
contributes taste and other technical effects listed in Sec. 170.3(o)
to food, the agency concludes that the preliminary requirement of Sec.
101.14(b)(3)(i) is satisfied.
3. The Substance Is Safe and Lawful
On May 11, 2001, the petitioner notified FDA of its view that D-
tagatose is generally recognized as safe (GRAS), through scientific
procedures, for use as a bulk sweetener, humectant, texturizer, or
stabilizer in a variety of foods. FDA replied to this notice on October
25, 2001, stating that based on the information provided by the
petitioner, as well as other information available to FDA, the agency
had no questions regarding the petitioner's determination that the
intended use of D-tagatose is GRAS (Agency Response Letter to GRAS
Notice No. GRN 000078, October 25, 2001) (Ref. 1, Appendix 2).
Furthermore, FDA is not aware of any scientific evidence that D-
tagatose, under the intended conditions of use, would be harmful. The
agency has not made its own determination regarding the GRAS status of
D-tagatose, however, and notes that authorization of a health claim for
a substance should not be interpreted as affirmation that the use of
the substance is GRAS.
The petitioner's May 11, 2001 submission reveals significant
evidence supporting the safety of the use of D-tagatose as a sweetener.
FDA is not aware of any evidence that provides a basis to reject the
petitioner's position that the use of D-tagatose as a sweetener is safe
and lawful. Therefore, FDA concludes that the petitioner has satisfied
the requirement of Sec. 101.14(b)(3)(ii) to demonstrate that the use
of D-tagatose as a sweetener is safe and lawful.
III. Review of Scientific Evidence of the Substance-Disease
Relationship
A. Basis for Evaluating the Relationship Between D-Tagatose and Dental
Caries
In the preamble to the 1996 dental caries health claim final rule,
the agency concluded that there was significant scientific agreement
among qualified experts to support the relationship between certain
sugar alcohols and the nonpromotion of dental caries (61 FR 43433). The
agency noted that it would take action to add additional sugar alcohols
to this regulation when presented with evidence that the additional
sugar alcohols will not lower plaque pH below 5.7, and that the
substance conforms to the requirements of Sec. 101.14(b) (61 FR 43433
at 43442).
In 1997, the agency amended the dental caries health claim to add
erythritol as an additional sugar alcohol eligible for the claim (62 FR
63653, December 2, 1997). The petition to amend Sec. 101.80 to add
erythritol (Docket No. 97P-0206) presented scientific data from a
rodent cariogenicity study and from a clinical indwelling plaque pH
test of erythritol. The agency was satisfied that the results of these
two studies were consistent with the results of the studies that
investigated the cariogenic potential of the sugar alcohols listed in
Sec. 101.80(c)(2)(ii)(B) and that erythritol met the requirements of
Sec. 101.14(b). Therefore, erythritol was added to the list of
eligible sugar alcohols.
The substance that is the subject of the current petition, D-
tagatose, is a sugar rather than a sugar alcohol. However, like the
sugar alcohols, the intended food ingredient use of D-tagatose is as a
nutritive sweetener with reduced caloric value relative to traditional
sugars. Also, as is the case with the sugar alcohols, the potential
dental health benefit from D-tagatose derives from its reduced
fermentability relative to traditional sugars. Consequently, the
criteria that were used to evaluate the sugar alcohols in the existing
dental caries health claim can be applied to D-tagatose to assess
whether it qualifies for such a claim. As discussed in section II.C of
this document FDA has concluded that D-tagatose satisfies the
requirements of Sec. 101.14(b).
B. Review of Scientific Evidence
1. Evidence Considered in Reaching the Decision
In the initial proposal to authorize a health claim relating sugar
alcohols and nonpromotion of dental caries (60 FR 37507, July 20,
1995), FDA considered evidence about the cariogenic potential of
several specific sugar alcohols from long-term controlled human caries
trials, in vivo and in vitro plaque pH measurements, demineralization
and remineralization techniques, and rat caries experimental models.
FDA's review focused on the scientific evidence from studies evaluating
changes in plaque pH, plaque acid production, decalcification or
remineralization of tooth enamel, and the incidence of dental caries
with sugar alcohols. FDA limited its review to these types of studies
because previous Federal Government and other authoritative reviews had
focused on these areas, and the majority of research efforts have also
focused on these areas (60 FR 37507 at 37523). The well-established
role of sucrose in the etiology of dental caries is related to the
ability of sucrose to be metabolized by oral bacteria into
extracellular polymers that adhere firmly to the tooth surfaces (i.e.,
plaque), at the same time forming acids that can demineralize tooth
enamel. FDA previously concluded that human studies show sugar
alcohols, relative to sucrose, are associated with reduced rate of acid
production in dental plaque and, in some studies, a reduced incidence
of dental caries (60 FR 37507 at 37523).
The current petition to amend the dental caries health claim
requires FDA to consider the effects of a sugar, D-tagatose, on the
rate of acid production in dental plaque and thus on the incidence of
dental caries. To determine whether there is an association between D-
tagatose and the nonpromotion of dental caries, FDA compared scientific
evidence regarding the cariogenic potential of D-tagatose from two
human studies investigating the rate of acid production in dental
plaque from D-tagatose relative to that of sucrose with the similar
evidence that the agency had previously reviewed regarding the
cariogenic potential of certain sugar alcohols. Upon review of this
evidence, FDA concluded that, like the sugar alcohols previously
authorized for this health claim, D-tagatose is associated with the
nonpromotion of dental caries.
2. Review of D-tagatose Studies
The petition included reports (Ref. 1, Appendix 3) from the
evaluation of D-tagatose using the indwelling plaque pH test described
in ``Identification of Low Caries Risk Dietary Components,'' T. N.
Imfeld, Volume 11, Monographs in Oral Science, 1983, which is
incorporated by reference in the dental caries health claim regulation
(Sec. 101.80(c)(2)(iii)(C)). This evaluation was conducted twice under
the same test protocol and with
[[Page 71464]]
the same six test subjects. The purpose of the repeat test was to
investigate the potential for oral bacteria adaptation to D-tagatose.
