[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