Revised Effectiveness Determination; Sunscreen Drug Products for Over-the-Counter Human Use, 35672-35678 [2011-14769]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 76, Number 117 (Friday, June 17, 2011)]
[Proposed Rules]
[Pages 35672-35678]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14769]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 201

[Docket No. FDA-1978-N-0018; formerly Docket No. 1978N-0038]
RIN 0910-AF43


Revised Effectiveness Determination; Sunscreen Drug Products for 
Over-the-Counter Human Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to limit 
the maximum labeled SPF value for over-the-counter (OTC) sunscreen drug 
products to ``50+.'' We are issuing this proposed rule after reviewing 
data and information we received on the safety and effectiveness of OTC 
sunscreen drug products after publication of our 2007 proposed rule. 
The record does not currently contain sufficient data to indicate that 
there is additional clinical benefit above SPF 50. This proposal is 
part of FDA's ongoing review of these products to ensure their safety 
and effectiveness.

DATES: Submit either electronic or written comments on the proposed 
rule by September 15, 2011. Submit comments on information collection 
issues under the Paperwork Reduction Act of 1995 (the PRA) by July 18, 
2011, (see the ``Paperwork Reduction Act of 1995'' section of this 
document). See section VII of this document for the proposed effective 
date of a final rule based on this proposal.

ADDRESSES: You may submit comments, identified by Docket No. FDA-1978-
N-0018 and RIN number 0910-AF43, by any of the following methods, 
except that comments on information collection issues under the PRA 
must be submitted to the Office of Regulatory Affairs, Office of 
Management and Budget (OMB) (see the ``Paperwork Reduction Act of 
1995'' section of this document).

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Fax: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency 
name, Docket No. FDA-1978-N-0018, and RIN 0910-AF43 for this 
rulemaking. All comments received may be posted without change to 
https://www.regulations.gov, including any personal information 
provided.
    Docket: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov, insert the docket 
numbers, found in brackets in the heading of this document, into the 
``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Reynold Tan, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 5411, Silver Spring, MD 20993-0002, 301-
796-2090.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Overview of This Document
    A. Summary of Proposal
    B. Enforcement Policy
II. Maximum Labeled SPF
    A. Summary of Public Submissions
    B. Discussion of Maximum SPF Values in Previous Sunscreen 
Rulemakings
    C. Validity of Testing Sunscreen Products With SPF Values Higher 
Than 50
    D. Insufficient Evidence of Additional Benefit at SPF Values 
Higher Than 50
    E. Data Necessary To Demonstrate Additional Benefit
    F. Alternatives for Addressing Maximum SPF Value
III. Analysis of Impacts
    A. Background
    B. Cost to Relabel SPF 50+ Products
    C. Small Business Analysis
IV. Paperwork Reduction Act of 1995
V. Environmental Impact
VI. Federalism
VII. Proposed Effective Date
VIII. References

I. Overview of This Document

A. Summary of Proposal

    This document proposes to specify one of the conditions under which 
OTC sunscreen products are considered to be generally recognized as 
safe and effective (GRASE) and not misbranded. We are proposing a 
maximum labeled sun protection factor (SPF) value of ``50+'' for all 
monograph sunscreen products. In a final monograph issued in 1999, and 
stayed prior to becoming effective, we determined that the maximum SPF 
permitted under the monograph should be ``30+'' (64 FR 27666 at 27674 
through 27675, May 21, 1999). In a 2007 proposed rule, we proposed to 
amend the sunscreen monograph in part 352 to permit products marketed 
under the monograph to be labeled with SPF values up to ``50+,'' and we 
expressed particular concern that sunscreen products with SPF test 
values above 50 could not be tested with acceptable accuracy and 
reproducibility (72 FR 49070 at 49085 through 49087, August 27, 2007) 
(the 2007 proposed rule). Although submissions in response to the 2007 
proposed rule demonstrated the accuracy and reproducibility of such 
tests at values as high as SPF 80, we are again proposing a maximum 
labeled SPF value of ``50+'' for sunscreen products marketed without 
approved applications, because the record continues to lack data 
demonstrating that sunscreen products with SPF values above 50 provide 
additional clinical benefit compared to SPF 50 products. In this 
document, we are inviting the submission of data demonstrating 
additional clinical benefit provided by sunscreen products with SPF 
values greater than 50.