Each of the six subjects of these trials had his or her normal
dental prosthesis replaced with a mandibular bridge-work that contained
a miniaturized telemeterized glass pH-electrode that transmits pH data
to an external recording device. Once the telemetric pH prosthesis was
inserted into the subject's mouth, the subject was asked not to alter
his or her eating habits. The prostheses remained in place throughout
the test period to allow an undisturbed growth of plaque over the tips
of the pH-electrodes. With the exception of water rinses, the subjects
also were asked to refrain from all oral hygiene measures. Following a
3- to 7-day plaque buildup period, the interdental plaque pH telemetry
test was conducted. The two tests differed only in that, for the first
test, exposure to D-tagatose was limited to a single 2-minute rinse
during the pH measurements that followed the plaque buildup period; in
the second test, subjects rinsed with D-tagatose five times per day
throughout the 3- to 7-day plaque buildup period to determine whether
the oral bacteria could adapt to utilize D-tagatose.
For both tests, baseline plaque pH was measured over a 15-minute
period after the subjects chewed a piece of paraffin for 3 minutes. The
subjects then rinsed with a 10-percent aqueous solution of D-tagatose,
followed by plaque pH measurements over a 30-minute period. The same
paraffin chew and rinse sequence was then repeated using a 10-percent
sucrose rinse. The sucrose rinse served as a positive control to
demonstrate the accurate functioning of the pH telemetric equipment and
of plaque metabolism.
The results of these tests showed that baseline plaque pH,
following the first paraffin chew, ranged from 6.7 to 7.15. The report
of these two studies notes that baseline plaque pH in these trials was
comparable to that of previous trials of other substances conducted
with the same subjects and plaque ages (Ref. 1, Appendix 3). During the
D-tagatose rinse and the 30 minutes following the D-tagatose rinse,
lowest plaque pH recorded among the six subjects ranged from 5.7 to
6.55. During and after the sucrose rinse, lowest plaque pH recorded
among the six subjects ranged from 4.10 to 4.90. Plaque pH measurements
during the first test (without exposure to D-tagatose during the plaque
build-up period) and the second test (with daily D-tagatose exposure
during the plaque buildup period) were substantially the same. The
report of these studies concluded that no critical decrease (i.e. below
pH 5.7) in the pH of interdental plaque due to bacterial fermentation
of D-tagatose occurred; and that dental plaque layers having grown up
under repeated exposure to D-tagatose were not more acidified by D-
tagatose bacterial fermentation than were nonexposed plaque layers in
the same volunteers. Although these two reports of in vivo dental
plaque pH tests of D-tagatose constitute a limited body of scientific
evidence on the cariogenic potential of D-tagatose, we are satisfied
that these reports, in conjunction with the information previously
considered by the agency on the etiology of dental caries and the
effects of slowly fermentable carbohydrates, are sufficient to enable
the agency to evaluate whether D-tagatose should be added to the list
of substances eligible for the dental caries health claim.
IV. Decision to Authorize a Health Claim Relating D-Tagatose to the
Nonpromotion of Dental Caries
FDA previously concluded that there is significant scientific
agreement among qualified experts to support the relationship between
certain sugar alcohols and the nonpromotion of dental caries in that
the rate and amount of acid production from the metabolism of sugar
alcohols by bacteria is significantly less than that produced from the
metabolism of sucrose and other fermentable carbohydrates and therefore
does not cause the loss of important minerals from tooth enamel (Sec.
101.80(b)). The petition contains evaluations of the cariogenic
potential of D-tagatose from two indwelling plaque pH tests. As
discussed previously, the results of the plaque pH tests demonstrate
that D-tagatose does not lower plaque pH below 5.7 and, therefore, does
not promote demineralization of dental enamel. The results of these
studies are consistent with the results of the studies that
investigated the cariogenic potential of the sugar alcohols originally
listed in Sec. 101.80(c)(2)(ii)(B), and are consistent with the
evidence relied upon by the agency when adding erythritol to this list.
Therefore, based on the totality of publicly available evidence
pertaining to the cariogenicity of D-tagatose and to the relationship
between dental plaque pH and dental caries, we conclude that there is
significant scientific agreement that D-tagatose does not promote
dental caries. Accordingly, we are amending Sec. 101.80 to authorize a
dental caries health claim for D-tagatose.
V. Request to Amend the Definition of ``Sugars'' in Sec.
101.9(c)(6)(ii) and Decision to Exempt Foods Containing D-Tagatose From
the Sugar-Free Requirement
Section 101.80 (c)(2)(ii)(A) (the dental caries health claim
regulation) requires that foods bearing the health claim be ``sugar
free'' as defined by (Sec. 101.60(c)(1)(i) (21 CFR 101.60(c)(1)(i)).
D-tagatose is a sugar under the nutrition labeling definition of
``sugars''\2\ in 21 CFR 101.9(c)(6)(ii); therefore, by definition, a
food containing D-tagatose is not ``sugar free.'' The petition urges
FDA to amend Sec. 101.9(c)(6)(ii) to exclude D-tagatose from the
``sugars'' definition, thereby qualifying D-tagatose-containing foods
for the ``sugar free'' nutrient content claim, and to provide for a
separate declaration of D-tagatose in nutrition labeling. The stated
purpose of this request was to assure consistency with other
regulations, and to permit D-tagatose-containing noncariogenic foods to
inform consumers that the product is ``sugar free'' in accordance with
21 CFR 101.60. (Ref. 1). However, the effect of this request also would
be to alter the reported information in the nutrition label for foods
containing D-tagatose, because if the request were granted, the amount
of D-tagatose in the product would not be recorded under sugars. Thus,
products containing D-tagatose and no other sugars would appear to
contain zero sugars for purposes of the nutrition label.
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\2\ Simple sugars (monosaccharides) consist of a single
polyhydroxy aldehyde or ketone unit. The most abundant simple sugars
are six-carbon molecules; i.e., hexoses. Two or more monosaccharides
can be combined to form disaccharides (e.g., sucrose and lactose)
and polysaccharides; however, in general, polysaccharides of more
than two saccharide units are not sweet. For purposes of food
labeling, the term ``sugar'' refers only to sucrose (Sec.
101.4(b)(20)). For nutritional labeling purposes FDA has defined the
term ``sugars'' as the sum of all mono- and disaccharides present in
a food (Sec. 101.9(c)(6)(ii)). Although the authorized nutrient
content claims that characterize the amount of sugars in a food
(e.g., sugar free) use the term ``sugar,'' the criteria for these
claims are based on the amount of ``sugars'' as defined in Sec.
