[Federal Register: September 17, 2007 (Volume 72, Number 179)]
[Rules and Regulations]
[Page 52783-52789]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17se07-5]
 
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
Food and Drug Administration
 
21 CFR Part 101
 
[Docket No. 2006P-0487]
 
 
Food Labeling; Health Claims; Dietary Noncariogenic Carbohydrate
Sweeteners 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 issuing this interim
final rule to amend the regulation authorizing a health claim on
noncariogenic carbohydrate sweeteners and dental caries, i.e., tooth
decay, to include isomaltulose, a noncariogenic sugar. FDA is taking
this action in response to a health claim petition submitted on behalf
of Cargill, Inc. Based on the totality of publicly available scientific
evidence, FDA now has determined that the nutritive sweetener
isomaltulose, like other noncariogenic carbohydrate sweeteners listed
in the dental caries health claim regulation, is not fermented by oral
bacteria to an extent sufficient to lower dental plaque pH to levels
that would contribute to the erosion of dental enamel. Therefore, FDA
has concluded that isomaltulose does not promote dental caries, and it
is amending the regulation authorizing a health claim relating certain
noncariogenic sweeteners and the nonpromotion of dental caries to
include isomaltulose as a substance eligible for the claim.
 
DATES: This interim final rule is effective September 17, 2007. Submit
written or electronic comments by December 3, 2007.
 
ADDRESSES: You may submit comments, identified by Docket No. 2006P-
0487, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov.
 
Follow the instructions for submitting comments.
    <bullet> Agency Web site: http://www.fda.gov/dockets/ecomments.
 
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
    Submit written submissions in the following ways:
    <bullet> FAX: 301-827-6870.
    <bullet> Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described previously, in
the ADDRESSES portion of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name
and Docket No. 2006P-0487 for this rulemaking. All comments received
may be posted without change to http://www.fda.gov/ohrms/dockets/default.htm,
including any personal information provided. For
additional information on submitting comments, see the ``Comments''
heading of the SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
 
FOR FURTHER INFORMATION CONTACT: Jillonne Kevala, Center for Food
Safety and Applied Nutrition (HFS-830), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1450.
 
SUPPLEMENTARY INFORMATION:
 
I. Background
 
    The Nutrition Labeling and Education Act of 1990 (the 1990
amendments) (Pub. L. 101-535) amended the Federal Food, Drug, and
Cosmetic Act (the act) in a number of important respects. One aspect of
the 1990 amendments was that they clarified FDA's authority to regulate
health claims on food labels and in food labeling.
 
[[Page 52784]]
 
    In 1993, FDA issued a regulation to implement the health claim
provisions of the 1990 amendments entitled ``Food Labeling: General
Requirements for Health Claims for Food'' (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
(21 CFR 101.70). This regulation became effective on May 8, 1993.
    The final rule that established Sec.  101.80 (21 CFR 101.80) (61 FR
43433, August 23, 1996) (the 1996 final rule), relating sugar alcohols
to the nonpromotion of dental caries, completed the first rulemaking
that FDA conducted in response to a health claim petition (Docket No.
1995P-0003). Section 101.80 (the dental caries health claim) was
subsequently amended, to expand the substances which are the subject of
the claim, to include noncariogenic carbohydrate sweeteners other than
sugar alcohols (67 FR 71461, December 2, 2002) (the 2002 amendment).
Section 101.80(a) describes the role of fermentable carbohydrates,
(i.e., most dietary sugars and starches), in the development of dental
caries. The fermentation of these carbohydrates by microorganisms
produces organic acids on the surface of teeth, which contribute to the
development of dental caries through erosion of tooth enamel. Section
101.80(b) explains that some carbohydrate sweeteners, such as sugar
alcohols, are relatively noncariogenic because they are fermented by
oral microorganisms more slowly than are fermentable carbohydrates and
consequently, the rate of acid production is lower than that from
fermentable carbohydrates. Noncariogenic carbohydrate sweeteners, when
used in place of fermentable sugars, are useful in that they do not
promote dental caries as do the sugars they replace. 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'' (Sec.  101.80(c)(2)(iii)(A)). Section 101.80(c)(2)(ii) also
lists 11 noncariogenic carbohydrate sweeteners (xylitol, sorbitol,
mannitol, maltitol, isomalt, lactitol, hydrogenated starch
hydrolysates, hydrogenated glucose syrups, erythritol, D-tagatose, and
sucralose) that are eligible for the claim. Section
101.80(c)(2)(iii)(C) further states that, ``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,' * * *.''
    FDA noted in the 1996 final rule that it would consider adding
other noncariogenic carbohydrate sweeteners in the list of sweeteners
eligible for the health claim based on a petition to amend the
regulation that would show how the substance conforms to the
requirements of Sec. Sec.  101.14(b) (21 CFR 101.14(b)) and 101.80 and
that provides evidence that the additional noncariogenic carbohydrate
sweetener will not lower dental plaque pH below 5.7 (61 FR 43433 at
43442). Section 101.80 was first amended in 1997 to list the sugar
alcohol erythritol as an additional noncariogenic carbohydrate
sweetener eligible for the claim (62 FR 63653, December 2, 1997). The
petition to list erythritol in Sec.  101.80 (Docket No. 1997P-0206)
presented scientific data from a rodent cariogenicity study and from a
human in vivo indwelling plaque pH test of erythritol. The agency was
satisfied that this evidence was consistent with the results of the
studies that investigated the cariogenic potential of the substances
previously listed in Sec.  101.80(c)(2)(ii)(A) and that erythritol met
the requirements of Sec.  101.14(b). Therefore, erythritol was added to
the list of sugar alcohols eligible as a noncariogenic carbohydrate
sweetener. Section 101.80 was again amended in the 2002 amendment to
add D-tagatose, a non-fermentable sugar, to the list of substances
eligible for the health claim. This action was based upon clinical
evidence that ingestion of D-tagatose would not lower plaque pH below
5.7 as measured by the indwelling plaque pH method. Because D-tagatose
is a sugar, not a sugar alcohol, the 2002 amendment also changed the
title of the regulation from ``sugar alcohols'' to ``noncariogenic
carbohydrate sweeteners.'' The most recent amendment of Sec.  101.80
was to list sucralose, a non-nutritive sweetener, as an eligible
noncariogenic sweetener (71 FR 15559, March 29, 2006).
 
