[Federal Register Volume 62, Number 231 (Tuesday, December 2, 1997)]
[Rules and Regulations]
[Pages 63653-63655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31587]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 97P-0206]
Food Labeling: Health Claims; Dietary Sugar Alcohols and Dental
Caries
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is announcing its
decision to amend the regulation that authorizes a health claim on
sugar alcohols and dental caries to include the sugar alcohol
erythritol among the substances that may be the subject of the claim.
Based on its review of evidence submitted with a comment on the
proposal, and the evidence described in the proposal, the agency has
concluded that there is significant scientific agreement that
erythritol does not promote dental caries. Therefore, FDA has decided
to amend the sugar alcohol and dental caries health claim to include
erythritol. FDA is announcing this action in response to a petition
filed by the Cerestar Holding B.V., Mitsubishi Chemical Corp., and
Nikken Chemicals Co. (the petitioners).
EFFECTIVE DATE: December 2, 1997.
FOR FURTHER INFORMATION CONTACT: Joyce J. Saltsman, Center for Food
Safety and Applied Nutrition (HFS-165), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5483.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 9, 1997 (62 FR 36749), the agency
proposed to amend the regulation that authorizes a health claim on
sugar alcohols and dental caries (Sec. 101.80 (21 CFR 101.80)) to
include the sugar alcohol erythritol among the substances that may be
the subject of the claim. FDA issued the proposed rule in response to a
petition filed under section 403(r)(3)(B)(i) and (r)(4) of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343(r)(3)(B)(i) and
(r)(4))). Section 403(r)(3)(B)(i) of the act states that the Secretary
of Health and Human Services (and, by delegation, FDA) shall issue
regulations authorizing health claims only if he or she determines,
based on the totality of publicly available scientific evidence
(including evidence
[[Page 63654]]
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) (21 CFR
101.14(c))). Section 403(r)(4) of the act sets out the procedures that
FDA is to follow in health claim rulemakings.
Section 101.80(c)(2)(ii) sets out the circumstances in which a
sugar alcohol is eligible to be the subject of a health claim. Section
101.80(c)(2)(ii)(A) states that the food must meet the requirement for
a sugar free food set out in 21 CFR 101.60(c)(1)(i). Section
101.80(c)(2)(ii)(B) lists the sugar alcohols that are eligible to bear
the claim, xylitol, sorbitol, mannitol, maltitol, isomalt, lactitol,
hydrogenated starch hydrolysates, hydrogenated glucose syrups, or a
combination of these. Section 101.80(c)(2)(ii)(C) states that:
When fermentable carbohydrates are present in the sugar alcohol-
containing food, the food shall not lower plaque pH below 5.7 by
bacterial fermentation either during consumption or up to 30 minutes
after consumption as measured by the indwelling plaque pH test found
in ``Identification of Low Caries Risk Dietary Components,'' * * *
which is incorporated by reference * * * .
At the time that it adopted Sec. 101.80, the agency stated that for
other sugar alcohols to be included in Sec. 101.80(c)(2)(ii)(B), a
petitioner must show how the substance conforms to the requirements of
Secs. 101.14(b) and 101.80 (61 FR 43433 at 43442, August 23, 1996). FDA
stated ``For those substances that are to be consumed at other than
decreased dietary levels, the petitioner must demonstrate to FDA's
satisfaction that the substance is safe and lawful under the applicable
food safety provisions of the act (Sec. 101.14(b)(3)(ii)).'' Likewise,
the petitioner would need to provide evidence that the sugar alcohol
will not lower plaque pH below 5.7. Therefore, before a claim can be
made for a new sugar alcohol, it must be shown to meet the requirements
for Sec. 101.80. When this is demonstrated, FDA will take action to add
the substance to the list in this regulation, which has been renumbered
as Sec. 101.80(c)(2)(ii)(B) (61 FR 43433 at 43442).
FDA considered the relevant scientific studies and data presented
in the petition as part of its review of the scientific literature on
erythritol and dental caries. The agency summarized this evidence in
the proposed rule (62 FR 36749).
Based on the available evidence, FDA tentatively concluded that the
use of erythritol in food is safe and lawful, and that this substance
meets the plaque pH and other requirements of Sec. 101.80.
Consequently, FDA proposed to amend Sec. 101.80(c)(2)(ii)(B) to include
erythritol as one of the sugar alcohols that is eligible to bear the
sugar alcohol and dental caries health claim. FDA did not propose to
make any other changes to Sec. 101.80.