101.9(c)(6)(ii); e.g. the criteria for a ``sugar free'' claim is
that the food contain less than 0.5 gram of ``sugars'' per reference
amount and per labeled serving (Sec. 101.60(c)(1)(i)). D-tagatose
is included within this definition of ``sugars'' as any other
monosaccharide sugar would be.
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The petition identifies D-tagatose as a sugar but asserts that: (1)
There is no compelling health or nutritional reason for D-tagatose to
be included in the nutrition labeling ``sugars'' definition and (2)
excluding D-tagatose from the ``sugars'' definition will help address
public health concerns about tooth decay and will improve the ability
of
[[Page 71465]]
the label to assist consumers in maintaining healthy dietary practices
with respect to dental health. The petition asserts that not excluding
D-tagatose from the definition of ``sugars'' will frustrate efforts to
address the public health concerns about dental caries.
FDA disagrees with these arguments. D-tagatose is a sugar (Ref. 3),
unlike sugar alcohols, which are not; therefore, a sugar-free claim for
D-tagatose would be neither scientifically accurate nor truthful.
Moreover, the petition provides no data to support the assertion that
identifying D-tagatose as a sugar in the nutrition label will frustrate
efforts to address public health concerns about dental caries. This
interim final rule provides the petitioner with an opportunity to use
health claim label statements to promote the usefulness of D-tagatose
as a sweetener that does not promote dental caries. The agency does not
believe that a ``sugar free'' nutrient content claim is essential to
the effectiveness of the dental caries health claim in communicating
the usefulness of D-tagatose as a sweetener that does not promote
dental caries.
The petition also asserts that the metabolic and nutritional
characteristics of D-tagatose are sufficiently different from those of
dietary sugars to justify excluding D-tagatose from the sugars
definition for nutrition labeling purposes. The petition further states
that, unlike dietary sugars and similar to sugar alcohols, D-tagatose
passes unabsorbed through the small intestine on to the large intestine
where it is reduced to short chain fatty acids via fermentation by
intestinal bacteria; for this reason, and because D-tagatose is
intended to substitute for dietary sugars, the petition argues that D-
tagatose should be exempted from the ``sugars'' definition as are the
sugar alcohols.
FDA disagrees with these assertions. FDA had proposed to include
the sugar alcohols within the nutrition labeling definition of
``sugars'' in the ``Food Labeling; Reference Daily Intakes and Daily
Reference Values'' proposed rule (56 FR 60366 at 60369, November 27,
1991). However, as explained in the 1993 final rule, we were persuaded
by public comments to revise our ``sugars'' definition to exclude the
sugar alcohols in recognition of their usefulness as sugar substitutes
in reducing the cariogenic potential of foods, and because of their
metabolic differences from dietary sugars, e.g., differences in
intestinal digestion and absorption (58 FR 2079 at 2099, January 6,
1993). We agree with the petitioner that these are attributes that the
sugar alcohols and D-tagatose have in common. However, a critical
difference is that sugar alcohols are sugar-like substances used in
foods to substitute for sugars, whereas D-tagatose is a sugar. The
current situation, therefore, is distinguishable from our previous
decision to exclude sugar alcohols from the nutrition labeling
``sugars'' definition.
We also had considered, in the 1993 mandatory nutrition labeling
final rule, public comments urging the exclusion of lactose from the
nutrition labeling ``sugars'' definition. These comments argued that
lactose, the disaccharide sugar of dairy products, should be excluded
from ``sugars'' because, due to its inefficient intestinal digestion
and absorption, the metabolism of lactose more closely resembles that
of complex carbohydrates than that of simple sugars (58 FR 2079 at
2098). FDA disagreed, stating:
* * * The agency has been persuaded of the need to define
``sugars'' * * * to be consistent with standard analytical
methodologies and in conformity with the traditional usage of the
term. Lactose, a di-saccharide, is clearly a sugar by conventional
standards and is identified with all other mono- and di-saccharides
in routine analytical procedures (58 FR 2079 at 2098).
Thus, although in 1993, FDA cited slow intestinal digestion and
absorption among the factors considered in our decision to exclude
sugar alcohols from the definition of ``sugars,'' those same factors
were rejected as a rationale for excluding lactose because, unlike
sugar alcohols, lactose is clearly a sugar within the traditional
definition and usage of the term, as well as by conventional standards.
Likewise, D-tagatose is clearly a sugar within the traditional
definition and usage of the term, as well as by conventional standards
(Ref. 3).
The petition asserts that identifying noncariogenic D-tagatose-
containing foods as ``sugar free'' is fully consistent with the
commonly understood meaning of a ``sugar free'' food and fully
consistent with consumer expectations. The petition further argues that
to exempt D-tagatose from the ``sugars'' definition, and thereby allow
a ``sugar free'' claim, would provide consumers with critical
information needed to select noncariogenic foods, reduced calorie
foods, and foods that help diabetics follow healthy dietary practices.
FDA is not persuaded by these arguments. The petition contains no
consumer survey data with regard to consumer understanding or
expectations of ``sugar free'' nutrient content claims. Absent factual
support for the petitioner's assertion that a ``sugar free'' claim on a
food sweetened with D-tagatose is consistent with consumer
understanding and expectations (to which we are open and which we would
consider), FDA finds no reason to depart from the accepted scientific
classification of D-tagatose as a sugar (Ref. 3). We remain skeptical
that a ``sugar free'' claim on the food label is critical information
needed for consumers to select D-tagatose-containing noncariogenic
foods when such foods will be permitted to bear the dental caries
health claim to identify them as noncariogenic. Neither are we
convinced that a ``sugar free'' claim is critical information required
for consumers to be able to select reduced calorie foods. The
``calories per serving'' declaration in the nutrition label, not a
``sugar free'' claim, is the primary food label information that
identifies the energy content of the food. Further, if a food meets the
criteria for a ``reduced calorie'' food (described in Sec. 101.60(b)),
the food may bear such a claim regardless of the sugar content of the
food. Finally, the subject of this health claim petition is D-tagatose
and nonpromotion of dental caries. A consideration of labeling
information useful to identify foods that help diabetics follow healthy
dietary practices is clearly outside the scope of this petition. This
health claim petition contains no scientific data regarding the
appropriateness of recommending D-tagatose for use by diabetics, and
FDA has not evaluated any such information.
