ࡱ> KMJ` bjbj 74PPPPPPPd8@Td ttR T T T T T T $ h1 x Px PP * * * FPPR * R * * PP* h p!0"* R 0 * " * P* (* x x   dddddddddPPPPPP The Labeling of Latex Condoms with Nonoxynol-9 We are especially concerned about the appropriate labeling of latex condoms to reflect the dangers associated with the use of N-9 in latex condoms and the protection against HIV/AIDS, STIs, and other STDs. Appropriately, the draft guidance for latex condoms with nonoxynol-9 (N-9) indicates that the N-9 lubricant does not protect against HIV/AIDS or other sexually transmitted diseases. Studies show that even at low doses, spermicides containing N-9 can cause massive, short-term damage to the rectal epithelium (lining), thereby increasing an individual's risk of contracting HIV and other STIs during anal intercourse. Therefore, we would like to express our great disappointment that the FDA has not banned the production of condoms lubricated with the N-9, and urge you to do so. These condoms have not been proven to provide any additional protection against pregnancy and have been shown to potentially increase risk of contracting HIV if the condom is used rectally, thereby posing a significant health hazard. However, if the FDA decides to take its current approach to labeling condoms with N-9, then the retail package and individual condom foil package should prominently warn consumers that Frequent use (more than once a day) of the spermicide nonoxynol-9 (N-9) can irritate the vagina, which may increase the risk of getting HIV/AIDS from an infected partner. N-9 can damage the rectum and may increase the risk of getting HIV/AIDS from an infected partner. You should never use condoms with N-9 for anal sex. Because N-9, when used vaginally multiple times a day, can cause genital lesions and because of the proven danger of the use of N-9 condoms for anal intercourse, we strongly believe that this warning should appear more prominently on the retail package and on the individual condom foil package. Should you have any questions or comments, please feel free to contact Carl Schmid, Director Federal Affairs for The AIDS Institute at (202) 835-8373 or cschmid@theaidsinstitute.org. Sincerely,  Dr. A. Gene Copello Executive Director The AIDS Institute (gcopello@theaidsinstitute.org) cc: Mr. Carl Schmid, Director of Federal Affairs, The AIDS Institute (cschmid@theaidsinstitute.org) TAI FDA Condom Labeling Comments