II. Petition and Grounds
 
A. The Petition
 
    On August 31, 2006, FDA received a health claim petition (Ref. 1)
from Hyman, Phelps & McNamara, P.C., submitted on behalf of Cargill,
Inc. (petitioner), under section 403(r)(4) of the act (21 U.S.C.
343(r)(4)). The petition requested that FDA amend Sec.  101.80 to
authorize a noncariogenic dental health claim for isomaltulose. FDA
notified the petitioner on December 8, 2006, that the initial review of
the petition had been completed and that the petition had been filed
for further action in accordance with section 403(r)(4) of the act. 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 for further action, 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 21 CFR
101.70(j)(3)(iii)). On March 5, 2007, FDA and the petitioner mutually
agreed to extend the deadline for the agency's decision on the petition
until September 5, 2007. The petitioner requested that FDA consider
exercise of its authority under section 403(r)(7) of the act to make
the amendment to Sec.  101.80 effective upon publication.
 
B. Nature of the Substance
 
    The petitioner identified the substance, which is the subject of
the petitioned health claim, to be isomaltulose. Isomaltulose (CAS Reg.
No. 13718-94-0) (6-O-[alpha]-D-glucopyranosyl-D-fructose) is a
disaccharide sugar. The petitioner identified the intended food use of
isomaltulose as a nutritive sweetener. A 2005 generally recognized as
safe (GRAS) notification to FDA (Ref. 2) identified use of isomaltulose
as a nutritive sweetener in a variety of foods to have been determined
to be GRAS for food use. For the purpose of a health claim, the term
``substance'' has been defined as ``* * * a specific food or component
of food * * *'' (Sec.  101.14(a)(2)). An ingredient added to a food as
a sweetener is a component of food. As such, FDA concludes that
isomaltulose is a ``substance'' as defined in Sec.  101.14(a)(2) for
the purpose of food labeling, which characterizes the relationship of
any substance to a disease or health-related condition.
 
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
    Dental caries continues to affect a large segment of the U.S.
population, notwithstanding its decline in recent years (Ref. 3). The
U.S. Department of Health and Human Services' Healthy People 2010
Objectives recognizes dental caries as the single most common chronic
disease during childhood, and states that 30 percent of adults have
untreated dental decay (Ref. 4). Based
 
