oversight

Cancer and Coal Tar Hair Dyes: An Unregulated Hazard to Consumers

Published by the Government Accountability Office on 1977-12-06.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

                           DOCUMENT BESU

04296 - [B34146693   (Restricted)                2
Cancer and Coal Tar Hair Dyes: AD Unregulated Bazard to
Consumers. HRD-78-22; B-164031(2). December 6, 1977. 20 pp.

Report to Rep. John E. Moss, Chairuan, House Committee on
Interstate and Foreign Commerce: Oversight and Investigations
SubcoL'ittee; by Elmer B. Staats, Comptroller General.

Issue Area: Consumer and Worker Prctection: Identification of
    Hazardous Consumer Products (909).
Contact: Human Resources Div.
Budget Function: Health: Preventiou and Control of Health
    Problems (553).
Organization Concerned: Department of Health, Education, and
    Welfare; Food and Drug Administration: Div. of Cosmetics
    Technology; National Institutes of Health: National Cancer
    Inst.; National Inst. fur Occupational Safety and Health;
    Cosmetic, Toiletry, and Fragrance Association.
Congressional Relevance: House Committee on Interstate and
    Foreign Commerce: Oversight and Investigations Subcommittee.
Authority: Federal Food, Drug, and Cosmetic Act, as amended (21
    U.S.C. 301 et seq.). P.L. 86-618. 28 C.F.R. 6439. 36 C.F.R.
    16902. Toilet Goods Association v. Finch (419 F.2d 21
    (1969).
         About 33 million women use hair dyes to temporarily or
permanently change their hair color. Most dyes marketed for use
by women are known as coal tar hair dyes because initially coal
tar was the only commercially practical source of material
needed to synthesize the colors used in them. Most coal tar hair
dyes contain colors derived from Petroleum rather than coal tar.
Because a color chemically identical to the petroleum-derived
color could be derived from coal tar, the Food and Drug
Administration (FDA) classifies petroleum-derived colors as coal
tar colors and regulates hair dyes containing them accordingly.
Coal tar hair dyes whose labeling contains a prescribed
statutory warning concerning possible skin irritation and
blindness are exempt from Federal Food, Drug, and Cosmetic Act
provisions concerning adulteration, bat they are not exempt from
misbranding provisions of the act. Findings/Ccnclusions:
Exemptions in the act do not permit FDA to regulate coal tar
hair dye products effectively; they bar the agency from banning
or restricting the use of cancer-causing coal tar hair dyes.
Although coal tar hair dyes are subject to FDA labeling
requirements, the agency has not used this authority to require
a cancer warning cn labels of dyes containing known human or
animal carcinogens. Colors known to cause or suspected of
causing cancer reportedly are being used in all three types of
ccal tar hair dyes. Data indicate that the cancer-causing coal
tar hair colors may be absorbed through the skin and scalp.
Colors that may be used in some temporary and semipermanent hair
dyes are derived from benzidine, a known carcinogen; they may be
a significant cancer risk because the colors may break down to
benzidine in the human body. Nine color additives banned for usa
in cosmetics other than coal tar hair dyes are listed in the
Cosmetic Ingredient Dictionary as available for use in coal tar
hair dyes. Reccmmendations: The Secretary of Health, Education,
and Welfare should direct the FDA Commissioner to evaluate
safety data on coal tar hair dye ingredients and require, where
applicable, a cancer or other appropriate warning on product
labels. The Congress should permit FDA to better regulate coal
tar hair dyes by repealing exempticns in section 601(a) and
601 (e) of the Food, Drug, and Cossetiz Act.. (Author/SW)
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           Py th Z;   -   A.                       L




REPORT OF THE
COMPTROLLER GENER4L
OF THE UNITED STATES



Cancer And Coal Tar Hair Dyes:
An Unregulated Hazard
1"o Consumers
 Some coal tar hair dyes may pose a signific, it
 risk of cancer to cLnsumers because they con-
 tain colors known to cause or suspected of
 causing cancer in humans or animals. Colors
 that may be used in some temporary and
 semipermanent hair dyes are derived from ben-
 zidine, a known human carcinogen, and may
 break down to benzidine in the body. Other
 colors suspected of causing cancer are used in
 temporary, semipermanent, and permanent
 coal tar hair dyes.
 However, exemptions granted to coal tar hair
 dyes under the Federal Food, Drug, and Cos-
 metic Act prevent the Food and Drug Admin-
 istration from regulating hair dyes effectively.
 The exemptions bar the agency from banning
 or restricting the use of coal tar hair dyes con-
 taining cancer-causing colors, if their labeling
 warns of possible skin irritation or blindness.
 The Congress should repeal these exemptions.




HRD-3-22                                          DECEMBER 6, 1977
                COMPTROLLER GENERAL OF THE UNITED 5TATEU
                           WAHINGTONo D.C.   adNG




B-164031(2)
The Honorable John E. Moss, Chairman
Subcommittee on Oversight and
  Investigations
Committee on Interstate and Foreign
  Commerce
House of Representatives
Dear Mr. Chairman:

     This is in response to your letter of October 19, 1977,
requesting information on coal tar derivtijve hair dyes.
The information in this report was developed as part of our
review of the Food and Drug Administration's regulation of
cosmetics and will also be included in our report to the
Congress on the results of that review.
      The Food and Drug Administration is part of the Depart-
r.ent of Health, Education, and Welfare. As you requested,
we did not seek formal Department comments on the report.
However, we did discuss the report's contents with Food and
Drug Administration officials and we considered their views
in preparing the report. The Department will be afforded
an opportunity to offer written comments on our report to
the Congress on cosmetics.
     As agreed with your office, no further distribution
of this report will be made before 30 days unless you publicly
announce its contents earlier.




