[Federal Register Volume 61, Number 195 (Monday, October 7, 1996)]
[Rules and Regulations]
[Pages 52285-52287]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25599]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 355

[Docket No. 80N-0042]
RIN 0910-AA01


Anticaries Drug Products for Over-the-Counter Human Use; Final 
Monograph; Technical Amendment; Partial Delay of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment; partial delay of effective 
date.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
regulation that established conditions under which over-the-counter 
(OTC) anticaries drug products (products that aid in the prevention of 
dental cavities) are generally recognized as safe and effective and not 
misbranded (60 FR 52478, October 6, 1995). This final rule makes a 
nonsubstantive change in the definition of a dentifrice, clarifies how 
OTC dentifrice gels are included in certain labeling aspects of the 
final monograph, and clarifies that the second general warning 
regarding ``accidental ingestion'' is the statement to be used for OTC 
fluoride-containing dentifrice, treatment rinse, and preventive 
treatment gel drug products. This amendment also revises the second 
general warning statement to indicate to consumers that ``accidental 
ingestion'' of these products means swallowing more than is used during 
normal brushing or rinsing. Because of the need to revise labeling for 
this minor revision, the agency is delaying the effective date of the 
regulation to provide manufacturers with an additional 6 months to 
comply with the labeling requirements of the monograph. This final rule 
is part of the ongoing review of OTC drug products conducted by FDA.

DATES: The effective date for Sec. 355.50 added at 60 FR 52508, October 
6, 1995, is delayed until April 7, 1997. This final rule is effective 
April 7, 1997.

FOR FURTHER INFORMATION CONTACT: William E. Gilbertson, Center for Drug 
Evaluation and Research (HFD-105), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2304.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 6, 1995 (60 FR 52478), FDA 
issued a final monograph for OTC anticaries drug products (21 CFR part 
355) establishing conditions under which the drug products that are 
subject to that monograph will be generally recognized as safe and 
effective and not misbranded. The effective date of the monograph is 
October 7, 1996.
    On April 17, 1996, the Joint Oral Care Task Group of the 
Nonprescription Drug Manufacturers Association (NDMA) and the Cosmetic, 
Toiletry and Fragrance Association (CTFA) (the Task Group) submitted 
three citizen petitions (Refs. 1, 2, and 3) to amend the final 
monograph for OTC anticaries drug products. The first petition 
requested a technical amendment to the final monograph to clarify the 
use of the term ``gel'' in the context of dentifrice gels and 
preventive treatment gels in Sec. 355.50(c) and (d). The petition 
indicated that this technical amendment would be helpful in avoiding 
unnecessary discussion and/or confusion about how OTC dentifrice gels 
are included in certain labeling aspects of the final monograph.
    The two other petitions requested an exemption from the 
requirements of the general warnings under Sec. 330.1(g) (21 CFR 
330.1(g)) for OTC fluoride-containing dentifrice, treatment rinse, and 
preventive treatment gel drug products based on these products' long 
history of safe use, the package size limitations to limit potential 
toxicity, and the potential for consumer confusion and alarm that the 
general warnings would cause.
    The Task Group added that the second general warning for these drug 
products is confusing with regard to the terms ``accidental overdose'' 
and ``accidental ingestion.'' Because these products are not intended 
for oral administration in the context of an orally administered 
medicine and because no dosage amounts are specified in the labeling, 
there is no ``overdose'' per se. The Task Group contended that 
consumers may mistakenly consider any accidental ingestion (even the 
swallowing of some product during normal usage) as dangerous and thus 
needlessly call health professionals in poison control centers, 
emergency rooms, and doctors' offices for assistance.

