[Federal Register Volume 67, Number 231 (Monday, December 2, 2002)]
[Rules and Regulations]
[Pages 71461-71470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30474]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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