[[Page 52785]]
 
on these facts, FDA concludes that, as required in Sec.  101.14(b)(1),
dental caries is a disease for which the general U.S. population is at
risk.
2. The Substance Is a Food
    When a health claim involves consumption of a substance at other
than decreased dietary levels, the substance that is the subject of the
health claim must contribute taste, aroma, or nutritive value, or any
other technical effect 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 (Sec.  101.14(b)(3)(i)). The
petitioner stated that the intended use of isomaltulose in food is as a
nutritive sweetener. Isomaltulose contributes taste (sweetness),
nutritive value (source of calories), and a technical effect (nutritive
sweetener) listed in Sec.  170.3(o)(21) to the food and retains these
attributes when consumed at levels that are necessary to justify a
claim. Thus, the agency concludes that the preliminary requirement of
Sec.  101.14(b)(3)(i) is satisfied.
3. The Substance Is Safe and Lawful
    Section 101.14(b)(3)(ii) requires that for a substance to be
eligible for a health claim, it must be a food or a food ingredient or
a component of a food ingredient whose use at the levels necessary to
justify a claim has been demonstrated by the proponent of a claim, to
FDA's satisfaction, to be safe and lawful under the applicable food
safety provisions of the act. FDA evaluates whether the substance is
``safe and lawful'' under the applicable food safety provisions of the
act. For conventional foods, this evaluation involves considering
whether the ingredient that is the source of the substance is GRAS,
approved as a food additive, or authorized by a prior sanction issued
by FDA (see Sec.  101.70(f)).
    The petitioner asserts that there is general recognition of safety,
based upon scientific procedures, for the use of isomaltulose as a
nutritive sweetener in food. FDA previously received a notice on
November 1, 2005, informing FDA that S[Uuml]DZUCKER AG, Mannheim/
Ochsenfurt, had determined through scientific procedures that use of
isomaltulose as a nutritive sweetener in a variety of foods is GRAS
(the 2005 GRAS notification). FDA issued a letter on March 20, 2006
(Ref. 2), in response to this notice stating that the agency had no
questions at the time regarding S[Uuml]DZUCKER's conclusion that
isomaltulose is GRAS under the intended conditions of use. The intended
conditions of use for isomaltulose stated in the 2005 GRAS notification
include use as a nutritive sweetener in the following food categories:
Baked goods and baking mixes (Sec.  170.3(n)(1)); beverages (Sec.
170.3(n)(2) and (n)(3)); cereal-based products (Sec.  170.3(n)(4));
chewing gum (Sec.  170.3(n)(6)); confectionery and frostings (Sec.
170.3(n)(9)); frozen dairy desserts and mixes (Sec.  170.3(n)(20));
fruit and water ices (Sec.  170.3(n)(21)); gelatins, desserts, and
puddings, etc. (Sec.  170.3(n)(22)); jams, jellies, and spreads (Sec.
170.3(n)(28)); milk products (Sec.  170.3(n)(31)); nuts and peanut
spreads (Sec.  170.3(n)(32)); processed fruit and fruit juices or
vegetable juices (Sec.  170.3(n)(35)) and (n)(36)); snack foods (Sec.
170.3(n)(37)); sugar substitutes (Sec.  170.3(n)(42)); and sweet
sauces, toppings, and syrups (Sec.  170.3(n)(43)). Other categories
include nutritive formulas at 5 to 20 percent, energy-reduced foods at
5 to 40 percent, and meal replacements/slimming foods at 5 to 20
percent. Furthermore, FDA is not aware of any scientific evidence that
isomaltulose, under the intended conditions of use, would be harmful.
The agency has not made its own determination regarding the GRAS status
of isomaltulose, 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. FDA concludes that the use of
isomaltulose in food as a nutritive sweetener at levels necessary to
justify the claim and in accordance with the 2005 GRAS notification
demonstrates to FDA's satisfaction that such use is safe and lawful
under applicable food safety provisions of the act. Therefore, FDA
concludes that the preliminary requirements in Sec.  101.14(b)(3)(ii)
are satisfied.
 
