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Salicylic Acid Regulations
Hi guys!
I’m Canadian so I’m looking for some solid advice on FDA regulations. I’m developing a gentle 1% Salicylic Acid serum which in Canada can be easily marketed as a cosmetic as it’s < 2%. If my marketing terminology is related more to texture and smooth skin and not acne - is it still considered an OTC in the United States. I’ve searched through the forum/internet and I haven’t gotten a ton of clarity on this.
Thanks!
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7 Replies
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Hi Jonah,
It is my understanding that using Salicylic Acid in concentrations of 0.5 - 2% is classified as an OTC drug in the United States, regardless of the product’s marketing. I believe it is only acceptable in cosmetics when included as part of a preservation system.
You may consider using White Willow Bark extract/powder instead, although you will have to research its efficacy.
I am not an expert and could very well be wrong.
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@Camel I guess I find it confusing because it doesn’t seem like the majority of products are registered drugs like the SA serums from The Ordinary for example. I wonder though is it a similar situation like in Canada where the claims do have an effect on the classification - drug claims or cosmetic claims.
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@JonahRay I just took a look at CeraVe products that contain SA. They make no claims about acne and aren’t labeled as an OTC, but they also don’t share what % of SA is in the product.
Hopefully someone more knowledgeable can help with this!
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If you are making Acne claims, then the SA range for OTC Acne products is 0.5% to 2.0%. If you are not making Acne claims, then you can use SA in this range as a cosmetic product … describe it as an product for exfoliation.
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@MarkBroussard Jeez I feel like it’s so unclear with the FDA whereas Health Canada lays it out it in a table haha. Okay so a 1% SA serum with claims of exfoliation is a cosmetic according to the FDA (sorry to clarify one last time)?
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Correct, a 1% SA serum with claims of exfoliation can be sold as a cosmetic product provided you make no mention of acne in your labelling, marketing & advertising.
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Canada allows up to 2% but consider labeling as well as claims. You need to add the warnings and they will check once you notify them.
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