Home Cosmetic Science Talk Formulating Cosmetic Industry Can you market a non-drug as an “acne fighter or acne solution” in the US based on a clinical trial?

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

    Posted by Zink on April 12, 2017 at 11:16 pm

    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?

    Zink replied 7 years, 2 months ago 5 Members · 7 Replies
  • 7 Replies
  • belassi

    April 12, 2017 at 11:55 pm

    They are doing a fantastic marketing job on the beauty bloggers. I was unable to find complete ingredient lists.

  • Microformulation

    April 13, 2017 at 1:40 am

    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.

  • OldPerry

    April 13, 2017 at 1:52 am

    I suspect someone will report them for selling a misbranded drug.

  • Zink

    April 13, 2017 at 2:28 am

    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 http://www.consumerreports.org/cro/2011/11/review-of-acne-treatments/index.htm


    April 13, 2017 at 3:23 am

    Acne Treatment is a drug claim so sooner or later they will get nailed

  • Anonymous

    April 13, 2017 at 2:07 pm

    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”

  • Zink

    April 18, 2017 at 10:26 pm

    Also I’m wondering why they’re not disclosing what lab performed the trials, aren’t they required to?

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