[Federal Register Volume 68, Number 128 (Thursday, July 3, 2003)]
[Rules and Regulations]
[Pages 39831-39833]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-16949]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 02P-0177]
Food Labeling: Health Claims; D-tagatose 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 sugar alcohols and
dental caries, i.e., tooth decay, to include the sugar D-tagatose as a
substance eligible for the dental caries health claim. FDA is taking
this action to complete the rulemaking initiated with the interim final
rule.
DATES: This rule is effective July 3, 2003.
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 December 2, 2002 (67 FR 71461), the
agency 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 sugar alcohols and dental caries (Sec. 101.80) to
include the sugar D-tagatose, a novel food ingredient. Under section
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 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 regulation
authorizing a health claim only 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.
On January 9, 2002, Arla Foods Ingredients amba, DK-8260 Viby,
Denmark (the petitioner) filed a petition requesting that the agency:
(1) Amend Sec. 101.80 to include the sugar D-tagatose as one of the
substances eligible to bear the dental caries health claim; (2) amend
Sec. 101.9, the nutrition labeling regulation, to exclude D-tagatose
from the definition of ``sugars'' (Sec. 101.9(c)(6)(ii)), thereby
allowing a ``sugar free'' nutrient content claim; and (3) modify the
text of Sec. 101.80 because D-tagatose is not a sugar alcohol (Ref.
1). FDA filed the petition for comprehensive review in accordance with
section 403(r)(4) of the act on April 19, 2002.
FDA considered the scientific evidence presented in the petition as
part of its review of the scientific literature on D-tagatose 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
interim final rule (67 FR 71461 at 71463). Based on the available
evidence, FDA concluded that dental caries is a disease for which the
U.S. population is at risk; D-tagatose is a food, because it
contributes taste and other technical effects listed in 21 CFR 170.3(o)
to food; the use of D-tagatose in food is safe and lawful; and there is
significant scientific agreement among qualified experts that D-
tagatose does not promote dental caries (67 FR 71461 at 71462 through
71464). Consequently, FDA published an interim final rule amending
Sec. 101.80 to authorize a dental caries health claim for D-tagatose.
As discussed in the interim final rule, the agency believes that it
would be false and misleading for D-tagatose containing foods to bear a
``sugar free'' claim because D-tagatose is a sugar (67 FR 71461 at
71466). Consequently, rather than exempting D-tagatose from the
definition of ``sugars'' as requested by the petitioner, the agency
instead exempted D-tagatose from the ``sugar free'' requirement of
Sec. 101.80. To address the incongruity of a sugar-containing food
bearing the dental caries health claim and to inform consumers about
the uniqueness of D-tagatose as a noncariogenic sugar, we added the
requirement that the claim identify D-tagatose as a sugar that, unlike
other sugars, does not promote the development of dental caries.
Accordingly, although products containing D-tagatose are not permitted
to be labeled as ``sugar-free,'' they are authorized to state that D-
tagatose sugar does not promote, or may reduce the risk of, tooth
decay.
II. Summary of Comments and the Agency's Response
The agency received one comment in support of the petition from a
manufacturer prior to publication of the interim final rule. Comments
from seven consumers were sent to this docket during the comment
period, none of which were relevant to this rulemaking.
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 D-tagatose as a substance eligible for the dental caries health
claim.
III. 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.
IV. Analysis of Impacts
A. Regulatory Impact Analysis
We have examined the economic implications of this final rule as
required by Executive Order 12866, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates
[[Page 39832]]
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).
With this final rule, FDA is adopting without change the provisions
of the interim final rule published in the Federal Register of December
2, 2002. The interim final rule amended the regulation authorizing a
health claim on the relationship between sugar alcohols and dental
caries to include the sugar D-tagatose as a substance eligible for the
health claim. We assessed the costs and benefits of the interim final
rule in that Federal Register document (67 FR 71461 at 71468 and
71469). By now reaffirming that interim final rule, FDA has not imposed
any new requirements. There are, therefore, no additional costs and
benefits associated with this final rule.
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.
Because this final rule does not impose any new costs on firms, we
certify that this final rule will not have a significant impact on a
substantial number of small entities. Therefore, under the Regulatory
Flexibility Act, no further analysis is required.
C. Unfunded Mandates
Section 202(a) 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 an expenditure by State, local, and tribal governments, in
the aggregate, or by the private sector, of $100,000,000 in any one
year (adjusted annually for inflation). 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 $100 million adjusted for inflation. The
current inflation-adjusted statutory threshold is $113 million.
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 D-tagatose 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
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, 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. That section 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'' certain food labeling requirements, unless an exemption is
provided by the Secretary of Health and Human Services (and by
delegation, FDA). Relevant to this final rule, one such requirement
that States and political subdivisions may not adopt is ``any
requirement respecting any claim of the type described in section
403(r)(1) of the act made in the label or labeling of food that is not
identical to the requirement of section 403(r) * * *'' (section
403A(a)(5) of the act (21 U.S.C. 343-1(a)(5)). Prior to the effective
date of this final rule and the interim rule that preceded it, this
provision operated to preempt States from imposing health claim
labeling requirements concerning D-tagatose and reduced risk of dental
caries because no such requirement had been imposed by FDA under
section 403(r) of the act. Under this final rule and the interim rule
that preceded it, States are preempted from imposing any health claim
labeling requirements for D-tagatose and reduced risk of dental cares
that are not identical to those required by this rule. 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). Although this rule has preemptive effect in that
it would preclude States from issuing regulations or adopting or
enforcing any requirements, including state tort-law imposed
requirements, for health claims about D-tagatose and reduced risk of
dental caries that are not identical to the requirements of the interim
final rule as adopted by this final rule, this preemptive effect is
consistent with what Congress set forth in section 403A of the act.
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.'' Similarly, section 6(c) of the Executive order states
that ``to the extent practicable and permitted by law, no agency shall
promulgate any regulation that has federalism implications and that
preempts state law, unless the agency, prior to the formal promulgation
of the regulation * * * consulted with State and local officials early
in the process of developing the proposed regulation.'' This
requirement, that FDA provide the States with an opportunity for
appropriate participation in this rulemaking, has been met. FDA sought
input from all stakeholders through publication of the interim final
rule in the Federal Register. No comments from State or local
government entities were received.
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 reference has 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.
[[Page 39833]]
1. Arla Foods Ingredients amba, ``Petition to Amend the
Regulation for 21 CFR Sec. 101.80 to Authorize a Noncariogenicity
Dental Health Claim for D-tagatose,'' CP-1, Docket No. 02P-0177,
January 9, 2002.
0
Accordingly, the interim final rule amending 21 CFR 101.80 that was
published in the Federal Register of December 2, 2002 (67 FR 71461), is
adopted as a final rule without change.
Dated: June 30, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-16949 Filed 7-1-03; 10:06 am]
BILLING CODE 4160-01-S