[Federal Register: February 1, 2008 (Volume 73, Number 22)]
[Rules and Regulations]
[Page 6014-6017]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01fe08-4]
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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