III. Review of Scientific Evidence of the Substance-Disease
Relationship
 
A. Basis for Evaluating the Relationship Between Isomaltulose and
Dental Caries
 
    As recognized in Sec.  101.80, certain carbohydrate sweeteners are
relatively noncariogenic compared to fermentable carbohydrates such as
starch and most sugars. The relationship between noncariogenic
sweeteners and dental caries involves slower fermentation by oral
bacteria than that of the dietary sugars they replace. Noncariogenic
sweeteners do not promote the development of dental caries because the
amount and rate of organic acids resulting from their metabolism by
oral bacteria is sufficiently less than that of the fermentable
carbohydrates, and they do not cause the loss of minerals from tooth
enamel. (Sec.  101.80(b)) The agency noted in the preamble to the 1996
final rule that it would take action to add additional sugar alcohols
to Sec.  101.80 when presented, in part, with evidence that the
additional sugar alcohols would not lower plaque pH (i.e., raise plaque
acidity) below 5.7 (61 FR 43433 at 43442). FDA has subsequently amended
Sec.  101.80 on three occasions to list additional noncariogenic
sweeteners in the regulation. The three added noncariogenic sweeteners
include a sugar alcohol (erythritol), a sugar (D-tagatose), and a non-
nutritive sweetener (sucralose). Although the noncariogenic sweeteners
that were initially the subject of the health claim were all sugar
alcohols, FDA has amended Sec.  101.80 to list additional noncariogenic
sweeteners that are not sugar alcohols. When doing so, FDA also changed
the title of the health claim from ``Dietary Sugar Alcohols and Dental
Caries'' to ``Dietary Noncariogenic Carbohydrate Sweeteners and Dental
Caries.''
    Isomaltulose, the subject of the current petition, is a sugar. As
is the case with the noncariogenic sweeteners now listed in the dental
caries health claim, the potential dental health benefit from
isomaltulose derives from its lower fermentability relative to most
sugars used as food ingredients. Consequently, the criteria that FDA
used to evaluate the other noncariogenic sweeteners in the existing
dental caries health claim can be applied to assess whether
isomaltulose also qualifies for the health claim.
 
B. Review of Scientific Evidence
 
1. Evidence Considered in Reaching the Decision
    The recognized 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., dental plaque), and at the same time to form acids that can
demineralize tooth enamel (Ref. 5). FDA initially proposed to authorize
a health claim relating noncariogenic carbohydrate sweeteners and
nonpromotion of dental caries (60 FR 37507, July 20, 1995), based on
scientific evidence from studies evaluating changes in human dental
plaque pH, plaque acid production, decalcification or remineralization
of tooth enamel, and the incidence of dental caries. FDA limited its
review to these types of studies because previous reviews by the
Federal Government and other authorities had focused on these areas,
and the majority of research efforts have also focused on these areas
(60 FR 37507 at 37523). FDA concluded that
 
 
[[Page 52786]]
 
human studies showing sugar alcohols to be associated with reduced rate
of acid production in dental plaque relative to sucrose and, in some
studies, a reduced incidence of dental caries, were evidence for the
association of sugar alcohols and a reduced risk of developing dental
caries (60 FR 37507 at 37523). In the 1996 final rule, FDA noted that
it would take action to add other sweeteners to the list of substances
eligible for this health claim when presented with a petition that
included, in part, evidence that the substance would not lower plaque
pH below 5.7 (61 FR 43433 at 43442). FDA did not specify a specific
method to be used in measuring plaque pH for considering the addition
of other sweeteners to the list of eligible substances for this health
claim. However, in order for a food that contains both noncariogenic
sweeteners and fermentable carbohydrates to qualify for this health
claim, Sec.  101.80(c)(2)(iii)(C) specifies that an indwelling pH
electrode method of measuring dental plaque pH is the procedure that
the agency will use to verify that a food bearing the health claim does
not result in a lowering of dental plaque pH below 5.7. The current
petition included a report (Ref. 1, Appendix B) from an assay of the
cariogenic potential of isomaltulose which used the indwelling pH
electrode method of measuring dental plaque pH specified in Sec.
101.80(c)(2)(iii)(C). This is the same type of evidence FDA considered
previously in its decisions to amend Sec.  101.80 to list D-tagatose
(67 FR 71461) and sucralose (71 FR 15559).
2. Review of Isomaltulose Noncariogenic Assay Data
    The petition included a report (Ref. 1, Appendix B) of an in vivo
assay of the cariogenic potential of isomaltulose. This assay was
conducted following the protocol described in ``Identification of Low
Caries Risk Dietary Components,'' by T. Imfield, vol. 11, Monographs in
Oral Science, 1983, which is incorporated by reference in the dental
caries health claim (Sec.  101.80(c)(2)(iii)(C)). This protocol
provides for the continuous telemetric recording of plaque pH in vivo.
The test was conducted for Cerestar R & D Center, Vilvoorde, Belgium,
by the University of Zurich, Dental Institute, Clinic of Preventive
Dentistry, Periodontology and Cariology, Bioelectric Unit.
    The plaque pH telemetry assays were performed with six test
subjects in good general health. All test subjects had previously
participated in similar studies and their response to positive control
procedures was known. Each subject had a miniaturized glass pH-
electrode implanted in a dental prosthesis. Once the plaque pH
telemetric prosthesis was inserted, it remained in place throughout the
test period. Test subjects refrained from all oral hygiene practices,
except for water rinses, to allow a 3 to 7 day undisturbed growth of
interdental plaque to accumulate over the tips of the pH electrodes.
    Baseline plaque pH was measured over a 15 minute period following a
3 minute period of chewing paraffin. Test subjects then rinsed for 2
minutes with 15 milliliters (mL) of a 10 percent aqueous solution of
isomaltulose; or alternatively sucking a 1.5 gram (g) tablet of pressed
isomaltulose. Plaque pH response to isomaltulose was recorded for 30
minutes following isomaltulose exposure. The paraffin chew/rinse
sequence was then repeated using a 10 percent sucrose rinse instead of
isomaltulose. The sucrose rinse serves as a positive control to
demonstrate the accurate functioning of the pH telemetric equipment and
of plaque metabolism.
    The study report commented that baseline plaque pH values measured
following paraffin chewing coincide with those found in earlier tests
with the same test subjects. The study report also commented that the
observed decrease of plaque pH subsequent to the sucrose rinse (lowest
pH value range was 4.40 to 4.90) demonstrates the accurate functioning
of the pH telemetric equipment and of plaque metabolism on the
telemetric prosthesis. The lowest interdental plaque pH recorded among
the six test subjects during the 30 minutes following the isomaltulose
rinse ranged from 6.00 to 6.35 (6.19  0.12, mean <plus-minus>
standard deviation, n=6). The lowest interdental plaque pH
recorded among the six test subjects during the 30 minutes following
the isomaltulose tablet ranged from 5.80 to 6.65 (6.38
0.39, mean  standard deviation, n=4). The study report
concluded that no critical decrease (i.e., below pH 5.7) in the
interdental plaque pH due to bacterial fermentation of isomaltulose
occurred following either the rinsing with 15 mL of a 10 percent
solution of isomaltulose nor the sucking of a 1.5 g tablet of pressed
isomaltulose. Although this report of an in vivo dental plaque pH test
of isomaltulose constitutes a limited body of scientific evidence on
the cariogenic potential of isomaltulose, FDA is satisfied that this
report, 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 isomaltulose should be added to the list of substances
eligible for the dental caries health claim.
 