II. The Agency's Response to the Petitions

    Based on these petitions, the agency has determined that in order 
to avoid possible confusion about how OTC dentifrice gels and powders 
are included in certain labeling aspects of the final monograph for OTC 
anticaries drug products, the definition of ``Dentifrice'' in 
Sec. 355.3(e) should be revised to read: ``An abrasive-containing 
dosage form (gel, paste, or powder) for delivering an anticaries drug 
to the teeth.''
    To clarify how OTC dentifrice gels are included in the labeling 
aspects in Sec. 355.10(a)(1), (b)(1), (b)(2), and (c)(1) and 
Sec. 355.50(d)(1)(i) and (d)(1)(ii) of the final monograph, this 
technical amendment revises the heading in each of these sections by 
adding the words ``gel or'' before the word ``paste.'' To better 
clarify how OTC dentifrice gels and preventive treatment gels are 
included in the labeling aspects in Sec. 355.50(c)(1) and (c)(2), 
respectively, this technical amendment includes the following 
revisions: (1) The heading in Sec. 355.50(c)(1) is revised to read: 
``For all fluoride dentifrice (gel, paste, and powder) products,'' and 
(2) the heading in Sec. 355.50(c)(2) is revised to read: ``For all 
fluoride rinse and preventive treatment gel products.'' 
    With regard to the second general warning in Sec. 330.1(g), the 
agency points out that the correct second general warning to be used 
for fluoride-containing gel, paste, powder, treatment rinse, and 
preventive treatment gel drug products included in the final monograph 
is the statement for accidental ingestion and not for accidental 
overdose. That statement reads: ``In case of accidental ingestion, seek 
professional assistance or contact a Poison Control Center 
immediately.'' The agency considers this information important to 
provide consumers guidance if an accidental ingestion occurs, 
particularly if a young child accidentally swallows or ingests an

[[Page 52286]]

excessive amount of an OTC anticaries drug product.
    However, the agency recognizes that this statement may be confusing 
to consumers who might think that any accidental ingestion of an OTC 
anticaries drug product during normal use may be dangerous. Therefore, 
to clarify to consumers that ``accidental ingestion'' does not refer to 
the amount of product swallowed during normal use, but refers to 
excessive ingestion of the drug product, this technical amendment 
revises the second general warning in Sec. 355.50(c)(1) and (c)(2) of 
the final monograph to read as follows: ``If you accidentally swallow 
more than used for'' (select appropriate word: ``brushing'' or 
``rinsing''), ``seek professional assistance or contact a Poison 
Control Center immediately.'' The agency considers these labeling 
revisions as minor clarifying changes that do not change the substance 
of the labeling requirements contained in the final rule.
    In a communication with the petitioner (Ref. 4), the agency 
indicated that it had not decided on the exact revised wording of the 
second general warning and asked the petitioner to make a suggestion. 
The petitioner subsequently suggested (Ref. 5) the following language: 
``If an amount larger than used for [brushing] is swallowed, call a 
Poison Control Center or doctor right away.'' The agency considered the 
first part of the petitioner's suggestion in developing the language 
that appears in this final rule. However, the agency is not changing 
the wording of the second part of this statement at this time because 
such a change would be more than a technical amendment, which would 
constitute a need for notice and comment rulemaking.
    In a future issue of the Federal Register, the agency intends to 
propose a revision to the general warnings labeling in Sec. 330.1(g). 
This revision will include changes in the language of the second part 
of this warning statement. The agency will provide an opportunity for 
full public comment before establishing the revised wording and will 
further consider the comment's suggestion at that time. The agency does 
not want to implement revised labeling for that part of the warning for 
only anticaries drug products at this time, but will implement revised 
labeling for all OTC drug products uniformly at a later date.
    Publication of this document constitutes final action on these 
changes under the Administrative Procedure Act (5 U.S.C. 553). This 
final rule institutes changes that are nonsubstantive in nature. 
Because the revisions are not controversial and because, when 
effective, they provide clarification of the final monograph for OTC 
anticaries drug products, FDA finds that the notice and comment 
procedures are unnecessary and not in the public interest (5 U.S.C 553 
(b) and (d)). The agency believes that delaying the effective date for 
6 months will provide sufficient time for industry to implement fully 
the labeling revisions included in this technical amendment.

III. References

    The following references are on display in the Dockets Management 
Branch (address above) and may be seen by interested persons between 9 
a.m. and 4 p.m., Monday through Friday.

