Regulatory Open Forum

 View Only

  • 1.  Question about US cosmetic and Internal use

    Posted 24-May-2023 06:36
    Are cosmetics in the US allowed to be used internally in the US? I’m excluding oral products in this case. I believe the EMA specifically states external use but am a little unclear about the US.


  • 2.  RE: Question about US cosmetic and Internal use

    Posted 25-May-2023 07:58

    Hi Christine.

    By definition in the US, a cosmetic cannot be ingested.  Check out the definition in the law and the regulations and the definition only allows for external use (poured, sprinkled, rubbed, etc.) none of which are considered internal or ingestible.



    ------------------------------
    Victor Mencarelli MS
    Global Director Regulatory Affairs
    New YorkNY
    United States
    ------------------------------

    Original Message


  • 3.  RE: Question about US cosmetic and Internal use

    Posted 25-May-2023 10:15

    Hi,

    FDA defines cosmetics as 
    "What is a cosmetic? The FDA defines a cosmetic as a product (excluding pure soap) intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance." Any ingestible will have to fulfill OTC monographs or DSHEA (Dietary supplements). 
    Cosmetic Overview for Imported Products

    U.S. Food and Drug Administration remove preview
    Cosmetic Overview for Imported Products
    This page provides an overview of cosmetics and the requirements that the FDA verifies/enforces at the time they are imported or offered for import into the United States. The FDA's Center for Food Safety and Applied Nutrition (CFSAN) Office of Cosmetics and Colors is responsible for overseeing the cosmetic program.
    View this on U.S. Food and Drug Administration >

    .

    If you are looking for ingestibles and using nutritional ingredients, I suggest for you to leverage DSHEA.  



    ------------------------------
    [Robert] [Falcone] PhD, FTOPRA, FRAPS
    ------------------------------

    Original Message


  • 4.  RE: Question about US cosmetic and Internal use

    Posted 25-May-2023 23:13

    It should be for external use.    

    The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product. 



    ------------------------------
    Aimei Wu RAC
    Manager, Product Safety and Regulatory Affairs
    Southlake TX
    United States
    ------------------------------

    Original Message


Related Content