Finally, the petition asserts that excluding D-tagatose from the
nutrition labeling ``sugars'' definition would allow consistency
between the dental caries health claim, the ``sugar-free'' nutrient
content claim, and nutrition labeling. The petition also asserts that
consumers will be thoroughly confused by a nutrition label showing a
food to contain sugars when the food label also bears a ``Does not
promote tooth decay'' health claim. The petition contains no data to
measure the extent of consumer understanding, misunderstanding, or
confusion from foods labeled both as noncariogenic and as containing
sugars. Therefore, we have no basis, other than the petitioner's
subjective views, to evaluate whether or not consumers would be
confused. We note that, in the future, it would be helpful to have data
like this submitted along with the petition. If such data are
submitted, FDA will consider them.
In summary, the petition presents two main arguments for why FDA
should omit D-tagatose from the term ``sugars'' as used in the
nutrition labeling of foods so as to permit D-tagatose-containing foods
to be labeled as ``sugar free'': (1) There is no compelling nutritional
or public health reason to include D-
[[Page 71466]]
tagatose within the definition of ``sugars,'' and (2) identifying D-
tagatose as a sugar will frustrate efforts to communicate the potential
dental health benefits of D-tagatose. The agency notes that the dental
caries health claim, which is the subject of this health claim
petition, is the most direct vehicle for promoting the dental health
benefits of the substance. Should there be some potential
misunderstandings on the part of consumers regarding the health claim,
such problems can be addressed by refining the wording of the health
claim. The declaration of ``sugars'' in the nutrition label and the use
of ``sugar free'' nutrient content claims are not label information
intended to communicate the specific disease-related health benefits
(e.g., nonpromotion of dental caries) of a food. Moreover, this
situation is not analogous to FDA's decision to exclude sugar alcohol,
a nonsugar substance, from the ``sugars'' declared in nutrition
labeling. To grant the petitioner's request would be to allow a
labeling claim identifying a sugar as a nonsugar. Such a claim would be
both false and misleading. For these reasons, FDA is not amending Sec.
101.9(c)(6)(ii) to exclude D-tagatose, a sugar, from the definition of
``sugars.''
The dental caries health claim regulation requires that a food
bearing the health claim meet the requirements of Sec.
101.60(c)(1)(i), the ``sugar free'' nutrient content claim (Sec.
101.80(c)(2)(ii)(A)). As discussed earlier, we are satisfied that the
scientific evidence presented in the petition demonstrates that the
cariogenic potential of D-tagatose, like that of certain sugar
alcohols, is significantly lower than the cariogenic potential of
sucrose. However, because D-tagatose is a sugar, we believe that it
would be false and misleading to allow D-tagatose containing foods to
bear a ``sugar free'' claim. Consequently, rather than granting the
petitioner's request and allowing a sugar to declare itself to be
``sugar free,'' we instead are exempting D-tagatose from the ``sugar
free'' requirement for the dental caries health claim by amending
redesignated Sec. 101.80(c)(2)(iii)(A) to provide that a food bearing
the claim be ``sugar free'' except for D-tagatose.
We do recognize that there is a potential incongruity in declaring
D-tagatose as a sugar in the nutrition label of a D-tagatose-containing
food bearing the dental caries health claim stating that foods high in
sugars promote tooth decay. To address this concern, we are adding a
new provision in the ``Nature of the Claim'' paragraph to inform
consumers about the uniqueness of D-tagatose as a noncariogenic sugar.
New Sec. 101.80(c)(2)(i)(H) will provide that where D-tagatose is the
substance referred to by the dental caries health claim, the claim must
identify D-tagatose as a sugar that, unlike other sugars, does not
promote tooth decay or dental caries.
VI. First Amendment Analysis
This interim final rule affects speech because it grants the
petitioner's request to authorize a health claim for D-tagatose and
dental caries, while denying the petitioner's request to permit a
``sugar free'' nutrient content claim for foods containing D-tagatose.
Because Government regulation of food labeling and other commercial
speech has constitutional implications, we are providing an analysis
explaining why our decision is consistent with the first amendment.
Speech that is inherently misleading is not protected by the first
amendment and may be prohibited. (Central Hudson Gas & Electric Corp.
v. Public Service Comm'n, 447 U.S. 557, 563-64 (1980)). The Supreme
Court has labeled as misleading, and thus not protected, both speech
that is inherently likely to deceive and that ``experience has proved *
* * is subject to abuse.'' (In re R.M.J., 455 U.S. 191, 203 (1982)).
The agency believes that a sugar-free nutrient content claim for D-
tagatose would be inherently likely to deceive, because it is simply
untrue. D-tagatose is a sugar and thus, by definition, cannot be sugar-
free.
However, even if a sugar-free nutrient content claim for D-tagatose
would be only potentially misleading, FDA's decision not to permit such
a claim, but to authorize a dental caries health claim for D-tagatose
by making an exception to the sugar-free requirement, is
constitutional. The Government may place restrictions on commercial
speech that is merely potentially misleading as long as the Government
interest is substantial, the restrictions directly advance the
Government interest, and the restrictions are no more extensive than
necessary to serve that interest. (Central Hudson, 447 U.S. at 566).
FDA's authorization of the dental caries health claim by making an
exception to the sugar-free requirement for foods containing the sugar
D-tagatose, rather than allowing such foods to be considered ``sugar
free'' and to bear a sugar-free claim as the petitioner requested,
passes this test.
First, the Government has a substantial and compelling interest in
ensuring that food labels are truthful, nonmisleading, and
scientifically valid. More specifically, FDA's interest in preventing
deceptive nutrient content claims from being made is clearly
substantial. The food labeling regulations seek to ensure that
consumers have access to information about food that is scientifically
valid, truthful, reliable, understandable, and not misleading. (58 FR
2478 at 2526, January 6, 1993). Consumers have a first amendment
interest in obtaining information on which to base a decision regarding
whether to buy a product, and this interest is ``served by insuring
that the information is not false or deceptive.'' (National Comm'n on
Egg Nutrition v. FTC, 570 F.2d 157, 162 (7th Cir. 1977), cert. denied,
439 U.S. 821 (1978)).
Second, this interim final rule regulating D-tagatose claims in
food labeling directly advances the Government interest. It allows the
petitioner and other marketers of D-tagatose to publicize the benefits
of D-tagatose in not promoting dental caries, without causing the
product to carry a false nutrient content claim (i.e., calling itself
sugar-free when it is actually a sugar). Thus, the interim final rule
reasonably and effectively ensures that claims for D-tagatose on food
labels will be scientifically valid, informative, and not misleading.
