Can you market a non-drug as an "acne fighter or acne solution" in the US based on a clinical trial?

I just stumbled across the brand True Botanicals where they're boldly presenting their clinical trial data vs proactive showing that their 4 product $$$ regimen was superior to proactive long term (Albeit the results are not impressive and could likely be bested by one product IMO).

None of their products are OTC drugs, but they're marketed as acne fighters or acne solutions; can they do this or are they begging for a warning letter?


  • BelassiBelassi Member, PCF student
    They are doing a fantastic marketing job on the beauty bloggers. I was unable to find complete ingredient lists.
    Cosmetic Brand Creation. Concept to name to IMPI search to logo and brand registration. In-house graphic design inc. Pantone specs. Cosmetic label and box design & graphics.
  • MicroformulationMicroformulation Member, Professional Chemist
    You have to dig down into the website to find the ingredient lists but they are there.

    They use some careful terminology (for acne prone skin), but I think they are playing it pretty close. However, they also come out and clearly ay "Acne treatment." This makes them noncompliant in the US Market.

    In summary, unless a product is not specifically listed in the Acne OTC Monograph, it can NOT be marketed for the treatment of acne. Period. They could use the data as part of a New Drug Application (NDA), but the Botanicals aren't patentable, their data is a mere sliver of what is required and the process is lengthy.

    They may not have been caught. Never mistake "not caught yet" with legal and allowed. Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications. BS.Pharm Albany College of Pharmacy, Union University.
  • PerryPerry Administrator, Professional Chemist
    I suspect someone will report them for selling a misbranded drug.
  • ZinkZink Member
    It surprises me that Unilever invested in them, who you would think would like to do things as kosher as possible.

    I like the idea of 3rd party efficacy trials though, but here they're not even disclosing who the 3rd party is. Consumerreport did something similar for acne treatments in 2011

  • Acne Treatment is a drug claim so sooner or later they will get nailed
  • Agreed - the FDA is doing a more thorough job these days looking at websites and claims. they actually now consider a website as a "label"
  • ZinkZink Member
    Also I'm wondering why they're not disclosing what lab performed the trials, aren't they required to?
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