This guidance was written prior to the February 27, 1997 implementation of FDA's 
Good Guidance Practices, GGP's. It does not create or confer 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 the applicable statute, regulations, or both. 
This guidance will be updated m th n&  revision to include the standard elernent s of GGP7s.  - .   $5 
,- 
.'"r  %J 
<\O 
. 
- 
DEPAltT.\l ENT OF HEALTH & HUAIAN SERVICES  7 06  q.  Pubk Health Snvice 
- 
- .   .  Food and Omg Administration 
APR  71981:  -  Rockvilla MO 20857 
.. 
To:  A11  U.S.  Condom Manufacturers,  Impo.r ters and Repackagers 
. 
- .  
Because of  the heightened interest i n  reducing the risks of 
acquiring sexually transmitted diseases  (STOs),  including Acquired 
Immune Oef icie ncy  Syndrome  (AIDS) , the Food and  Drug  Administration 
(FDA)  is prdviding this guidance t o  manufacturers,  importers and 
repackagers  of condoms. 
Ifd esigned,  manufactured  and  tested properly,  the condom  i s  a 
barrier that may  prevent the transmission of STDs.  With the spread 
of  STDs,  it has  become  very important that users be  fully aware that 
latex condoms  provide protection,  but do not guarantee  it, and  that 
protection  i s  lost i f  condoms  are not used properly.  Given the 
urgent pub1 i c  heal th concerns  regarding this issue,  FDA urges your 
cooperztion i n  informing consumers  about realistic expectations  they 
should have r-egardlng the protection afforded  by condoms,  and  i n  
educating them  about  how condoms  should be used to maximize 
-protection against IsT~~--- ;- ----------- 
I 
I F  you are currentdl y marketing a latex condom  and wish to claim that 
your  product  provi es protection against  STDs , you  should -jnclu de 
appropriate la bel itig that ref1e  cts  accurately the real istic 
expectations  a  condumer should have about the condom's 
effectiveness.  An exarnpl e of such  labeling appears  i n  Attachment  A. 
Natural membranei day  have a different permeability than latex and' 
may  not lend themselves t o  the same degree of unifonity i n  
manufacture as  syn$hetic materials such  as  latex.  In the interest 
' 
of  prudence,  thereqore,  FDA  i s  requesting that you not label .natural 
. 
membrane  condoms  fqr  protection against  STDs 
I 
- 
FDA  is a1 so  requesding that  a1 1 condoms,  whether  they are 1a  belled 
for  protection zgailnst  STOs  or not,  and whether made  from latex, 
natural membrane,  9r   any  other material,  includk adequate 
.  instructions  for  u e  t o  maximize the degree of  protection they 
-  afford.  An  examp1 4 of  such  instfuctions  for use to provide 
protection against STDs .appears i n  Attachment  8. 
1 
If YOU  are currentljy marketing  a condom you may  change  the labeling  . 
and  instructions  fc/r%se of Your  product to implement  the guidance 
-  provided i n  this  lqtter without  seeking clearance  from  FDA. 
However,  you must dbtain clearance  from  FDA if   you wish to modify 
significantly your condom's  design or manufacturing,  or i f  you wish 
to use label ing si$nificantly  different  Prom  that shown  i n  the 
d tt achments..  I 
For  example,  you will 1  need  FDA  clearance  if you wish  to make  claims 
that your  condom  i s  better than other condoms  or that  i t  i-s 
d 
specifically desig ,ed  for AIDS.  A l l   new manufacturers  of condoms 
are  a1 so  required  tlo  obtain FDA  clearance.  -. -  'Attachment  A 
An  acceptable statement of  intended use  for  the prevention of 
1 . transmission of  sexually transmitted diseases  follows: 
.I  ' 
"When  used properly,  the latex condom may  prevent 
the transmission of many  sexually transmitted 
diseases  (STDS)  such as  syphil is,  gonorrhea, 
chlamydia1 infections,  genital  herpes,  and  AIDS. 
It cannot  eliminate the risk.  For maximum 
piatection,  it is important to follow the 
accompanying  instructions.  Failure to do  so may 
result. i n  loss of protection.  Ouring intimate 
contact,  lesions and  various body  fluids  can 
transmit STDs.  Therefore,  the condom  should be 
." 
appl ied before any  such contact 
Oifferent  wording may be employed,  but the wording  should convey 
a balanced description of  risks and  benefits,  and  there should be 
a  warning  about  the loss of protection resulting from  improper. 
.use. 
# 
- 
. 
.--' -ArEItceptabl e  statement  of intended -use for prevention of -  I 
' 
pregnancy could be similarly constructed,