[Federal Register Volume 73, Number 102 (Tuesday, May 27, 2008)]
[Rules and Regulations]
[Pages 30299-30301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-11802]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2006-P-0404] (Formerly Docket No. 2006P-0487)


Food Labeling: Health Claims; Dietary Noncariogenic Carbohydrate 
Sweeteners and Dental Caries

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is adopting as a final 
rule, without change, the provisions of the interim final rule that 
amended the regulation authorizing a health claim on noncariogenic 
carbohydrate sweeteners and dental caries, i.e., tooth decay, to 
include isomaltulose as a substance eligible for the health claim. FDA 
is taking this action to complete the rulemaking initiated with the 
interim final rule.

DATES: This rule is effective May 27, 2008.

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

    In the Federal Register of September 17, 2007 (72 FR 52783), FDA 
published an interim final rule to amend the regulation in part 101 (21 
CFR part 101) that authorizes a health claim on the relationship 
between noncariogenic carbohydrate sweeteners and dental caries (Sec.  
101.80) to include the noncariogenic sugar isomaltulose. Under section 
403(r)(3)(B)(i) and section 403(r)(7) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 343(r)(3)(B)(i) and 343(r)(7)), FDA 
issued this interim final rule in response to a petition filed under 
section 403(r)(4) of the act. Section 403(r)(3)(B)(i) of the act states 
that the Secretary of Health and Human Services (and, by delegation, 
FDA) shall issue a

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regulation authorizing a health claim if he or she ``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 
Sec.  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. Section 
403(r)(7) of the act permits FDA to make a proposed regulation issued 
under section 403(r) effective upon publication pending consideration 
of public comment and publication of a final regulation if the agency 
determines that such action is necessary for public health reasons.
    On August 31, 2006, Cargill, Inc. (petitioner), submitted a health 
claim petition to FDA requesting that the agency amend the ``dietary 
noncariogenic carbohydrate sweeteners and dental caries'' claim at 
Sec.  101.80 to authorize a noncariogenic dental health claim for 
isomaltulose. FDA filed the petition for comprehensive review in 
accordance with section 403(r)(4) of the act on December 8, 2006. The 
petitioner requested that FDA grant an interim final rule by which 
foods containing isomaltulose could bear the health claim prior to 
publication of the final rule. FDA and the petitioner mutually agreed 
to extend the deadline for the agency's decision on the petition to 
September 5, 2007.
    As part of its review of the scientific literature on isomaltulose 
and dental caries, FDA considered the scientific evidence presented in 
the petition 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 interim final 
rule (72 FR 52783 at 52784 to 52786). Based on the available evidence, 
FDA concluded that isomaltulose, like other noncariogenic carbohydrate 
sweeteners listed in Sec.  101.80(c)(2)(ii), does not promote dental 
caries. Consequently, FDA amended Sec.  101.80(c)(2)(ii) to broaden the 
health claim to include isomaltulose as an additional substance 
eligible for the health claim.

II. Summary of Comments and the Agency's Response

    FDA solicited comments on the interim final rule. The comment 
period closed on December 3, 2007. The agency received four letters of 
response, three from consumers and one from a manufacturer. The 
manufacturer supported the interim rule. Two of the consumers' comments 
addressed issues that are outside the scope of this rulemaking and will 
not be addressed here. The remaining comment suggested that there had 
been insufficient testing to demonstrate the safety of isomaltulose, 
but did not provide any information or analysis to support revision of 
the agency's conclusion.
    Given the absence of contrary evidence on the agency's decisions 
announced in the interim final rule, FDA is adopting as a final rule, 
without change, the interim final rule that amended Sec.  101.80 to 
include isomaltulose as a substance eligible for the dental caries 
health claim.

III. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act of 1995 (Public Law 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 final rule is not a significant regulatory action under 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 final rule allows new voluntary 
behavior and imposes no additional restrictions on current practices, 
the agency certifies that the 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 $127,000,000, using the most current (2006) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any one-year expenditure that would meet or 
exceed this amount.
    FDA received no comments relevant to economic impact. The costs and 
benefits of available regulatory alternatives analyzed in the interim 
final rule (72 FR 52783 at 52787 to 52788) are adopted without change 
in this final rule. By now affirming that interim final rule, FDA has 
not imposed any new requirements. Therefore, there are no additional 
costs and benefits associated with this final rule.

IV. 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.

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 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'' (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)(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

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identical to the requirement of section 403(r) * * *
    On September 17, 2007, FDA published an interim final rule which 
imposed requirements under section 403(r) of the act. This final rule 
affirms the September 17, 2007, amendment to the 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 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. Riegel v. Medtronic, 128 S. Ct. 999 (2008).
    FDA believes that the preemptive effect of this 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.'' On 
August 1, 2007, 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). 
FDA received no comments from any States in response to this notice.
    In addition, the agency sought input from all stakeholders through 
publication of the interim final rule in the Federal Register on 
September 17, 2007 (72 FR 52783). FDA received no comments from any 
States on the interim final rule.
    In conclusion, the agency believes that it has complied with all of 
the applicable requirements of Executive Order 13132 and has determined 
that the preemptive effects of this rule are consistent with the 
Executive order.

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
Accordingly, the interim final rule amending Sec.  101.80 that was 
published in the Federal Register of September 17, 2007 (72 FR 52783), 
is adopted as a final rule without change.

    Dated: May 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-11802 Filed 5-23-08; 8:45 am]
BILLING CODE 4160-01-S