The legality, safety and classification of certain AHA/BHA skin care products

I've spent a lot of time reading through this forum and now it's pretty clear for me that products formulated with AHA and BHA are a very serious topic. But all of the discussions made me wonder about the status of certain skin care products that are currently on the market. More specifically:

-The Ordinary's 30% AHA + 2% BHA Peeling solution
-Paula's Choice 2% BHA liquid exfoliant

I do not live in the United States, but from what I read here, all products containing over 0.5% of salicylic acid would be considered as Over The Counter drugs, right? Which means that both of those products would fall under that category. But I've never seen anything that would suggest they are in fact considered an OTC. Should this status be obvious for the consumer? Or is it possible that they're registered as an OTC, even if their packaging and labels are not clear about the product being a form of medication? Is it legal to produce and sell them if they are not registered as an OTC? I'm very curious about this because they're very popular products among consumers and I would think that it's very hard for a famous brand to go unnoticed by the FDA.

And regarding the product from The Ordinary, if the CIR determined that AHAs were safe to use in cosmetics with a concentration below 10%, does this mean that the product is unsafe to use as it contains three times the safe amount? If those concentrations are allowed in professional products only, is it legal to sell the product to the general public? Could The Ordinary get in trouble for that specific product? They list all of the necessary precautions to take while using the peeling solution, but I'm curious to know how USA regulations work in those cases.

Comments

  • Check the pH of these products. It’s not low enough to make them work at full strength.
  • Also, AHA/BHA peel isn’t for leaving on skin. It’s a ‘mask’ that supposed to be rinsed off. The highest leave in product they have is 10% lactic acid.
  • Yes, I'm aware that it's a rinse off product. Do regulations for those specific ingredients change if the product is meant to stay on the skin? Because professional peels are not supposed to stay on the skin either, but they're still considered professional only products.

    And while the acids wouldn't be working at full strength, if my calculations are correct, they would still work above the 0.5% concentration covered by the OTC monograph, wouldn't they?

    Presuming they don't work at the OTC monograph concentration, is it legal to include OTC amounts of active substances and claim your product is a cosmetic if you're not formulating them to be fully active? 
  • SunSkin said:
    ....claim your product is a cosmetic ...
    These are the key words I think. The US cosmetic  definition is governed  by  claiming to only alter (by cleaning or 'beautifying' for example) the appearance of skin/ hair/ what have you.  Plenty of cosmetics include OTC ingredients but only claim them to be for improving appearance. Technically the FDA has some semantics  that say if the potential 'drug' has a well known use to treat a condition they can still hit the manufacturer with a misbranding warning but in my limited experience I haven't seen that happen. 

    take a look at the  marketing terms of the companies you mentioned:

    Paulas Choice : ....visibly reduces fine lines and wrinkles ..... younger-looking skin

    Now the Ordinary plays it a little more on the edge I think.  For that particular product they say
    ...help fight visible blemishes and for improved skin radiance....

    notice how they explicitly mention appearance or use nonsense terms (are they actually quantifying how much skin is radiating?)

    Not an expert on regulations but I think they are very interesting


  • PerryPerry Administrator, Professional Chemist
    No, not all products with over 0.5% Sal Acid are considered drugs. It depends on the claims you make about the product. If you said anti-acne then it would be a drug. If you don't, it remains a cosmetic.

    @EVchem - I'd agree. The difference is all about what you claim. You still have to be able to prove your product is safe, so if you do use things that might otherwise be drug actives, you'll have to be able to prove safety. And if you in any way imply that your product will have some drug effect, that could get you in trouble too.

    In those claims examples however, I think Paula's Choice actually pushes the envelop more than the Ordinary.  It makes the specific claim "visibly reduces fine lines & wrinkles" while the Ordinary says "help fight..."  What does it mean to help fight a blemish? It's metaphorical and can mean almost anything.

    It's really up to the FDA and the FTC to decide whether they are going to go after a brand or not. Technically, all the spray sunscreens were breaking the OTC rules (it wasn't an approved form) but the FDA just said they would let it slide. They recently put out an addendum to the Sunscreen monograph that now allows the spray form but before that, it was not allowed. 

  • @Perry I get what you are saying. I suppose you could quantify the size of the lines and wrinkles? I know our regulatory team has a conniption if we mention 'fighting blemishes' on any product with sal acid  because it kind of suggests an anti-acne function.

     I'm not sure how I feel about the cosmetic regulations leaving so much up to interpretation in general (this topic fascinates me), and the repercussions in my opinion aren't enough to dissuade companies who cut corners. the system seems broken
  • Very interesting, I thank you all for your responses. I was very confused about the way these regulations would work.

    Regarding the 30% AHA in the peeling solution, would you consider the product safe to use for it's intended market (the general public), despite the CIR statement that such a product is only supposed to be applied by trained professionals? Is it possible for The Ordinary to get in trouble for disregarding the information from the CIR?
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