IV. Decision to Authorize a Health Claim Relating Isomaltulose to the
Nonpromotion of Dental Caries
 
    FDA previously concluded that there was significant scientific
agreement among qualified experts to support the relationship between
certain noncariogenic carbohydrate sweeteners (e.g., some sugar
alcohols, D-tagatose, and sucralose) and the nonpromotion of dental
caries. The principal evidence that substantiates this relationship is
in vivo data on the effects of noncariogenic carbohydrate sweeteners on
human dental plaque pH (Sec.  101.80(b)). The current petition based
its assertion that isomaltulose is noncariogenic on evidence from an
indwelling telemetric plaque pH assay of the cariogenic potential of
isomaltulose. As discussed in section III of this document, the plaque
pH assay demonstrated that isomaltulose did not result in decreases in
plaque pH below the critical level of pH 5.7, when introduced as either
an aqueous solution or as a tablet, and therefore, would be considered
to not promote demineralization of dental enamel. The results of the
isomaltulose plaque pH assay are consistent with the evidence relied
upon by the agency when adding other noncariogenic sweeteners to the
list of sweeteners eligible for this health claim. Therefore, based on
the totality of publicly available evidence pertaining to the
cariogenic potential of isomaltulose and to the relationship between
dental plaque pH and dental caries, FDA concludes that there is
significant scientific agreement that isomaltulose does not promote
dental caries. Accordingly, FDA is amending Sec.  101.80 to authorize
extending the dental caries health claim to include isomaltulose.
 
V. Description of Modifications to Sec.  101.80
 
A. Requirements
 
    Specific requirements for use of the dental caries health claim are
provided in Sec.  101.80(c)(2). Section 101.80(c)(2)(ii) lists
noncariogenic carbohydrate sweeteners eligible for the health claim.
Eligible sugar alcohols, sugars, and non-nutritive sweeteners are
listed in Sec.  101.80(c)(2)(ii)(A), (B), and (C), respectively. FDA is
amending Sec.  101.80(c)(2)(ii)(B) to include isomaltulose as an
additional eligible noncariogenic sugar. Section
 
[[Page 52787]]
 
101.80(c)(2)(iii) specifies eligibility criteria for a food to bear the
health claim on its label. The first criterion in this paragraph is
that the food be ``sugar free,'' as defined in Sec.  101.60(c)(1)(i),
except that the food may contain D-tagatose (Sec.
101.80(c)(2)(iii)(A)). FDA is amending Sec.  101.80(c)(2)(iii)(A) to
include isomaltulose, in addition to D-tagatose, in the exception to
the ``sugar free'' criterion of eligible foods.
 