Finally, FDA's regulation of D-tagatose claims in food labeling is
no more extensive than necessary to serve the Government interest.
Under City of Cincinnati v. Discover Network, Inc., regulations that
are narrowly tailored to serve the government interest will meet this
prong of the Central Hudson test. (507 U.S. 410, 418n.13 (1993); see
also 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 507-08 (1996)).
``A regulation need not be absolutely the least severe that will
achieve the desired end,'' but in determining whether a restriction on
commercial speech is reasonable, an agency must consider whether there
are ``numerous and obvious less-burdensome alternatives.'' (id.) By
exempting D-tagatose from the sugar-free requirement, rather than
allowing a sugar to carry a sugar-free claim, FDA has found a
reasonable balance between the interest in making information available
about the relationship between D-tagatose and dental caries and the
interest in ensuring that information about D-tagatose on food labels
is truthful, nonmisleading, and scientifically valid. The restriction
on ``sugar-free'' claims for foods containing D-tagatose is no more
extensive than necessary to serve the Government's interest in
preventing the dissemination of false and misleading information
through food labeling, and there do not
[[Page 71467]]
exist numerous and obvious less-burdensome alternatives in this case.
Moreover, we know of no disclaimer that could cure the deception
that would be caused by allowing a sugar to be called ``sugar free.''
(See Continental Wax Corp. v. Federal Trade Comm'n, 330 F.2d 475 (2d
Cir. 1964) (holding that no disclaimer could cure the deception
implicit in the name ``Continental Six Month Floor Wax'' where the
evidence showed that the wax would not be effective for 6 months)).
Where ``the offending deception is caused by a clear and unambiguous
false representation implicit in the product's name,'' courts routinely
deny the use of disclaimers because ``the addition of a qualifying
phrase denying the truth of that representation would lead to a
confusing contradiction in terms.'' (id. at 479-80; see also Bakers
Franchise Corp. v. Federal Trade Comm'n, 302 F.2d 258, 261 (3d Cir.
1962) (use of the phrase ``Lite Diet'' with the phrase ``not a low
calorie bread'' or ``not low in calories'' would be ``a contradiction
in terms and would completely confuse the public'' where the bread at
issue contained the same number of calories as other white bread but
had thinner slices)). Here, allowing a sugar to be exempted from the
definition of ``sugars'' and thus market itself as ``sugar-free'' would
be inherently misleading. We are not aware of any evidence that a
disclaimer could cure this deception, and common sense counsels against
any such conclusion.
Thus, this interim final rule, allowing the dental caries health
claim for foods containing D-tagatose but prohibiting ``sugar-free''
claims for such foods, meets the Central Hudson test and does not
violate the first amendment.
VII. Description of Modifications to Sec. 101.80
A. Title of the Regulation
Although in this interim final rule we are responding to a specific
petition to authorize a claim about D-tagatose and dental caries, we
are amending Sec. 101.80 to establish a framework that will allow the
agency to readily add to the list of eligible substances additional
noncariogenic sugars, as well as additional sugar alcohols. This will
provide flexibility for the inclusion of other noncariogenic
carbohydrate sweeteners when adequate data are provided to demonstrate
that they do not lower plaque pH below 5.7 and, therefore, that they do
not promote tooth decay.
We are amending the title of Sec. 101.80 to reflect that the
amended regulation includes a noncariogenic sugar, in addition to sugar
alcohols, as a substance that is eligible for the health claim about
nonpromotion of dental caries. The amended title is: ``Health Claims:
dietary noncariogenic carbohydrate sweeteners and dental caries.''
Throughout the regulation references to ``sugar alcohols'' have been
changed to ``noncariogenic carbohydrate sweeteners.''
B. Requirements
1. General Requirements
Section 101.80 (c)(1) specifies that all of the requirements set
forth in Sec. 101.14 are to be met, except that sugar alcohol-
containing foods are exempt from Sec. 101.14(e)(6). Section
101.14(e)(6) specifies that, except for dietary supplements or where
provided for in other 21 CFR part 101 regulations, foods making health
claims must contain 10 percent or more of the Reference Daily Intake or
the Daily Reference Value for vitamin A, vitamin C, iron, calcium,
protein, or dietary fiber per reference amount customarily consumed
before any nutrient addition. We are amending Sec. 101.80(c)(1) to
broaden the exception from the nutrient content requirement in Sec.
101.14(c)(6) to include foods sweetened with any noncariogenic
carbohydrate sweetener listed in new paragraph (c)(2)(ii) of this
section, including D-tagatose, because of the public health benefit of
having a dental caries health claim on the types of foods to which
these noncariogenic sweeteners may be added (i.e., chewing gums and
confections).
2. Requirements on the Nature of the Claim
Section 101.80 (c)(2)(i) contains requirements on the nature of the
claim. For simplicity, we are allowing D-tagatose to be identified in
the claim statement as ``tagatose.'' In addition to expanding the
coverage of this section from ``sugar alcohols'' to ``noncariogenic
carbohydrate sweeteners,'' we are adding new paragraph (c)(2)(i)(H) to
require that when a noncariogenic sugar, such as D-tagatose, is the
subject of a claim, the claim must explain that the substance is a
sugar, but unlike other sugars, does not promote the development of
dental caries.
3. Requirements on the Nature of the Substance
As part of establishing a framework to facilitate the addition of
other noncariogenic carbohydrate sweeteners to the dental caries health
claim, we are adding a new paragraph (c)(2)(ii) to Sec. 101.80 in
which to list substances eligible for the claim. This format is
consistent with that of most other authorized health claim regulations
in which the specific requirements of the claim (Sec. 101.80 (c)(2))
are divided into three parts: (c)(2)(i) Nature of the claim, (c)(2)(ii)
Nature of the substance, and (c)(2)(iii) Nature of the food. Existing
Sec. 101.80 (c)(2)(ii) is redesignated as Sec. 101.80 (c)(2)(iii).
The list of sugar alcohols eligible for the dental caries health
claim, which is now in the ``Nature of the food'' section, is being
moved to new Sec. 101.80 (c)(2)(ii)(A). The noncariogenic sugars
currently eligible for the claim, i.e., D-tagatose, are being listed in
new Sec. 101.80 (c)(2)(ii)(B).