B. Enforcement Policy

    Elsewhere in this issue of the Federal Register, we are issuing a 
final regulation establishing effectiveness

[[Page 35673]]

testing and labeling requirements for OTC sunscreen products containing 
specified active ingredients and marketed without approved 
applications. This regulation will become effective 1 year after its 
date of publication in the Federal Register. However, because we are 
considering certain active ingredient safety issues further, there is 
not yet a sunscreen final monograph in effect that specifies which 
sunscreen active ingredients may be included in a sunscreen product 
that is determined to be GRASE and not misbranded. Our further 
consideration of these active ingredient issues does not preclude us 
from identifying in this document an additional condition that is 
necessary for a sunscreen product to be GRASE and not misbranded. In a 
forthcoming rulemaking, we intend to request additional data regarding 
the safety of the individual sunscreen active ingredients. The issuance 
of the final labeling rule for certain OTC sunscreen products marketed 
without approved applications combined with the absence of an effective 
final monograph for OTC sunscreen products may give rise to questions 
regarding FDA's enforcement policy for OTC sunscreen products marketed 
without approved applications. To clarify expectations for industry, we 
are issuing a draft guidance document explaining our intended 
enforcement policy for these products in the absence of an effective 
sunscreen final monograph.

II. Maximum Labeled SPF

    In this document, we propose to set an upper limit for labeled SPF 
values at ``50+,'' as proposed in the 2007 proposed rule. This limit 
would permit sunscreen products with SPF test results above 50 to be 
labeled with a ``50+'' value, but would not allow the specific values 
above 50 to be listed on the label. The remainder of this section of 
the document summarizes the public submissions regarding the maximum 
SPF value, most of which support this maximum specific SPF value of 50. 
We also summarize how the maximum SPF value has increased over the 
history of sunscreen rulemakings and discuss the two criteria for 
allowing these increases:
     First Criteria: Does the SPF test provide accurate and 
reproducible results for sunscreen products with higher SPF values?
     Second Criteria: Do sunscreen products with higher SPF 
values provide additional clinical benefit?
    The first criterion has been met for sunscreen products with SPF 
values up to 80. However, we are proposing that the maximum specific 
labeled SPF be 50, unless we receive data to meet the second criterion 
that products with SPF values higher than 50 provide additional 
clinical benefit. These data are critical to show that SPF values 
measured in the laboratory setting correspond to additional clinical 
benefit in actual use conditions. We do not have sufficient data to 
establish that products with SPF values higher than 50 provide 
additional clinical benefit over SPF 50 sunscreen products. We describe 
the types of additional studies that would need to be submitted to 
support increasing the maximum specific SPF value above 50.

A. Summary of Public Submissions

    In response to the 2007 proposed rule, we received 13 submissions 
concerning the upper limit for the SPF value (Ref. 1):
     Four submissions disagreed with the proposed upper limit 
of ``50+'' and argued that the upper limit should be decreased to 
``30+''
     Six submissions supported raising the upper limit from 30 
to ``50+''
     Three submissions disagreed with the proposed upper limit 
of ``50+'' and argued that FDA should not specify an upper limit
    The submissions requesting that the upper limit be decreased to 
``30+'' argued that consumers would not benefit significantly from the 
availability of higher SPF sunscreen products. The submissions noted 
that consumers might reapply higher SPF sunscreen products less 
frequently than SPF 30+ sunscreen products and, therefore, would not 
derive the additional protection that higher SPF products are claimed 
to provide. One of the submissions provided data showing that increases 
in the concentrations of ingredients in higher SPF products might lead 
to increases in skin sensitization and/or irritation problems. Another 
one of the submissions submitted data to demonstrate that an increase 
in SPF value from 28 to 50 requires roughly twice the amount of active 
ingredients in a sunscreen product and suggested that this result may 
lead to increases in skin sensitization and/or irritation problems. The 
submission argued that the safety risks associated with increased 
exposure to sunscreen active ingredients were not justified in light of 
what it defined as a small increase in UV protection.
    The submissions that support our raising the proposed upper limit 
from 30+ to 50+ came from the American Academy of Dermatology, the 
American Society of Dermatologic Surgery, two sunscreen manufacturers, 
the Personal Care Products Council, and a consumer. These submissions 
collectively made the following arguments:
     The increased protection provided by an SPF 50 sunscreen 
product compared to an SPF 30 sunscreen product is important and 
necessary for some consumers (e.g., those with skin type I, a history 
of skin cancer, or an immunosuppression condition).
     Increasing the upper limit from ``30+'' to ``50+'' 
compensates for inadequate application of sunscreen by consumers.
     The SPF test has been validated to ensure accuracy and 
reproducibility for sunscreen products with SPF 50, but not for 
sunscreen products with SPF above 50.
     An SPF upper limit of ``50+'' is harmonized with many 
other countries, including Japan and those in the European Union.
     An SPF 50 sunscreen product provides the maximum 
protection needed by consumers.
    The submissions requesting that FDA not establish an upper limit on 
the SPF value argued that some consumers may need more sun protection 
than that provided by SPF 50 sunscreen products (e.g., lifeguards and 
athletes who cannot reapply sunscreen products frequently). Two of the 
submissions submitted data that they argue support an upper limit for 
SPF values above 50. One submission included data intended to validate 
that the SPF test can accurately and reproducibly measure sunburn 
protection for sunscreen products with SPF values as high as 80. The 
other submission included data intended to demonstrate that sunscreen 
products with SPF values above 50 provide additional protection under 
actual use conditions.

