[Federal Register: December 2, 2002 (Volume 67, Number 231)]
[Notices]
[Page 71577-71579]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02de02-101]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00P-1378]
Draft Guidance for Industry on Labeling for Topically Applied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availability of a draft guidance entitled ``Guidance for Industry:
Labeling for Topically Applied Cosmetic Products Containing Alpha
Hydroxy Acids as Ingredients.'' FDA has considered evidence that
suggests that topically applied cosmetic products containing alpha
hydroxy acids (AHAs) may increase the sensitivity of skin 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. The purpose of this draft guidance is to
educate manufacturers to help ensure that their labeling for AHA-
containing cosmetic products is not false or misleading. The draft
guidance suggests content for a labeling statement for AHA-containing
cosmetic products. This action was prompted by a citizen petition filed
by the Cosmetic, Toiletry, and Fragrance Association (CTFA), which
requested that FDA issue a regulation establishing sun alert labeling
on AHA-containing products.
DATES: Submit written or electronic comments by January 31, 2003, to
ensure their adequate consideration in preparation of the final
document. Comments on this draft guidance may be submitted at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Cosmetics and Colors (HFS-100), Center for
Food Safety and Applied Nutrition, Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740. Submit electronic comments
on the draft guidance to http://www.fda.gov/dockets/ecomments. Send one
self-addressed adhesive label to assist that office in processing your
request or include a fax number to which the guidance may be sent.
Submit written comments on the draft guidance to the Dockets Management
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. See the SUPPLEMENTARY INFORMATION section
for electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Julie N. Barrows, Center for Food
Safety and Applied Nutrition (HFS-105), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3412.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance entitled
``Guidance for Industry: Labeling for Topically Applied Cosmetic
Products Containing Alpha Hydroxy Acids as Ingredients.'' This draft
guidance explains FDA's suggested labeling of topically applied
cosmetic products that contain AHAs to alert consumers of the need to
use sun protection when using these products. The guidance will educate
manufacturers to help ensure that their labeling for AHA-containing
cosmetic products is not false or misleading under 21 U.S.C. 362(a) and
321(n).
AHAs are organic acids with a hydroxyl group on the carbon adjacent
to the carboxylic acid group. The predominant AHAs present in cosmetic
products are glycolic acid and lactic acid. Other AHAs that are found
in cosmetic products include citric acid, -hydroxyoctanoic acid, and -
hydroxydecanoic acid (Ref. 1). Since the early 1990s, there has been a
proliferation of AHA-containing cosmetic and salon products (Ref. 2).
AHAs have been formulated into skin products, make-up, hair products,
nail products, bath products, colognes, and suntan preparations. Most
AHA-containing products are ``leave on'' products that are intended for
daily use on the skin or mucous membrane or are ``discontinuous use''
products that are intended to be applied to the skin for a short period
of time (e.g., less than an hour) followed by thorough rinsing. Salon
products are usually discontinuous use products.
FDA received a total of 107 adverse dermatologic experience reports
for AHA-containing skin care products between 1992 and 2000, with the
maximum number (32) in 1994 (Ref. 2). The reported adverse experiences
include: Burning (43), dermatitis or rash (33), swelling (26),
pigmentary changes (15), blisters or welts (13), skin peeling (12),
itching (12), irritation or tenderness (6), chemical burns (6), and
increased sunburn (3).
Starting in 1994, CTFA's Cosmetic Ingredient Review (CIR) Expert
Panel, FDA's AHA Review Committee, and FDA reviewed the safety of
topically applied AHAs in cosmetic products
[[Page 71578]]
(Refs. 2 through 4). The reviewers evaluated human clinical studies
that investigated the effects of ultraviolet (UV) radiation on the skin
after exposure to AHAs. The studies demonstrated that topically applied
AHAs increase skin sensitivity to UV radiation during application and
that this increased skin sensitivity to UV radiation diminishes after
discontinuing application for a week.
Sensitivity to UV radiation is the main reason for the skin's
sensitivity to the sun (Ref. 5). Short-term exposure to the sun may
cause sunburn, and chronic long-term exposure to the sun may increase
the risk of premature skin aging (Ref. 5). Experimental and
epidemiological studies have demonstrated that prolonged exposure to
the UV radiation in sunlight is a primary risk factor for certain types
of skin cancer (Refs. 6 through 8).
The human clinical studies provided data for the effects of UV
radiation on the skin after short-term (up to 12 weeks) topical
exposure to AHAs. The evidence from the clinical studies suggests that
increased skin sensitivity to UV radiation may increase the possibility
of sunburn for consumers. Adverse experience reports of increased
sunburn after AHA use support this conclusion (Ref. 2). The increased
skin sensitivity to UV radiation also may result in other harmful
effects to the skin, but the data available to FDA's Center for Food
Safety and Applied Nutrition (CFSAN) are still inconclusive on this
point.
