Food Labeling; Health Claims; Dietary Noncariogenic Carbohydrate Sweeteners and Dental Caries, 52783-52789 [E7-18196]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 72, Number 179 (Monday, September 17, 2007)]
[Rules and Regulations]
[Pages 52783-52789]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-18196]


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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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: https://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:
     FAX: 301-827-6870.
     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 https://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 https://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  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: https://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: 
https://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: https://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: https://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