[Federal Register Volume 73, Number 22 (Friday, February 1, 2008)]
[Rules and Regulations]
[Pages 6014-6017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-1818]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 347

[Docket Nos. 1978N-0021 and 1978N-0021P] (formerly Docket Nos. 78N-0021 
and 78N-0021P)
RIN 0910-AF42


Skin Protectant Drug Products for Over-the-Counter Human Use; 
Reduced Labeling; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
regulation that establishes conditions under which over-the-counter 
(OTC) skin protectant drug products are generally recognized as safe 
and effective (GRASE) and not misbranded. This amendment revises 
labeling requirements for OTC skin protectant drug products formulated 
and marketed as lip protectants.

DATES: This rule is effective March 3, 2008.

FOR FURTHER INFORMATION CONTACT: Michael L. Koenig, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Silver Spring, MD 20993, 301-796-2090.

SUPPLEMENTARY INFORMATION:

I. Why Are We Publishing This Document?

    This document addresses submissions that FDA received in response 
to a June 4, 2003, final rule for OTC skin protectant drug products (68 
FR 33362). The final rule establishes reduced labeling requirements for 
the following products (68 FR 33362 at 33374):
     products formulated and labeled as lip protectants that 
meet the criteria established in Sec.  201.66(d)(10) (21 CFR 
201.66(d)(10)) (Sec.  347.50(e));
     products containing only cocoa butter, petrolatum, or 
white petrolatum

[[Page 6015]]

identified in Sec.  347.10(d), (m), and (r), used singly or in 
combination with each other, and marketed other than as a lip 
protectant (Sec.  347.50(f));
     sunscreen drug products labeled for use only on specific 
small areas of the face (e.g., lips, nose, ears, and around the eyes) 
and that meet the criteria established in Sec.  201.66(d)(10) (Sec.  
352.52(f)); and
     products containing combinations of skin protectant and 
sunscreen active ingredients (Sec.  352.60(b)(2), (c), and (d)).
    Because we had not previously proposed this reduced labeling, we 
requested comments specifically on these new labeling requirements. 
This document addresses the five issues presented in the three sets of 
comments that we received after the final rule. All of the comments 
request changes to existing regulatory requirements. As explained in 
section II of this document, we agree to make the changes requested in 
two of the comments and are, therefore, amending the final rule to:
     add an alternative statement of identity for skin 
protectant products formulated and marketed as lip protectants and
     allow omission of a warning for lip protectant products 
that meet the criteria established in Sec.  201.66(d)(10).
As also explained in section II of this document, we do not agree to 
make the other three changes requested in the submissions.

