[Federal Register Volume 70, Number 92 (Friday, May 13, 2005)]
[Proposed Rules]
[Pages 25496-25502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-9608]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 70, No. 92 / Friday, May 13, 2005 / Proposed
Rules
[[Page 25496]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 2004P-0294]
Food Labeling; Health Claims; Dietary Noncariogenic Carbohydrate
Sweeteners and Dental Caries
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the regulation authorizing a health claim on noncariogenic carbohydrate
sweeteners and dental caries, i.e., tooth decay, to include sucralose,
a nonnutritive sweetener. Similar to the sweeteners currently
authorized to make a health claim, sucralose is used as a sugar
substitute that is minimally fermented, relative to sugar, by oral
microorganisms and thus does not contribute to production of organic
acids by plaque bacteria as do the fermentable sugars for which it is a
substitute. FDA is taking this action in response to a health claim
petition filed by McNeil Nutritionals. The agency 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, FDA now has
determined that the nonnutritive sweetener sucralose, like the sugar
alcohols, 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 sucralose does not
promote dental caries, and it is proposing to amend the regulation
authorizing a health claim relating certain noncariogenic sweeteners
and nonpromotion of dental caries to include sucralose as a substance
eligible for the claim.
DATES: Submit written or electronic comments by July 27, 2005. See
section XII of this document for the proposed effective date of a final
rule based on this document.
ADDRESSES: You may submit comments, identified by the Docket Number
2004P-0294, by any of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: http://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
E-mail: [email protected]. Include Docket No. 2004P-
0294 and/or RIN number ------ in the subject line of your e-mail
message.
FAX: 301-827-6870
Mail/Hand delivery/Courier [for paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the agency name
and Docket Number or Regulatory Information Number (RIN) for this
rulemaking. All comments received will be posted without change to
http://www.fda.gov/ohrms/dockets/default.htm, including any personal
information provided. For detailed instructions on submitting comments
and additional information on the rulemaking process, 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 prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, room 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: James E. Hoadley, 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) (Public Law 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.
FDA issued several new regulations in 1993 that implemented the
health claim provisions of the 1990 amendments. Among these were Sec.
101.14 Health claims: general requirements (21 CFR 101.14) (58 FR 2478,
January 6, 1993) and Sec. 101.70 Petitions for health claims (21 CFR
101.70) (58 FR 2478), 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 that established Sec. 101.80 (21 CFR 101.80) (61 FR
43433, August 23, 1996), relating sugar alcohols to 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. 1995P-0003).\1\ 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 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 noncariogenic carbohydrate
sweeteners are fermented by oral microorganisms more slowly than
fermentable carbohydrates. Consequently, the rate of acid production is
lower than that from fermentable carbohydrates. Noncariogenic
carbohydrate sweeteners, when used in place of fermentable sugars, are
therefore 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
[[Page 25497]]
the requirement that the food bearing the claim be ``sugar free''
(Sec. 101.80(c)(2)(iii)(A)). This section also specifies 10
noncariogenic carbohydrate sweeteners (xylitol, sorbitol, mannitol,
maltitol, isomalt, lactitol, hydrogenated starch hydrolysates,
hydrogenated glucose syrups, erythritol, and D-tagatose) that are
eligible for the claim (Sec. 101.80(c)(2)(ii)). Section
101.80(c)(2)(iii)(C) further states that:
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\1\Section 101.80 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).
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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 * * *.''
In the dental caries health claim final rule, the agency stated
that for other noncariogenic carbohydrate sweeteners to be included in
the list of sweeteners eligible for the health claim, 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
noncariogenic carbohydrate sweetener will not lower dental plaque pH
below 5.7 (61 FR 43433 at 43442).
In 1997, the agency amended the dental caries health claim to
include erythritol as an additional noncariogenic carbohydrate
sweetener eligible for the claim (62 FR 63653, December 2, 1997). The
health claim petition to add erythritol to Sec. 101.80 (Docket No.
1997P-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 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. In 2002,
the agency again amended Sec. 101.80 (67 FR 71461) 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 the sweetener added to the
health claim in the 2002 amendment was not a sugar alcohol, the 2002
amendment also changed the substance in the title of the regulation
from ``sugar alcohols'' to ``noncariogenic carbohydrate sweeteners.''