B. Discussion of Maximum SPF Values in Previous Sunscreen Rulemakings

    We have addressed the issue of establishing maximum SPF values in 
many earlier sunscreen rulemakings. We have raised the maximum SPF 
value over time in the rulemakings in accordance with the two 
previously mentioned criteria:
     Does the SPF test provide accurate and reproducible 
results for sunscreen products with higher SPF values?
     Do sunscreen products with higher SPF values provide 
additional clinical benefit?
    Maximum SPF values were first addressed in an advance notice of 
proposed rulemaking (ANPRM) published in 1978 (43 FR 38206 at 38213 
through 38214, August 25, 1978). A panel of sunscreen experts 
recommended categorizing products based upon the protection they

[[Page 35674]]

provided against sunburn. Products that provided the most protection 
from sunburn were those with SPF values of 15 or higher. The panel 
recommended the use of these higher SPF products for individuals with 
skin types that always burn easily. In the 1993 proposed rule, we 
considered raising the maximum SPF value to a value higher than 15 (58 
FR 28194 at 28221 through 28225, May 12, 1993). Based on the data 
available at that time, we stated that sunscreen products with SPF 
values higher than 15 are beneficial to consumers and proposed 
increasing the maximum value to 30. We focused on the question of 
whether there was additional benefit from these sunscreen products with 
higher SPF values. We were not concerned about the accuracy of SPF 
testing because available data demonstrated that the SPF test was 
accurate and reproducible for sunscreen products with SPF values as 
high as 30.
    In the stayed 1999 final rule, we considered increasing the SPF 
maximum value from 30 to 50 (64 FR 27666 at 27674 through 27675). We 
discussed both the question of additional benefit and the question of 
testing accuracy and reproducibility in deciding not to increase the 
maximum SPF value to 50. We expressed concern about the ``extremely 
small'' additional sunburn protection afforded by an SPF 50 sunscreen 
product compared to an SPF 30 sunscreen product (64 FR 27666 at 27675). 
We explained that the increase in sunburn protection becomes 
increasingly small with increasing SPF values. We stated that this 
nonlinear nature of SPF rating system is difficult to translate to 
labeling. We also expressed concern about the ``ability of current 
testing methods to accurately and reproducibly determine SPF values for 
high SPF products'' (64 FR 27666 at 27675). The higher UV test doses 
required to test high SPF products can make it difficult to obtain 
accurate and reproducible results. Therefore, because we did not have 
data validating testing for SPF 50 sunscreen products, we retained a 
maximum SPF value of 30 in the 1999 final rule, which is currently 
stayed.
    In the 2007 proposed rule, we proposed increasing the maximum 
labeled SPF value to ``50+'' based on our receipt of sufficient 
supporting data (72 FR 49070 at 49085 through 49087). Our decision to 
limit the labeled SPF values to 50+ was based primarily on concerns 
about expected increased SPF test variability for sunscreen products 
with SPF values higher than 50 and the lack of validation data for 
these products. We stated that we would consider SPF values above 50 
upon receipt of validation data demonstrating that accurate and 
reproducible test results could be obtained. We further specified that 
these data should include SPF test results from multiple laboratories 
testing the same sunscreen formulations with statistical analyses of 
the overall results. We also discussed the clinical benefits provided 
by SPF 50 sunscreen products for ``those sun-sensitive consumers who 
require such products based upon personal knowledge, planned sun 
exposure, geographical location, or advice of a health professional'' 
(72 FR 49070 at 49086). We explained in the 2007 proposed rule that SPF 
50 sunscreen products are expected to provide additional benefit by 
compensating for inadequate application and infrequent reapplication of 
sunscreen products (72 FR 49070 at 49086).

