drug vs cosmetic claim regarding eczema

mhart123mhart123 Member
Would these be considered cosmetic claims?

"deeply nourishing for sensitive, eczema-prone skin"
"balm that works to replenish, soothe, and restore your little one’s lipid-depleted, eczema-prone skin"

These are commercial products that are not OTC but have these statements on the label. I am working on a baby balm for a customer and they are wondering what kind of claims we can make regarding eczema-prone skin, however we are not using any OTC monographed ingredients for eczema.


  • PerryPerry Administrator, Professional Chemist
    This is more of a legal question than a cosmetic chemistry question. So, you'd get more reliable advice from a lawyer. 

    In my non-legal experience, however, if you mention "eczema" in your claim, you make your product a drug.  This is implying that your product will treat or prevent eczema.  That makes the FDA view it as a drug.

    This is a relevant read.
  • PharmaPharma Member, Pharmacist
    Depends also on the country you're selling in.
    As an example, Eucerin AtopiControl is okay in EU but in Switzerland, the word AtopiC in the name is enough to make it a drug, hence the Swiss version is called Eucerin AtoControl.
    Eczema may be genetic, which means either you've got it and therefore have eczema-prone skin (= need a doctor) or you don't have it (= don't need your product). Other forms of eczema may simply be cause by dry skin (= only need your product)... As layers usually say: Two layers, three opinions. Give your administration a call (would work here, dunno how cooperative yours is).
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