[Federal Register Volume 71, Number 60 (Wednesday, March 29, 2006)]
[Rules and Regulations]
[Pages 15559-15564]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-3007]


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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.

[[Page 15560]]


ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
decision to authorize the use of a health claim regarding the 
association between sucralose and the nonpromotion of dental caries. 
Based on its review of evidence described in the proposed rule and 
comments submitted on the proposed rule, the agency has concluded that 
sucralose does not promote dental caries. Therefore, the agency has 
decided to amend the regulation that authorizes a health claim 
regarding noncariogenic carbohydrate sweeteners to include sucralose.

DATES: This final rule is effective March 29, 2006.

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

    In the Federal Register of May 13, 2005 (70 FR 25496), the agency 
published a proposed rule to amend Sec.  101.80 (21 CFR 101.80), the 
regulation which authorizes a health claim regarding the relationship 
between noncariogenic carbohydrate sweeteners and dental caries, to 
include sucralose, a non-nutritive sweetener food ingredient. Under 
403(r)(3)(B)(i) of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 343(r)(3)(B)(i)), FDA issued this proposed rule in response 
to a petition filed under section 403(r)(4) of the act (21 U.S.C. 
343(r)(4)). Section 403(r)(3)(B)(i) of the act states that the 
Secretary of Health and Human Services (Secretary) (and, by delegation, 
FDA) shall issue a regulation authorizing a health claim only if the 
Secretary determines, based on the totality of publicly available 
scientific evidence (including evidence from well-designed studies 
conducted in a manner which is consistent with generally recognized 
scientific procedures and principles), that there is significant 
scientific agreement, among experts qualified by scientific training 
and experience to evaluate such claims, that the claim is supported by 
such evidence (see also 21 CFR 101.14(c)). Section 403(r)(4) of the act 
sets out the procedures that FDA is to follow upon receiving a health 
claim petition.
    On April 2, 2004, McNeil Nutritionals, of Brunswick, NJ (the 
petitioner) submitted a petition requesting that the agency amend Sec.  
101.80 to include the non-nutritive sweetener sucralose as one of the 
substances eligible to bear the dental caries health claim (Ref. 1). 
FDA filed the petition for comprehensive review in accordance with 
section 403(r)(4) of the act on July 9, 2004.
    FDA considered the scientific evidence presented in the petition as 
part of its review of the scientific literature on sucralose and dental 
caries, as well as information previously considered by the agency on 
the etiology of dental caries and the effects of slowly fermentable 
carbohydrates. The agency summarized this evidence in the proposed rule 
(70 FR 25496 at 25498 to 25499). Based on the available evidence, FDA 
concluded that dental caries is a disease for which the U.S. population 
is at risk; sucralose is a food because it contributes taste and other 
technical effects listed in 21 CFR 170.3(o) to food; the use of 
sucralose as a non-nutritive sweetener in food is safe and lawful; and 
there is significant scientific agreement among qualified experts that 
sucralose does not promote dental caries (70 FR 25496 at 25499). 
Consequently, FDA proposed amending Sec.  101.80 (the sucralose 
proposed rule) to broaden the health claim to include sucralose as an 
additional noncariogenic carbohydrate sweetener eligible for the health 
claim.