                                   Comptroller General
                                   of the United States
    COMPTROLLER GENERAL'S REPORT
    TO THE HONORABLE JOHN E.                CANCER AND COAL TAR HAIR
                                                                     DYES:
    HOUSE OF REPRESENTATIVES MOSS           AN UNREGULATED HAZARD
                                            TO CONSUMERS
                 D I G E S T
                About 33 million women use
                                             hair dyes to
                 temporarily or permanently
                                             change
                fair color. There is increasing their
                that some colors used in            evidence
                                          coal tar hair
                dyes--the dyes most widely
                a significant risk of cancerused--may carry
                                               to users.
                Cosmetics, including hair
                lated under the Federal    dyes, are regu-
                                         Food, Drug, and
                Cosmetic Act.
               Exemptions in the act do
                                        not permit the
               Food and Drug Administration
                                            to regulate
               coal tar hair dye products
                                          effectively;
               they bar the agency from
                                        banning or re-
               stricting the use of cancer-causing
               tar hair dyes.                      coal

              The Congress should repeal
                                          these
              tions.   If that is done, colors exemp-
              these Ayes will be subject,       used in
              other color additives, to    similar  to
              proval by the Food and Drugpremarket ap-
                                           Administra-
              tion for safety. Manufacturers
              have to prove the safety         will
                                        of these colors.
             Although coal tar hair dyes
                                          are
             to Food and Drug Administration subject
             requirements, the agency          labeling
                                       has not used
             this autnority to require
             ing on labels of coal tar a cancer warn-
                                        hair
             taining known human or animal dyes con-
             gens.                           carcino-

             The Secretary of Health,
             Welfare should direct the Education, and
                                        Commissioner
             of the Food and Drug Administration
             evaluate safety data on                to
                                      coal
             dye ingredients and require,  tar  hair
             plicable, a cancer or other where ap-
             warning statement on product appropriate
                                           labe..s.
TIr Sheet.   Upon removal, the report
cover date should be noted hereon
                                        i                      HRD-78-22
 Coal tar hair dyes are divided into
                                      three
 groups--temporary, semipermanent,
                                    and
 permanent--depending on the type of
                                      coal
 tar color used, the method used to
                                     apply
 the dye, and the permanence of the
                                     color.
 -- Temporary hair dyes are rinses,
                                    removable
    With one shampooing.

 -- Semipermanent heir dyes usually
                                    are
    plied in a Iiquid base and are left ap-
                                         on
    the hair for 20 to 40 minutes before
                                          be-
    ing rinsed out; they wear off after
    several shampoos.

 -- Permanent hair dyes, accounting
                                     for about
    $3 out of every $4 spent on hair dyes,
    produce color only after they are
                                        oxi-
    dized inside the hair fiber by hydrogen
    peroxide or another oxidant; they
    lort readiiy removed by shampooing. are

Generally, a cosmetic is considered
                                     adul-
terated if it contains any poisonous
                                      or
deleterious substance.

Coal tar hair dyes whose labeling
                                  contains
a prescribed statutory warning concerning
possible skin irritation and blindness
exempt from these provisions.            are
                               In addition,
a cosmetic is considered adulterated
                                      if it
contains a color additive not approved
                                         for
safety by the Food and Drug Administration
under the color additive provisions
                                     of
the act. Again, however, coal tar
                                    hair
dyes are exempted.

A cosmetic is considered misbranded
                                     if
its labeling is false or misleading.
Coal tar hair dyes are not exempt
                                  from
the misbranding provisions.

Colors known to cause or suspected
                                    of
causing cancer reportedly are being
in all three types of coal tar hair used
                                     dyes.
Data indicates that the cancer-causing
coal tar hair colors may be absorbed
through the skin and scalp.  (See p. 4.!


                     ii
            Colors that may be used in some temporary
            and semipermanent hair dyes are derived
            from benzidine, a ';nown carcinogen; they
            may be a significant cancer risk because
            the colors may break down to benzidine in
            the human body.

            Benzidine was identified as a human car-
            cinogen in the 1930s.  Many scientists
            believe that cancer can result from in-
            gestion, inhalation, or skin absorption of
            benzidine.

            The Cosmetic, Toiletry, and Fragrance
            Association, an industry trade group,
            lists eigiht coal tar colors derived frorm
            benzidine in the second edition of its
            Cosmetic Ingredient Dictionary. Hair
            dye manufacturers voluntarily reported to
            the Food and Drug Administration the use
            of these dyes in 26 coal tar hair dye
            products.   Because many cosmetic manu-
            facturers do not report their product
            formulations to the Food and Drug Admin-
            istration, the total number of products
            containi'ng the benzidine-derived colors
            has not been determined.

            Ni:-e color additives banned for use in
            cos;..etics other than coal tar hair
            dyes are listed in the Cosmetic Ingre-
            dient Dictionary as available for use
            in coal tar hair dyes.

            Colors of this type normally are used
            in temporary hair dyes.  Hair dye manu-
            facturers voluntarily reported the use
            of these colors in 21 hair dye products.
            Four of the 9 colors--known as FD&C
            Green No. 2, FD&C Red No. 2, FD&C Violet
            No. 1, and FD&C Red No. 1--have been
            found to cause cancer in animals.

            Eleven other colors identified Ln ani-
            mal tests as suspected carcinogens are
            listed in the Cosmetic Ingredient Dic-
            tionary as available for use in coal
            tar hair dyes.
Tear heet

                                iii
GAO could not readily identify individual
products that contain the 11 colors. Gen-
erally, such colors would be used in tempo-
rary or semipermanent hair dyes.

Screening tests and animal-feeding studies
provide evidence that some widely used per-
manent hair dye ingredients may be carcino-
genic or mutagenic.

University of California researchers tested
169 marketed permanent hair dyes using a
sensitive and simple bacterial screening
test and found that 150 were mutagenic and
possibly carcinogenic.   They found also
that 9 of 16 ingredients used in permanent
hair dyes were mutagenic

The bacterial test is believed to offer
strong evidence of carcinogenicity but,
according to the Food and Drug Administra-
tion, does not alone provide sufficient
evidence to conclude that a substance is
harmfu'. to humans.

Animal-feeding studies are being conducted
on a number of per.inent hair dye ingre-
dients for the National Cancer Institute.
Although analysis of the studies has not
been completed, the Institute advised the
Food and Drug Administration on October 18,
1977, that two of the ingredients--toluene-
2,4-diamine and 2,4-diaminoanisole sulfate--
were carcinogenic in animals.

Hair dye manufacturers have reported to
the Food and Drug Administration the use
of toluene-2,4-diamine in 7 hair dyes and
the use of 2,4-diaminoanisole or its sul-
fate salt in 407 hair dyes.

The Cosmetic, Toiletry, and Fragrance Asso-
ciation has questioned the appropriateness
of screening tests and feeding studies for
determining the safety of hair dye products.
It cites five skin-painting studies in
which a hair dye was applied to the skin



                     iv
of the test animal with no adverse effects
tu demonstrate the safety of toluene-2,4-
diamine and 2,4-diaminoanisole.

Although skin-painting studies mole closely
approximate the actual conditions of hair
dye use, some researchers have questioned
the rdequacy of the studies performed.

