Guidance for Industry: Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients; Availability, 1721-1724 [05-381]
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Federal Register / Vol. 70, No. 6 / Monday, January 10, 2005 / Notices
Section 1116 of the Social Security Act (42
U.S.C. 1316); 42 CFR 430.18.
(Catalog of Federal Domestic Assistance
Program No. 13.714, Medicaid Assistance
Program)
Dated: January 5, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 05–445 Filed 1–7–05; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Pediatric Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
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Name of Committee: Pediatric
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To provide advice and
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Date and Time: The meeting will be
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Reporting, as mandated in Section 17 of
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BREVIBLOC (esmolol), MALARONE
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The committee will also be asked to
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event reviews and reporting as
mandated by BPCA.
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Dated: December 30, 2004.
William K. Hubbard,
Associate Commissioner for Policy and
Planning.
[FR Doc. 05–382 Filed 1–7–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2000P–1378]
Guidance for Industry: Labeling for
Topically Applied Cosmetic Products
Containing Alpha Hydroxy Acids as
Ingredients; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance document
entitled ‘‘Guidance for Industry:
Labeling for Topically Applied
Cosmetic Products Containing Alpha
Hydroxy Acids as Ingredients.’’ The
guidance recommends content for a
labeling statement for cosmetic products
containing alpha hydroxy acids (AHAs)
as ingredients. This action was
prompted by a citizen petition filed by
the Cosmetic, Toiletry, and Fragrance
Association, which requested that FDA
issue a regulation establishing labeling
requirements relating to sun protection
with use of cosmetic products
containing AHAs.
DATES: You may submit written or
electronic comments on the guidance
document at any time.
ADDRESSES: Submit written requests for
single copies of the guidance document
to the Office of Cosmetics and Colors,
Center for Food Safety and Applied
Nutrition (HFS–100), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740–3835.
Include a self-addressed adhesive label
to assist that office in processing your
request or include a fax number to
which the guidance document may be
sent.
Submit written comments on the
guidance document to the Division of
Dockets Management (HFA–305), 5630
Fishers Lane, rm. 1061, Rockville, MD
20852. Submit electronic comments to
https://www.fda.gov/dockets/ecomments.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
guidance document.
FOR FURTHER INFORMATION CONTACT: Julie
N. Barrows, Center for Food Safety and
Applied Nutrition (HFS–125), Food and
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Federal Register / Vol. 70, No. 6 / Monday, January 10, 2005 / Notices
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740–3835,
301–436–1344.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance document entitled
‘‘Guidance for Industry: Labeling for
Topically Applied Cosmetic Products
Containing Alpha Hydroxy Acids as
Ingredients.’’
On December 2, 2002 (67 FR 71577),
FDA announced the availability of the
draft version of this guidance document
in the Federal Register.
II. Comments on Draft Guidance
FDA has evaluated the seven
comments received in response to the
draft guidance recommending ‘‘Sunburn
Alert’’ labeling on cosmetic products
that contain AHAs as ingredients.
One comment from a nurse’s
association fully supported the AHA
labeling statement. The comment stated
that the inclusion of the ‘‘Sunburn
Alert’’ on skin care products containing
AHAs is an important step in
empowering health providers and
consumers with valuable information
about how to protect their skin while
using these products.
Three comments stated that the
guidance should apply only to products
intended to function as an exfoliant. For
example, the comments suggested that
the guidance should not apply to
products containing citric acid when it
is used for adjusting the hydrogen-ion
concentration (pH) in shampoos and
other products.
Limiting the recommended labeling
statement to products with exfoliation
claims may leave out products that FDA
believes should bear the labeling
statement. FDA’s surveys indicated that
approximately half of the products on
the market that contain an AHA as an
ingredient have an intended use as an
exfoliant, as determined by the presence
of exfoliant claims in the product
labeling. Even some salon products
containing high levels of AHAs did not
contain exfoliation claims in the
labeling. FDA has no data suggesting
that citric acid has less of an effect on
the skin than glycolic acid or lactic acid,
the predominant AHAs present in
cosmetic products, regardless of its
intended use. FDA has not modified the
guidance in response to these
comments.
Two comments requested that FDA
provide an exemption from the AHA
labeling statement for products that
exceed an appropriately high pH level.
Percutaneous absorption studies
suggest that topically applied AHAs in
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any cosmetic product may be absorbed
by the skin to some extent, depending
on product formulation, pH, and contact
time (Refs. 1 and 2). The studies
measured absorption of glycolic acid,
lactic acid, and other AHAs by human
skin at pH 3 and pH 7 using various
product formulations. Although much
greater absorption was observed at pH 3,
substantial absorption was observed at
pH 7. FDA has not modified the
guidance in response to these
comments.