B. Model Health Claims
 
    Section 101.80(e) provides examples of statements that meet the
requirements to make a health claim about nonpromotion of dental
caries. FDA emphasizes that these ``model health claims'' are
illustrative only. These model claims illustrate both the elements of
the health claim statement required under Sec.  101.80(c)(2)(i) and
some of the optional elements permitted under Sec.  101.80(d). FDA is
amending Sec.  101.80 to add isomaltulose as an additional
noncariogenic carbohydrate sweetener eligible for the health claim, and
is not approving specific wording of claim statements. Manufacturers
continue to be free to design their own claim so long as it is
consistent with agency regulations.
    Under Sec.  101.80(c)(2)(i)(H), there is a requirement that 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. This
requirement was added to Sec.  101.80, along with the addition of the
sugar D-tagatose as a sweetener eligible for the claim, to address the
potential incongruity arising from a sugar-containing food bearing a
dental caries health claim stating that foods high in sugars promote
tooth decay. The model health claim examples in Sec.  101.80(e)(1)(iii)
and (iv) and Sec.  101.80(e)(2)(iii) and (iv) are examples of health
claim statements for use with D-tagatose-containing foods. FDA is
revising these model health claims to change from the specific sugar
``tagatose'' to ``name of a sugar from paragraph (c)(2)(ii)(B) of this
section'' to be inclusive of either tagatose or isomaltulose, or other
noncariogenic sugars that may be added to the rule in the future.
    Current Sec.  101.80(e)(1) consists of examples of the full claim,
and Sec.  101.80(e)(2) consists of examples of the shortened claim for
use on packages with less than 15 square inches of surface area
available for labeling. The ``shortened claim'' version provided for in
Sec.  101.80(c)(2)(i)(G) may omit: (1) Stating the relationship of
frequent between-meal consumption of foods high in sugars and starches
and the promotion of dental caries (Sec.  101.80(c)(2)(i)(A)), and (2)
identification of the substance by name or as a sugar alcohol (Sec.
101.80(c)(2)(i)(C)). The ``shortened claim'' version, however, does not
omit the requirement that when a noncariogenic sugar is the subject of
the claim, the substance be identified in the claim statement as a
sugar. As such, the model ``shortened claims'' provided by FDA in Sec.
101.80(e)(2) identify by name either tagatose or isomaltulose.
 
VI. Analysis of Impacts
 
    FDA has examined the impacts of the interim final rule under
Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
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). The agency believes that
this interim final rule is not a significant regulatory action as
defined by the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this interim final rule concerns voluntary
claims, the agency certifies that the interim final rule will not have
a significant economic impact on a substantial number of small
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any 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 one year.'' The current threshold after adjustment
for inflation is $122 million, using the most current (2005) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
interim final rule to result in any 1-year expenditure that would meet
or exceed this amount.
    FDA identified the following three options regarding this petition:
(1) Deny the petition, (2) authorize the petition (add only
isomaltulose to Sec.  101.80), or (3) add isomaltulose to Sec.  101.80
and also expand the scope of the claim to include all noncariogenic
carbohydrate sweeteners. FDA concludes that authorizing the petition by
adding only isomaltulose to the dental caries health claim is the best
option of those identified.
Option One: Deny the Petition
    The agency can only define costs and benefits relative to a
baseline, and FDA usually selects the option of taking no action as the
baseline because it helps readers identify the costs and benefits of
actions that change the status quo. In this case, denying the petition
would correspond to taking no action because it would imply no change
in the dental caries health claim and thus the continuation of the
status quo. By definition, the baseline itself has no costs or
benefits. This does not mean that FDA ignores the costs and benefits of
the baseline. Instead, it means that the agency expresses the costs and
benefits of the baseline in how it calculates the costs and benefits of
the other regulatory options.
Option Two: Authorize the Petition (Add Only Isomaltulose to Sec.
101.80)
    This option would allow producers who use isomaltulose to use the
dental caries health claim on their product labels under certain
conditions. Producers would only choose to change product labels or
reformulate products if they believe that doing so will increase
profits more than the costs of making those changes. Providing this
information may increase profits for some producers because some
consumers may find this information valuable when choosing products.
Some consumers may find this information valuable because it may allow
them to reduce their risk of dental carries. FDA has determined that
this information has sufficient scientific support and, when provided
in labeling under certain conditions, is truthful and not misleading to
consumers. Therefore, using the claims will not generate offsetting
costs for consumers. The agency does not know how many producers will
find it worthwhile to use this claim. However, if this interim final
rule is finalized without change, it is sure that to whatever extent
producers use the claim, both producers and consumers will be made
better off under option two than under option one. The agency can
conclude that adding isomaltulose to the dental caries health claim
will generate either a net increase in social benefits or, if no
producers find it worthwhile to use the claims, no impact on social
welfare.
Option Three: Add Isomaltulose to Sec.  101.80 and Also Expand the
Scope of the Claim to Include All Noncariogenic Carbohydrate Sweeteners
 