As requested by the Subcommittee, GAO did
not obtain written comments from the Food
and Drug Administration. However, GA) has
considered the views of the Food and Drug
Administration in preparing this report.




                     v
                        Contents


DIGEST                                                        i
CHAPTER

      1    INTRODUCTION                                       1
               Types of coal tar hair dyes                    1
               Regulation of hair dyes                        2
               Scope of review                                3
      2    SOME COAL TAR HAIR DYES MAY POSE CANCER
             RISK TO CONSUMERS                                4
               Skin absorption                                4
               Banned colors used in hair dyes                6
               Benzidine-derived azo colors
               Other suspected carcinogens in
                 temporary and semipermanent
                 hair dyes                                    9
               Possible carcinogenicity of
                 permanent hair dyes                       10
               Epidemiological studies                     14
      3    NEED TO REPEAL HAIR DYE EXEMPTIONS              16
               Coal tar hair dye exemptions                16
               Exemptions hinder effective
                 regulation                                17
               Conclusions                                 19
               Recommendation to the Secretary,
                 HEW                                       20
               Recommendation to the Congress              20
                        ABBREVIATIONS
CTFA       Cosmetic, Toiletry, and Fragrance Association
EDF        Environmental Defense Fund
FDA        Food and Drug Administration
FD&C Act   Federal Food, Drug, and Cosmetic Act, as amended
HEW        Department of Health, Education, and welfare
NCI        National Cancer Institute
NIOSH      National Institute of Occupational Safety and
             Health
                          CHAPTER 1

                        INTRODUCTION
     According to a representative of the Cosmetic, Toiletry,
and Fragrance Association (CTFA), an industry trade associa-
tion, a&¢ut 33 m: lion women use hair dyes to temporarily
or permanently ci snge their hair color. Most dyes marketed
for use by women are known as coal tar hair dyes because ini-
tially coal tar was the only commercially practical source
of material needed to synthesize the colors used in them.
The re-ainder of the women's hair dye market is livided be-
tween f.utallic dyes, which are advertised to gradually cover
gray hair, and vegetable dies, such as henna, which are na-
tural dyes. Although some men use coal tar hair dyes, the
mosc popular dyes marketed for men are metallic dyes. Esti-
mates on the numbe: of men who use hair dyes were not readily
available.
     The Deputy Directo- of the Food and Drug Administration's
(FDA's) Division of Cos...etics Technology told us that most
coal tar hair dyes contain colors derived from petroleum
rather than coal tar.   Because a color chemically identical
to the petroleum-derived color could be derived from coal
tar, FDA classifies petroleum-derived colors as coal tar
colors and regulates hair dyes contain-nJ them accordingly.
Throughout this report we refer to all hair dyes containing
petroleum-derived and coal-tar-derived colors as coal tar
hair dyes.
TYPES OF COAL TAR HAIR DYES

     Coal tar lair dyes are divided into three groups--
temporary, semipermanent, and permanent--depending )r.the
type of coal tar color used, the method used to apply the
dye, and the permanence of the color.

     Temporary hair dyves are rinses which add highlights
and brightness to natural color, improve shades of gray
hair, and blend unevenly colored hair. The first rinses
were introduced ia 1922 and were 2atterned after a similar
product used to color curtains and .ther textiles. Com-
mercial products generally contain a mixture of several
colors to obtain a given shade. Temporary dyes are usually
applied to the base of the hair and are combed through to
the tip. The dyes are deposited on the surface of the
hair fiber. Because they do not generally penetrate the hair,
they are completely removable with one shampooing.
     Semipermanent hair dyes penetrate the hair but wear off
after several shampoos. They are often used to blend streaked
hair, to improve the coloring of white or gray hair, or to
add highlights to naturally blond hair. Semipermanent dyes
are usually applied in a liquid base which is left on the
hair for 20 to 40 minutes before being rinsed out. Because
no chemical reaction takes place during application, semi-
permanent dyes do not significantly affect the structure and
the color of hair as do permanent hair dyes. Like temporary
hair dyes, semipermanent dyes generally contain a blend of
several colors to obtain the desired shade.
     Permanent, or oxidation, hair dyes account for about S3
out of every $4 spent on hair dyes. Such dyes work through
a series of chemical reactions. The coal tar ingredients
in permanent hair dyes are mostly colorless "intermediates"
which produce color only after they are oxidized inside the
hair fiber by hydrogen peroxide o' another oxidant 1/. Per-
manent hair dyes produce fast colors that are not readily
removed by shampooing. Subsequent dyeing, perhaps monthly,
is required to color new hair growth and restore the color
of preriously dyed hair.

REGULATION OF HAIR DYES
     Cosmetics, including hair dyes, are regulated under the
Federal Food, Drug, and Cosmetic Act, as amended (FD&C Act)
(21 U.S.C. 301 et seq.). Generally, cosmetics are considered
adulterated if Ftey contain any poisonous or deleterious sub-
stance and are considered misbranded if their labeling is
false or misleading. However, coal tar hair dyes that con-
form to statutory labeling requirements are exempt from the
adulteration provisions of the act.
     Problems in regulating coal tar hair dyes under exist-
ing legislation art discussed in chapter 3.



1/The primary intermediates, such as para-phenylenediam.ne
  and para-aminophenol, are oxidized by hydrogen peroxide
  or another oxidant. The resulting products react with
  a coupler, such as 2,4-diaminoanisole, resorcinol, meta-
  aminophenol, and 1,5-dihydroxynaphthalene, or with another
  unoxidized "para" dye to give the desired shade.




                               2
SCOPE OF REVIEW

     We reviewed legislation, regulations, and practices
relating to FDA's regulation of cosmetics, including coal
tar hair dyes; examined FDA's records on coal tar hair
dyes; and reviewed reports of scientific studies on the
safety of coal tar hair dyes. We also interviewed offi-
cials from FDA and the Department of Health, Education,
and Welfare's (HEW's) National Cancer Institute.




                              3
                             CHAPTER 2

                  SOME COAL TAR HAIR DYES MAY POSE
                     CANCER RISK TO CONSUMERS

     There is increasing evidence that some coal tar hair
dyes may pose a significant risk of cancer to users because
known or suspected cancer-causing colors in these dyes may
be absorbed through the skin and scalp. Specifically:
     -- Temporary hair dyes may contain coal tar colors shown
        to cause cancer in laboratory animals and banned by
        FDA for use in other cosmetic products.

