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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).
https://truebotanicals.com/pages/clinical-trial-results-clear-collection
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?
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7 Replies
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They are doing a fantastic marketing job on the beauty bloggers. I was unable to find complete ingredient lists.
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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.
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I suspect someone will report them for selling a misbranded drug.
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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
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Acne Treatment is a drug claim so sooner or later they will get nailed
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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”
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Also I’m wondering why they’re not disclosing what lab performed the trials, aren’t they required to?
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