Three comments requested that FDA
provide an exemption from the AHA
labeling statement for cosmetic products
containing low concentrations of AHAs.
One comment suggested that products
containing AHA ingredients at
concentrations of 1 percent or less
should be exempted. The comments did
not provide any data to support their
request.
The evidence reviewed so far by FDA
suggests that topical application of a
cosmetic product containing an AHA as
an ingredient at any concentration may
increase skin sensitivity to the sun and
the possibility of sunburn. FDA
analyzed approximately 100 cosmetic
products containing AHAs as
ingredients and found concentrations of
AHAs ranging from 0.01 percent to 67
percent (Ref. 3). Most of the analyzed
products with very low levels of some
AHAs also contained higher levels of
other AHAs. One product for which
FDA received five adverse experience
reports (e.g., skin irritation, burning)
contained only 0.3 percent ahydroxydecanoic acid and 0.4 percent
a-hydroxyoctanoic acid, for a total of 0.7
percent AHAs, suggesting that AHAs
may be associated with adverse
reactions even at these low
concentrations. FDA has not modified
the guidance in response to these
comments.
FDA recognizes that an AHA can be
present in a cosmetic product as an
incidental ingredient. As defined in
§ 701.3(l) (21 CFR 701.3(l)), incidental
ingredients are ingredients that are
present in a cosmetic at insignificant
levels and that have no technical or
functional effect in the cosmetic.
Incidental ingredients are not required
to be declared in the ingredient lists on
cosmetic labels. Therefore, if an AHA
were used only as an incidental
ingredient in a cosmetic product, its
presence would not require declaration
on the label. The agency finds that
providing for a ‘‘Sunburn Alert’’
labeling statement on a cosmetic
product in which the only use of an
AHA was as an incidental ingredient
would have very limited utility in
protecting the consumer. Moreover, the
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presence of the ‘‘Sunburn Alert’’
labeling statement could be confusing to
consumers because the ingredient label
would not declare the presence of an
AHA. Therefore, FDA has modified the
guidance to state that the agency’s
recommendation for the AHA labeling
statement does not apply to products in
which an AHA is present as an
incidental ingredient, as defined in
§ 701.3(l).
Three comments noted that AHA
ingredients are used in a wide range of
products as pH adjusters, chelating
agents, fragrance ingredients,
humectants, and skin conditioning
agents and asserted that AHAs present
in a product for these uses could not be
reasonably anticipated to cause
increased susceptibility to sunburn. An
example given was citric acid. Two of
the comments requested that the
guidance apply only to AHA-containing
cosmetic products used on areas of the
body normally susceptible to sunburn.
The comments addressed a range of
intended uses for AHAs in cosmetic
products, as well as identified many
different types of products that contain
AHAs as ingredients, but did not
provide data to support their request.
The percutaneous absorption studies
discussed previously suggest that
topically applied AHAs in any cosmetic
product, regardless of intended use, may
be absorbed by the skin, including the
skin on the scalp or under the arms. The
draft guidance did not address the
possibility of unintentional topical
application of AHAs to parts of the skin
or mucous membrane that are exposed
to the sun. Therefore, FDA has modified
the guidance to state that FDA
recommends ‘‘Sunburn Alert’’ labeling
for cosmetic products that contain an
AHA as an ingredient and that are
intended for application to areas of the
body that may result in unintentional
application to the skin or mucous
membrane that are exposed to the sun.
FDA recognizes that AHAs can be
present in cosmetic products that are
applied to areas of the body that are not
sun exposed. Such products include
mouthwashes, breath fresheners, and
douches. Therefore, FDA has modified
the guidance to state that the guidance
does not apply to cosmetic products that
contain an AHA as an ingredient and
that are intended for application to nonsun exposed areas of the body.
Three comments recommended
modified labeling statements for AHAcontaining products that also contain a
sunscreen. The comments stated that
the AHA labeling statement may not be
appropriate for products containing
sunscreens and may be confusing to
consumers. One comment suggested
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that inclusion of a sunscreen at an
appropriate level might serve as a basis
for not recommending the AHA labeling
statement. Two comments proposed that
the AHA labeling statement for products
containing a sunscreen should be
shortened to address only the need to
use a sunscreen for 7 days after use of
the AHA product is discontinued.
When an AHA is present in a product
that is labeled to contain a sunscreen,
that product meets the definition of a
drug-cosmetic. Such products must
comply with the requirements for drugs
and cosmetics, including applicable
over-the-counter sunscreen drug
product regulations. FDA has modified
the guidance to state that the
recommended AHA labeling statement
does not apply to drug-cosmetic
products that contain an AHA as an
ingredient and also are labeled to
contain a sunscreen for sunburn
protection. FDA intends to address
labeling for such products in a future
document.