4. Requirements on the Nature of the Food
Redesignated Sec. 101.80 (c)(2)(iii) contains requirements on the
nature of the food bearing the dental caries health claim. Current
Sec. 101.80 (c)(2)(ii)(A), redesignated as Sec. 101.80 (c)(iii) (A),
reads ``The food shall meet the requirement in Sec. 101.60(c)(1)(i)
with respect to sugars content.'' This means that a criterion of the
health claim is that the food be ``sugar free.'' As previously
discussed, we are amending redesignated Sec. 101.80 (c)(2)(iii)(A) to
exempt D-tagatose from the ``sugar free'' requirement for a food
bearing the dental caries health claim. Amended Sec. 101.80
(c)(2)(iii)(A) will read ``The food shall meet the requirement in Sec.
101.60(c)(1)(i) with respect to sugars content, except that the food
may contain D-tagatose.'' As discussed in section V of this document we
are taking this action as an alternative to the petitioner's
recommendation that D-tagatose be excluded from the ``sugars''
definition.
We are amending redesignated Sec. 101.80 (c)(2)(iii)(B) to reflect
the addition of D-tagatose as a substance eligible for a dental caries
health claim. As amended, the section will state ``A food whose
labeling includes a health claim under this section shall contain one
or more of the noncariogenic carbohydrate sweeteners listed in
paragraph (c)(2)(ii) of this section.'' We also are amending
redesignated Sec. 101.80 (c)(2)(iii)(C) to reflect the broadening of
the scope of the claim beyond sugar alcohols only. This paragraph now
will provide that when carbohydrates other than noncariogenic
sweeteners eligible for the claim are present in a food bearing the
claim, the food shall not lower plaque pH below 5.7 by bacterial
fermentation, as measured by the indwelling plaque test specified in
Sec. 101.80 (c)(2)(iii)(C). The address of the Center for Food Safety
and Applied
[[Page 71468]]
Nutrition also has been updated in this paragraph.
The agency is not specifying a qualifying level of D-tagatose in
the food product because, like sugar alcohols, D-tagatose will be used
as a substitute for fermentable sugars. Therefore, the amount of the
substance required is that needed to achieve a desired level of
sweetness.
C. Optional Information
Section 101.80(d) lists the optional information that may be
included in the dental caries health claim. We are amending this
paragraph to reflect the fact that the claim now includes a
noncariogenic carbohydrate sweetener other than sugar alcohols.
D. Model Health Claims
Section 101.80 (e) provides model health claims as examples of
statements that meet the requirements to make a claim about
nonpromotion of dental caries. FDA emphasizes that these model health
claims are illustrative only. These model claims illustrate the
required, and some of the optional, elements of the interim final rule.
Because the agency is authorizing a claim about the relationship
between D-tagatose and the nonpromotion of dental caries, and not
approving specific claim wording, manufacturers will be free to design
their own claim so long as it is consistent with Sec. 101.80(c) and
(d).
Current Sec. 101.80 (e)(1) consists of two model claims as
examples of the full claim, and Sec. 101.80 (e)(2) consists of two
model claims as examples of the shortened claim for use on packages
with less than 15-square inches of surface area available for labeling.
We are amending Sec. 101.80(e)(1) and (e)(2) to add model claims for
D-tagatose. The first example of the full claim states: ``Frequent
eating of foods high in sugars and starches as between-meal snacks can
promote tooth decay. Tagatose, the sugar used to sweeten this food,
unlike other sugars, may reduce the risk of dental caries.'' (Sec.
101.80(e)(1)(iii)). The second example of the full claim states:
``Frequent between-meal consumption of foods high in sugars and
starches promotes tooth decay. Tagatose, the sugar in [name of food],
unlike other sugars, does not promote tooth decay.'' (Sec.
101.80(e)(1)(iv)). We are amending Sec. 101.80 (e)(2) by adding two
shortened model claims (paragraphs (e)(2)(iii) and (e)(2)(iv)) that
read ``Tagatose sugar does not promote tooth decay'' and ``Tagatose
sugar may reduce the risk of tooth decay.''
VIII. Issuance of an Interim Final Rule and Immediate Effective Date
We are issuing this rule as an interim final rule, effective
immediately, with an opportunity for public comment. Section 403(r)(7)
of the act authorizes us to make proposed regulations issued under
section 403(r) of the act effective upon publication pending
consideration of public comment and publication of a final regulation,
if the agency determines that such action is necessary for public
health reasons. This authority enables us to act promptly on petitions
that provide for information that is necessary to: (1) Enable consumers
to develop and maintain healthy dietary practices, (2) enable consumers
to be informed promptly and effectively of important new knowledge
regarding nutritional and health benefits of food, or (3) ensure that
scientifically sound nutritional and health information is provided to
consumers as soon as possible. Proposed regulations made effective upon
publication under this authority are deemed to be final agency action
for purposes of judicial review. The legislative history indicates that
such regulations should be issued as interim final rules (H. Conf.
Rept. No. 105-399, at 98 (1997)).
We are satisfied that all three of the criteria in section
403(r)(7)(A) of the act have been met in the petition submitted by Arla
Food Ingredients. This health claim will help enable consumers to
develop and maintain healthy dietary practices, such as limiting snacks
that contain fermentable sugars. The health claim also will provide
consumers with important new knowledge regarding the reduced cariogenic
potential of D-tagatose relative to that of other sugars, and will
provide consumers with scientifically sound information on the dental
health benefits of foods containing D-tagatose . Therefore, we are
using the authority given to us in section 403(r)(7)(A) of the act to
issue an interim final rule authorizing a health claim for D-tagatose
and nonpromotion of dental caries, effective immediately.
FDA invites public comment on this interim final rule. The agency
will consider modifications to this interim final rule based on
comments made during the comment period. Interested persons may submit
to the Dockets Management Branch (see ADDRESSES) written comments
regarding this interim final rule by February 18, 2003. Two copies of
any comments are to be submitted, except that individuals may submit
one copy. Submit electronic comments to http://www.fda.gov/dockets/ecomments.
Comments are to be identified with the docket number found
in brackets in the heading of this document. Received comments may be
seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday
through Friday.
This regulation is effective upon publication in the Federal
Register. The agency will address comments and confirm or amend the
interim final rule in a final rule.
IX. Analysis of Impacts
A. Regulatory Impact Analysis
We have examined the economic implications of this interim final
rule as required by Executive Order 12866. 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, and other
advantages; distributive impacts; and equity). Executive Order 12866
classifies a rule as significant if it meets any one of a number of
specified conditions, including: Having an annual effect on the economy
of $100 million or more or adversely affecting in a material way a
sector of the economy, competition, or jobs. A regulation is also
considered a significant regulatory action if it raises novel legal or
policy issues. We have determined that this interim final rule is not a
significant regulatory action as defined by Executive Order 12866.