II. What Are Our Conclusions on the Submissions?

    (Comment 1) A drug manufacturer requested that we include the term 
``lip protectant'' as an alternative statement of identity for skin 
protectants marketed as lip protectants (Ref. 1). The manufacturer 
notes that we have distinctly identified products formulated and 
marketed as lip protectants in other areas of the skin protectant final 
rule, including Sec. Sec.  347.3 and 347.50(b)(2)(ii), (e), and (f). 
The manufacturer further points out that we have permitted a product 
used to treat poison ivy, oak, and sumac to be distinctly identified as 
a ``poison ivy, oak, sumac protectant'' in Sec.  347.50(a)(3).
    We agree with the manufacturer and are including the term ``lip 
protectant'' as an alternative statement of identity for skin 
protectant drug products formulated and marketed as lip protectants. We 
agree that the term ``lip protectant'' accurately describes this 
category of products and is readily understood by consumers. 
Accordingly, we are adding the following new paragraph in Sec.  
347.50(a): For any product formulated as a lip protectant. ``Skin 
protectant,'' ``lip protectant,'' or ``lip balm'' (optional, may add 
dosage form, e.g., ``cream,'' ``gel,'' ``lotion,'' or ``ointment'').
    (Comment 2) A drug manufacturer requested that we allow reduced 
labeling for all lip protectant products, whether or not they meet the 
criteria established in Sec.  201.66(d)(10) (i.e., whether or not they 
are sold in small packages) (Ref. 1). The manufacturer states that the 
skin protectant final rule (68 FR 33362 at 33380 to 33381) amends the 
final rule for OTC sunscreen drug products to allow reduced labeling 
``without the need to meet the criteria established in Sec.  
201.66(d)(10)'' for the following products:
     Sunscreen products that are marketed as lip protectants or 
lipsticks (Sec.  352.52(c)(2) and (d)(4)) and
     Combination sunscreen-skin protectant drug products 
marketed as lip protectants or lipsticks (Sec.  352.60(c) and (d)).
Because the skin protectant monograph (Sec.  347.50(e)) allows reduced 
labeling only for lip protectants that meet the criteria in Sec.  
201.66(d)(10), the manufacturer argues that the skin protectant and 
sunscreen monographs are inconsistent.
    We have determined that the reduced labeling requirements 
established under Sec.  347.50(e) for OTC lip protectant products are 
appropriate only if the criteria of Sec.  201.66(d)(10) are met. If the 
criteria of Sec.  201.66(d)(10) are not met, at least one of the 
factors upon which we relied to conclude that minimal information is 
needed for safe and effective use of lip protectants would not apply, 
namely, the product would not necessarily be sold in small packages 
(see 68 FR 33362 at 33371). Further, if the Sec.  201.66(d)(10) 
criteria are not met, space constraints would not exist to support 
reduced labeling. We believe the current labeling requirements for lip 
protectant products that do not satisfy the Sec.  201.66(d)(10) 
criteria benefit consumers and should continue to apply.
    Therefore, we are not revising the criteria for reduced labeling in 
the skin protectant monograph. We will address, in a separate 
rulemaking for the sunscreen monograph, whether sunscreen lip 
protectant products (i.e., sunscreen products marketed as lip 
protectants or combination sunscreen-skin protectant drug products 
marketed as lip protectants or lipsticks) should also be required to 
satisfy the conditions of Sec.  201.66(d)(10) in order to qualify for 
reduced labeling requirements. We intend to publish a sunscreen 
rulemaking in a future issue of the Federal Register. The rulemaking 
will address various labeling and testing requirements for both 
ultraviolet A (UVA) and ultraviolet B (UVB) rays, including reduced 
labeling requirements for sunscreen lip protectant products.
    (Comment 3) A drug manufacturer argued that the warning statement 
exemption allowed for sunscreens combined with skin protectants (Sec.  
352.60(c)) should be extended to all lip protectant products (Ref. 1). 
Section 352.60(c) of the sunscreen monograph permits sunscreen-skin 
protectant combinations to omit the warning in Sec.  347.50(c)(3): 
``Stop use and ask a doctor if [bullet] condition worsens [bullet] 
symptoms last more than 7 days or clear up and occur again within a few 
days.'' The manufacturer points out that the skin protectant monograph 
does not allow this warning to be omitted for skin protectants 
formulated and labeled as lip protectants. Section 347.50(e)(1)(iii) of 
the skin protectant monograph allows the warning to be shortened (i.e., 
``Stop use and ask a doctor if condition lasts more than 7 days'') but 
not omitted. The manufacturer argues that the requirement for this 
warning makes the skin protectant and sunscreen monographs 
inconsistent.
    We agree with the manufacturer and are changing the skin protectant 
monograph to allow the warning to be omitted for lip protectant 
products that meet the requirements in Sec.  201.66(d)(10). In the 
preamble to the skin protectant final rule, we concluded that minimal 
information is needed for safe and effective use of lip protectant 
products because of specific characteristics of these products (68 FR 
33362 at 33371), including that they:
     are typically packaged in small amounts,
     are applied to limited areas of the body,
     have high therapeutic index,
     are extremely low risk in consumer use situations,
     provide a favorable public health benefit,
     require no specified dosage limitation, and
     require few specific warnings and no general warnings.
Because minimal information is needed for their safe and effective use, 
we agree that lip protectant products meeting the criteria in Sec.  
201.66(d)(10) can be exempted from the 7-day warning requirement 
otherwise applicable to skin protectants under Sec.  347.50(c)(3). We 
believe consumers can safely and effectively use these products without 
this warning. Accordingly, we are revising Sec.  347.50(e)(1)(iii) in 
the skin protectant monograph to read: ``The

[[Page 6016]]