Three comments requested changes to
FDA’s recommended AHA labeling
statement. Two comments urged FDA to
reconsider identifying AHAs in the
labeling statement because the presence
of an AHA ingredient does not always
result in increased sun sensitivity or
likelihood of sunburn. Another
comment stated that FDA’s AHA
labeling statement is quite long,
especially for labeling cosmetic
products packaged in small containers.
The comment submitted a statement
that is about three-fourths the length of
FDA’s recommended statement.
In the AHA guidance, FDA discusses
research on effective labeling
statements. The research suggests that
an effective labeling statement would
begin with a signal phrase, identify the
subject of the statement, identify the
consequences of not heeding the
statement, and provide instructions on
what to do (or not do) to avoid these
consequences. Removal of any of these
elements may significantly decrease the
effectiveness of the statement.
Therefore, FDA finds that all of the
recommendations in the ‘‘Sunburn
Alert’’ are important components of
information for an AHA labeling
statement.
FDA’s current thinking on sun
protection is that a total program to
reduce harmful effects from the sun
would include limiting sun exposure,
wearing protective clothing, and using
sunscreens. Therefore, in accordance
with this current thinking on sun
protection, the agency has modified the
‘‘Sunburn Alert’’ labeling statement that
we recommended in our draft guidance
to add the words ‘‘wear protective
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clothing’’ to the list of actions that may
be taken to reduce the possibility of
sunburn when using cosmetic products
that contain an AHA as an ingredient.
FDA recognizes that there is limited
labeling space on cosmetic products
packaged in small containers and has
modified the guidance to clarify that it
recommends that the AHA labeling
statement appear prominently and
conspicuously once in the labeling of a
cosmetic product.
One comment recommended that a
‘‘Sunburn Alert’’ labeling statement be
extended to products containing poly
hydroxy acid and/or beta hydroxy acid.
The comment noted that these
compounds are exfoliants with the same
increased skin sensitivity concern as
that for AHAs. The comment did not
define the term ‘‘poly hydroxy acid’’
and did not provide data to support its
recommendation to extend a ‘‘Sunburn
Alert’’ labeling statement to products
containing poly hydroxy acid and/or
beta hydroxy acid. FDA does not have
data on the effect of topical use of these
compounds on the skin. Therefore, FDA
finds that there is currently no basis to
recommend that the ‘‘Sunburn Alert’’
statement appear in the labeling of
cosmetics that contain the compounds
discussed in this comment. FDA has not
modified the guidance in response to
this comment.
Finally, two comments on the draft
guidance requested that FDA provide an
exemption from the AHA labeling
statement for properly formulated
cosmetic products when the
manufacturer or distributor has
competent and reliable scientific
evidence demonstrating that the product
containing an AHA at any level of
concentration and pH does not increase
sun sensitivity or the likelihood of
sunburn. To support its contention, one
comment provided documentation of a
study of the effects of ultraviolet (UV)
radiation on skin pre-treated with lactic
acid.
In its report (Ref. 4), published in
1998, the Cosmetic Ingredient Review
(CIR) Expert Panel reported the
following conclusion:
Based on the available information
included in this report, the CIR Expert Panel
concludes that Glycolic and Lactic Acid,
their common salts and their simple esters,
are safe for use in cosmetic products at
concentrations ≤10 percent, at final
formulation pH ≥3.5, when formulated to
avoid increasing sun sensitivity or when
directions for use include the daily use of
sun protection. These ingredients are safe for
use in salon products at concentrations ≤30
percent, at final formulation pH ≥3.0, in
products designed for brief, discontinuous
use followed by thorough rinsing from the
skin, when applied by trained professionals,
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1723
and when application is accompanied by
directions for the daily use of sun protection.
* * *
FDA reviewed the study submitted in
the second comment and determined
that the study used less sensitive
methods than did the studies reviewed
for the guidance (Ref. 5). For example,
the study reported that exposure of
control sites (i.e., sites without topical
treatment with AHA-containing test
samples) to 1 minimal erythema dose
(MED) of UV radiation resulted in
sunburn cell formation in only 4 out of
18 subjects. However, in the studies that
FDA reviewed for the guidance and that
used sunburn cell formation as an
indicator of UV radiation-induced
damage, exposure of control sites to 1
MED of UV radiation resulted in
sunburn cell formation in 71 out of 72
subjects. (The MED is the minimum
level of UV radiation needed to cause
skin redness and has to be measured for
each subject.)