II. Petition and Grounds
A. The Petition
On April 2, 2004, McNeil Nutritionals, of New Brunswick, NJ
(petitioner) submitted a petition under section 403(r)(4) of the act
(21 U.S.C. 343(r)(4)) (Ref. 1). The petition requested that we amend
Sec. 101.80 to include the nonnutritive sweetener sucralose as one of
the substances eligible to bear the dental caries health claim. On July
9, 2004, we notified the petitioner that we had completed our initial
review of the petition 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 Sec. 101.70(j)(3)(iii)). On
April 5, 2005, FDA and the petitioner mutually agreed to extend the
deadline to publish a proposed regulation until October 7, 2005.
B. Nature of the Substance
The petition has identified the substance, which is the subject of
the petitioned health claim, to be sucralose (CAS Reg. No. 56038-13-2),
a substituted carbohydrate in which there is a selective replacement of
three hydroxyl groups on a sucrose molecule with chlorine atoms. The
food additive use of sucralose is as a general purpose sweetener in
both conventional foods and dietary supplements (Sec. 172.831 (21 CFR
172.831)). Sucralose, used as a general purpose sweetening food
additive, is a specific component of food. The term ``substance''
within the meaning of a health claim includes ``* * * a specific food
or component of food * * *'' (Sec. 101.14(a)(2)). As such, FDA
concludes that sucralose is a ``substance'' as defined in Sec.
101.14(a)(2) for the purpose of a food label statement 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
The petition noted that the scientific literature establishing the
relationship between dental caries and fermentable carbohydrates is
described and referenced in the final rule for the dental caries health
claim (61 FR 43433). When authorizing the health claim relating
noncariogenic carbohydrate sweeteners and dental caries, 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 widespread throughout
the U.S. population (Sec. 101.80(a)(3)). 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 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)). As noted
by the petition, the use of sucralose as a nonnutritive sweetener in
conventional foods and dietary supplements is prescribed by the food
additive regulation under Sec. 172.831. The sweetness intensity of
sucralose is approximately 600 times that of sucrose (Ref. 3), as such
the amount of sucralose used as a sugar substitute is in milligrams per
serving and the caloric contribution of sucralose to a food is
insignificant. The food additive use of sucralose is as a ``non-
nutritive sweetener,'' one of the technical effects listed in Sec.
170.3(o) for which human food ingredients may be added to foods.
Because sucralose contributes to food taste, one of the technical
effects listed in Sec. 170.3(o), the agency concludes that the
preliminary requirement of Sec. 101.14(b)(3)(i) is satisfied.
3. The Substance is Safe and Lawful
The petition notes that FDA has evaluated the use of sucralose in
the food supply and has issued a food additive regulation setting out
the conditions of its safe use in foods. The safe use of sucralose as a
general purpose sweetener in foods in accordance with current good
manufacturing practice in an amount not to exceed that reasonably
required to accomplish the intended effect is
[[Page 25498]]
prescribed by the food additive regulation under Sec. 172.831. This
food additive regulation establishes the food use of sucralose under
conditions prescribed by the regulation to be safe and lawful under
section 409 of the act (21 U.S.C. 348). Therefore, FDA concludes that
the petitioner has satisfied the requirement of Sec. 101.14(b)(3)(ii)
to demonstrate, to FDA's satisfaction, that the use of sucralose as a
sweetener is safe and lawful under the provisions of the act.
III. Review of Scientific Evidence of the Substance-Disease
Relationship
A. Basis for Evaluating the Relationship Between Sucralose 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 at
43443). 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 would not lower plaque pH (i.e., raise plaque
acidity) below 5.7, and that the substance conformed to the
requirements of Sec. 101.14(b) (61 FR 43433 at 43442).
The substance that is the subject of the current petition,
sucralose, is a chlorine-substituted sugar rather than a sugar alcohol.
However, like the sugar alcohols, the intended food ingredient use of
sucralose is as a sugar substitute. Also, as is the case with the sugar
alcohols, the potential dental health benefit from sucralose derives
from its lower 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
assess whether sucralose also qualifies for such a claim.