`external use only' warning in Sec.  347.50(c)(1) and in Sec.  
201.66(c)(5)(i) of this chapter may be omitted. The warnings in Sec.  
347.50(c)(2), (c)(3), and (c)(4) are not required.'' This revision will 
make the skin protectant and sunscreen monographs consistent in this 
regard, as requested by the manufacturer.
    (Comment 4) A law firm requested that we allow additional reduced 
labeling for lip protectants and all other skin protectant drug 
products by eliminating the requirement to list the established name of 
an active ingredient both on the principal display panel (PDP) and in 
the Drug Facts box (Ref. 2). The law firm argues that the PDP for skin 
protectants and, in fact, most OTC drug products should only include 
the general pharmacological category as the statement of identity.
    The issue raised by the law firm is outside the scope of the 
reduced labeling issues for which we sought comments in the skin 
protectant final rule. We do not believe it appropriate to address this 
issue in this document because the issue impacts the labeling for all 
OTC drug products. The law firm, or any other party interested in 
amending the OTC labeling regulations, can submit a citizen petition in 
accordance with 21 CFR 10.30.
    (Comment 5) A drug manufacturers' association requested that we 
consider a greater degree of flexibility in the reduced labeling 
allowed for skin protectant (lip protectant) and skin protectant-
sunscreen combination products (Ref. 3). Specifically, the association 
asks that we permit manufacturers to list inactive ingredients 
somewhere other than on the container label for ``products such as lip 
balms and lip balms with sunscreen,'' which are sold in very small 
containers similar to lipsticks containing sunscreens. The association 
notes that we permit this labeling exception for some cosmetic 
products.
    We are denying the request to list inactive ingredients somewhere 
other than on the container label for skin protectant and skin 
protectant-sunscreen combination drug products. We do allow listing of 
inactive ingredients for some cosmetic products in labeling 
accompanying the product rather than on the container label (21 CFR 
701.3(i)). However, we do not allow inactive ingredients to be listed 
somewhere other than on the container label if the cosmetic product is 
also a drug product (e.g., a lipstick containing sunscreen).
    Section 502(e)(1)(A)(iii) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 352(e)(1)(A)(iii)) requires that the inactive 
ingredients of a drug be listed on the outside of the retail package 
and, if determined to be appropriate by FDA, on the immediate 
container. Under Sec.  201.66, the regulation implementing section 
502(e)(1)(A)(iii) for OTC drugs, inactive ingredients must be listed on 
the outside container of a retail package or on the immediate container 
of the product if there is no outside container or wrapper. The 
association asserts that section 502(e)(1)(B) of the act (21 U.S.C. 
352(e)(1)(B)) gives us the ``authority to grant relief from the 
inactive ingredient listing requirements in appropriate 
circumstances.'' However, section 502(e)(1)(B) addresses only 
prescription drug labeling. We do not find a basis for allowing an 
option to list the inactive ingredients of an OTC drug product in a 
different location, such as in other labeling accompanying the product.

III. Analysis of Economic Impacts

    We have examined the impacts of this final rule under Executive 
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates 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). We believe that this 
final rule is not a significant regulatory action under the Executive 
order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. This rule provides an additional statement of 
identity for OTC skin protectant drug products. The revision provides 
manufacturers of OTC lip protectant drug products the option to label 
their products as a ``lip protectant'' or ``lip balm'' in addition to 
``skin protectant,'' as required by the monograph. The rule also allows 
manufacturers to omit a warning if the packaging meets the requirements 
of Sec.  201.66(d)(10). Thus, this rule does not impose any new 
requirements. Rather, manufacturers may make these changes if they wish 
to do so. If manufacturers choose to make the changes, they may do so 
when ordering new labeling in the normal course of business. Therefore, 
we do not believe that this final rule will have a significant economic 
impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $127 million, using the most current (2006) Implicit 
Price Deflator for the Gross Domestic Product. We do not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.

IV. Paperwork Reduction Act of 1995

    We conclude 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)).

V. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. We have determined that this final 
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 or 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 751 of the act (21 U.S.C. 379r) is an 
express preemption provision. Section 751(a) of the act (21 U.S.C. 
379r(a)) provides that ``* * * no State or political subdivision of a 
State may establish or continue in effect any requirement--(1) that 
relates to the regulation of a drug that is not subject to the 
requirements of section 503(b)(1) or 503(f)(1)(A); and (2) that is 
different from or in addition to, or that is otherwise not identical 
with, a requirement under this Act, the Poison Prevention Packaging Act 
of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling 
Act (15 U.S.C. 1451 et seq.).'' Currently, this provision operates to 
preempt States from