II. Summary of Comments and the Agency's Response

    The agency received four responses, each containing one or more 
comments, to the sucralose proposed rule. Two responses were from 
individual consumers, one from an industry trade organization, and the 
other from the petitioner. One consumer comment had no relevance to the 
proposed amendment, and the other consumer comment opposed a health 
claim for this non-nutritive sweetener but provided little specific 
information. The industry trade organization and the petitioner agreed 
with the proposed amendment without providing grounds for this support 
other than those grounds already provided by FDA in the preamble to the 
sucralose proposed rule. The petitioner also made several comments 
regarding FDA's evaluation of the evidence, which are discussed in 
detail in comments 1 to 4 of this section II.
    (Comment 1) The petitioner commented that it was inappropriate for 
FDA to refer to sucralose-based sugar substitute products by brand 
names in the preamble; specifically in regards to statements about 
specific SPLENDA sugar substitute products not meeting the eligibility 
criteria of Sec.  101.80(c)(2)(iii). The petitioner noted that the 
SPLENDA brand name did not appear in the petition and thus FDA's 
conclusions should have referred to the eligibility of sucralose-based 
sugar substitute formulations generically. The petitioner further noted 
that SPLENDA brand name product formulations can be changed and may in 
the future meet Sec.  101.80(c)(2)(iii) eligibility criteria.
    (Response) The petition cites dental plaque pH studies conducted 
with sucralose-based formulations representative of commercially 
marketed SPLENDA sugar substitute products. FDA discussed these 
products in the preamble to clarify that although the petition included 
plaque pH data representative of these products, FDA was concluding 
that the available evidence did not support the eligibility of these 
sucralose-based formulations for the health claim. FDA referred to 
these formulations by their specific product names (i.e., SPLENDA 
Granular, and SPLENDA Packet) for the sake of convenience. The 
amendment to Sec.  101.80 provides for the use of the dental caries 
health claim in food labeling of sucralose-containing products in 
general and does not prohibit the use of the health claim in labeling 
of any SPLENDA brand name product that meets Sec.  101.80(c)(2)(iii) 
eligibility criteria.
    (Comment 2) The petitioner commented that FDA incorrectly concluded 
that the use of the dental caries health claim in the labeling of 
SPLENDA Granular would not be appropriate. The petitioner asserted that 
the petition contains insufficient information to warrant this 
conclusion. FDA had concluded that evidence contained in the petition 
does not demonstrate that SPLENDA Granular would prevent plaque pH from 
falling below 5.7 when measured, as specified in Sec.  
101.80(c)(2)(iii)(C), by the indwelling electrode method (70 FR 24596 
at 25500). The petition included data on the impact of SPLENDA Granular 
on plaque pH as measured by the micro-touch method, a measurement 
method different from the indwelling electrode method specified in 
Sec.  101.80(c)(2)(iii)(C). The petitioner also asserted in this 
comment that the tests conducted involved the equivalent of two 
servings of SPLENDA Granular, rather than one, and that this was not 
taken into consideration by the FDA.
    (Response) FDA agrees that a more appropriate conclusion would have 
been that the submitted evidence is insufficient to establish the 
eligibility of the sucralose-maltodextrin formulation for the claim, 
rather than concluding that the available evidence shows the use of the 
dental caries health claim in

[[Page 15561]]