    (1) Comment No. CP6 (Vol. 22), Docket No. 80N-0042, Dockets 
Management Branch.
    (2) Comment No. CP6 (Vol. 24), Docket No. 80N-0042, Dockets 
Management Branch.
    (3) Comment No. CP6 (Vol. 26), Docket No. 80N-0042, Dockets 
Management Branch.
    (4) Letter from D. Bowen, FDA, to R. W. Soller, Nonprescription 
Drug Manufacturers Association, coded as LET32, Docket No. 80N-0042, 
Dockets Management Branch.
    (5) Letter from R. W. Soller, Nonprescription Drug Manufacturers 
Association, to D. Bowen, FDA, dated July 11, 1996, Docket No. 80N-
0042, Dockets Management Branch.

IV. Analysis of Impacts

    FDA has examined the impacts of this final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
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 consistent with the regulatory philosophy and 
principles identified in the Executive Order. The agency therefore 
concludes that none of these technical changes included in this final 
rule is a major rule. In addition, this final rule is not a significant 
regulatory action as defined by the Executive Order and so is not 
subject to review under the Executive Order.
    Under the Regulatory Flexibility Act, if a rule has a significant 
impact on a substantial number of small entities, an agency must 
analyze regulatory options that would minimize any significant impact 
of a rule on small entities. This final rule makes a minor revision in 
some labeling that was to become effective on October 7, 1996, but 
which will not be required now until April 7, 1997. Thus, this final 
rule will not impose a significant economic burden on affected 
entities. Therefore, under the Regulatory Flexibility Act (5 U.S.C. 
605(b)), the Commissioner of Food and Drugs certifies that this final 
rule will not have a significant economic impact on a substantial 
number of small entities. No further analysis is required.

V. Paperwork Reduction Act of 1995

    FDA concludes that the labeling requirements in this document 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 et seq.). Rather, the 
labeling statements are 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. Environmental Impact

    The agency has determined under 21 CFR 25.24(c)(6) 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.

List of Subjects in 21 CFR Part 355

    Labeling, Over-the-counter drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
355 is amended as follows:

PART 355--ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

    1. The authority citation for 21 CFR part 355 continues to read as 
follows:

    Authority: Secs. 201, 501, 502, 503, 505, 510, 701 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353, 
355, 360, 371).

    2. Section 355.3 is amended by revising paragraph (e) to read as 
follows:


Sec. 355.3  Definitions.

* * * * *
    (e) Dentifrice. An abrasive-containing dosage form (gel, paste, or 
powder) for delivering an anticaries drug to the teeth.
* * * * *


Sec. 355.10  [Amended]

    3. Section 355.10 is amended in the headings for paragraphs (a)(1), 
(b)(1), (b)(2), and (c)(1) by adding the words ``gel or'' before the 
word ``paste''.

[[Page 52287]]

    4. Section 355.50 is amended by revising paragraphs (c)(1) and 
(c)(2), and in the headings for paragraphs (d)(1)(i) and (d)(1)(ii) by 
removing the word ``Paste'' and adding in its place the words ``Gel or 
paste'' to read as follows:


Sec. 355.50  Labeling of anticaries drug products.

* * * * *
    (c) * * *
    (1) For all fluoride dentifrice (gel, paste, and powder) products. 
``Keep out of the reach of children under 6 years of age. If you 
accidentally swallow more than used for brushing, seek professional 
assistance or contact a Poison Control Center immediately.'' These 
warnings shall be used in place of the general warning statements 
required by Sec. 330.1(g) of this chapter.
    (2) For all fluoride rinse and preventive treatment gel products. 
``Keep this and all drugs out of the reach of children. If you 
accidentally swallow more than used for'' (select appropriate word: 
``brushing'' or ``rinsing''), ``seek professional assistance or contact 
a Poison Control Center immediately.'' These warnings shall be used in 
place of the general warning statements required by Sec. 330.1(g) of 
this chapter.
* * * * *
    Dated: September 30, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-25599 Filed 10-4-96; 8:45 am]
BILLING CODE 4160-01-P