In response to the proposal, the agency received one comment from a
manufacturer. The comment supported the proposed amendment to
Sec. 101.80 to include erythritol.
Given the absence of any evidence to the contrary, FDA is
confirming the tentative conclusions that it reached in the proposal.
Based on these conclusions, FDA is amending Sec. 101.80 to add
erythritol to the substances listed in Sec. 101.80(c)(2)(ii)(B) that
may be the subject of the claim.
II. Environmental Impact
The agency has previously considered the environmental effects of
this rule as announced in the proposed rule (62 FR 36749). The proposed
rule incorrectly cited a claim of categorical exclusion under previous
21 CFR 25.24(a)(11). The agency reviewed the information submitted by
the petitioner in an environmental assessment prepared under 21 CFR
25.31a(b)(5). Based on this information, the agency determined that
there is no significant impact on the human environment and that an
environmental impact statement is not required. No new information or
comments have been received that would affect the agency's previous
determination. The agency's finding of no significant impact and the
evidence supporting that finding, contained in an environmental
assessment, may be seen in the Dockets Management Branch (address
above) between 9 a.m. and 4 p.m., Monday through Friday.
III. Executive Order 12866 Analysis
FDA has examined the impacts of the final rule under 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 the regulatory approach that maximizes net
benefits (including potential economic, environmental, public health
and safety effects; distributive impacts; and equity). Executive Order
12866 classifies a rule as significant if it meets any one of a number
of specified conditions, including having an annual effect on the
economy of $100 million or adversely affecting in a material way a
sector of the economy, competition, or jobs, or if it raises novel
legal or policy issues. FDA finds that this rule is not a significant
rule as defined by Executive Order 12866.
The authorization of health claims about the relationship between
erythritol and dental caries results in either costs or benefits only
to the extent that food manufacturers elect to take advantage of the
opportunity to use the claim. This rule will not require that any
labels be redesigned, or that any product be reformulated.
This final health claim will allow manufacturers to highlight the
benefits of the sugar alcohol erythritol in addition to other sugar
alcohols for which FDA has already approved a health claim. The benefit
of establishing this health claim is to provide for new information in
the market regarding the relationship of erythritol and dental caries
and to provide consumers with the assurance that this information is
truthful, not misleading, and scientifically valid.
IV. Small Entity Analysis
FDA has examined the impacts of the final rule under 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 agencies to analyze regulatory options that would minimize
the economic impact of that rule on small entities.
Small entities will incur costs only if they opt to take advantage
of the marketing opportunity presented by this regulation. FDA cannot
predict the number of small entities that will choose to use the claim.
However, no firm, including small entities, will choose to bear the
cost of redesigning labels unless they believe that the claim will
result in increased sales of their product. Therefore, this rule will
not result in either a decrease in revenues or a significant increase
in costs to any small entity. Accordingly, under the Regulatory
Flexibility Act (5 U.S.C. 605(b)), the agency certifies that this final
rule will not have a significant economic impact on a substantial
number of small entities.
V. Paperwork Reduction Act
This final rule contains no information collection or recordkeeping
requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.)
VI. References
The following reference has been placed on display in the Dockets
Management Branch (address above)
[[Page 63655]]
and may be seen by interested persons between 9 a.m. and 4 p.m., Monday
through Friday.
1. Cerestar Holding B. V., Mitsubishi Chemical Corp., and Nikken
Chemicals Co., ``Petition to amend the regulation for 21 CFR 101.80
to authorize a noncariogenicity dental health claim for the sugar
alcohol erythritol (1,2,3,4-butanetetrol),'' April 4, 1997, [CP1].
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
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
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.
2. Section 101.80 is amended by revising paragraph (c)(2)(ii)(B) to
read as follows:
Sec. 101.80 Health claims: dietary sugar alcohols and dental caries.
* * * * *
(c) * * *
(2) * * *
(ii) * * *
(B) The sugar alcohol in the food shall be xylitol, sorbitol,
mannitol, maltitol, isomalt, lactitol, hydrogenated starch
hydrolysates, hydrogenated glucose syrups, erythritol, or a combination
of these.
* * * * *
Dated: November 21, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-31587 Filed 12-1-97; 8:45 am]
BILLING CODE 4160-01-F