labeling of SPLENDA Granular would not be appropriate. However, this 
discussion does not bear on the amendment to Sec.  101.80 in the final 
rule because the amendment addresses sucralose, not specific SPLENDA 
brand products.
    (Comment 3) The petitioner objected to FDA specifically identifying 
SPLENDA Packet as not eligible for use of the dental caries claim 
because the product does not meet the definition for ``sugar free.'' 
The petitioner noted that SPLENDA Packet could in the future be 
reformulated using nonfermentable bulking agents in order to be ``sugar 
free,'' or to lower the level of dextrose in each packet in order to 
meet the ``sugar free'' criterion. Furthermore, the petitioner asserted 
that the plaque pH performance criterion is a more important test than 
is the ``sugar free'' standard in the health claim requirements, adding 
that if plaque pH is not lowered below 5.7 by the indwelling pH method, 
then it should not matter how much sugar the product contains on a per 
serving basis.
    (Response) The preamble of the proposed rule explicitly stated that 
this specific sucralose formulation, for which the petitioner submitted 
plaque pH data, was not being included in our consideration and stated 
the reason for our decision. FDA believes that we correctly decided to 
exclude the sucralose formulation in question, but we agree that our 
comment applies only to that formulation, which was tested in the 
submitted studies, and not to the SPLENDA Packet brand name. In any 
case, the petition did not request any amendment to the regulation with 
respect to the ``sugar free'' requirement. Furthermore, FDA does not 
rank the importance of the various eligibility criteria in assessing 
whether the food in question can make the claim, as each of the 
requirements listed in Sec.  101.80(c), including the ``sugar free'' 
standard, must be met for the claim to be made.
    (Comment 4) The petitioner commented that the evidence submitted in 
the petition demonstrates that sucralose is not fermented at all, and 
therefore FDA's conclusion that sucralose is ``minimally fermented'' 
and ``not fermented by oral bacteria to an extent sufficient to lower 
dental plaque pH * * *'' is inconsistent with the available evidence.
    (Response) FDA considers it a difficult task to demonstrate 
conclusively that sucralose would not be fermented to any extent by any 
species of oral bacteria. FDA's decision to add sucralose to the dental 
caries health claim does not turn on a distinction between ``minimally 
fermented'' or ``not fermented.'' The amount of sucralose, an intense 
sweetener, used per serving is in milligram amounts. Even if sucralose 
were fermented by oral bacteria, considering the amount of sucralose 
involved, the complete and rapid fermentation of the amount of 
sucralose contained in one serving would likely not contribute 
significantly to a change in plaque pH. Thus, whether sucralose is 
``minimally fermented'' or ``not fermented'' does not affect our 
decision to authorize this amendment to the dental caries health claim.
    Given the information discussed in the preamble to the proposed 
rule and the absence of contrary information in the comments, FDA is 
adopting as a final rule, without change, the proposed amendment of 
Sec.  101.80 to include sucralose as a substance eligible for the 
dental caries health claim.

III. Environmental Impact

    The agency has previously considered the environmental effects of 
this rule as announced in the proposed rule. No new information or 
comments have been received that would affect the agency's previous 
determination that there is no significant impact on the human 
environment and that an environmental impact statement is not required.

IV. Analysis of Impacts

A. Regulatory Impact Analysis

    FDA has examined the economic implications of this final rule as 
required by Executive Order 12866. Executive Order 12866 directs 
agencies to assess all costs and benefits of available regulatory 
alternatives and, when regulation is necessary, to select regulatory 
approaches that maximize net benefits (including potential economic, 
environmental, public health and safety, and other advantages; 
distributive impacts; and equity). Executive Order 12866 classifies a 
rule as significant if it meets any one of a number of specified 
conditions, including the following: 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. We have determined that this 
final rule is not a significant regulatory action as defined by 
Executive Order 12866.
    FDA identified the following 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 final rule will affect the following 
three sets of stakeholders: Consumers, producers using sucralose, and 
producers not using sucralose. We 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. 2). 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. The following are several risk factors for developing 
dental caries: Genetic factors, eating behaviors, types and 
characteristics of foods eaten, and dental hygiene (Ref. 3). 
Specifically, consumption of dietary sugars and starches have been 
linked to development of dental caries.
    Option two (final rule): The option chosen by the agency permits 
producers who use sucralose to place the dental caries health claim in 
their labeling under certain conditions. If these producers decide to 
do so they will have to pay to redesign and replace their labels. If 
they 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

[[Page 15562]]

labeling change. Producers who use sucralose 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 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 make this 
choice, they reveal that they value the more expensive products more 
highly than 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 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 now 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 reduce the risk 
of dental caries. This reformulation would lead to benefits to 
consumers in reduced costs associated with dental caries. If some 
producers 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 result 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 previously, 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. Because 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 final rule 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 final rule 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

    We have examined the economic implications of this final rule as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a 
rule has a significant impact on a substantial number of small 
entities, the Regulatory Flexibility Act requires the agency to analyze 
regulatory options that would minimize the economic impact of the rule 
on small entities.
    As previously explained, this final rule will not generate any 
compliance costs for any small entities, because it does not require 
small entities to undertake any new activity. No small business will 
choose to use the dental caries health claim authorized by this rule 
unless it believes that doing so will increase private benefits by more 
than it increases private costs. Accordingly, we certify that this 
final rule will not have a significant impact on a substantial number 
of small entities. Under the Regulatory Flexibility Act, no further 
analysis is required.

