Would not have guessed this was a medical device

PerryPerry Administrator, Professional Chemist
I just learned that personal lubricants are classified by the FDA as a medical device.

Who knew?


  • That definition is...excruciatingly in depth and specific.
  • DavidWDavidW Member, PCF student
    Have made many, never knew.
  • MarkBroussardMarkBroussard Member, Professional Chemist
    edited January 2016
    Yes, the FDA really focused on personal lubricants over the past year, so these are relatively new regulations.  Basically, a personal lubricant now has to meet the same criteria as lubricants used on lubricated condoms.  So, quite a few products had to be pulled from store shelves until they passed the required testing.  As if the government didn't have more important things to take of.  
    Chemist/Microbiologist formulating in the Organic & Naturals & Clean Beauty arena under ECOCert/Natural Products Assn/Whole Foods/National Organic Program/Clean At Sephora/Credo Clean guidelines focused skincare & haircare products. 

    See website for details www.desertinbloomcosmeticslab.com
  • DavidWDavidW Member, PCF student
    I used to make a spray fixative for microscope slides for a company.  I think it was sold to gynecologists offices.  Turns out this was a medical device too.
  • I have a question kind of regarding this. Would creams, washes, or masks that are sold to be use in the genital area be considered a medical device? Also would something sold to treat ingrown hairs need to labeled and tested as a cosmeceutical? 
Sign In or Register to comment.