     -- Temporary and semipermanent hair dyes may contain azo
        colors 1/ derived from benzidine, a known human car-
        cinogen. Such colors contain benzidine as a con-
        taminant, and some of the colors may breakdown in the
        body and release benzidine.
     --Other coal tar colors available for use in temporary
       or semipermanent hair dyes have reportedly caused
       cancer in laboratory animals.
     -- Evidence from screening tests or animal studies indi-
        cate that several coal tar colors used in permanent
        hair dyes, including toluene-2,4-diamine and
        2,4-diaminoanisole 2/ may cause cancer.
Existing epidemiological studies provide limited and conflict-
ing evidence about the incidence of cancer among coal tar hair
dye users.

SKIN ABSORPTION

     Several studies have demonstrated that coal tar hair dye
ingredients are absorbed through the skin and scalp.


l/Azo colors contain an "azo" group--two connected nitrogen
  atoms, each of which is usually linked to a carbon atom.
2/2,4-diaminoanisole is commonly referred to as 4-methoxy-
  m-phenylenediamine on hair dye labels.




                                 4
      In a study published in 1968 1/ three permanent hair
dye ingredients--p-phenylenediamine, m-phenylenediamine,
and toluene-2,5-diamine--were applied to the skin of dogs
in gels and fluids, such as those used in hair dyes.   The
amount of dye absorbed was calculated from the concentra-
tions found in the blood or the urine.   About 1 percent of
the p-phenylenediamine applied was absorbed in 3 hours. The
amount absorbed increased to about 7 percent if the gel was
covered with aluminum foil immediately after application.
Absorption decreased to about 0.1 percent if the dye was
mixed with hydrogen peroxide before application.   About
3 and 4 percent, respectively, were absorbed after applying
toluene-2,5-diamine and m--phenylenediamine.

     A second study 2/ demonstrated the absorption of
toluene-2,5-diamine through human skin.  The hair of five
persons was dyed with a dye composed of toluene-2,5-diamine,
resorcinol, and hydrogen peroxide.  About 0.3 percent of
the toluene-2,5-diamine was absorbed.

     In a 1975 study report 3/, University of California
researchers noted that many aromatic amines and diamines,
such as benzidine, are absorbed through human skin.  They
estimated that women could absorb as much as 1 percent of
the hair dye chemicals applied to the scalp.

     FDA has received several reports of consumers experienc-
ing brown or discolored urine following use of hair dyes.
Although we identified several reports stating that the
colors in semipermanent hair dyes are absorbed, we could not
find any studies identifying the extent to which they are
absorbed.


1/Kiese, M., Rachor, M., and Rauscher, E., "The Absorption
  of Some Phenylenediamines Through the Skin of Dogs,"
  Toxicology and Applied Pharmacology, vol. 12, pp. 495-507,
 1968.

2/Kiese, M., and Rauscher, E., "The Absorption of
  p-Toluenediamine [toluene-2,5-diamine] Through Human Skin
  in Hair Dyeing," Toxicology and Applied Pharmacology,
  vol. 13, pp. 325-331, 1968.

3/Ames, B., Kammen, H.O., and Yamasaki, E., "Hair Dyes Are
  Mutagenic:  Identification of a Variety of Mutagenic In-
  gredients," Proceedings of the National Academy of Sciences
  of the United States of America, vol. 72, no. 6.,
  pp. 2423-2427, June 1975.

                             5
BANNED COLORS USED IN HAIR DYES

     Only color additives permanently or provisionally listed
by FDA as safe can be legally used in food, drugs, or cosme-
tics other than coal tar hair dyes. Coal tar hair dyes are
exempt from the color additive provisions of the FD&C Act
and, therefore, coal tar color additives banned from use in
food, drugs, or other cosmetics may continue 'o be used in
coal tar hair dyes.  (See ch. 3.)
      Nine color additives banned for use in cosmetics are
listed in the second edition of the CTFA Cosmetic Ingredient
Dictionary 1/ as available for use in coal tar hair dyes.
According to FDA officials, such colors would generally be
used in temporary hair dyes. We found evidence that four of
the nine colors--FD&C Green No. 2, FD&C Red No. 2, FD&C
Violet No. 1, and FD&C Red No. 1--cause cancer in laboratory
animals. The dictionary refers to these colors as Acid
Green 5, Acid Red 27, Acid Violet 49, and HC Red No. 6,
respectively. The remaining five colors (and their CTFA
references)    e: External D&C Red No. 11 (Acid Red 1),
External D&C Red No. 13 (Acid Red 73), External D&C Red
No. 8 (Acid Red 88), External D&C Yellow No. 3 (Acid
Yellow 11), and External D&C Blue No. 1 (Basic Blue 9).
We did not identify the toxic effects associated with these
colors.
     From data submitted by cosmetic manufacturers under
FDA's voluntary program for filing cosmetic product ingredient
statements 2/, we identified four hair dyes containing FD&C
Red No. 2, Tour containing FD&C Red No. 1, and thirteen con-
taining External D&C Blue No. 1. Because of the limited
participation in tne voluntary program, the total number of
products containing the nine colors could not be determined.


1/The dictionary was prepared by CTFA based on data supplied
  by the cosmetic industry on the ingredients being used or
  promoted for use in cosmetic products. The second edition
  was issued in 1977.

2/FDA lacks authority to require cosmetic manufacturers to
  submit data on the ingredients used in their products.
  The voluntary program was established in 1972, but par-
  ticipation has been limited.




                             6
BENZIDINE-DERIZVED AZO COLORS

     Among the coal tar colors that may be used in temporary
and semipermanent hair dyes are several azo colors derived
from benzidine.  According to the Environmental Protection
Agency, benzidine-derived azo colors may contain up to
20 parts per million of benzidine.  More significant, how-
ever, are data indicating that some of the benzidine-derived
azo colors may reconvert to benzidine in the body.

     Benzidine was identified as a human carcinogen in the
1930s when factory workers exposed to benzidine developed an
increased incidence of bladder cancer.  Many scientists be-
lieve that cancer can result from ingestion, inhalation  or
skin absorption of benzidine.  Tn animal studies benzidine
caused liver tumors in mice, rats, and hamsters and bladder
cancer in dogs.

      In a study report published in July 1975 1/, two re-
searchers from the New York University Medical Center re-
ported on the metabolic reduction of benzidine-derived azo
colors in the rhesus monkey.   Monkeys were fed by stomach
tube a single dose of benzidine or a benzidine-derived azo
color disolved in dimethyl sulfoxide.   Four benzidine-derived
azo colors were included in the study.   Control urine was
collecteO from each monkey before the test was begun.