B. Review of Scientific Evidence
1. Evidence Considered in Reaching the Decision
In the initial proposal to authorize a health claim relating
noncariogenic carbohydrate sweeteners and nonpromotion of dental caries
(60 FR 37507, July 20, 1995), FDA considered evidence from long-term
controlled human caries studies, in vivo and in vitro plaque acidity
studies, tooth decalcification and remineralization studies, and
experimental rat caries studies for the noncariogenic potential of
several specific sugar alcohols. FDA's review focused on the 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). 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), and at the same time to form acids that
can demineralize tooth enamel. FDA had previously concluded that human
studies show sugar alcohols are associated with reduced rate of acid
production in dental plaque and, in some studies, a reduced incidence
of dental caries, in comparison to sucrose (60 FR 37507 at 37523).
In consideration of the amendment requested in the current
petition, FDA compared scientific evidence regarding the cariogenic
potential of sucralose from three human studies which investigated the
rate of acid production in dental plaque resulting from exposure to
sucralose-containing solutions. This is the same type of clinical
evidence that the agency previously reviewed regarding the cariogenic
potential of certain sugar alcohols and of D-tagatose. As discussed in
section II.C of this document, FDA has concluded that sucralose
satisfies the requirements of Sec. 101.14(b).
Sucralose is used as a nonnutritive food additive in processed
foods. Sucralose is also marketed directly to consumers in several
formulations for use in sweetening foods and beverages (Splenda Packet,
Splenda Sugar Blend for Baking, and Splenda Granular). Splenda Packet
is a formulation of sucralose dispersed in a dextrose/maltodextrin
blend containing greater than 0.5 gram (g) dextrose sugar per labeled
serving, and packaged in single serving packets for consumer use as a
``table top'' sweetener. Splenda Sugar Blend for Baking is a
formulation of sucralose dispersed in sucrose, containing 2 g sugar per
labeled serving, and packaged for consumer use as a sugar replacement
in cooking and baking. The dental caries health claim regulation
requires that a food bearing the claim be ``sugar-free'' as defined in
the regulations, except that the food may contain D-tagatose (see Sec.
101.80(c)(2)(iii)(A) and Sec. 101.60(c)(1)(i) (21 CFR
101.60(c)(1)(i)). Neither Splenda Packet nor Splenda Sugar Blend for
Baking meet the definition of ``sugar-free'' as set out in Sec.
101.60(c)(1)(i). Therefore, neither of these two sucralose formulations
are eligible for use of the health claim, and the dental plaque pH data
provided in the petition for Splenda Packet has not been considered as
evidence for amending the health claim regulation. The petition did not
include dental plaque pH data for Splenda Sugar Blend for Baking.
There are three primary methods used for measuring the impact of
foods on plaque acidity in humans: Plaque sampling, micro-touch, and
indwelling electrode methods (Ref. 4). The plaque sampling method
involves the scraping of plaque from tooth surfaces, dispersing the
collected plaque in distilled water, and in vitro pH measurement of the
plaque suspension. The micro-touch method involves measurements of
plaque pH in situ, at the plaque surface, by touching a small pH
electrode against tooth surfaces. The indwelling electrode method
involves mounting a small pH electrode in a removable partial denture
such that it is positioned adjacent to a natural tooth crown, allowing
in situ pH measurements under the plaque layer that accumulates on the
electrode. Since these three methods measure pH at different locations
and at different depths in the plaque, they yield somewhat different pH
values. Both the micro-touch and indwelling electrode methods have been
reported to satisfactorily identify relative differences in acidogenic
foods compared to a positive control (Refs. 4 and 5). However, in
studies which directly compare the absolute pH values obtained from the
different plaque pH measurement methods, the indwelling electrode
method consistently yields lower minimum pH values than do either the
plaque sampling or micro-touch methods (Refs. 4 to 6).
When initially authorizing the dental caries health claim, 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. On the other hand, in order for foods that contain
both noncariogenic sweeteners and fermentable carbohydrates to qualify
for this health claim, Sec. 101.80(c)(2)(iii)(C) specifies that
[[Page 25499]]
the indwelling electrode method is the procedure that the agency will
use.