FDA has modified the guidance to
state that it may be possible in the
future to formulate a cosmetic product
that contains an AHA as an ingredient
and that does not increase the
sensitivity of skin to the sun. However,
FDA is not aware of the current
existence of such a product.
Based on evidence reviewed so far,
FDA concludes that topically applied
cosmetic products containing AHAs as
ingredients may increase skin
sensitivity to the sun while the products
are used and for up to a week after use
is stopped, and that this increased skin
sensitivity to the sun may increase the
possibility of sunburn. FDA does not
know the extent of consumer awareness
of the potential for increased skin
sensitivity to the sun from the topical
use of AHA-containing cosmetic
products. The agency is publishing this
guidance to help assure consumer
awareness of this potential and to
educate manufacturers to help ensure
that their labeling is not false or
misleading.
Publication of this guidance is an
interim measure while FDA continues
to review the data on the effects of
AHA-containing products on skin
sensitivity to UV radiation, including a
photocarcinogenicity study by the
National Toxicology Program’s Center
for Phototoxicology and recent studies
published in peer-reviewed journals.
FDA invites comments to continue to
inform FDA of new studies when they
become available.
FDA is issuing this guidance as a level
1 guidance consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). This guidance represents the
agency’s current thinking on the
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labeling of topically applied cosmetic
products that contain an AHA as an
ingredient. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
the approach satisfies the requirements
of applicable statutes and regulations.
Effects of Repetitive Cutaneous Application
of Test Materials Containing Alpha Hydroxy
Acid on the Sensitivity of Skin to Ultraviolet
(UV) Light,’’ July 1, 2003.
III. Comments on Guidance
BILLING CODE 4160–01–S
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. The guidance
and received comments may be seen in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
IV. Electronic Access
Copies of this guidance also are
available on the Internet at https://www/
cfsan.fda.gov/~dms/guidance.html.
V. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
1. Sah, A., S. Mukherjee and R. R. Wickett,
‘‘An In Vitro Study of the Effects of
Formulation Variables and Product Structure
on Percutaneous Absorption of Lactic Acid,’’
Journal of Cosmetic Science, vol. 49, pp.
257–273, 1998.
2. Kraeling, M. E. K. and R. L. Bronaugh,
‘‘In Vitro Percutaneous Absorption of Alpha
Hydroxy Acids in Human Skin,’’ Journal of
the Society of Cosmetic Chemists, vol. 48, pp.
187–197, 1997.
3. Yates, R. L. and D. C. Havery,
‘‘Determination of Phenol, Resorcinol,
Salicylic Acid and a-Hydroxy Acids in
Cosmetic Products and Salon Preparations,’’
Journal of Cosmetic Science, vol. 50, pp.
315–325, 1999.
4. Andersen, F. A., ed., ‘‘Final Report on
the Safety Assessment of Glycolic Acid,
Ammonium, Calcium, Potassium, and
Sodium Glycolates, Methyl, Ethyl, Propyl,
and Butyl Glycolates, and Lactic Acid,
Ammonium, Calcium, Potassium, Sodium,
and TEA-Lactates, Methyl, Ethyl, Isopropyl,
and Butyl Lactates, and Lauryl, Myristyl, and
Cetyl Lactates,’’ International Journal of
Toxicology, vol. 17, supplement 1, pp. 1–241,
1998.
5. Wamer, W., Office of Cosmetics and
Colors, CFSAN, Review of Documents from
Access Business Group: Aupperlee, D., et al.,
‘‘The Effects of UV Light on Skin Pre-Treated
With Alpha Hydroxy Acid Moisturizers,’’
and Thomas J. Stevens and Associates, ‘‘The
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Dated: December 29, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–381 Filed 1–7–05; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Privacy Act of 1974; New System of
Records
Health Resources and Services
Administration, DHHS.
ACTION: Notification of a new system of
records.
AGENCY:
SUMMARY: In accordance with the
requirements of the Privacy Act, the
Health Resources and Services
Administration (HRSA) is publishing
notice of a proposal to add a new system
of records. The new system of records,
‘‘State-Provided Physician Records for
the Application Submission &
Processing System, SDB, BHPr, HRSA,’’
will cover health care practitioners who
are the subjects of databases collected
and maintained by State Primary Care
Offices/Associations. Such health care
practitioners include physicians (both
M.D.s and D.O.s), licensed or otherwise
authorized by a State to provide health
care services. This system of records is
required to comply with the
implementation directives of the Act,
Public Law 108–20. The records will be
used to support the Application
Submission and Processing System
electronic application for the
development, submission, and review of
applications for HPSAs and MUPs. The
most critical requirement for accurate
designation determinations is accurate
data on the location of primary care
providers relative to the population. To
this end, SDB continually tries to obtain
the latest data on primary care providers
and their practice location(s) at the
lowest geographical level possible for
use in the designation process, with the
objective of minimizing the level of
effort required on the part of States and
communities seeking designations.
