[Federal Register Volume 67, Number 231 (Monday, December 2, 2002)]
[Notices]
[Pages 71577-71579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30340]


-----------------------------------------------------------------------

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Draft Guidance for Industry on Labeling for Topically Applied 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.

-----------------------------------------------------------------------

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availability of a draft guidance entitled ``Guidance for Industry: 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 The purpose of this draft guidance is to 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 The draft 
guidance suggests content for a labeling statement for AHA-containing 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 Comments on this draft guidance may be submitted at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Cosmetics and Colors (HFS-100), Center for 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on the draft guidance to http://www.fda.gov/dockets/ecomments.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Submit written comments on the draft guidance to the Dockets Management 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