2. Review of Sucralose Studies
The petition included published reports from three separate
randomized, double-blind studies of the effect of sucralose on dental
plaque pH in humans (Refs. 7 to 9). Each study was conducted with
essentially the same experimental protocol, and in each study
interdental plaque pH was measured with a hand-held miniature pH
electrode (the micro-touch method). Exposure to sucralose was
accomplished by a 1 minute rinsing of the mouth with the test sweetener
substances dissolved in water (Ref. 7), hot coffee (Ref. 8), or iced
tea (Ref. 9).
Each study recruited subjects older than 18 years of age and with
high caries susceptibility as demonstrated by: (1) Greater than seven
decayed, missing, or filled teeth, and (2) a plaque pH measurement
below 5.7 when challenged with a 4.7 percent sucrose rinse. Subjects
refrained from oral hygiene procedures for 48 hours prior to each test
and refrained from smoking and all food and drink, except for water,
for at least 4 hours prior to each test to allow for the development of
an undisturbed resting plaque layer. At each test session, pre-rinse
baseline pH was measured at the mesiobuccal surface of six teeth, after
which subjects rinsed with a test sweetener solution for 1 minute, and
then pH measurements at the same six sites were repeated at timed
intervals over 60 minutes.
Each study included test solutions of: (1) Sucralose alone, (2)
sucralose with maltodextrin (Splenda Granular), (3) sucralose with a
dextrose-maltodextrin blend (Splenda Packet), and (4) sucrose alone.
The sucrose rinse served as a positive control. The sweetness of the
sucralose solutions (0.007 percent by weight) and sucrose solution (4.7
percent by weight) were equivalent to 2 teaspoons of sucrose in 6 fluid
ounces. A fifth test solution (unsweetened coffee or iced tea) was
included in two of the reported studies (Refs. 8 and 9). Test sessions
were conducted at 1-week intervals, and at approximately the same time
of day for each individual. One sweetener solution was tested per test
session and each individual tested all test solutions for the study
they were enrolled in.
The reported mean minimum plaque pH values following a sucralose
rinse were 6.56 0.23 (water), 6.04 0.44
(coffee), and 6.73 0.34 (iced tea). The reported mean
minimum plaque pH values following a Splenda Granular rinse were 6.15
0.36 (water), 5.59 0.35 (coffee), and 6.20
0.31 (iced tea). The reported mean minimum plaque pH
values following a Splenda Packet rinse were 5.84 0.47
(water), 5.34 0.29 (coffee), and 6.02 0.42
(iced tea). The reported mean minimum pH values following a sucrose
rinse were 5.29 0.30 (water), 5.35 0.37
(coffee), and 5.46 0.33 (iced tea). The reported mean
minimum pH values following a rinse with unsweetened beverage were 5.92
0.41 (coffee), and 6.79 0.31 (iced tea).
These results show that exposure to sucralose alone by an oral rinse
did not result in a increase in plaque acidity as measured by the
micro-touch pH method. As such, these data are evidence that sucralose
will not lower plaque pH below 5.7. However, exposure by an oral rinse
to Splenda Granular and Splenda Packet did, in some instances, lower
plaque pH below 5.7. For instance, when the oral rinse medium was
coffee, mean plaque pH was reduced below pH 5.7 for both Splenda
Granular and Splenda Packet.
The human in situ plaque pH evidence for non-fermentability of
sucralose is supported by pre-clinical study evidence submitted with
the petition. The petitioner submitted reports from in vitro studies of
sucralose metabolism by oral bacteria. These data indicate that
sucralose does not support the growth of Streptococcus mutans nor of
other strains of acidogenic plaque bacteria, nor do the bacteria
produce acid from sucralose (Refs. 10 and 11). Studies with
experimental rat models for caries development indicate that sucralose
is noncariogenic in rats (Refs. 12 and 13). The preclinical data taken
in total support a conclusion that sucralose is not a substrate for
cariogenic bacteria and is not a contributor to caries development.
IV. Decision to Authorize a Health Claim Relating Sucralose to the
Nonpromotion of Dental Caries
FDA previously concluded that there is significant scientific
agreement among qualified experts to support the relationship between
certain noncariogenic carbohydrate sweeteners (e.g., some sugar
alcohols and D-tagatose) and the nonpromotion of dental caries. The
principal evidence, which substantiates this relationship, is in situ
human plaque pH data showing that the metabolism of sugar alcohols and
D-tagatose by oral bacteria is significantly less than the metabolism
of sucrose and other fermentable carbohydrates, and therefore does not
contribute to the loss of minerals from tooth enamel (Sec. 101.80(b)).