FDA has identified three options: (1) Deny the petition; (2) add D-
tagatose to the dental caries health claim and amend Sec.
101.80(c)(2)(ii)(A), the ``Nature of the Food'' requirement that the
food be ``sugar free'' except for D-tagatose; or (3) add D-tagatose to
the dental caries claim and amend Sec. 101.9(c) to exclude D-tagatose
from sugars.
Option one: FDA's denial of the petition would mean no change in
the dental caries health claim. Therefore, this option generates no new
costs and benefits and is the point of comparison for all other
options.
Option two: Option two, the option chosen by the agency, permits
foods that contain D-tagatose to bear the dental caries health claim
under certain conditions. It will generate social benefits because it
provides additional information to consumers who wish to avoid dental
caries. Treatment of dental caries creates considerable costs. Dental
caries is the most common chronic childhood disease and 94 percent of
adults have either untreated decay or fillings in the crowns of their
teeth, with an average of 22 affected surfaces, according to the
National Oral Health
[[Page 71469]]
Survey, part of the National Health and Nutrition Examination Survey
(Ref. 6). The cost of treating tooth caries includes: The cost of
applying an amalgam, maintaining that amalgam for an individual's
lifetime, and lost work time for the application of the amalgam. The
median life of an amalgam is 9 to 14 years, and so it must be replaced
regularly as long as the tooth remains. The estimated average, weighted
lifetime cost of a carious surface is 100.62 dollars in 1995 (Ref. 5).
This cost estimate includes: The discounted future costs of replacement
amalgams and lost work time, and incorporates the incidence of dental
caries by age and the age distribution of the U.S. population. With
inflation, the cost is 118.37 dollars in 2002. This estimate does not
include pain and suffering associated with dental caries, or possible
problems associated with failure to treat dental caries, such as tooth
losses or root canals. There are a number of risk factors for
developing dental caries: Genetic factors, eating behaviors, and types
and characteristics of foods eaten (Ref. 4). Specifically, consumption
of dietary sugars and starches have been linked to development of
dental caries. Substitution of D-tagatose for other sugars in foods,
such as gum, candies, and baked goods, can potentially reduce the risk
of dental caries. This would lead to benefits in reduced expenditures
on dental care, less work time lost for dental visits, and other
complications, such as tooth loss.
Option two will not generate any compliance costs relative to
option one, because use of the claim is voluntary. No firm will choose
to use the claim allowed by this interim rule unless the firm believes
that doing so will increase its profits. However, because the interim
rule specifies the manner in which a health claim can be made in
product labeling, this interim rule imposes restrictions that may lead
to greater or smaller social benefits or costs compared with
alternative requirements for making the claim. The expected net
benefits of option two are positive.
Option 3: Allowing the addition of D-tagatose to the dental caries
claim and amending the definition of sugars also would aid consumers in
choosing foods that do not promote dental caries. However, D-tagatose
is a sugar. Amending the nutrition labeling definition of sugars to
exclude D-tagatose would be counter to the commonly understood
definition of sugars. To declare D-tagatose not to be a sugar would
mislead consumers and undermine the scientific accuracy of the
nutritional labeling, which many consumers currently rely on to make
healthy food choices. It is not possible to quantify this cost.
Amending the definition of sugars to exclude D-tagatose, and therefore,
allowing foods containing D-tagatose to be labeled ``sugar free,''
could potentially generate considerable benefits to the petitioner in
its efforts to market D-tagatose. However, these benefits would be
offset by the costs of providing invalid information to consumers.
B. Regulatory Flexibility Analysis
We have examined the economic implications of this interim final
rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612).
If a rule has a significant impact on a substantial number of small
entities, the Regulatory Flexibility Act requires the agency to analyze
regulatory options that would minimize the economic impact of the rule
on small entities.
As previously explained, this interim final rule will not generate
any compliance costs for any small entities, because it does not
require small entities to undertake any new activity. No small business
will choose to use the dental caries health claim authorized by this
rule unless it believes that doing so will increase its profits.
Accordingly, we certify that this interim final rule will not have a
significant impact on a substantial number of small entities. Under the
Regulatory Flexibility Act, no further analysis is required.
C. Unfunded Mandates
Title II of the Unfunded Mandates Reform Act of 1995 (Public Law
104-4) requires cost-benefit and other analyses before any rulemaking
if the rule would include a ``Federal Mandate that may result in the
expenditure by State, local, and tribal governments, in the aggregate,
or by the private sector, of $100,000,000 or more (adjusted annually
for inflation) in any 1 year.'' We have determined that this interim
final rule does not constitute a significant regulatory action under
the Unfunded Mandates Reform Act.
X. Environmental Impact
We have determined under 21 CFR 25.32(p) that the actions resulting
from this interim final rule are categorically excluded. Therefore,
neither an environmental assessment nor an environmental impact
statement is required.
XI. Paperwork Reduction Act
FDA concludes that the labeling provisions of this interim final
rule are not subject to review by the Office of Management and Budget
because they do not constitute a ``collection of information'' under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the
food labeling health claim on the association between D-tagatose and
the nonpromotion of dental caries is a ``public disclosure of
information originally supplied by the Federal Government to the
recipient for the purpose of disclosure to the public.'' (5 CFR
1320.3(c)(2)).
XII. Federalism
We have analyzed this interim final rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
the rule does not contain policies that have substantial direct effects
on the States or on the relationship between the National Government
and the States, or on the distribution of power and responsibility
among the various levels of government. Accordingly, we have concluded
that the interim final rule does not contain policies that have
federalism implications as defined in the order and, consequently, a
federalism summary impact statement is not required.
XIII. References
The following references have been placed on display in the Dockets
Management Branch (see ADDRESSES) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Arla Foods Ingredients amba, ``Petition to amend the
regulation for 21 CFR Sec. 101.80 to authorize a noncariogenicity
dental health claim for D-tagatose,'' CP-1, Docket No. 02P-0177,
January 9, 2002.
2. U.S. Department of Health and Human Services, ``Oral
Health,'' Chapter 21 in Healthy People 2010, vol. II, part B, 2d
ed., Washington, DC., U.S. Government Printing Office,
(www.health.gov/healthypeople/Document/HTML/Volume2/21Oral.htm),
November 2000.