FDA's National Center for Toxicological Research (NCTR) currently
is investigating the effects of long-term exposure to AHAs in a
photocarcinogenicity study by the National Toxicology Program's Center
for Phototoxicology (Ref. 2). The purpose of the NCTR study is to allow
quantitative determination of the effect AHA treatment (glycolic acid)
has on the induction of mouse skin cancer (SKH-1 hairless mouse) by
simulated solar radiation.
FDA believes that increased skin sensitivity to the sun, and
particularly the possibility of sunburn following AHA use, may be
material facts that manufacturers should disclose to users under 21
U.S.C. 362(a) and 321(n) and 21 CFR 1.21. Accordingly, FDA believes
that if manufacturers inform users of AHA-containing products about the
potential for increased skin sensitivity to the sun and particularly
the possibility of sunburn, and what steps a user may take to avoid
such consequences, this will help avoid the potential that the products
are misbranded under 21 U.S.C. 362(a) and 321(n).
In the draft guidance, FDA suggests that the following statement
appear on the label of AHA-containing cosmetic products:
``Sunburn Alert: This product contains an alpha hydroxy acid
(AHA) that may increase your skin's sensitivity to the sun and
particularly the possibility of sunburn. Use a sunscreen and limit
sun exposure while using this product and for a week afterwards.''
FDA expects that a label statement such as the recommended ``Sunburn
Alert'' will be a source of new information about sun protection for
most consumers, as well as a reminder about sun protection for
consumers who already are aware of the need to use sun protection when
using these products (Ref. 2).
CTFA submitted a citizen petition (dated June 29, 2000, and
assigned FDA Docket No. 00P-1378/CP1), which requested that under 21
U.S.C. 362(a), FDA issue a regulation on cosmetic labeling in 21 CFR
part 701 establishing labeling requirements related to sun protection
with use of cosmetics containing AHAs. FDA is issuing this draft
guidance entitled ``Guidance for Industry: Labeling for Topically
Applied Cosmetic Products Containing Alpha Hydroxy Acids as
Ingredients'' rather than a proposed regulation.
FDA is announcing the availability of this draft guidance at this
time pending the results of the NCTR study because the agency believes
interim action is warranted to recommend that manufacturers label
topically applied cosmetic products that contain AHAs to alert
consumers of the need to use sun protection when using these products.
After assessing the results of the photocarcinogenicity study and the
effectiveness of any final guidance, the agency intends to determine if
additional agency action is appropriate.
This draft guidance is a level 1 guidance issued consistent with
FDA's regulation on good guidance practices (21 CFR 10.115). The draft
guidance represents the agency's current thinking on the 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 such approach satisfies the requirements of
applicable statutes and regulations.
II. Comments
Interested persons may, at any time, submit written comments on the
draft guidance to the Dockets Management Branch (see ADDRESSES). Two
copies of any comments are to be submitted, except that individuals may
submit one 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 office above between 9 a.m. and 4
p.m., Monday through Friday.
III. Electronic Access
An electronic version of this draft guidance is available on the
Internet at http://www.cfsan.fda.gov/[tilde]dms/guidance.html.
IV. References
The following references are on display in the Dockets Management
Branch (see ADDRESSES) and may be seen by interested persons between 9
a.m. and 4 p.m., Monday through Friday.
1. Yates, R. L., and D. C. Havery, ``Determination of Phenol,
Resorcinol, Salicylic Acid and -Hydroxy Acids in Cosmetic Products
and Salon Preparations,'' Journal of Cosmetic Science, vol. 50, pp.
315-325, 1999.
2. Barrows, Julie N., memorandum to the administrative file,
``Guidance for Industry: Labeling for Topically Applied Cosmetic
Products Containing Alpha Hydroxy Acids as Ingredients,'' Office of
Cosmetics and Colors, CFSAN, FDA, September 12, 2002.
3. 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.
4. FDA, memoranda of meetings of AHA Review Committee, May 6,
1997, and February 12, 1997, and index of reviewed information.
5. Hawk, J. L. M., Ed., ``Photodermatology,'' Arnold Publishers,
chapters 4, 6, and 7, pp. 43-52 and 69-102, 1999.
6. DeGruijl, F. R., J. B. VanDerMeer, and J. C. VanDerLeun,
``Dose-Time Dependency of Tumor Formation by Chronic UV Exposure,''
Photochemistry and Photobiology, vol. 37, pp. 53-62, 1983.
7. Strickland, P. T., et al., ``Quantitative Carcinogenesis in
Man: Solar Ultraviolet B Dose Dependence of Skin Cancer in Maryland
Watermen,'' Journal of the National Cancer Institute, vol. 81, pp.
1910-1913, 1989.
8. Forbes, P. D., et al., ``Simulated Stratospheric Ozone
Depletion and Increased Ultraviolet Radiation: Effects on
Photocarcinogenesis in Hairless Mice,'' Cancer Research, vol. 42,
pp. 2796-2803, 1982.
[[Page 71579]]
Dated: November 15, 2002.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 02-30340 Filed 11-29-02; 8:45 am]
BILLING CODE 4160-01-S