The current petition evaluated the cariogenic potential of sucralose
based on three studies which measured the acidogenic potential of
sucralose with in situ plaque pH tests. As discussed previously, these
plaque pH tests demonstrate that rinsing of the mouth with sucralose
did not result in decreases in plaque pH below pH 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), and are consistent with the evidence
relied upon by the agency when adding erythritol (62 FR 63653) and D-
tagatose (67 FR 71461) to this list. Therefore, based on the totality
of publicly available evidence pertaining to the cariogenicity of
sucralose and to the relationship between dental plaque pH and dental
caries, we conclude that there is significant scientific agreement that
sucralose does not promote dental caries. Accordingly, we are proposing
to amend Sec. 101.80 to authorize extending the dental caries health
claim to include sucralose.
Section 101.80(c)(2)(iii) contains requirements for the nature of
the food bearing the dental caries health claim. Section
101.80(c)(2)(iii)(A) states ``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.'' That is, one criterion of the health
claim is that the food be ``sugar free,'' i.e., the food contains less
than 0.5 grams of sugar per reference amount customarily consumed and
per labeled serving. The agency notes that ``Splenda Packet'' contains
in excess of 0.5 g of dextrose per serving and as such does not meet
the ``sugar free'' requirement of Sec. 101.80 and thus is ineligible
to bear the dental caries health claim. The petition does not request
amendments to the ``sugar-free'' requirement in Sec. 101.80(c)(2)(iii)
in order to accommodate use of the dental caries health claim by
Splenda Packet, nor has the agency considered amending this paragraph.
The predominant ingredient, by weight, of Splenda Granular is
maltodextrin, a fermentable carbohydrate. The data provided by the
petitioner indicates that rinsing with one serving of Splenda Granular
(sweetness equivalent to 2 teaspoons of sucrose) resulted in plaque
acidity between pH 5.6 and 6.2, depending on the beverage in which it
was suspended, as measured by the micro-touch plaque pH measurement
method. As mentioned in section III.B.1 of this document, plaque pH
values measured by the indwelling electrode pH measurement method are
consistently lower than are
[[Page 25500]]
the pH values obtained by the micro-touch method.
A provision of the Sec. 101.80 health claim regulation requires
that when carbohydrates other than those eligible for the claim are
present in a food bearing the dental caries health claim, bacterial
fermentation of the food must not lower plaque pH below 5.7, either
during consumption or up to 30 minutes after consumption, as measured
by an indwelling electrode pH method (see Sec. 101.80(c)(2)(iii)(C)).
The petitioner's micro-touch pH measurement method data do not satisfy
the pH evidence requirement of Sec. 101.80(c)(2)(iii)(C) for Splenda
Granular (i.e., plaque pH remains above pH 5.7 as measured by the
indwelling electrode method). Therefore, FDA concludes that the use of
the dental caries health claim on the label of Splenda Granular would
not be appropriate.
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). The noncariogenic carbohydrate
sweeteners now eligible for the health claim are listed within the
nature of the substance paragraph (Sec. 101.80(c)(2)(ii)). FDA is
proposing to amend Sec. 101.80(c)(2)(ii) to include sucralose as an
additional eligible noncariogenic carbohydrate sweetener.
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 only
illustrative. 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). Because the
agency is proposing to amend Sec. 101.80 to add sucralose as an
additional noncariogenic carbohydrate sweetener eligible for the health
claim, and is not approving specific claim wording, manufacturers will
be free to design their own claim so long as it is consistent with
agency regulations.
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 petition recommends amending Sec.
101.80(e) to include examples of both the full claim and the shortened
claim specific for sucralose. One of the requirements of the dental
caries health claim is that the claim statement specify the substance
as ``sugar alcohol,'' ``sugar alcohols,'' or by the name of the
substance, e.g., sorbitol or tagatose (Sec. 101.80(c)(2)(i)(C)). The
health claim regulation provides that packages with less that 15 square
inches of surface area available for labeling are exempt from the Sec.