C. Unfunded Mandates

    Title II of the Unfunded Mandates Reform Act of 1995 (Public Law 
104-4) requires that agencies prepare a written statement of 
anticipated costs and benefits before issuing any final rule that may 
result in the expenditure by State, local, and tribal governments, in 
the aggregate, or by the private sector, of

[[Page 15563]]

$115,000,000 or more (adjusted annually for inflation) in any 1 year. 
The Unfunded Mandates Reform Act does not require FDA to prepare a 
statement of costs and benefits for this rule, because the rule is not 
expected to result in any 1 year expenditure that would exceed 
$115,000,000.

V. Paperwork Reduction Act

    FDA concludes that the labeling provisions of this 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 sucralose and the 
nonpromotion of dental caries is a ``public disclosure of information 
originally supplied by the Federal Government to the recipient for the 
purpose of disclosure to the public.'' (5 CFR 1320.3(c)(2)).

VI. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
will have 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) of the act (21 U.S.C. 
343-1(a)) provides that:
    (a)* * * 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). * * *
    Currently, this provision operates to preempt States from imposing 
health claim labeling requirements concerning sucralose and reduced 
risk of dental caries because no such requirement had been imposed by 
FDA under section 403(r) of the act. This final rule amends existing 
food labeling regulations to add sucralose as an eligible noncariogenic 
carbohydrate sweetener to the dietary noncariogenic carbohydrate 
sweeteners and dental caries health claim. Although this rule would 
have a preemptive effect, in that it would preclude States from issuing 
any health claim labeling requirements for sucralose and reduced risk 
of dental caries that are not identical to those required by this 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 the final rule would be 
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 when it sought input from all stakeholders through 
publication of the proposed rule in the Federal Register on May 13, 
2005 (70 FR 25496). FDA received no comments from any states on the 
proposed rulemaking.
    In addition, on December 23, 2005, FDA's Division of Federal and 
State Relations provided notice by fax and email transmission to State 
health commissioners, State agriculture commissioners, food program 
directors, and drug program directors as well as FDA field personnel of 
FDA's intended amendment to add sucralose as a sweetener to the 
noncariogenic carbohydrate sweeteners and dental caries health claim 
(21 CFR 101.80). The notice provided the States with further 
opportunity for input on the rule. It advised the States of the 
publication of the proposed rule and encouraged State and local 
governments to review the notice and to provide any comments to the 
docket (docket number 2004P-0294), opened in the May 13, 2005, Federal 
Register notice, by a date 30 days from the date of the notice (i.e., 
by January 23, 2006), or to contact certain named individuals. FDA 
received no comments in response to this notice. The notice has been 
filed in the above numbered docket.
    In conclusion, the agency believes that it has complied with all of 
the applicable requirements under the Executive Order and has 
determined that the preemptive effects of this rule are consistent with 
Executive Order 13132.

VII. References

    The following references have been placed on display in the 
Division of Dockets Management, (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and 
may be seen by interested persons between 9 a.m. and 4 p.m., Monday 
through Friday.
    1. McNeil Nutritionals, ``Petition to Amend the Regulation for 
21 CFR Sec. 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, National 
Institute of Dental and Craniofacial Research, ``Results of National 
Oral Health Survey Released'' (press release), Rockville MD, http://www.hhs.gov/news/press/1996pres/960311.html, March 11, 1996.
    3. U.S. Department of Health and Human Services, National 
Institute of Dental and Craniofacial Research, ``Oral Health in 
America: A Report of the Surgeon General,'' executive summary 
(monograph on the Internet), Rockville MD, http://www.nidcr.nih.gov/AboutNIDCR/SurgeonGeneral/ExecutiveSummary.htm, May 2000.

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 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

[[Page 15564]]

used to sweeten this food, unlike sugars, does not promote tooth decay.
* * * * *

    Dated: March 21, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-3007 Filed 3-28-06; 8:45 am]
BILLING CODE 4160-01-S