Home Cosmetic Science Talk Formulating General Salicylic Acid Regulations

  • Salicylic Acid Regulations

    Posted by JonahRay on February 14, 2022 at 1:30 am

    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!

    Rockstargirl replied 2 years, 4 months ago 4 Members · 7 Replies
  • 7 Replies
  • Camel

    Member
    February 14, 2022 at 2:10 am

    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.

  • JonahRay

    Member
    February 14, 2022 at 2:33 am

    @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.

  • Camel

    Member
    February 14, 2022 at 3:06 am

    @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! 

  • MarkBroussard

    Member
    February 14, 2022 at 12:16 pm

    @JonahRay

    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.

  • JonahRay

    Member
    February 14, 2022 at 12:18 pm

    @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)?

  • MarkBroussard

    Member
    February 14, 2022 at 12:51 pm

    @JonahRay

    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.

  • Rockstargirl

    Member
    February 14, 2022 at 11:24 pm

    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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