101.80(c)(2)(i)(C) requirement of specifying the substance in the claim
statement (Sec. 101.80(c)(2)(i)(G)). As such, the shortened claim
provided for by Sec. 101.80(c)(2)(i)(G) need not specify the substance
and therefore FDA is not proposing to amend Sec. 101.80(e)(2) to add
examples of the shortened claim specific for sucralose. FDA notes that
the lack of a model shortened claim specifying ``sucralose'' in Sec.
101.80(e)(2) does not preclude a manufacturer from using, on packages
with less that 15 square inches of surface area available for labeling,
a shortened claim that mentions sucralose specifically, as was proposed
by the petition. We are proposing to amend Sec. 101.80(e)(1) to add
the model claim for sucralose proposed by the petition. The added
example of the full claim will state: ``Frequent eating of foods high
in sugars and starches as between-meal snacks can promote tooth decay.
Sucralose, the sweetening ingredient used to sweeten this food, unlike
sugars, does not promote tooth decay.'' (proposed Sec.
101.80(e)(1)(v)).
VII. Analysis of Impacts
A. Regulatory Impact Analysis
FDA has examined the economic implications of this proposed 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, adversely affecting a sector of the economy in a material way,
adversely affecting competition, or adversely affecting jobs. A
regulation is also considered a significant regulatory action if it
raises novel legal or policy issues. FDA has determined that this
proposed rule is not a significant regulatory action as defined by
Executive Order 12866.
FDA has identified three options regarding this petition: (1) Deny
the petition; (2) add sucralose to the dental caries health claim using
the standards previously applied for making that claim; or (3) add
sucralose to the dental caries health claim using different standards
from those standards previously applied for making that claim, so that
the claim could be applied to products such as Splenda Granular and
Splenda Packet. This rule will affect three sets of stakeholders:
Consumers, producers using sucralose, and producers not using
sucralose. The agency will evaluate each of the three options with
respect to their effect on each of these three sets of stakeholders.
Option one: FDA's denial of the petition would mean no change in
the dental caries health claim. This option generates no new costs and
benefits and is the point of comparison for all other options.
Producers using sucralose would not change labels to provide more
information on sucralose and dental caries. Producers not using
sucralose would not be affected by changes in the information given to
consumers about sucralose and dental caries or changes in the relative
prices of sweeteners or products using sweeteners. Consumers would
continue to experience dental caries unaffected by information on
sucralose and dental caries.
If we deny the petition, then the state of treatment of dental
caries would not be affected. 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 Survey, part
of the National Health and Nutrition Examination Survey (Ref. 14). The
cost of dental caries includes the costs of dental treatment as well as
the value of lost productivity and pain and suffering associated with
dental caries. There are several risk factors for developing dental
caries: Genetic factors, eating behaviors, and types and
characteristics of foods eaten (Ref. 15). Specifically, consumption of
dietary sugars and starches have been linked to development of dental
caries.
Option two: The option chosen by the agency under certain
conditions permits producers who use sucralose to place the dental
caries health claim in their labeling. If these producers decide to do
so they will have to pay to redesign and replace their labels. If they
voluntarily make this choice, then their choice reveals that they value
the ability to place the health claim on their products more highly
than they value the cost they must bear to make the labeling change.
Producers who use sucralose
[[Page 25501]]
are better off under option two than under option one because under
option two they have additional ways to market their products to
consumers.
This option under certain conditions permits producers who use
sucralose to give consumers more information about sucralose and dental
carries. Some consumers may find this information valuable to them
while choosing products. As stated previously, 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. Consumption of products containing sucralose, such as gum
and soft drinks, can potentially reduce the risk of dental caries. This
would lead to benefits in reduced expenditures and other health costs
related to dental caries. It is possible that the health claim could
draw some consumers to choose foods that are more expensive. If they
voluntarily make this choice, they reveal that they value the more
expensive products more highly than the they value the additional
expenditure. It is also possible that the prices of products containing
sucralose may rise and cause some consumers to seek other, less
expensive products with less protection against dental caries. If they
voluntarily make this choice, they reveal that they value the less
expensive products more highly than the increased probability of
bearing the consequences of dental caries. Regardless of their choices,
consumers are better off under option two than under option one because
they can have more information related to their health and can make the
choices that seem best to them.