[[Page 52788]]
 
    This option would allow producers who use isomaltulose and all
other noncariogenic carbohydrate sweeteners to use the dental caries
health claim on their product labels under certain conditions rather
than just listing specific individual sweeteners. Similar to option
two, producers would only choose to change product labels or
reformulate products if they believe that the benefits that they will
derive from doing so are at least as great as the costs of making those
changes. In addition, this option would reduce the future burden on
manufacturers of petitioning FDA to use the dental caries health claim
for additional noncariogenic carbohydrate sweeteners, and it would also
reduce FDA's burden of evaluating each petition for each individual
noncariogenic carbohydrate sweetener.
    However, FDA does not know the identity of all the sweeteners that
may fall under the category of ``all noncariogenic carbohydrate
sweeteners.'' Thus, FDA would have to extrapolate the data applicable
to the known noncariogenic carbohydrate sweeteners to unknown
noncariogenic carbohydrate sweeteners in that category, even though the
science may not support such an extrapolation. By expanding the use of
the claim to all noncariogenic carbohydrate sweeteners without
reviewing the scientific data on each individual sweetener, FDA would
not be able to verify that the claim was being used under circumstances
where it is truthful and not misleading to consumers. If producers used
the expanded claim on a product that was, in fact, not noncariogenic,
then the expanded claim could actually result in an increase in the
number of dental caries.
    Based on these considerations, FDA cannot conclude that the
potential cost savings of option three would necessarily outweigh the
increased risk of producers making a false or misleading claim under
the expanded claim. Therefore, FDA cannot conclude that option three
would be better for social welfare than option two.
    In addition, the agency notes that it does not believe this option
is legally feasible. FDA believes that expanding the dental caries
health claim to all carbohydrate sweeteners without reviewing the
scientific data supporting such a claim of noncariogenicity for each
individual carbohydrate sweetener would be a failure to carry out FDA's
statutory responsibility under section 403(r)(3)(B) of the act to issue
health claim regulations only when FDA determines that there is
significant scientific agreement that the claim is supported by the
totality of publicly available scientific evidence.
 
VII. Environmental Impact
 
    The agency has determined under 21 CFR 25.32(p) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
 
VIII. 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 consumption of
isomaltulose 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'' (see 5
CFR 1320.3(c)(2)).
 
IX. Federalism
 
    FDA has analyzed this interim final rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the rule has a preemptive effect on State law. Section 4(a) of the
Executive order requires agencies to ``construe * * * a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.'' Section 403A of the act (21 U.S.C. 343-1) is an
express preemption provision. Section 403A(a)(5) of the act provides
that:
    * * * no State or political subdivision of a State may directly
or indirectly establish under any authority or continue in effect as
to any food in interstate commerce--* * *
    (5) any requirement respecting any claim of the type described
in section 403(r)(1) made in the label or labeling of food that is
not identical to the requirement of section 403(r) * * *
    This interim final rule amends existing food labeling regulations
to add isomaltulose to the authorized health claim for noncariogenic
carbohydrate sweeteners and dental caries. Although this rule has a
preemptive effect in that it precludes States from issuing any health
claim labeling requirements for isomaltulose and the nonpromotion of
dental caries that are not identical to those required by this interim
final rule, this preemptive effect is consistent with what Congress set
forth in section 403A of the act. Section 403A(a)(5) of the act
displaces both State legislative requirements and State common law
duties. Medtronic v. Lohr, 518 U.S. 470, 503 (1996) (Breyer, J.,
concurring in part and concurring in judgment); id. at 510 (O'Connor,
J., joined by Rehnquist, C. J., Scalia, J., and Thomas, J., concurring
in part and dissenting in part); Cipollone v. Liggett Group, Inc., 505
U.S. 504, 521 (1992) (plurality opinion); id. at 548-49 (Scalia, J.,
joined by Thomas, J., concurring in judgment in part and dissenting in
part).
    FDA believes that the preemptive effect of this interim final rule
is consistent with Executive Order 13132. Section 4(e) of the Executive
order provides that ``when an agency proposes to act through
adjudication or rulemaking to preempt State law, the agency shall
provide all affected State and local officials notice and an
opportunity for appropriate participation in the proceedings.'' FDA
provided the States with an opportunity for appropriate participation
in this rulemaking on August 1, 2007, when FDA's Division of Federal
and State Relations provided notice via fax and e-mail transmission to
State health commissioners, State agriculture commissioners, food
program directors, and drug program directors as well as FDA field
personnel of FDA's intent to amend the health claim regulation
authorizing health claims for noncariogenic carbohydrate sweeteners and
dental caries (Sec.  101.80). It advised the States of FDA's possible
action and encouraged the States and local governments to review the
notice and to provide any comments to the docket (Docket No. 2006P-
0487), until September 1, 2007. FDA received no comments from any
States in response to the fax and e-mail transmission. FDA is also
providing an opportunity for State and local officials to comment on
this interim final rule.
    In conclusion, the agency has determined that the preemptive
effects of this interim final rule are consistent with Executive Order
13132.
 
