[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