If the agency under certain conditions permits producers who use
sucralose to place the dental caries health claim in their labeling,
products that do not contain sucralose may be affected. Some producers
may be hurt if consumers choose to stop consuming their products and
instead consume products containing sucralose. Some producers may be
helped if changes in the prices of products using sucralose make their
products look less expensive to consumers. Producers not using
sucralose will be affected differently depending on the type of product
that they produce, and it is impossible to tell beforehand how the
approval of this health claim will affect different producers.
Some producers not currently using sucralose may decide to
reformulate their products to contain sucralose. Substitution of
sucralose for sugars in some foods, such as gum and soft drinks can
potentially reduce the risk of dental caries. This reformulation would
lead to benefits to consumers in reduced costs associated with dental
caries. If some producers voluntarily choose to reformulate their
products, they reveal that they value the ability to place the health
claim on their products more highly than they value the cost of
reformulating their products. Whatever the effects of this option on
producers not using sucralose, they will be the results of the product
choices made by consumers who respond to the new information and make
the choices that seem best to them.
Option three: This option would relax some of the restrictions
imposed by the agency in option two so that the claim could be applied
to products such as Splenda Granular and Splenda Packet. Option three
would use different standards for approving this claim than previously
applied to other products.
Option three would give producers using sucralose more
opportunities to make the health claim than under option two. If, when
given this option, producers decide to make the claims, they would have
to pay to redesign and replace their labels, and they could decide to
change more labels than under option two. However, if they voluntarily
make this choice, they reveal that they value the ability to place the
health claim on their product more highly than they value the cost of
the label change regardless of how many labels they would change.
Therefore, producers who use sucralose are better off under option
three than under option two because they have additional opportunities
for marketing their products to consumers using the health claim.
Option three makes producers using sucralose better off while
making consumers worse off. As stated above, the intended use of
Splenda Granular is in the preparation of foods likely to lower plaque
pH below 5.7 when measured by the indwelling electrode method. It also
is designed to be used in the cooking and baking of many foods
containing starch. Since foods containing starch are associated with
increased plaque acidity and thus increased risk of dental caries,
consumers would not benefit from seeing the health claim on products
such as Splenda Granular. Also, as stated previously, Splenda Packet
contains dextrose, and therefore is not ``sugar free'' and may promote
tooth decay. Therefore, consumers would be made worse off under option
three than under option two. Having the health claim on these
additional types of products may mislead consumers and undo some of the
benefit (reduced dental caries) of allowing the claim on products
containing sucralose that meet the conditions set forth by the agency.
For producers not using sucralose, the effect of option three is
generally the same as for option two, though allowing the claim to
appear on more products would likely make for larger effects.
We can conclude that the option chosen by the agency (option two)
is better for society than option one because the impact on consumers
and on producers using sucralose is positive and the impact on
producers not using sucralose is indeterminate and depends only on
choices made by better informed consumers. We can also conclude that
the option chosen by the agency (option two) is better for society than
option three because under option three any advantage to producers
using sucralose comes at the disadvantage of consumers.
The petition also raises the issue of the effect the increased use
of sucralose could have on weight loss in the U.S. population. We have
not addressed that issue here because the products involved and the
amounts consumed are so small that a health claim relating sucralose to
reduced dental caries would not have an impact big enough to cause a
noticeable change in weight.
B. Regulatory Flexibility Analysis
FDA has examined the economic implications of this proposed 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 proposed 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 private benefits by more
than it increases private costs. Accordingly, we certify that this
proposed 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,
[[Page 25502]]
or by the private sector, of $100,000,000 or more (adjusted annually
for inflation) in any 1 year.'' FDA has determined that this proposed
rule does not constitute a significant regulatory action under the
Unfunded Mandates Reform Act.
VIII. Environmental Impact
FDA 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.
IX. Paperwork Reduction Act
FDA concludes that this proposed rule contains no collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). Therefore, clearance by the Office of Management and Budget
under the Paperwork Reduction Act of 1995 is not required.
X. Federalism
FDA has analyzed this proposed 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, FDA has concluded
that the proposed rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.
