Labeling Products with Salicylic Acid

Hopefully my question isn't too slly.  I have reviewed the monograph published by the FDA which stipulates activity levels for OTC drug products indented to treat acne.  What I am still confused on, however, is if I formulate a product containing 2% BHA but do not intend to sell the product as a drug (that is, do not intend to label the product as one intended to treat acne), do I still need to list BHA as an active ingredient on the label?  I suppose, in general, if the product I intend to sell contains the OTC salicylic acid, must it be labeled as a topical acne-care product, even if the intended use of the BHA is simple exfoliation and not " intended for use in the diagnosis, cure, mitigation, treatment, or prevention of [acne]"?

Thanks,
George.

Comments

  • @george:

    (1)  Cosmetic don't have "Active Ingredients" like OTC drug products.  So, no, you should not list BHA as an active ingredient if you are not making acne claims.

    You're treading on water where your product could be considered both a cosmetic and a drug due to the BHA at 2%.

    Perhaps you should consider a natural source of salicylates such as Wintergreen or White Willow instead a straight up Salicylic Acid.
    Chemist/Microbiologist formulating in the Organic & Naturals arena under ECOCert/Natural Products Assn/Whole Foods/National Organic Program guidelines focused skincare & haircare products. 

    Provides Formulation Development and Lab-Scale Contract Manufacturing Services.  See website for details www.desertinbloomcosmeticslab.com

  • @MarkBroussard
    Are you saying that where a more natural source is used, even though it could achieve the same results as the synthetic version, would easily pass as cosmetics instead of being termed as a drug?
  • In EU you are allowed to use up to 2% Salicylic acid in cosmetics, but you can't make a drug claim (see last blog by Perry)
  • @Braveheart:

    What I am saying is that the US OTC Monograph specifically states "Salicylic Acid" at up to 2.0% as the drug active ingredient in acne OTC products.  Since George stated he was using Salicylic Acid at 2.0% that falls right in light with the OTC Monograph.  So, it would seem very easy for the FDA to conclude that his product was both a drug and a cosmetic even if he is not making acne claims.

    Perhaps less so with a natural base of mixed salicylates.
    Chemist/Microbiologist formulating in the Organic & Naturals arena under ECOCert/Natural Products Assn/Whole Foods/National Organic Program guidelines focused skincare & haircare products. 

    Provides Formulation Development and Lab-Scale Contract Manufacturing Services.  See website for details www.desertinbloomcosmeticslab.com

  • @MarkBroussard:
    Thanks for the clarification.

    If I were George, then I would be using the ingredient at between 1.5 - 1.8%, that way the product would not be classified as a drug, even though the effectiveness may drop, I don't think it will be consequential to the integrity of the cosmetic aim.
  • The FDA also has a regulation that says, essentially, if you use an ingredient that's recognized by consumers as a drug ingredient, then your product falls under the drug regulations anyway, even if you are not making any claims at all, and the only place that ingredient is mentioned is on the LOI.

    As an example, I couldn't make a cosmetic product and put penicillin in it, even if it was only listed on the ingredient label and nowhere else.
    Robert Zonis, Sr. Formulation Chemist, Beaumont Products "All opinions and comments expressed are my own, have no relation to Beaumont Products, are fully copyrighted, and may not be used without written permission."
  • But... this leaves the situation wide open for the approach suggested by @MarkBroussard.

    If you use just enough Willow Extract to give you an effective level of 1.8% - 1.9% BHA, you are clear in every direction - as long as you don't make any drug claims.
    Robert Zonis, Sr. Formulation Chemist, Beaumont Products "All opinions and comments expressed are my own, have no relation to Beaumont Products, are fully copyrighted, and may not be used without written permission."
  • Hi everyone,
    I think OTC is a drug, so if we use 0.5~2% salicylic acid, the product would be a OTC drug even though you don't claim it as a drug, right ? In my understanding, OTC products must comply with both cosmetics and drug 's regulations. 
    It's safe if we use salicylic acid less than 0.5%, it's definitely a cosmetics.

    But I dont know if we use term "willow bark" or something else, could we cover the "drug" part and make it become a cosmetics ?
  • You can use Willow Bark but strictly as a cosmetic:the drug part comes into play when you make a drug claim.
  • @jolie:

    Again, you're treading on thin ice.  You can use straight-up Salicylic Acid if it is part of a preservative.  But, using straight Salicylic Acid at 0.5%, you're probably falling into the dual drug/cosmetic category.  If you're going to use SA, make certain it is below 0.5% and best if it is included as part of a preservative blend.  Don't just throw in SA at less than 0.5% and think you're in the clear.

    I think your statement "if we use salicylic acid less than 0.5%, it's definitely a cosmetics is not correct.  The Monograph is SA up to 2.0% is considered a drug.
    Chemist/Microbiologist formulating in the Organic & Naturals arena under ECOCert/Natural Products Assn/Whole Foods/National Organic Program guidelines focused skincare & haircare products. 

    Provides Formulation Development and Lab-Scale Contract Manufacturing Services.  See website for details www.desertinbloomcosmeticslab.com

  • In reality, it all comes down to the claims whether FDA considers product drug or cosmetic.
  • I agree with drbob. Whether a product is a cosmetic or a drug is determined by a its intended use only. 
  • Prior to joliejolie contributing to the thread, the last post here was January 2015. I think the query has been settled.
  • @luisafanzani

    Actually, it is not correct to state that whether a product is a cosmetic is determined solely by its intended use.

    Case in point:  Salicylic Acid ... it's a Monograph OTC drug ingredient at up to 2% for acne.  If one includes Salicylic Acid at 1% in a face cream product and claims it's a cosmetic, that company would then benefit from the inclusion of an OTC drug active in a cosmetic without having to register their product with the FDA and manufacture it in OTC registered manufacturing plants.  So, they benefit from lower cost and regulatory compliance issues giving them an advantage over OTC acne product manufacturers who must comply with those more stringent regulations.

    That is why the FDA has categories where a product can be classified as both a cosmetic and a drug.  You many intend that your face cream with Salicylic Acid is just a cosmetic since you don't make acne claims, but it will perform exactly the same as an OTC face cream with the same % of Salicylic Acid in it.

    Including an OTC drug active in a product and then trying to claim that it's a cosmetic because you don't make drug claims is a violation of regulations ... plain and simple.  There's no skirting the issue.


    Chemist/Microbiologist formulating in the Organic & Naturals arena under ECOCert/Natural Products Assn/Whole Foods/National Organic Program guidelines focused skincare & haircare products. 

    Provides Formulation Development and Lab-Scale Contract Manufacturing Services.  See website for details www.desertinbloomcosmeticslab.com

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