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Fine line between cosmetic and “drug” claims
I want to say that my deo “changes your microbiome.”
What do you think, would that be too much like a drug claim, not a cosmetics claims?
Anyone knows that kind of microbiome-related descriptions are allowed or not?
I had read that stuff like “antimicrobial” is really not allowed as cosmetics (is that true? But I feel like I’ve seen those. But maybe those were cosmetics/OTC dual).
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8 Replies
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Pretty sure that would not be a drug claim - but give me break. That’s BS.
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What’s BS? That it changes your microbiome? It’s definitely not a BS. I’m a microbiome scientist.
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Yes, anti microbial claims are not allowed for cosmetics in the US.
Microbiome claims are not likely to be considered drug claims. But I could envision a lawsuit in the future against microbiome claims, so if you’re going to make the claim you should have some way to prove what you’re saying is true. I don’t think these would be considered “puffery”.
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I have a concrete reason to believe that my thing changes people’s microbiome.
Nevertheless, FDA says:
articles (other than food) intended to affect the structure or any function of the body of man or other animals
are drugs.
Are antiperspirants and sunscreens considered cosmetics?
Because the FDA also has this funny statement:
“Among other cosmetic/drug combinations are […]deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims. Such products must comply with the requirements for both cosmetics and drugs.”
I’m a bit confused here-do they mean that if you want to sell an antiperspirant or sunscreen you need to show human data a priori?
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The FDA has a classification called OTC (over the counter) Drugs. So, a product can be both a cosmetic and a drug. If you sell an antiperspirant, sunscreen, anti-dandruff product, toothpaste with fluoride, etc. These are all considered both drugs and cosmetics. You have to follow the FDA monograph for the specific product. It specifies the active ingredients you can use (and the amounts) plus the claims you can make. See this post for a full list. Cosmetics that are drugs
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Yeah, I was reading from there.
So I’m making deo sprays, I do want to include stuff that helps cooling to hopefully cut down sweat like menthol or menthyl lactate, but I will be careful with claims around that, if any.
I think you have seen a lot in the industry to know that “changes your microbiome” is unlikely to be considered a drug claim in cosmetics when the product actually does that. Thanks!
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Love to see the ‘concrete reason.”
To your question - the relevant OTC drug monographs establish data requirements needed you need to market.
https://www.fda.gov/drugs/otc-drug-review-process-otc-drug-monographs
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I haven’t seen this thread from the FDA, thanks for bringing this to my attention.
I look forward to the day when I “out” my thing and hear your final verdict. ????
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