DATES: HRSA invites interested parties
to submit comments on the proposed
New System of Records on or before
February 22, 2005. As of the date of the
publication of this Notice, HRSA has
sent a Report of New System of Records
to Congress and to the Office of
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Management and Budget (OMB). The
New System of Records will be effective
40 days from the date submitted to OMB
unless HRSA receives comments that
would result in a contrary
determination.
ADDRESSES: Please address comments to
Health Resources and Services
Administration (HRSA) Privacy Act
Officer, 5600 Fishers Lane, Room 14A–
20, Rockville, Maryland 20857;
telephone (301) 443–3780. This is not a
toll-free number. Comments received
will be available for inspection at this
same address from 9 a.m. to 3 p.m.,
Monday through Friday.
FOR FURTHER INFORMATION CONTACT:
Associate Administrator, Bureau of
Health Professions, Health Resources
and Services Administration (HRSA),
5600 Fishers Lane, Room 8–05,
Rockville, Maryland 20857; telephone
(301) 443–5794. This is not a toll-free
number.
SUPPLEMENTARY INFORMATION: The
Health Resources and Services
Administration (HRSA) proposes to
establish a new system of records:
‘‘State-Provided Physician Records for
the Application Submission &
Processing System, SDB, BHPr, HRSA.’’
The new system of records, ‘‘StateProvided Physician Records for the
Application Submission & Processing
System, SDB, BHPr, HRSA,’’ will cover
health care practitioners who are the
subjects of databases collected and
maintained by State Primary Care
Offices/Associations. Such health care
practitioners include physicians (both
M.D.s and D.O.s), licensed or otherwise
authorized by a State to provide health
care services. The records will be used
to support the Application Submission
and Processing System electronic
application for the development,
submission, and review of applications
for HPSAs and MUPs. The most critical
requirement for accurate designation
determinations is reliable data on the
location of primary care providers
relative to the population. To this end,
SDB continually tries to obtain the latest
data on primary care providers and their
practice location(s) at the lowest
geographical level possible for use in
the designation process, with the
objective of minimizing the level of
effort required on the part of States and
communities seeking designations. The
system will include records that show a
value for each of the following fields for
all of the physicians that are included
in each States’ database: Provider ID
(System-Assigned); Provider Type;
Provider Status; First Name; Middle
Name; Last Name; Suffix; Physician
License Number; Specialty Code; Visa
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]]>Agencies
[Federal Register Volume 70, Number 6 (Monday, January 10, 2005)]
[Notices]
[Pages 1721-1724]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-381]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2000P-1378]
Guidance for Industry: Labeling for Topically Applied Cosmetic
Products Containing Alpha Hydroxy Acids as Ingredients; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance document entitled ``Guidance for Industry:
Labeling for Topically Applied Cosmetic Products Containing Alpha
Hydroxy Acids as Ingredients.'' The guidance recommends content for a
labeling statement for cosmetic products containing alpha hydroxy acids
(AHAs) as ingredients. This action was prompted by a citizen petition
filed by the Cosmetic, Toiletry, and Fragrance Association, which
requested that FDA issue a regulation establishing labeling
requirements relating to sun protection with use of cosmetic products
containing AHAs.
DATES: You may submit written or electronic comments on the guidance
document at any time.
ADDRESSES: Submit written requests for single copies of the guidance
document to the Office of Cosmetics and Colors, Center for Food Safety
and Applied Nutrition (HFS-100), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740-3835. Include a self-
addressed adhesive label to assist that office in processing your
request or include a fax number to which the guidance document may be
sent.
Submit written comments on the guidance document to the Division of
Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments to https://www.fda.gov/dockets/
ecomments. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Julie N. Barrows, Center for Food
Safety and Applied Nutrition (HFS-125), Food and
[[Page 1722]]
Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-
3835, 301-436-1344.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance document entitled
``Guidance for Industry: Labeling for Topically Applied Cosmetic
Products Containing Alpha Hydroxy Acids as Ingredients.''
On December 2, 2002 (67 FR 71577), FDA announced the availability
of the draft version of this guidance document in the Federal Register.
II. Comments on Draft Guidance
FDA has evaluated the seven comments received in response to the
draft guidance recommending ``Sunburn Alert'' labeling on cosmetic
products that contain AHAs as ingredients.
One comment from a nurse's association fully supported the AHA
labeling statement. The comment stated that the inclusion of the
``Sunburn Alert'' on skin care products containing AHAs is an important
step in empowering health providers and consumers with valuable
information about how to protect their skin while using these products.