     The researchers analyzed urine collected from the monkeys
over a 72-hour period and found benzidine and a benzidine
metabolite (monoacetyl benzidine) in extracts of urine from
both the monkeys fed benzidine and those fed benzidine-derived
azo colors.  They found that the metabolic reduction of the
colors to benzidine was nearly total.

     The researchers stated that the results of their work
support the implication of an earlier study (1973) that an
increased incidence of bladder cancer found in Japanese silk
kimono painters resulted from benzidine metabolically derived
frcm ingested azo colors.  The earlier study had demonstrated
the reduction of benzidine-derived azo colors to benzidine in
the presence of certain bacteria.


1/Rinde, E., and Troll, W.; "Metabolic Reduction of Benzidine
  Azo Dyes to Benzidine in the Rhesus Monkey," Journal of the
  National Cancer Institute, vol. 55, no. 1, pp. 181-182,
  July 1975.




                                7
     HEW's National Institute of Occupational Safety and
Health (NIOSH) began a study in 1977 to determine the degree
of occupational risk to workers in the textile-dyeing and
leather-tanning industries exposed to benzidine-derived
colors.  N1OSH notes that most dyestuffs are of a chemical
class which offers the potential for rapid skin and lung
absorption but that it is not known if t;&, metabolites re-
sulting from such occupational exposure differ from those
reported in the New York University study.

     We could not locate any studies on the extent to which
benzidine-derived azo colors are absorbed TArough the skin.

     The CTFA Cosmetic Ingredient Dictionary lists eight
benzidine-derived azo colors as available for use in coal
tar hair dyes.   From data submitted to FDA by cosmetic manu-
facturers under its voluntary program for filing cosmetic
product ingredient statements, we identified, as shown in
the following table, 26 hair dye products that contained
benzidine-derived azo colors.


      Benzidine-derived         Number of hair dye
          azo color          products containing color

      Direct   Black 38                  7
      Direct   Black 131                 4
      Direct   Blue 6                    1
      Direct   Brown 1                   2
      Direct   Brown 1:2                 2
      Direct   Brown 2                   6
      Direct   b;own 31                  4
      Direct   Brown 154

                                        26

     All of the identified oroducts were temporary rinses.
FDA officials told us, however, that benzidine-derived colors
may also be used in semipermanent hair dyes.  Because of the
limited participation in the voluntary program, the total
number of products containing the eight benzidine-derived azo
colors could not be determined.

     Two of the eight colors were included in the New York
University study, and one of them--Direct Black 38--also
reportedly was used by the Japanese kimono painters who
developed an increased incidence of cancer.




                              e
    The university researchers concluded that

    "It is not our intent to imply that all azo
    dyes are biologicaly [sic] reduced to car-
    cinogens, but those derived from carcinogenic
    aromatic amines should receive particular
    attention."

     The CTFA dictionary lists other azo colors derived from
toluene-2,4-diamine, toluene-2,4-diamine sulfate, and
o-tolidine, each of which is a known or a suspected animal
carcinogen.
OTHER SUSPECTED CARCINOGENS IN TEMPORARY
AND SEMIPERMANENT HAIR DYES

     Eleven other colors liEted as suspected carcinogens in
the 1976 NIOSH Registry of Toxic Effects of Chemical Sub-
stances were listed in the CTFA Cosmetic Ingredient Dic-
tionary as available for use in coal tar hair dyes. The
NIOSH registry lists the studies upon which the list is
based. Neither we nor NIOSH, however, have reviewed the
adequacy of the studies or the appropriateness of the
studies as a basis for determining the safety of the colors
for use in hair dyes.

     The table below lists the 11 colors, the animal species
in which the study was made, and the route by which the color
was administered to the animal.
                                                   Route of
      Color                Test animal          administration

Acid Blue 9                    Rat               Subcutaneous
                               Rat                Parenteral
Acid Blue 9                    Rat               Subcutaneous
  ammonium salt                Rat                Parenteral
Acid Blue 74                   Rat               Subcutaneous
Acid Red 18                    Rat                   Oral
Acid Red 87                    Rat               Subcutaneous
Acid Yellow 73
  sodium salt                  Rat               Subcutaneous
Basic Orange 2                Mouse                  Oral
Basic Violet 10                Rat               Subcutaneous
Disperse Yellow 3       a/Not identified        Not identified
Pigment Red 53          a/Not identified        Not identified
Pigment Red 53:1        a/Not identified        Not identified

a/Reviewed by the World Health Organization's International
  Agency for Research on Cancer. Available data were in-
  definite with respect to carcinogenicity.

                               9
      Although the CTFA dictionary indicated
                                              that these colors
 are available for use in coal tar hair dyes,
 readily able to identify individual products we were not
                                               that contain
 the 11 colors.

POSSIBLE CARCINOGENICITY
OF PERMANENT HAIR DYES

     Screening tests and animal-feeding studies
                                                  Provide addi-
tional evidence that some widely used permanent
gredients may be carcinogenic or mutagenic.       hair dye in-
                                               CTFA has ques-
tioned the appropriateness of such studies
the safety of hair dye products and has     for determining
                                         cited certain animal-
skin-painting studies to support the safety
                                              of these products.
However, some scientists have questioned
studies cited by CTFA to establish the    the  adequacy of the
                                        safety o'f coal tar
hair dyes.

     We reviewed some of the more significant
                                              studies, which
are briefly discussed below.

Screening tests

      University of California researchers have
very sensitive and simple bacterial screening developed a
                                                test for detect-
ing chemical mutagens.   The test is also believed to offer
strong evidence of possible carcinogenicity.
                                                The researchers
reported that 85 percent of the chemicals
in animal studies were detected as mutagensfound  carcinogenic
                                             in the bacterial
test.   By contrast, less than
classified as noncarcinogenic 10  percent of the chemicals
                               in animal studies showed muta-
genic potential in the bacterial tests.

