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Acne products in the US
Hi All,
So I appreciate that there is an FDA monograph for OTC acne products and to put claims on your label that your skin cream is for acne you must comply with the monograph in formulation, label and manufacturing requirements. Guidance around cosmetics appears to be not so well defined.
However, there are a lot of natural products (not in the monograph) out there that claim to have activity against acne…honey, tea tree oil etc etc. These would apparently require an NDA to be legally marketed for acne in the US but nevertheless some products may be available be they legal or not.
Can anyone comment on whether there are any cosmetic descriptions of acne you can claim that allow a product to remain a cosmetic in the US?
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4 Replies
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Honestly…I’d consult with a lawyer to be sure. But a lawyer’s job is to make sure that you’re completely safe, while you want to get much closer to the edge, so that might not be very helpful. The FDA has some good material to read about this.The big dividing line as far as I can tell is “appearance”. Anything that affects your appearance is ok, therefore “diminishes the appearance of wrinkles” is ok, but “tightens skin to remove wrinkles” is not, because it implies that you are changing the skin, which a cosmetic is not allowed to claim to do. Claiming “diminishes the appearance of blemishes/acne” might still be a problem, though, if you don’t have make-up type ingredients, since the FDA could decide that you are making a drug claim (changing the skin to reduce redness, for example)To be completely safe, the only thing I’d claim is “contains honey, tea tree oil, etc.”, and maybe say ‘for use on adolescent skin”. Or, I’d make a product with blurring microspheres, so that I could point to that ingredient and say that it’s the source of all of my “changing appearance” claims, while also adding “contains honey, tea tree oil, etc.”At one time, the industry was ok with: “Contains Honey. Honey has been used by Native Americans for centuries to combat Acne”, but I think most brands have abandoned that strategy as being too risky. -
You might try “blemish” or “blemish-prone”, but you’re skirting on the edge there. You cannot use the word acne anywhere on your labelling or advertising, obviously. In the US, it can also be found that your product is both a cosmetic AND a drug.
There is a really good reason why a new acne active has not been approved by the FDA in some 30 to 40 years. -
Thanks Bob and Mark,
Those are helpful comments and I appreciate the benefit of your experience!
Perhaps one day honey will make it into the monograph but I guess someone will have to petition the FDA and assemble the body of evidence to support it.
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I’m not so confident it will make it on to the monograph. If it worked demonstrably better than the current drugs (and it has undoubtedly been tested) I’m sure a big company would include it in a standard formula without making claims on it. But I could be mistaken about my predictions in the future. I often am.
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