Three comments stated that the guidance should apply only to
products intended to function as an exfoliant. For example, the
comments suggested that the guidance should not apply to products
containing citric acid when it is used for adjusting the hydrogen-ion
concentration (pH) in shampoos and other products.
Limiting the recommended labeling statement to products with
exfoliation claims may leave out products that FDA believes should bear
the labeling statement. FDA's surveys indicated that approximately half
of the products on the market that contain an AHA as an ingredient have
an intended use as an exfoliant, as determined by the presence of
exfoliant claims in the product labeling. Even some salon products
containing high levels of AHAs did not contain exfoliation claims in
the labeling. FDA has no data suggesting that citric acid has less of
an effect on the skin than glycolic acid or lactic acid, the
predominant AHAs present in cosmetic products, regardless of its
intended use. FDA has not modified the guidance in response to these
comments.
Two comments requested that FDA provide an exemption from the AHA
labeling statement for products that exceed an appropriately high pH
level.
Percutaneous absorption studies suggest that topically applied AHAs
in any cosmetic product may be absorbed by the skin to some extent,
depending on product formulation, pH, and contact time (Refs. 1 and 2).
The studies measured absorption of glycolic acid, lactic acid, and
other AHAs by human skin at pH 3 and pH 7 using various product
formulations. Although much greater absorption was observed at pH 3,
substantial absorption was observed at pH 7. FDA has not modified the
guidance in response to these comments.
Three comments requested that FDA provide an exemption from the AHA
labeling statement for cosmetic products containing low concentrations
of AHAs. One comment suggested that products containing AHA ingredients
at concentrations of 1 percent or less should be exempted. The comments
did not provide any data to support their request.
The evidence reviewed so far by FDA suggests that topical
application of a cosmetic product containing an AHA as an ingredient at
any concentration may increase skin sensitivity to the sun and the
possibility of sunburn. FDA analyzed approximately 100 cosmetic
products containing AHAs as ingredients and found concentrations of
AHAs ranging from 0.01 percent to 67 percent (Ref. 3). Most of the
analyzed products with very low levels of some AHAs also contained
higher levels of other AHAs. One product for which FDA received five
adverse experience reports (e.g., skin irritation, burning) contained
only 0.3 percent [agr]-hydroxydecanoic acid and 0.4 percent [agr]-
hydroxyoctanoic acid, for a total of 0.7 percent AHAs, suggesting that
AHAs may be associated with adverse reactions even at these low
concentrations. FDA has not modified the guidance in response to these
comments.
FDA recognizes that an AHA can be present in a cosmetic product as
an incidental ingredient. As defined in Sec. 701.3(l) (21 CFR
701.3(l)), incidental ingredients are ingredients that are present in a
cosmetic at insignificant levels and that have no technical or
functional effect in the cosmetic. Incidental ingredients are not
required to be declared in the ingredient lists on cosmetic labels.
Therefore, if an AHA were used only as an incidental ingredient in a
cosmetic product, its presence would not require declaration on the
label. The agency finds that providing for a ``Sunburn Alert'' labeling
statement on a cosmetic product in which the only use of an AHA was as
an incidental ingredient would have very limited utility in protecting
the consumer. Moreover, the presence of the ``Sunburn Alert'' labeling
statement could be confusing to consumers because the ingredient label
would not declare the presence of an AHA. Therefore, FDA has modified
the guidance to state that the agency's recommendation for the AHA
labeling statement does not apply to products in which an AHA is
present as an incidental ingredient, as defined in Sec. 701.3(l).
Three comments noted that AHA ingredients are used in a wide range
of products as pH adjusters, chelating agents, fragrance ingredients,
humectants, and skin conditioning agents and asserted that AHAs present
in a product for these uses could not be reasonably anticipated to
cause increased susceptibility to sunburn. An example given was citric
acid. Two of the comments requested that the guidance apply only to
AHA-containing cosmetic products used on areas of the body normally
susceptible to sunburn.
The comments addressed a range of intended uses for AHAs in
cosmetic products, as well as identified many different types of
products that contain AHAs as ingredients, but did not provide data to
support their request. The percutaneous absorption studies discussed
previously suggest that topically applied AHAs in any cosmetic product,
regardless of intended use, may be absorbed by the skin, including the
skin on the scalp or under the arms. The draft guidance did not address
the possibility of unintentional topical application of AHAs to parts
of the skin or mucous membrane that are exposed to the sun. Therefore,
FDA has modified the guidance to state that FDA recommends ``Sunburn
Alert'' labeling for cosmetic products that contain an AHA as an
ingredient and that are intended for application to areas of the body
that may result in unintentional application to the skin or mucous
membrane that are exposed to the sun.