     The researchers subjected 169 marketed
                                             permanent hair
dyes to the bacterial test.  The dyes -'re tested both before
and after mixing with hydrogen peroxide.
                                           Of the 169 dyes
tested, 150 (89 percent) were found to
                                       be mutagenic. Most
of the dyes retained their mutagenic activity
                                               after mixing
with hydrogen peroxide.  The researchers also tested 25 semi-
permanent type hair dyes and found mot
                                         to be mutagenic.
      In addition, the researchers obtained
resentatives 18 chemicals used in permanent from industry rep-
                                             hair dyes and
tested them for mutagenic properties. Nine
                                             of the 18 showed




                             10
various degrees of mutagenicity 1/. Oxidation by
                                                  hydrogen
peroxide caused three of the chemicals to become strongly
mutagenic.

      According to an official from FDA's Division of Cosme-
tics Technology, although screening tests offer strong
cations of possible carcinogenicity and mutagenicity,   indi-
alone do not provide sufficient evidence to conclude   they
substance is harmful to humans. The official stated that a
                                                      that
such tests need corroboration by tests on animals.
National Cancer Institute studies

     The National Cancer Institute (NCI) has
studies on the carcinogenicity of 16 coal tar initiated  animal
                                               hair dye in-
gredients.  The studies, which were being performed
tractors, involve feeding the dye ingredients to ratsby con-
mice or applying the dye ingredient to the skin of      and
and mice.                                           rabbits

     As :f October 1.977 NCI had not completed the analysis
of any of the studies. According to an NCI official,
completion of NCI's analysis of many of the studies     the
                                                     has been
delayed by higher priority work involving pesticides
                                                       and in-
dustrial solvents. NCI's Associate Ditector for Carcino-
genesis Testing Program said, however, that because
structural similarity of the coal tar colors being of the
to known carcinogens, he expects many of them to be tested
carcinogenic. He said that analysis probably would found
                                                     nGo be
completed before the spring of 1978.
      On September 2, 1977, the FDA Commissioner wrote to
NCI Director requesting that priority be given to          the
                                                   completion
of the evaluations of 2 ,4-diaminoanisole, toluene-2,4-diamine,
and any other ingredients which show positive effects.
letter s-ated:                                            The


l/The nine ingredients were:    2 ,4-diaminoanisole,
  o-phenylenediamine, 2 -nitro-p-phenylenediamine, 4-nitro-
  2 ,5-diaminoanisole, 2
                         -amino-5-nitrophenol, m-phenylene-
  diamine, o-phenylenediamine, 2 -amino-4-nitrophenol,
                                                        and
  toluene-2,5-diamine.




                             11
         "Possible positive results with
                                          respect to
         two of the compounds studied,
         2 4                           in particular,
          , -diaminoanisole (2,4 DAA) and
                                           toluene-2,4-
         diamine (2,4 TDA) 1/ have attracted
         tion. In addition, there is evidenceour atten-
                                                that
         compounds such as these do penetrate
         skin.                                 intact

         "In light of this and the extensive
         hair dyes * * * the need to confirm use of
                                             the con-
         clusions suggested by preliminary
                                           reviews in
         an orderly scientific manner is
                                         obvious."
       By letter dated October 18, 1977,
 Director for Carcinogenesis Testing     NCI's Associate
                                      Program advised the FDA
 Commissioner that NCI had found       2 4
 toluene-2,4-diamine carcinogenic both , -diaminoanisole and
                                   in animals. The Associate
 Director gave FDA a draft of a
 2                               technical report on
   ,4-diaminoanisole and advised
                                 FDA that results of the other
 study would be submitted to the
                                  "Journal of the National
 Cancer Institute" for publication.

       By letter dated October 21, 1977,
of FDA's Bureau of Foods notified        the Acting Director
                                    NCI that FDA was beginning
an immediate evaluation of the
                                 draft technical report on
2, 4 -diaminoanisole.

      On October 17, 1977, the Environmental
(EDF), a private nonprofit national              Defense Fund, Inc.
petitioned FDA to require all          consumer organization,
2
                                 hair dye products containing
  ,4-diaminoanisole or 2 ,4 -diaminoanisole
cancer warning label.                        sulfate to bear a
         2               EDF stated that its evaluation
data on     4
           , -diaminoanisole comniled, but                 of the
NCI, showed the dye to be carcinogenic       not  yet released   by
following oral ingestion.                 in  both  rats and mice
                              EDF noted that the dye caused
statistically significant increase                             a
                                      in certain types of tumors
in male and female rats and mice.
     2
       ,4-diaminoanisole is a basic component
nent hair dyes.                                  of most Derma-
                  We identified, from data submitted
facturers to FrA, 407 hair dye                          by manu-
2                                  products containing
  ,4-diaminoanJsole or 2 , 4 -diaminoanisole
                                             sulfate.

I/Most cosmetic manufacturers
  2
                               stopped using toluene-
    ,4-diamine in hair dyes after
                                   it was found to cause
  cancer in laboratory animals.
                                   However, data submitted
  to FDA under its voluntary program
  product ingredient statements        for filing cosmetic
                                  indicates that it is still
  used in at least seven permanent
                                     hair dye products.


                               12
Skin-painting   studies
     Skin-painting stLdies involve applying a chemical or a
chemical mixture to the qkin of the test animal. Because
topical application more closely approximates the actual
conditions of hair dye use and permits testing the actual
mixture of compounds produced during oxidation, CTFA believes
that only skin-painting studies can offer meaningful results
on hair dye carcinogenicity.
     CTFA noted that 2,4-diaminoanisole and toluene-2,4-diamine
had been included in five skin-painting studies in which no
problems had been found. While some researchers recognize
the usefulness of skin-painting studies; they have questioned
the adequacy of the studies performed. Two of these studies
are discussed below.

     Study 1 1/ involved the twice weekly application of
toluene-2,5-dlamine, either alone in a vehicle (a carboxy-
methylcellulose gel) or in a mixture with two other hair dye
ingredients (resorcinol and 2,4-diaminoanisole) to the shaved
dorsal skin of Sprague-Dawley rats for 2 years. Two control
groups were used; one group was treated with the vehicle only
and the other group remained untreated. No positive control
group was used (i.e., no group received a known carcinogen).
All rats surviving the 2-year application period were observed
for another 6 months.

     The researchers reported:

     -- There was no evidence that the hair dye ingredients
        caused any adverse effects.

     -- There was no difference between the control and
        treated rats with respect to lifespan or the type
        and the incidence of tumors.
     -- There were no tumors or other skin reactions at the
        site of application.

     --Histopathological studies of the liver, kidney, and
       lungs provided no evidence of degenerative change or
       functional disturbance.