X. Issuance of an Interim Final Rule and Immediate Effective Date
 
    FDA is 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
 
[[Page 52789]]
 
determines that such action is necessary. This authority enables the
agency 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)).
    The petitioner requested the agency to consider making any proposed
regulation on the petitioned health claim effective upon publication of
an interim final rule. FDA acknowledges that all three of the criteria
in section 403(r)(7)(A) of the act have been met in the petition
submitted by Hyman, Phelps & McNamara, P.C. on behalf of Cargill, Inc.
The health claim will 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
knowledge regarding the reduced cariogenic potential of isomaltulose
relative to that of other sugars, and will provide consumers with
scientifically sound information on the dental health benefits of foods
containing isomaltulose. Therefore, FDA is 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 isomaltulose and the 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 Division of Dockets Management, in any of the ways noted in the
ADDRESSES section at the beginning of this document, comments regarding
this interim final rule by December 3, 2007. 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 Division of Dockets
Management 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.
 
XI. Comments
 
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
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
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
 
XII. References
 
    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Cargill, Inc., ``Petition to Amend 21 CFR 101.80 to Authorize
a Noncariogenicity Dental Health Claim for Isomaltulose,'' Docket
No. 2006P-0487, August 31, 2006.
    2. Agency Response Letter to GRAS Notice No. GRN 000184, Food
and Drug Administration, Center for Food Safety and Applied
Nutrition, Office of Food Additive Safety, March 20, 2006. Available
at: http://www.cfsan.fda.gov/~rdb/opa-g184.html.
 
    3. U.S. Department of Health and Human Services, Oral Health in
America: A Report of the Surgeon General--Executive Summary,
Rockville, MD, National Institute of Dental and Craniofacial
Research, National Institutes of Health, May 2000. Available at:
http://www2.nidcr.nih.gov/sgr/execsumm.htm.
 
    4. U.S. Department of Health and Human Services, ``Oral
Health,'' chapter 21, Healthy People 2010, vol. II, part B, 2d ed.,
Washington, DC., U.S. Government Printing Office, November 2000.
Available at: http://www.healthypeople.gov/document/html/volume2/21oral.htm.
 
    5. Medline Plus Medical Encyclopedia, ``Dental Cavities.''
Available at U.S. National Library of Medicine and the National
Institutes of Health MedlinePlus: http://www.nlm.nih.gov/medlineplus/ency/article/001055.htm.
 
 
List of Subjects in 21 CFR Part 101
 
    Food labeling, Nutrition, Reporting and recordkeeping requirements.
 
0
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
 
0
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.
 
0
2. Section 101.80 is amended by revising paragraphs (c)(2)(ii)(B),
(c)(2)(iii)(A), (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.
 
* * * * *
    (c) * * *
    (2) * * *
    (ii) * * *
    (B) The sugars D-tagatose and isomaltulose.
* * * * *
    (iii) * * *
    (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 or isomaltulose.
* * * * *
    (e) * * *
    (1) * * *
    (iii) Frequent eating of foods high in sugars and starches as
between-meal snacks can promote tooth decay. [Name of sugar from
paragraph (c)(2)(ii)(B) of this section], 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. [Name of sugar from paragraph
(c)(2)(ii)(B) of this section], the sugar in [name of food], unlike
other sugars, does not promote tooth decay.
* * * * *
    (2) * * *
    (iii) [Name of sugar from paragraph (c)(2)(ii)(B) of this section]
sugar does not promote tooth decay.
    (iv) [Name of sugar from paragraph (c)(2)(ii)(B) of this section]
sugar may reduce the risk of tooth decay.
 
    Dated: September 6, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-18196 Filed 9-14-07; 8:45 am]
 
BILLING CODE 4160-01-S

Final Rule on Dietary Noncariogenic Carbohydrate Sweeteners and Dental Caries (73 FR 30299)