C. Validity of Testing Sunscreen Products With SPF Values Higher Than 
50

    We now have data demonstrating that the SPF test can be accurately 
and reproducibly performed for sunscreen products with SPF values as 
high as 80. The data were included in one of the submissions requesting 
an upper limit above SPF 50 (Ref. 2). Multiple laboratories, testing 
multiple sunscreen formulations, determined the same SPF values for the 
same sunscreen products.

D. Insufficient Evidence of Additional Benefit at SPF Values Higher 
Than 50

    Despite the new testing, the record does not contain adequate data 
demonstrating that a sunscreen product with an SPF value over 50 
provides an increase in clinical benefit over a sunscreen product with 
an SPF value of 50. For reasons explained in the remainder of this 
section, it is critical that the data demonstrate that SPF values 
measured in the laboratory setting correspond to additional clinical 
benefit in actual use conditions. Consumers have become familiar with 
SPF values because SPF values have appeared on sunscreen product labels 
for many decades. Consumers have learned to associate higher SPF values 
with greater sun protection. Consumers would likely assume that a 
product with an SPF value higher than 50 provides greater protection 
than a product with an SPF value of 50 (e.g., assume that an SPF 80 
sunscreen provides greater protection than an SPF 50 sunscreen). 
However, we lack evidence that a product with an SPF value higher than 
50 provides additional clinical benefit compared to a product with an 
SPF value of 50. In the absence of data demonstrating additional 
clinical benefit, we are concerned that labeling a product with a 
specific SPF value higher than 50 would be misleading to the consumer.
    It is important to understand that SPF values are determined in a 
laboratory where human subjects are given ultraviolet (UV) radiation 
doses produced by a solar simulator (i.e., a UV lamp). Under those 
circumstances, products with increasingly higher SPF values are shown 
to prevent sunburn against increasingly higher UV doses produced by the 
solar simulator. However, because the solar simulator can produce far 
higher UV radiation doses than a consumer would ever receive even under 
the most severe sun exposure situations (i.e., locations and times 
associated with the most intense sun exposure), the theoretical 
increase in protection implied by higher SPF values generated in the 
lab does not necessarily correspond to meaningful additional sunburn 
protection for consumers in actual use conditions, where a consumer may 
be receiving effectively maximal protection against their actual UV 
exposure with a lower SPF product.
    We are only aware of one study that examined the relative 
effectiveness of sunscreen products with SPF values of 50 compared to 
products with SPF values above 50. Russak et al. compared the sunburn 
protection provided by an SPF 85 sunscreen product compared to an SPF 
50 sunscreen product (Ref. 3). In the double-blind study, each subject 
was randomly assigned to apply the SPF 85 product to one side of the 
face and the SPF 50 product to the other. Following a one-time morning 
application, subjects went skiing or snowboarding during a bright, 
sunny day at a well-known ski resort.
    Nine of 56 subjects, who averaged 5 hours of sun exposure, 
developed sunburn. Eight of the sunburned subjects developed sunburn on 
the SPF 50 product side of the face but not on the SPF 85 side of the 
face. The remaining sunburned subject developed sunburn on both sides 
of the face. The study authors concluded that these results demonstrate 
that an SPF 85 sunscreen product provides significantly better sunburn 
protection than an SPF 50 sunscreen product. However, this single study 
summary is not an adequate basis upon which we may conclude that 
sunscreen products with SPF values above 50 provide additional sun 
protection compared to an SPF 50 sunscreen product. For example, we 
cannot determine from the study summary the amounts of sunscreen 
products applied, length of sun exposure for individual subjects, or

[[Page 35675]]