1/Kinkel, H. J., and Holzmann, S., "Study of Long-term
  Percutaneous Toxicity and Carcinogenicity of Hair Dyes
  (Oxidizing Dyes) in Rats," Food Cosmetic Toxicology,
  vol. 11, pp. 641-648, Pergamon Press, 1973.


                             13
      However, University of California researchers
                                                     questioned
 the usefulness of the study in evaluating the
 dyes, because of the small number of animals   safety of hair
                                               and low dosages
 used in the study. They noted that      experiment could not
 detect a chemical that increased tht    *ience of canter in
 the population by 5 percent.
      Study 2 1/ involved applying one of three different
 dye formulations 2/ to the skin of mice. Each              hair
                                                formulation,
 and a control formulation without a dye intermediate,
 administered, after n'xing with hydrogen peroxide,     was
 groups of mice--one weekly and one every 2 weeks    to two
                                                  foL
 18 months. A positive control group and an untreated
 trol group were also used.                             con-

     The researchers reported that no evidence
or carcinogenicity had been noted. They noted of toxicity
gr{.ient used in the tests, toluene-2,4-diamine,that one in-
viously been shown to cause liver cancer when     had pre-
                                               fed to rats.
     The University of California researchers, however,
                                                         be-
lieved that this study was also inadequate for
safety for humans. They noted that, compared    evaluating
vious study, smaller doses had been used, the to the Dre-
occurred weekly or every 2 weeks rather than dyeings
and the animals had been sacrificed after onlytwice a week,
                                                18 months.
EPIDEMIOLOGICAL STUDIES

      Epidemiology is a science that
distribution, and control of disease deals with the incidence,
                                      in a given population.
Epidemiological studies compare the incidence
such as bladder cancer, in a population exposedof a disease,
                                                 to a parti-
cular chemical to the incidence of the disease
                                                in  an un-
exposed population in order to identify causes
disease. The two populations should be closely  for  the
                                                 matched
according to such factors as age, sex, and smoking
                                                     habits.

1/Burnett, C., Lanman, B., Giovacchini, R., Wolcott,
  Scala, R., and Keplinger, M., "Long-Term Toxicity G.,
  on Oxidation Hair Dyes," Food Cosmetic Toxicology, Studies
  pp. 353-357, Pergamon Press, 1975.                  vol. 13,

2/Each formulation contained oleic acid, isopropanol,
  sulphite, ammonia, toluene-2.5-diamine sulphate,      sodium
  p-phenylenediamine, resorcinul, and deionized
  addition, each formulation contained one of thewater.   In
                                                   following:
  toluene-2,4-diamine base, 2 ,4-diaminoanisolc
                                                sulphate, or
  m-phenylenediamine base.

                              14
     Although extensive epidemiological studies have not been
performed for users of coal tar hair dyes, two studies on
breast cancer patients have been performed with conflicting
results. However, deficiencies have been noted in both
studies.

     In one study 1/ a New lork physician compared the use
of coal tar hair dyes   _..:ong his women breast cancer patients
to use of the dyes by women of the same age who did not have
breast cancer. The study showed that 87 of 100 breast cancer
patients had been longtime ;over 5 years) users of coal tar
hair dyes whereas only 26 percent of the women without breast
cancer were longtime users. The women ''are apparently matched
by age, but not by other factors which could affect the in-
cidence of cancer, such as smoking habits.

     In the second study 2/ 191 women with breast cancer and
561 women without breast cancer were matched according to
age, marital status, and social class. Althouoh data on
factors known to affect the incidence of breast cancer was
obtained from the women, the women were not matched according
to those factors. The study showed no relationship between
breast cancer and use of hair dyes.

     According to the October ].7, 1977, EDF petition to FDA,
the second study is inadequate because of the short followup
p _lod. EDF maintains that the latent period fr development
of cancer after exposure to hair dye use will probably be
over 15 years, but too few women in the study had used hair
dyes for more than 14 or 15 years before cancer diagnosis to
make the data useful.


l/Shafer, N., and Shafer, R. W., "Potential of Carcinogenic
  Effects of Hair Dyes,' New York State Journal of Medicine,
  March 1976, pp. 394-396.

2/Kinlen, L. J., Harris, R., Garrod, A., and Rodriquez, K.,
  "Use of Hair Dyes by Patients with Brecst Cancer:  A Case
  Control Study," British Medical Journal, 1977, vol. 2,
  pp. 366--368.




                              15
                          CHAPTER 3

              NEED TO REPEAL HAIR DYE EXEMPTIONS

     Although coal tar hair dyes expose consumers to poten-
tially serious hazards, FDA cannot effectively regulate them
because it lacks adequate legislative authority.  The FD&C
Act requires cosmetics to be properly labeled and to be un-
adulterated.  However, coal tar hair dyes whose labeling con-
tains a prescribed statutory warning concerning possible skin
irritation and blindness are exempt from the adulteration pro-
visions of the act.  Because the labeling of most such dyes
bears the statutory warning, they are generally exempt from
FDA regulation under the adulteration provisions even if they
pose hazards, such as cancer, not covered by the statutory
warning.

COAL TAR HAIR DYE EXEMPTIONS

     Section 601(a) of the act states that a cosmetic shall
be deemed to be adulterated if it bears or contains any
poisonous or deleterious substance that may render it in-
jurious to users under normal use. It further states, how-
ever, that:
     "* * * this provision shall not apply to coal-
     tar hair dye, the label of which bears the
     following legend conspicuously displayed there-
     on:    'Caution--This product contains ingre-
     dients which may cause skin irritation on cer-
     tain individuals and a preliminary test accord-
     ing to accompanying directions should first be
     made. This product must not be used for dyeing
     the eyelashes or eyebrows; to do so may cause
     blindness.', and the labeling of which bears
     adequate directions for such preliminary test-
     ing.1"
According to the November 1974 issue of the FDA Consumer,
an agency periodical, the coal tar hair dye exemption was
granted because industry persuasively argued that while
the dyes could not meet safety standards of the FD&C Act,
they should nonetheless be sold to meet popular demand.

     Since July 12, 1960, the Color Additive Amendments to
the FD&C Act (Public Law t6-618) hare required the estab-
lishment of regulations listing color additives that are
safe for use in food, drugs, and cosmetics. Under these




                               16
amendments, FDA must approve a color additive for safety
before its use in cosmetics is permitted.  However, coal
tar hair dyes were granted an exemption from the color
additive provisions of the FD&C Act. Under section
                                                    601(e),
a cosmetic is considered adulterated:

     "If it is not a hair dye and it is, or it
     bears or contains, a color additive which is
     unsafe within the meaning of section 706(a)."