FDA recognizes that AHAs can be present in cosmetic products that
are applied to areas of the body that are not sun exposed. Such
products include mouthwashes, breath fresheners, and douches.
Therefore, FDA has modified the guidance to state that the guidance
does not apply to cosmetic products that contain an AHA as an
ingredient and that are intended for application to non-sun exposed
areas of the body.
Three comments recommended modified labeling statements for AHA-
containing products that also contain a sunscreen. The comments stated
that the AHA labeling statement may not be appropriate for products
containing sunscreens and may be confusing to consumers. One comment
suggested
[[Page 1723]]
that inclusion of a sunscreen at an appropriate level might serve as a
basis for not recommending the AHA labeling statement. Two comments
proposed that the AHA labeling statement for products containing a
sunscreen should be shortened to address only the need to use a
sunscreen for 7 days after use of the AHA product is discontinued.
When an AHA is present in a product that is labeled to contain a
sunscreen, that product meets the definition of a drug-cosmetic. Such
products must comply with the requirements for drugs and cosmetics,
including applicable over-the-counter sunscreen drug product
regulations. FDA has modified the guidance to state that the
recommended AHA labeling statement does not apply to drug-cosmetic
products that contain an AHA as an ingredient and also are labeled to
contain a sunscreen for sunburn protection. FDA intends to address
labeling for such products in a future document.
Three comments requested changes to FDA's recommended AHA labeling
statement. Two comments urged FDA to reconsider identifying AHAs in the
labeling statement because the presence of an AHA ingredient does not
always result in increased sun sensitivity or likelihood of sunburn.
Another comment stated that FDA's AHA labeling statement is quite long,
especially for labeling cosmetic products packaged in small containers.
The comment submitted a statement that is about three-fourths the
length of FDA's recommended statement.
In the AHA guidance, FDA discusses research on effective labeling
statements. The research suggests that an effective labeling statement
would begin with a signal phrase, identify the subject of the
statement, identify the consequences of not heeding the statement, and
provide instructions on what to do (or not do) to avoid these
consequences. Removal of any of these elements may significantly
decrease the effectiveness of the statement. Therefore, FDA finds that
all of the recommendations in the ``Sunburn Alert'' are important
components of information for an AHA labeling statement.
FDA's current thinking on sun protection is that a total program to
reduce harmful effects from the sun would include limiting sun
exposure, wearing protective clothing, and using sunscreens. Therefore,
in accordance with this current thinking on sun protection, the agency
has modified the ``Sunburn Alert'' labeling statement that we
recommended in our draft guidance to add the words ``wear protective
clothing'' to the list of actions that may be taken to reduce the
possibility of sunburn when using cosmetic products that contain an AHA
as an ingredient.
FDA recognizes that there is limited labeling space on cosmetic
products packaged in small containers and has modified the guidance to
clarify that it recommends that the AHA labeling statement appear
prominently and conspicuously once in the labeling of a cosmetic
product.
One comment recommended that a ``Sunburn Alert'' labeling statement
be extended to products containing poly hydroxy acid and/or beta
hydroxy acid. The comment noted that these compounds are exfoliants
with the same increased skin sensitivity concern as that for AHAs. The
comment did not define the term ``poly hydroxy acid'' and did not
provide data to support its recommendation to extend a ``Sunburn
Alert'' labeling statement to products containing poly hydroxy acid
and/or beta hydroxy acid. FDA does not have data on the effect of
topical use of these compounds on the skin. Therefore, FDA finds that
there is currently no basis to recommend that the ``Sunburn Alert''
statement appear in the labeling of cosmetics that contain the
compounds discussed in this comment. FDA has not modified the guidance
in response to this comment.
Finally, two comments on the draft guidance requested that FDA
provide an exemption from the AHA labeling statement for properly
formulated cosmetic products when the manufacturer or distributor has
competent and reliable scientific evidence demonstrating that the
product containing an AHA at any level of concentration and pH does not
increase sun sensitivity or the likelihood of sunburn. To support its
contention, one comment provided documentation of a study of the
effects of ultraviolet (UV) radiation on skin pre-treated with lactic
acid.