the time of day during which subjects were exposed to the sun. 
Furthermore, although current sunscreen directions instruct consumers 
to reapply sunscreen products no less frequently than every two hours, 
the subjects in this study were explicitly told not to reapply 
sunscreen products. Therefore, we do not have adequate data to conclude 
that sunscreen products with SPF values above 50 provide additional 
clinical benefit when compared to SPF 50 sunscreen products.
    The requirement that higher SPF sunscreen products provide 
additional clinical benefit when compared to lower SPF sunscreen 
products also flows from the principle that the GRASE determination 
requires consideration of the benefit-to-risk ratio for the drug (21 
CFR 330.10(a)(4)(ii) and (iii)). If the addition of ingredients to a 
drug does not provide additional clinical benefit, but potentially 
increases the risk associated with the drug (e.g., increased skin 
irritation), then this benefit-risk calculation shifts, and the drug is 
not GRASE. For the reasons noted above, the record does not currently 
contain sufficient data to indicate that there is additional clinical 
benefit above SPF 50.
    Our combination policy also illustrates this principle. As stated 
in 21 CFR 330.10(a)(4)(iv), active ingredients should not be combined 
in a drug product unless ``each active ingredient makes a contribution 
to the claimed effect(s).'' An active ingredient should not be added to 
a drug product unless the combination with the active ingredient has 
additional benefit. Similarly, increased concentrations of active 
ingredients should not be included in sunscreen products unless there 
is evidence that these increases result in improved effectiveness under 
conditions of actual use. Therefore, we are requiring data sufficient 
to support a general conclusion that sunscreen products with specific 
SPF values above 50 provide additional protection over SPF 50 sunscreen 
products. If we receive such data, and sufficient accompanying data 
regarding accuracy and reproducibility of testing, we may be able to 
allow those specific SPF values to be included in labeling. For 
example, as we now have data addressing the reproducibility of SPF 
testing up to SPF 80, if we received sufficient clinical data 
demonstrating additional clinical benefit for products with specific 
SPF values between 50 and 80, we may include those products under the 
monograph. However, the final determination may also depend on safety 
data on those products, and the question of whether the benefit-risk 
calculation remains favorable to finding them GRASE.

E. Data Necessary To Demonstrate Additional Benefit

    To increase the maximum specific SPF value above 50, we would need 
data demonstrating that sunscreen products with SPF values above 50 
provide additional clinical benefit relative to SPF 50 sunscreen 
products. The study by Russak et al. described earlier in this section 
of the document is one type of study that we would accept for 
consideration, if it would have contained the detail required to make a 
determination of its adequacy. There may be other types of studies that 
would support such an increase. However, it is important that any such 
studies be well-designed so that we can draw conclusions from them. We 
recommend that anyone interested in conducting these types of studies 
contact FDA before beginning the studies.
    We recognize that sunscreen products with SPF values above 50 could 
have utility for consumers in certain settings, such as skiing at high 
altitudes, or with certain conditions that predispose them to 
developing skin cancer. If such products are needed in unique 
situations but not in typical situations of sunscreen use (e.g., beach 
or gardening), it is possible that different labeling may be necessary 
for these unique situations. Possibly, sunscreen products with specific 
SPF values above 50 should be labeled only for certain situations or 
populations, while sunscreen products with SPF 50 or lower could 
contain the labeling included in the 2011 final rule published 
elsewhere in this issue of the Federal Register. Additional data would 
enable us to identify the appropriate target population (e.g., high 
altitude skiers or people diagnosed with skin cancer) for sunscreen 
products with SPF values above 50.

F. Alternatives for Addressing Maximum SPF Value

    In this and prior rulemakings, we have proposed monograph 
conditions addressing SPF labeling, which would have the effect of 
limiting the maximum SPF value that can be declared on the label of a 
sunscreen under the monograph. As we have described, we are concerned 
that in the absence of data supporting additional clinical benefit for 
products with specific SPF values above 50 (but below 80, the current 
limit of validated testing), declaring specific SPF values higher than 
50 would mislead consumers into thinking that they are obtaining 
superior protection from these products, which has not been 
substantiated. Similarly, we solicit comment on whether, absent data 
demonstrating additional clinical benefit, allowing a product with a 
tested SPF value above 50 to be labeled as ``SPF 50 plus'' is itself 
misleading, in suggesting a greater level of protection than a product 
labeled simply as ``SPF 50.''
    In addition to our proposals to limit the maximum SPF value stated 
in labeling to ``50'' or ``50 plus,'' we solicit comment on whether we 
should establish a maximum SPF value for sunscreen formulations 
marketed under the monograph. If a maximum SPF value were established, 
a product with a tested SPF above that value would no longer be 
permitted to be marketed under the monograph. For example, if the 
maximum SPF value were set at 50, then a product with a tested SPF 
value of 65 would no longer be permitted under the monograph, even if 
labeled as ``SPF 50 plus'' or ``SPF 50.'' We seek comment on this 
alternative because, as noted previously, FDA's general approach to 
combination drugs prohibits the inclusion of additional active 
ingredients if they do not provide additional benefit. More 
specifically, if having an SPF above 50 does not confer additional 
clinical benefit in a sunscreen, the risk benefit-assessment for these 
sunscreens may no longer be favorable. Manufacturers may have economic 
incentives to limit their formulations to the minimum necessary active 
ingredients if they were limited to labeling their product as ``50'' or 
``50 plus.'' However, we solicit comment on whether FDA should address 
this issue through a direct limit on product formulation rather than 
through labeling. We also solicit comment and data on how to establish 
the maximum SPF value as a formulation limit (if one were to be set).

III. Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct 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). OMB has determined that this proposed rule is a significant 
regulatory action as defined by Executive Order 12866. Consistent

[[Page 35676]]

with Executive Order 13563, the approach taken here maintains 
``flexibility and freedom of choice for the public,'' above all by 
providing ``information for the public in a form that is clear and 
intelligible.''
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because the proposed rule would lead to at most a 
small one-time relabeling cost for some small businesses, the Agency 
proposes to certify that the final rule will not 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 $136 million, using the most current (2010) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
proposed rule to result in any 1-year expenditure that would meet or 
exceed this amount.

A. Background

    This proposed rule would require that ``SPF 50+'' be the maximum 
labeled SPF value for sunscreens marketed under the monograph because 
products with SPF values above 50 have not been shown to provide 
additional clinical benefit. Currently, about 2 percent of all products 
are labeled with SPF values above 50. Manufacturers of broad spectrum 
products that have products labeled with SPF values greater than 50 
will have to relabel the SPF value on their products to ``50+.''
    The science regarding the sun's harmful effects on skin has evolved 
in recent years, and we now know that protection from sunburn is not 
enough to prevent harmful or undesirable long-term effects from too 
much sun exposure, such as skin cancer and premature skin aging. We 
also now have evidence to demonstrate that when used as directed with 
other sun protection measures, products with Broad Spectrum SPF values 
of 15 or higher reduce the risk of skin cancer and premature skin 
aging, as well as helping prevent sunburn. No evidence, however, 
indicates that SPF values above 50 provide additional protection.

B. Cost To Relabel SPF 50+ Products

    Broad spectrum products labeled with SPF values greater than 50 
would have to relabel the SPF value to ``50+''. We estimate that about 
2 percent of the SKUs, or a total of 72, have SPF values greater than 
50 (Ref. 4). We used the new FDA labeling cost model to estimate the 
costs of relabeling these products. The estimated total one-time costs 
for relabeling, range from about $200,000 to $650,000 (see table 1 of 
this document).

             Table 1--Total Cost to Relabel SPF 50+ Products
------------------------------------------------------------------------
                                            Low       Medium      High
------------------------------------------------------------------------
SKUs relabeling SPF 50+................         72         72         72
    Total Costs ($)....................   $208,327   $381,287   $657,108
------------------------------------------------------------------------

    The principal alternative to this proposed rule would be allowing 
claimed SPF values as high as 80, which would reduce costs by 80 
percent or more because most marketed products labeled with SPF values 
higher than 50 are in the 50 to 80 range. The SPF test has not been 
validated for values over 80. Another problem with this alternative is 
that we lack the evidence of additional clinical benefit from these 
higher SPF ratings.

C. Small Business Analysis

    Most major suppliers of sunscreen products are drug manufacturers, 
for which the Small Business Administration (SBA) defines a small 
entity as having fewer than 750 employees. The U.S. Census, however, 
classifies sunscreen firms as Toilet Preparation Manufacturers under 
code number 325620 under the North American Industry Classification 
System (NAICS), where the SBA's definition of a small business is fewer 
than 500 employees. Census data from 2002 indicate that about 97 
percent of the establishments in NAICS 325620 would be considered small 
using the SBA definition. A casual analysis of the sunscreen 
manufacturers suggests, however, that there are a higher percentage of 
large firms manufacturing sunscreens than indicated by using all 
manufacturers classified in NAICS 325620. We estimate that about 78 of 
100 manufacturers of sunscreen products would be considered small under 
the SBA definitions. Some of these firms may be currently marketing 
products that would have to be relabeled as a result of this rule. If 
the relabeling cannot be coordinated with scheduled labeling changes, 
the FDA labeling cost model estimates the one-time labeling cost per 
Universal Product Code (UPC) to range from $3,028 to $9,555. If 
labeling changes can be coordinated with other scheduled changes, the 
cost per UPC ranges from $140 to $270. Because small manufacturers 
would on average be marketing few affected UPCs and only 72 UPCs in all 
would need changing, FDA concludes that this proposed rule would not 
have a significant economic impact on a substantial number of small 
entities. FDA requests comments on this tentative conclusion.