[[Page 6017]]

imposing requirements related to the regulation of nonprescription drug 
products. Section 751(b) through (e) of the act outlines the scope of 
the express preemption provision, the exemption procedures, and the 
exceptions to the provision.
    This final rule provides an additional statement of identity for 
skin protectants formulated and marketed as lip protectants and allows 
omission of a warning for certain lip protectant products. Any final 
rule has a preemptive effect in that it precludes States from issuing 
requirements related to the labeling of OTC skin protectant drug 
products that are different from or in addition to, or not otherwise 
identical with a requirement in the final rule. This preemptive effect 
is consistent with what Congress set forth in section 751 of the act. 
Section 751(a) of the act displaces both State legislative requirements 
and State common law duties. We also note that even where the express 
preemption provision is not applicable, implied preemption may arise 
(see Geier v. American Honda Co., 529 US 861 (2000)).
    We believe that the preemptive effect of the final rule is 
consistent with Executive Order 13132. 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.''
    We provided the States with an opportunity for appropriate 
participation in this rulemaking when we sought input from all 
stakeholders on the reduced labeling requirements that this rulemaking 
addresses, through publication of the request for comments in the 
Federal Register in the preamble to the final rule on June 4, 2003 (68 
FR 33362). We received no comments from any States in response to the 
request.
    In addition, on December 10, 2007, FDA's Division of Federal and 
State Relations provided notice via e-mail transmission to elected 
officials of State governments and their representatives of national 
organization. The notice provided the States with further opportunity 
to comment. It advised the States of the publication of the request for 
comments and encouraged State and local governments to review the 
request and to provide any comments to the dockets for this rulemaking 
(Docket Nos. 1978N-0021 and 1978N-0021P) by a date 30 days after the 
date of the notice (i.e., by January 10, 2008), or to contact certain 
named individuals. FDA received no comments in response to this notice. 
The notice has been filed in the previously mentioned dockets.
    In conclusion, we believe that we have complied with all of the 
applicable requirements under the Executive order and have determined 
that the preemptive effects of this rule are consistent with Executive 
Order 13132.

VI. Environmental Impact

    We have determined under 21 CFR 25.31(a) 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.

VII. References

    The following references are on display in the Division of Dockets 
Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 under 
Docket No. 1978N-0021 and may be seen by interested persons between 9 
a.m. and 4 p.m., Monday through Friday.
    1. Comment No. C67.
    2. Comment No. C68.
    3. Comment No. C69.

List of Subjects in 21 CFR Part 347

    Labeling, Over-the-counter drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
347 is amended as follows:

PART 347--SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN 
USE

0
1. The authority citation for 21 CFR part 347 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

0
2. Section 347.50 is amended by revising paragraphs (a) and (e)(1)(iii) 
to read as follows:


Sec.  347.50  Labeling of skin protectant drug products.

* * * * *
    (a) Statement of identity. The labeling of the product contains the 
established name of the drug, if any, and identifies the product with 
one or more of the following:
    (1) For any product. ``Skin protectant'' (optional, may add dosage 
form, e.g., ``cream,'' ``gel,'' ``lotion,'' or ``ointment'').
    (2) For any product formulated as a lip protectant. ``Skin 
protectant,'' ``lip protectant,'' or ``lip balm'' (optional, may add 
dosage form, e.g., ``cream,'' ``gel,'' ``lotion,'' or ``ointment'').
    (3) For products containing any ingredient in Sec.  347.10(b), (c), 
(j), (s), (t), and (u). ``Poison ivy, oak, sumac drying'' (optional, 
may add dosage form, e.g., ``cream,'' ``gel,'' ``lotion,'' or 
``ointment'').
    (4) For products containing any ingredient in Sec.  347.10(b), (c), 
(f), (j), (o), (s), (t), and (u). ``Poison ivy, oak, sumac 
protectant.''
* * * * *
    (e) Products formulated and labeled as a lip protectant and that 
meet the criteria established in Sec.  201.66(d)(10) of this chapter. * 
* *
    (1) * * *
    (iii) The ``external use only'' warning in Sec.  347.50(c)(1) and 
in Sec.  201.66(c)(5)(i) of this chapter may be omitted. The warnings 
in Sec.  347.50(c)(2), (c)(3), and (c)(4) are not required.
* * * * *

    Dated: January 28, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-1818 Filed 1-31-08; 8:45 am]
BILLING CODE 4160-01-S