2004N-0556
  

  
 Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC33
  



  

  
Submitter : 
  

  
Mr. Frank C  Sadlo
  

  
Date & Time: 
  

  
02/17/2006 01:02:20
  



  

  
Organization : 
  

  
Oceans Seven, Int'l
  



  

  
Category : 
  

  
Device Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
      I would like to submit the following comments in reference to Docket No. 2004N-0556 - Condom Labeling, regarding 'Typical Use' and 'Proper Use' of the barrier methods:   



     TYPICAL USE: Page 24 of the Draft Document for this Docket shows examples of possible new labeling recommendations. In reading the Statement proposed for the condom package Insert, under Pregnancy Rates for Barrier Birth Control Methods:  

'Typical Use' rates mean that the method was not always used correctly or was not used with every act of sexual intercourse or was used correctly but failed anyway.'  

     I believe the average consumer looking at the package Insert would absorb the message much easier if the language of the statement was simplified (for example: if the 'not, or, not, or, and  but' conjunctions used in the single sentence were listed as something such as:  

 

'Typical rates' include that the method was:  

1) not always used correctly, or   

2) was not used with every act of sexual intercourse, or  

3) was not always used correctly but failed anyway   



     PROPER USE: Additonally, in line with the 'is it half-empty or half-full' perspective, I believe it would be helpful to consumers to add a statement such as:   

 

for 'Non-typical' users who are careful to:  

1) always use the method correctly, and/or  

2) use the method with every act of sexual intercourse  

the rates are... (thus, also listing on the package Insert the Rates for Non-typical Users who are careful to use the method correctly and who use the method with every act of sexual intercourse).    



     Listing the Rates for those who are careful to use the method with every act of sexual intercourse and/or always use the method properly would present a more accurate picture for users in this group. Of course, a major goal of labeling and precautions on packages is to encourage proper use every time the method is used. Thus, also showing the Rates for proper usage, wherein the product should be shown to be more effective, should serve to further encourage proper usage.