[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