XI. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments in response to FDA's
proposed rule. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Identify comments 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. Proposed Effective Date
FDA proposes that any final regulation that may issue based on this
proposal become effective 30 days after its date of publication in the
Federal Register.
XIII. 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. McNeil Nutritionals, ``Petition to Amend 21 CFR 101.80 to
Authorize a Noncariogenicity Dental Health Claim for Sucralose,''
CP-1, Docket No. 2004P-0294, April 2, 2004.
2. U.S. Department of Health and Human Services, ``Oral
Health,'' chapter 21, Healthy People 2010, volume II, part B, 2d
ed., Washington, DC: U.S. Government Printing Office
(www.health.gov/healthypeople/Document/HTML/Volume2/21Oral.htm,
visited 03/17/2005), November 2000.
3. G.A. Miller, ``Sucralose,'' Alternative Sweeteners, 2d ed.
L.O. Nabors and R.C. Gelardi, eds. Marcel Dekker, Atlanta, pp. 173-
175, 1991.
4. P. Lingstr[ouml]m, T. Imfeld, and D. Birkhed, ``Comparison of
Three Different Methods for Measurement of Plaque-pH in Humans After
Consumption of Soft Bread and Potato Chips,'' Journal of Dental
Research, 72:865-870, 1993.
5. D.S. Harper, R. Gray, J.W. Lenke, et al., ``Measurement of
Human Plaque Acidity: Comparison of Interdental Touch and Indwelling
Electrodes,'' Caries Research, 19:536-546, 1985.
6. M.E. Jensen and C.F. Schachtele, ``Plaque pH Measurements by
Different Methods on the Buccal and Approximal Surfaces of Human
Teeth After Sucrose Rinse,'' Journal of Dental Research, 62:1058-
1061, 1983.
7. L.M. Steinberg, F. Odusola, J. Yip, et al., ``Effect of
Aqueous Solutions of Sucralose on Plaque pH,'' American Journal of
Dentistry, 8:209-211, 1995.
8. L.M. Steinberg, F. Odusola, J. Yip, et al., ``Effect of
Sucralose in Coffee on Plaque pH in Human Subjects,'' Caries
Research, 30:138-142, 1996.
9. C. Meyerowitz, E.P. Syrrakov, and R.F. Raubertas, ``Effect of
Sucralose--Alone or Bulked With Maltodextrin and/or Dextrose--on
Plaque pH in Humans,'' Caries Research, 30:439-444, 1996.
10. D.A. Young and W.H. Bowen, ``The Influence of Sucralose on
Bacterial Metabolism,'' Journal of Dental Research, 69:1480-1484,
1990.
11. D.B. Drucker and J. Verron, ``Comparative Effects of the
Substance Sweeteners Glucose, Sorbitol, Sucrose, Xylitol, and
Trichlorosucrose on Lowering of pH by Two Oral Streptococcus Mutans
Strains In Vitro,'' Archives of Oral Biology, 24:965-970, 1980.
12. W.H. Bowen, D.A. Young, and S.K. Pearson, ``The Effects of
Sucralose on Coronal and Root-Surface Caries,'' Journal of Dental
Research, 69:1485-1487, 1990.
13. W.H. Bowen, S.K. Pearson, and J.L. Falany, ``Influence of
Sweetening Agents in Solution on Dental Caries in Desalivated
Rats,'' Archives of Oral Biology, 35:839-844, 1990.
14. 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 03/17/2005),
March 11, 1996.
15. 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://www2.nidcr.nih.gov/sgr/execsumm.htm,
visited on 03/17/2005), 2000.
List of Subjects in 21 CFR Part 101
Food labeling, 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 proposed to be 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 adding (c)(2)(ii)(C) and (e)(1)(v)
to read as follows:
Sec. 101.80 Health claims: dietary noncariogenic carbohydrate
sweeteners and dental caries.
* * * * *
(c) * * *
(2) * * *
(ii) * * *
(C) Sucralose.
* * * * *
(e) * * *
(1) * * *
(v) Frequent eating of foods high in sugars and starches as
between-meal snacks can promote tooth decay. Sucralose, the sweetening
ingredient used to sweeten this food, unlike sugars, does not promote
tooth decay.
Dated: May 4, 2005..
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-9608 Filed 5-12-05; 8:45 am]
BILLING CODE 4160-01-S