3. Lubert Stryer, ``Carbohydrates,'' Chapter 18 in Biochemistry,
4th ed., New York, W. H. Freeman and Co., 1995.
4. U.S. Department of Health and Human Services, Oral Health in
America: A Report of the Surgeon General--Executive Summary,
Rockville, MD, U.S. Department of Health and Human Services,
National Institute of Dental and Craniofacial Research, National
Institutes of Health, (http://www.nidcr.nih.gov/sgr/execsumm.htm),
2000.
5. Susan O. Griffin, Kari Jones, and Scott L. Tomar, ``An
Economic Evaluation of Community Water Fluoridation,'' Journal of
Public Health Dentistry, 61:78-86, 2001.
6. Department of Health and Human Services, Results of National
Oral Health Survey Results Released (press release), (http://www.hhs.gov/news/press/1996pres/960311.html
, visited on 6/11/2002),
March 11, 1996.
[[Page 71470]]
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:
PART 101--FOOD LABELING
1. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371; 42 U.S.C. 243, 264, 271.
2. Section 101.80 is amended by redesignating paragraph (c)(2)(ii)
as paragraph (c)(2)(iii); by revising the section heading, paragraph
(a)(4), the first two sentences in paragraph (b), paragraphs (c)(1),
(c)(2)(i) introductory text, (c)(2)(i)(B), (c)(2)(i)(C), (c)(2)(i)(E),
and (c)(2)(i)(F); by revising newly redesignated paragraph (c)(2)(iii);
by revising paragraphs (d)(1), (d)(4), and (e) introductory text; and
by adding new paragraphs (c)(2)(i)(H), (c)(2)(ii), (e)(1)(iii),
(e)(1)(iv), (e)(2)(iii), and (e)(2)(iv) to read as follows:
Sec. 101.80 Health claims: dietary noncariogenic carbohydrate
sweeteners and dental caries.
(a) * * *
(4) Noncariogenic carbohydrate sweeteners, such as sugar alcohols,
can be used to replace dietary sugars, such as sucrose and corn
sweeteners, in foods such as chewing gums and certain confectioneries.
Noncariogenic carbohydrate sweeteners are significantly less cariogenic
than dietary sugars and other fermentable carbohydrates.
(b) Significance of the relationship between noncariogenic
carbohydrate sweeteners and dental caries. Noncariogenic carbohydrate
sweeteners do not promote dental caries. The noncariogenic carbohydrate
sweeteners listed in paragraph (c)(2)(ii) of this section are slowly
metabolized by bacteria to form some acid. * * *
(c) Requirements. (1) All requirements set forth in Sec. 101.14
shall be met, except that noncariogenic carbohydrate sweetener-
containing foods listed in paragraph (c)(2)(ii) of this section are
exempt from Sec. 101.14(e)(6).
(2) Specific requirements--(i) Nature of the claim. A health claim
relating noncariogenic carbohydrate sweeteners, compared to other
carbohydrates, and the nonpromotion of dental caries may be made on the
label or labeling of a food described in paragraph (c)(2)(iii) of this
section, provided that:
(A) * * *
(B) The claim shall state that the noncariogenic carbohydrate
sweetener 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 substances
listed in paragraph (c)(2)(ii) of this section, e.g., ``sorbitol.'' D-
tagatose may be identified as ``tagatose.''
(D) * * *
(E) The claim shall not attribute any degree of the reduction in
risk of dental caries to the use of the noncariogenic carbohydrate
sweetener-containing food.
(F) The claim shall not imply that consuming noncariogenic
carbohydrate sweetener-containing foods is the only recognized means of
achieving a reduced risk of dental caries.
(G) * * *
(H) When the substance that is the subject of the claim is a
noncariogenic sugar, the claim shall identify the substance as a sugar
that, unlike other sugars, does not promote the development of dental
caries.
(ii) Nature of the substance. Eligible noncariogenic carbohydrate
sweeteners are:
(A) The sugar alcohols xylitol, sorbitol, mannitol, maltitol,
isomalt, lactitol, hydrogenated starch hydrolysates, hydrogenated
glucose syrups, and erythritol, or a combination of these.
(B) The sugar D-tagatose.
(iii) Nature of the food. (A) The food shall meet the requirement
in Sec. 101.60(c)(1)(i) with respect to sugars content, except that
the food may contain D-tagatose.
(B) A food whose labeling includes a health claim under this
section shall contain one or more of the noncariogenic carbohydrate
sweeteners listed in paragraph (c)(2)(ii) of this section.
(C) When carbohydrates other than those listed in paragraph
(c)(2)(ii) of this section are present in the 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,'' dated 1983, by T. N. Imfeld, in Volume 11,
Monographs in Oral Science, 1983. The Director of the Office of the
Federal Register has approved the incorporation by reference of this
material in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may
obtain copies from Karger AG Publishing Co., P.O. Box, Ch-4009 Basel,
Switzerland, or you may examine a copy at the Center for Food Safety
and Applied Nutrition's Library, Harvey W. Wiley Federal Building, 5100
Paint Branch Pkwy., College Park, MD, or at the Office of the Federal
Register, 800 North Capital 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 noncariogenic carbohydrate
sweeteners and dental caries.
* * * * *
(4) The claim may indicate that a substance listed in paragraph
(c)(2)(ii) of this section serves as a sweetener.
(e) Model health claim. The following model health claims may be
used in food labeling to describe the relationship between
noncariogenic carbohydrate sweetener-containing foods and dental
caries.
(1) Examples of the full claim:
(i) * * *
(ii) * * *
(iii) Frequent eating of foods high in sugars and starches as
between-meal snacks can promote tooth decay. Tagatose, the sugar used
to sweeten this food, unlike other sugars, may reduce the risk of
dental caries.
(iv) Frequent between-meal consumption of foods high in sugars and
starches promotes tooth decay. Tagatose, the sugar in [name of food],
unlike other sugars, does not promote tooth decay.
(2) Examples of the shortened claim for small packages:
(i) * * *
(ii) * * *
(iii) Tagatose sugar does not promote tooth decay.
(iv) Tagatose sugar may reduce the risk of tooth decay.
Dated: November 25, 2002.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 02-30474 Filed 11-27-02; 1:26 pm]
BILLING CODE 4160-01-S