Page  PAGE 1 ./ C 0 1 ^_$%&  ˣtdtW@t-jh|h070JCJOJQJU^JaJh|h070JCJaJh070JCJOJQJ^JaJ$h|h070JCJOJQJ^JaJhEjh075U\h\lh07OJQJ^Jh{4h07OJQJ^J!hjQh075>*OJQJ\^Jh07OJQJ^JhjQh07OJQJ^J)h{4h075>*CJOJQJ\^JaJ#h075>*CJOJQJ\^JaJ/ 0 1 56^_`$&:M`L1$7$8$H$^Lgd07 1$7$8$H$gd07`gd07gd07gd07$a$gd07 1$7$8$H$gd07¾hEh07 h|h07CJOJQJ^JaJ)h070JCJOJQJ^JaJmHnHu-jh|h070JCJOJQJU^JaJ50P:p07/ =!"#$% DDd 8 &P  S A"RzC 6 HI8dVCDFNC 6 HI8dJFIF Photoshop 3.08BIMx(HHR[ (424P'd0@!5L2 8BIM8BIM x8BIM8BIM 8BIM 8BIM' 8BIM5-8BIM8BIM@@8BIM8BIMu Untitled-18BIM8BIM8BIM p,P9JFIFHHAdobed            ,p"?   3!1AQa"q2B#$Rb34rC%Scs5&DTdE£t6UeuF'Vfv7GWgw5!1AQaq"2B#R3$brCScs4%&5DTdEU6teuFVfv'7GWgw ?*iM,mUT` kZѵck4IJMŲ7 op ?UN[pl-[^5oqvϴ^>_51>on .boS3VNײ=\oԧIaquedTUkXk^Zkd<m~&-ĔI%)% }_e!kF{kZ <3qۓKyp8cUe1{,bJLI$$I)T\ל*3zPnen̻M`}4})Gu773}_sFޤ[.pd]]U[vUާVв32S֌l[nscqMBe~ҷ2O'zfOJ="A2QvV+eo+xoFCkڲz}O:zrhet_)܏Jjh%h}ͣ~g&mfJla>KdXq_`] W.f>bYeWUWvE6?^ֆd;OkL7,6;z?Où :uc$mUFed} agmUԿ+ԧ3z2p6]Ѻf+{+-v]/&2Lz(g}FI`S>[,uu-e{!UvUaWv-s+ɱ~ O|:2gRcٛOn;ld1n=}?ϷWgI)_Ttl鵿O9[-g SzX5c zZ ~MvƱlX=A\+iŦݵ06w㶛r_F_?h 7Ӳ_?X=@-yUP7b=2Zsz~ 5u ,M{J{,0)m˟cTR6[kʪԾ*ǪW92rWq*vM76ʞKtdwbYsُ?o۵;0' 7 >o̸n32ݓU9 }/}˺=\m7խOs6`>i̎RzAdՌexAۮsheߕzUzK5f-v_r/u-YbUUfXkZ=wW^4SO?tZsj,=Fsmzgo>0fS͔e11jջv;gceZŠJhzf=M;~ݙ7oyh\kXJ+tU2Xڪֵk75i$$:Jak { @st"Gjа_݉MneoHosURI$I%?8BIM!UAdobe PhotoshopAdobe Photoshop 6.08BIMAdobedC ; s!1AQa"q2B#R3b$r%C4Scs5D'6Tdt& EFVU(eufv7GWgw8HXhx)9IYiy*:JZjz?6lٳf͛6lٳf͛6lٳf͛6lٳf͛6lٳf͛6lٳf͛6lٳf͛66lٳf͛6lٳf͛6lٳf͛6lٳf͛6lٳf͛6lٳf͛6lٳf͛?6lٳf͛6lٳf͛6lٳf͛6lٳf͛6lٳf͛6lٳf͛6lٳf͛66lٳf͛6l18+(?3yIo]k+b ]GjBsf͛6lٳf͛6lٳf͛6lٳf͛6lٳf͛6lٳf͛66lٳf͛6l/յm3Aҵ=s[-EW.Xm4*$hǚ4]oFM_ɒ_O.hm1Chj%CUѕ2>͛6lٳf͛6lٳf͛6lٳf͛6lٳf͛6lٳg6lٳf͛6l99AݯJ~eO8C ڄWߦ`{mɢ $nX-N=Hdy).u?8htWllg|do՜U=$y.o#`}͛>1{%$> `A1ZT*~#ʀҠWq]Ry_IWwt=0^>KjY_I~D'rk6lٳf͛6lٳf͛6lٳf͛6lٳf͛6lٳf͟6lٳf͛6xsr+R?:?4?=?9/~dX`7&}N>,F *?3,'sy,ՅldO% Crl=۟,'4?Oğmum_RϞst8ldL,:. +Sfύ?r/r+qS~r<˫_IeoժR\fm/⿾??#?-u)yHJҴXlٯ5X`_N gH5VWHxe/9on&.iRk]YhUq$C?~xyW~]@|͢C'94G.-dV+fY3f͛6lٳf͛6yrgro^Wo2y}O^EjlȀѣQ)pK59~#Kzյ7jI3^T.Dsq(Ln5 qJ5O̽fYKSOH’J$ī7O ^yQ'=iwд8V[jFy?“QS%f͛6l6lٳf͞6?)'uko83韖7p4нڴYu-RzvԌ'xFc{?2 <Z _U[i"9w{yK k[F!XC$1&-Ԉ#r %P6|ђ~c=Ԛ7ln"ID vd'Gޔ<+_^d4_8ybOH:.\][aBhDY~jy|2yzF9zL4hY?wiY=:C"{cTv` |Uf͛6lٰZִ-Xũ/XT,ƈHʈ;>~Ph``>gO,ݥݤZN'GPݲZ͠zhY~yssBMu]9]l|};˾Z7#k7/ F#g-ewGgca7s0H%.v $ϖּA~{G[]{c7n*Tqٳ]<?j5 l4)I}ug#mWP*$e!ce_[lٳf͛6lٲ#!7Fmec9䫻X̻{7GYՄ>L<8iK89g2_Ju B X`aI z61%<Uweߘ^smGL=n'B0,XYf84$XBG6 ~|kZqYu7.[? 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