     The U.S. Court of Appeals, Second Circuit, ruled in
the 1969 case of Toilet Goods Association v. Finch (419 F.
2d 21 (1969)) that the-above exemption-aoes not apply
                                                       to
coloring ingredients in hair dyes not derived from coal
tar, such as the metallic and vegetable dyes.  The court
noted that the legislative history of the Color Additive
Amendments contained no indication that the Congress
                                                      in-
tended to broaden the 601(a) exemption.

     Under section 602 a cosmetic is considered misbranded
if its labeling is false or misleading in any particular.
Coal tar hair dyes are not exempt from the misbranding
                                                       pro-
visions of the act.
EXEMPTIONS HINDER EFFECTIVE REGULATION

     Many coal tar hair dye products contain ingredients
                                                          that
have been shown to cause cancer in humans or animals.
                                                        Ordi-
narily FDA could ban the use of such ingredients in
                                                     a cosme-
tic product under the adulteration provisions of the
                                                      act, if
the substance may cause cancer under the conditions
                                                     of use
of the cosmetic.  Because of the exemption, however,
not ban the use of a cancer-causing coal tar hair dye FDA can-
                                                       even
if the evidence suggests that the dye is a human carcinogen,
such as a hair dye containing a benzidine-derived azo
                                                       color.
     In recognition of this problem, FDA in 1963 issued reg-
ulations defining the conditions under which the exemption
applied.  The regulation excluded from the exemption any
coal tar hair dyes which posed a hazard that was different
from those covered by the statutory warning (28 F.R.
                                                     6439,
June 22, 1963).  According to the regulation,

    "If the poisonous or deleterious substance
    in the 'hair dye' is one to which the cau-
    tion is inapplicable and for which patch-
    testing provides no safeguard, the exemp-
    tion does not apply * * I




                             -7
A patch test is a test on the forearm, on the bend of the
elbow, or behind the ear to detect allergic sensitivity.

     However, in the 1969 case the U.S. Court of Appeals
upheld a district court ruling (278 F. Supp. 786) invalidat-
ing that portion of the regulation. The court of appeals
found that

     "The Government's argument should indeed be
     appealing to a legisla':or--what good is the
     warning to make a patch test if the test will
     not disclose the danger? But a court must
     take the statute as it is, and Congress wrote
     with great specificity. Whether it relied
     solely on the patch test warning because it
     was unaware in 1938 that coal-tar dyes might
     have damaging effects not detectable by such
     a test, as the Government asserts but the
     industry denies, OL because it thought such
     instances so rare as not to warrant indenta-
     tion of the exemption, the language is too
     clear for us to read it as meaning something
     different from what it so plainly says, at
     least in the absence of persuasive legisla-
     tive history."  (419 F. 2d 21, 29 (1969))

     Thus the court ruled that even if a coal tar hair dye
were found to cause cancer or some other adverse effect
which would not be detected by a patch test, the dye could
not be removed from the market under the adulteration pro-
visions of the FD&C Act if the products' labeling bore the
statutory warning.  In 1971 FDA revised the regulation to
delete the objectionable statement (36 F.R. 16902, Aug. 25,
1971).

     In the opinion of an FDA attorney, FDA could probably
require under the misbranding provisions of the act that an
additional warning be placed on the labeling of coal tar
hair dyes posing hazards under conditions of use, such as
cancer not covered by the statutory warnings.

     However, because section 601(e) exempts coal tar hair
dyes from the color additives provisions of the act, FDA
cannot require the manufacturers of these hair dyes to prove
the safety of their products under the color additive re-
quirements, and, therefore, FDA has the burden of proof for
any additional label warnings it may require.  By contrast,
FDA can require the manufacturers of colors used in metallic
and vegetable hair dyes to prove the safety of their colors


                              18
because the law does not similarily exempt these hair
                                                      dye
products from the color additive requirements.

     In its October 17, 1977, petition to FDA, EDF asked
agency to require the following warning on labels of coal the
tar hair dyes containing 2,4-diaminoanisole.

     "This product contains the chemical 2,4 DAA
     [2,4-diaminoanisole], which can enter your
     bloodstream through your scalp and has been
     shown to cause cancer in animals."
FDA is considering this matter. As of October 31, 1977,
had not responded to the petition or taken action to       FDA
                                                      require
cancer warning labels on other coal tar hair dyes containing
known animal carcinogens, such as toluene-2,4-diamine
                                                       and
FD&C Red No. 2.

CONCLUSIONS

     Many coal tar hair dyes contain known or suspected car-
cinogen; that pose a potential hazard to the consumer
                                                      because
they may be absorbed through the skin and scalp. However,
the exemptions in the FD&C Act do not permit FDA to effec-
tively regulate coal tar hair dye products in that they
                                                         bar
FDA from banning or restricting the use of coal tar hair
that may cause cancer under the conditions of use.        dyes

     Although coal tar hair dyes are subject to FDA labeling
requirements, the agency has not used this authority
quire a cancer warning on labels of coal tar hair dyesto re-
                                                        con-
taining known human or animal carcinogens. The issuance
such regulations is made difficult by the fact that the of
of proof for their need rests with FDA, rather than the burden
                                                         manu-
facturers. If the coal tar hair dye exemptions were
                                                      repealed,
the color ingredients used in these dyes would be subject,
similar to other color additives, to premarket approval
FDA for safety and manufacturers would have to prove     by
safety of the colors.                                the

      In February 1974 testimony before the Subcommittee on
Health, Senate Committee on Labor and Public Welfare,
supported the elimination of the exemptLins.           FDA
                                               FDA testified
that:

    "coal tar hair d-es should not receive privileged
    treatment but should be subject to the same regu-
    lation and safety appraisal as other cosmetics."




                             19
     Therefore, to strengthen regulation of coal tar hair
dyes and to provide a greater measure of protection to users,
the exemptions should be repealed.

RECOMMENDATION TO THE SECRETARY, HEW

     We recommend that the Secretary, HEW, direct the FDA
Commissioner to evaluate safety data on coal tar hair dye
ingredients and require, where applicable, a cancer or other
appropriate warning on product labels.

RECOMMENDATION TO THE CONGRESS

      To permit FDA to better regulate coal tar hair dyes,
we recommend that the Congress repeal exemptions in sec-
tions 601(a) and 601(e) of the FD&C Act concerning these
dyes.




(10859)                       20
                              20