IV. Paperwork Reduction Act of 1995

    This proposed rule contains certain information collection 
provisions addressing SPF labeling and associated testing that are 
subject to review by OMB under the Paperwork Reduction Act of 1995 (the 
PRA) (44 U.S.C. 3501-3520). Specifically, if finalized, this rule would 
modify the information collection associated with Sec.  201.327(a)(1), 
which is based on testing in Sec.  201.327(i), by requiring that 
products with tested SPF values above 50 be labeled as ``50+'' or ``50 
plus,'' rather than with the specific numerical SPF value that results 
from the testing under Sec.  201.327(i) (21 CFR 201.327(i)). Elsewhere 
in this issue of the Federal Register, in accordance with section 
3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)), we are publishing a 
60-day notice soliciting public comment on the collections of 
information resulting from Sec.  201.327(a)(1) and (i) as established 
in the 2011 final rule published elsewhere in this issue of the Federal 
Register and will then submit these information collection provisions 
to OMB for approval. Those requirements will not be effective until we 
obtain OMB approval.
    A description of the information collection provisions in this 
proposed rule, which would modify those resulting from Sec.  
201.327(a)(1) and (i), is

[[Page 35677]]

given in this section with an estimate of the annual third-party 
disclosure burden. Included in the estimate is the time for reviewing 
instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information.
    We invite comments on these topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
SPF Labeling and Testing Requirements for OTC Sunscreen Products With 
SPF Values Greater Than 50
    In this proposed rule, we propose that the maximum labeled SPF 
value for any product marketed under the OTC monograph for sunscreens 
be ``50+'' or ``50 plus.'' Under Sec.  201.327(a)(1), a final rule 
published elsewhere in this issue of Federal Register which will be 
become effective 1 year after its date of publication, these products 
are required to be labeled with the numerical SPF value resulting from 
testing under Sec.  201.327(i)), resulting in a third party disclosure. 
If the proposal included in this document is finalized, that 
requirement would be amended so that products with tested SPF values 
above 50 would no longer include that specific numerical SPF value in 
their labeling, but instead would substitute the statement ``SPF 50+'' 
or ``Broad Spectrum SPF 50+'', as applicable.
    We believe that this proposed rule, if finalized, would modify the 
information collection associated with the present version of Sec.  
201.327, in that currently marketed sunscreens labeled with specific 
SPF values above 50 would be required to make a one-time revision to 
their labeling to replace the specific SPF value with the ``50+'' 
statement. In our PRA estimate for the current version of Sec.  
201.327(a)(1), we estimate that manufacturers would require 0.5 hours 
per SKU to insert the tested SPF value, and we believe this is 
therefore also an appropriate estimate of the time that would be 
required to revise those labels to include the term ``50 plus''. We 
estimate that there are a total of 3,600 currently marketed SKUs, of 
which 2 percent, or a total of 72, are products with SPF values above 
50. We estimate that these 72 SKUs are manufactured by 50 firms 
(respondents). While manufacturers would need to examine all their 
products in order to determine which ones to revise, we estimate that 
the amount of time needed to accomplish this review is negligible, as 
SPF values would be apparent on the face of existing labels, and 
manufacturers are likely to have existing data compiled for their own 
business needs on which of their products are labeled with SPF values 
above 50. As a result, we include in our estimate of burden only the 
labels actually requiring revision. We annualize this one-time burden 
of 36 hours (0.5 hours per label times 72 labels) across the 3-year 
period for which we are seeking approval, for an annualized burden of 
12 hours.
    We note that no additional product testing under Sec.  201.327(i) 
would be required to support this relabeling; existing products would 
merely reexamine their prior test values in light of the new labeling 
requirement.
    With respect to new sunscreen products entering the market after 
the effective date of a final rule based on this proposal, we believe 
that the effect of this rule would be either to leave unchanged or 
slightly reduce the information collection burden associated with Sec.  
201.327(a)(1). The burden of SPF testing of all new formulations in 
order to ascertain the content of the SPF labeling statement (third 
party disclosure) is already accounted for in the estimate of burden 
for the 2011 final rule and would not be changed by this rule. If this 
proposal is finalized, new products with tested SPF values above 50 
will simply create labeling that states ``SPF 50+'' or ``Broad Spectrum 
SPF 50+'' instead of including their specific tested value. We estimate 
that approximately 60 new products will be introduced each year, and 
based on currently marketed products, that 2 percent of these will have 
SPF values greater than 50, for a total of 1 such product per year. 
This labeling is estimated to require no more than the 0.5 hours 
estimated for creating labeling bearing a specific SPF value, which is 
already included in the estimate for the 2011 final rule.
    In sum, we estimate the burden of this collection of information as 
follows:

                           Table 2--Estimated Annual Third-Party Disclosure Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                     Annual
           Activity                 No. of       frequency per    Total annual      Hours per      Total hours
                                  respondents       response        responses       response
----------------------------------------------------------------------------------------------------------------
Labeling new sunscreen                       1              1                 1             0.5              0.5
 products with SPF values
 greater than 50 with ``Broad
 Spectrum SPF 50 plus'' or
 ``SPF 50 plus'' in lieu of
 specific SPF values..........
Reexamining/relabeling of                   17              1.4              24             0.5             12
 effectiveness statement on
 existing sunscreen PDPs to
 replace specific SPF values
 above 50 with the phrase
 ``50+'' or ``50 plus'' in
 accordance with revisions to
 201.327(a)(1) \2\............
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ...............  ..............  ..............             12.5
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Actual first year burden hours have been divided by 3 to avoid double counting in OMB's tracking system.

    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3407(d)), we have submitted the information collection provisions of 
this proposed rule to OMB for review. Interested persons are requested 
to send comments regarding information collection by (see DATES) to the 
Office of Information and Regulatory Affairs, OMB. To ensure that 
comments on information collection are received, OMB recommends that 
written comments be faxed to the Office of Information and Regulatory 
Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-6974, or e-mailed to 
oira_submission@omb.eop.gov. All comments should be identified with 
the

[[Page 35678]]

title ``SPF Labeling and Testing Requirements for OTC Sunscreen 
Products with SPF Values Greater Than 50.''

V. 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.

VI. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. 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.'' The sole statutory provision giving preemptive 
effect to the proposed rule is section 751 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379r).
    We believe that the preemptive effect of this proposed rule, if 
finalized, would be consistent with Executive Order 13132. Through the 
publication of this proposed rule, we are providing notice and an 
opportunity for State and local officials to comment on this 
rulemaking.

VII. Proposed Effective Date

    Any final rule based on this proposal would become effective 1 year 
after the date of its publication in the Federal Register.

VIII. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES), under Docket No. FDA-1978-N-0018 (formerly 
Docket No. 1978N-0038) unless otherwise noted, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. We 
have verified the Web site addresses, but we are not responsible for 
any subsequent changes to the Web sites after this document publishes 
in the Federal Register.
    1. FDA List of Docket Submissions Addressed in This Proposed Rule.
    2. Comment C716 from Playtex Products, Inc., Docket No. FDA-1978-N-
0018.
    3. Russak, J. E. et al., ``A Comparison of Sunburn Protection of 
High-Sun Protection Factor (SPF) Sunscreens: SPF 85 Sunscreen Is 
Significantly More Protective Than SPF 50,'' Journal of the American 
Academy of Dermatology, 62:348-9, 2010.
    4. Eastern Research Group, ``Sunscreen Drug Formulations for Over-
the-Counter Human Use,'' Task Order No. 21, Contract No. 223-03-8500, 
2010.

List of Subjects in 21 CFR Part 201

    Drugs, Labeling, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 201, as amended June 17, 2011, effective June 
18, 2012, be further amended as follows:

PART 201--LABELING

    1. The authority citation for 21 CFR part 201 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360, 
360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.

    2. Section 201.327 is amended by revising paragraph (a) 
introductory text and paragraphs (a)(1)(i)(A) and (a)(1)(ii) to read as 
follows:


Sec.  201.327  Over-the-counter sunscreen drug products; required 
labeling based on effectiveness testing.

* * * * *
    (a) Principal display panel. In addition to the statement of 
identity in paragraph (b) of this section, the following statements 
shall be prominently placed on the principal display panel:
    (1) Effectiveness claim.--(i) For products that pass the broad 
spectrum test in paragraph (j) of this section. (A) The labeling states 
``Broad Spectrum SPF [insert numerical SPF value resulting from testing 
under paragraph (i) of this section. For values over 50, insert ``50+'' 
or ``50 plus''].''
* * * * *
    (ii) For sunscreen products that do not pass the broad spectrum 
test in paragraph (j) of this section. The labeling states ``SPF 
[insert numerical SPF value resulting from testing under paragraph (i) 
of this section. For values over 50, insert ``50+'' or ``50 plus''].'' 
The entire text shall appear in the same font style, size, and color 
with the same background color.
* * * * *

    Dated: June 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-14769 Filed 6-14-11; 8:45 am]
BILLING CODE 4160-01-P