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B-164031(2).152 1 (1978-05-31)

handle is hein.gao/gaobadoqu0001 and id is 1 raw text is: 

                                                                      1 047
iN             COMPTFOLLER GENERAL OF THE UNITED STATES                                         047 ,.
                          WASHINGTON, D.C. aoN8




8-164031(2).152                                     si sia 7.,



,he Honorable arrison A.. Williams, Jr,                                                          li'i
Chairman, Committee on Ruan Reources
united States Senate

Dear Mr. Chairmn:                                                                                   4

     We have rmviewd S. 2365, a bill to mend the Federal Food, Drug,
and Cosmetic Act (FD&C Act) with respect to comMtic safety, as
requested by your letter of January 11, 1978. We beleve the bili
could b. strengthened by providing the Fodd and Drug Aduzi tration
(FDA) additional authority to regulate coal tar hair dyes and coetic
preservati ves *l.

     Many of the colors used in coal tar hair dyes are Ixmu to cause
or suspected of causing camer and there are indicatilos that these
colors may be absorbed through the scalp, thereby posiug a potential
hazard to eousu    . Ezetins gr ted to eal tax hair dyes tider
sections 601(a) and 601(e) of the YD&C Act currently prevent FDA from
effectively regplating these dyes. Although S3 2365 would repeal lbs
601(s) exetion, the 601(e) ezemption would r eman in effect..

     Since July 12, 1960, the color additves atanduents to the FD&C
Act have required the establ19hent of reulatione listing color
additive. that are afe fo r use in food, druts, aud cosetice. Under
these seudments, FDA must approve a color additive for safety before
Its use in cosmetics is permitted. Heowever, section 601(e) of the Act
exepts coal tar hair dyes from these requirenents.

     We believe that coal tar hair dyes should be subject to the same                             [
regulation and safety appraisal as other cosmetlis. Our report of
December 6, 1977, to the Chairman of the Subcomittee on Oversight and                             ',
Investigations, Comittee on Interstate and rorfeign Comaeree,. Uiited                           [''(
States House of Representatives, entitled Cancer and Coal Tar  yes:                               Q.
An Unaregulated lazard to Consumers, recommended that the Congress
repeal the esemptions in both sectlos 601(a) and 601(e) of the VD&C                                 1
Act to enable FDA to better repulate coal tar har dyes. Woe therefore
reconomd that S. 2363 be amended to repeal the exemption in section


     We also believe that it is necessary to prove the effectivenass
 of preservatives used in cosmetics. S. 2365 foud not provide FDA


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