In its report (Ref. 4), published in 1998, the Cosmetic Ingredient
Review (CIR) Expert Panel reported the following conclusion:
Based on the available information included in this report, the
CIR Expert Panel concludes that Glycolic and Lactic Acid, their
common salts and their simple esters, are safe for use in cosmetic
products at concentrations <=10 percent, at final formulation pH
>=3.5, when formulated to avoid increasing sun sensitivity or when
directions for use include the daily use of sun protection. These
ingredients are safe for use in salon products at concentrations
<=30 percent, at final formulation pH >=3.0, in products designed
for brief, discontinuous use followed by thorough rinsing from the
skin, when applied by trained professionals, and when application is
accompanied by directions for the daily use of sun protection. * * *
FDA reviewed the study submitted in the second comment and
determined that the study used less sensitive methods than did the
studies reviewed for the guidance (Ref. 5). For example, the study
reported that exposure of control sites (i.e., sites without topical
treatment with AHA-containing test samples) to 1 minimal erythema dose
(MED) of UV radiation resulted in sunburn cell formation in only 4 out
of 18 subjects. However, in the studies that FDA reviewed for the
guidance and that used sunburn cell formation as an indicator of UV
radiation-induced damage, exposure of control sites to 1 MED of UV
radiation resulted in sunburn cell formation in 71 out of 72 subjects.
(The MED is the minimum level of UV radiation needed to cause skin
redness and has to be measured for each subject.)
FDA has modified the guidance to state that it may be possible in
the future to formulate a cosmetic product that contains an AHA as an
ingredient and that does not increase the sensitivity of skin to the
sun. However, FDA is not aware of the current existence of such a
product.
Based on evidence reviewed so far, FDA concludes that topically
applied cosmetic products containing AHAs as ingredients may increase
skin sensitivity to the sun while the products are used and for up to a
week after use is stopped, and that this increased skin sensitivity to
the sun may increase the possibility of sunburn. FDA does not know the
extent of consumer awareness of the potential for increased skin
sensitivity to the sun from the topical use of AHA-containing cosmetic
products. The agency is publishing this guidance to help assure
consumer awareness of this potential and to educate manufacturers to
help ensure that their labeling is not false or misleading.
Publication of this guidance is an interim measure while FDA
continues to review the data on the effects of AHA-containing products
on skin sensitivity to UV radiation, including a photocarcinogenicity
study by the National Toxicology Program's Center for Phototoxicology
and recent studies published in peer-reviewed journals. FDA invites
comments to continue to inform FDA of new studies when they become
available.
FDA is issuing this guidance as a level 1 guidance consistent with
FDA's good guidance practices regulation (21 CFR 10.115). This guidance
represents the agency's current thinking on the
[[Page 1724]]
labeling of topically applied cosmetic products that contain an AHA as
an ingredient. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if the approach satisfies the requirements of
applicable statutes and regulations.
III. Comments on Guidance
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. The guidance and received comments may
be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.
IV. Electronic Access
Copies of this guidance also are available on the Internet at
https://www/cfsan.fda.gov/dms/guidance.html.
V. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Sah, A., S. Mukherjee and R. R. Wickett, ``An In Vitro Study
of the Effects of Formulation Variables and Product Structure on
Percutaneous Absorption of Lactic Acid,'' Journal of Cosmetic
Science, vol. 49, pp. 257-273, 1998.
2. Kraeling, M. E. K. and R. L. Bronaugh, ``In Vitro
Percutaneous Absorption of Alpha Hydroxy Acids in Human Skin,''
Journal of the Society of Cosmetic Chemists, vol. 48, pp. 187-197,
1997.
3. Yates, R. L. and D. C. Havery, ``Determination of Phenol,
Resorcinol, Salicylic Acid and [agr]-Hydroxy Acids in Cosmetic
Products and Salon Preparations,'' Journal of Cosmetic Science, vol.
50, pp. 315-325, 1999.
4. Andersen, F. A., ed., ``Final Report on the Safety Assessment
of Glycolic Acid, Ammonium, Calcium, Potassium, and Sodium
Glycolates, Methyl, Ethyl, Propyl, and Butyl Glycolates, and Lactic
Acid, Ammonium, Calcium, Potassium, Sodium, and TEA-Lactates,
Methyl, Ethyl, Isopropyl, and Butyl Lactates, and Lauryl, Myristyl,
and Cetyl Lactates,'' International Journal of Toxicology, vol. 17,
supplement 1, pp. 1-241, 1998.
5. Wamer, W., Office of Cosmetics and Colors, CFSAN, Review of
Documents from Access Business Group: Aupperlee, D., et al., ``The
Effects of UV Light on Skin Pre-Treated With Alpha Hydroxy Acid
Moisturizers,'' and Thomas J. Stevens and Associates, ``The Effects
of Repetitive Cutaneous Application of Test Materials Containing
Alpha Hydroxy Acid on the Sensitivity of Skin to Ultraviolet (UV)
Light,'' July 1, 2003.
Dated: December 29, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-381 Filed 1-7-05; 8:45 am]
BILLING CODE 4160-01-S
