Article by: Perry Romanowski

According to the FDA statute first written in 1938, cosmetics are products used for beautification and enhancement of the appearance of skin or hair. By law they must not affect the structure and function of skin. Products that do are considered drugs in the United States and fall under much more stringent regulations.

With a multi-year and hundreds of millions of dollars registration process, it’s no wonder cosmetic companies avoid saying that their products have an affect on the structure and function of skin. But is this true?

Not according to the famous dermatologist Albert Kligman. He stated in an article published in C&T in 1993 that

The truth is that all topical substances, whether as simple as water or as complex as multi-ingredient moisturizers, inevitably will affect the structure and function of skin. No topical is completely inert.

Recently I had been investigating a claim that the level of skin cell growth is affected by the amount of moisture in the outer layers of the skin. If this were true, any moisturizer should be legally considered a drug under US law. Indeed, I discovered that this was the case. This means that ANY skin product you make is actually a drug. Technically, there are no cosmetics. At least skin products. I suppose you could apply a hair product that does not interact with skin.

So what can the cosmetic industry do about it?

I don’t know. It seems better regulations need to be written to encompass the science that has been discovered science the original Food, Drug, and Cosmetic Act was written some 80+ years ago. Companies need better guidelines to reflect the range of biological impact that various compounds can have on the body. As it stands, all cosmetic companies are at risk of having their US skin products recalled as illegal drugs. This won’t likely happen but it could.

Unfortunately, I doubt anything will be done about this situation in the near future. After all, this is an agency that has taken over 30 years to publish a sunscreen monograph. The FDA is underfunded and really has better things to do with their resources. Fortunately cosmetics have been safely produced and used for years so there isn’t much impetus to change things.

What do you think the difference is between a cosmetic and a drug? Leave your comments below.


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    Hi Perry, first, the actives are different. As far as I know retinoic acid isn’t approved for use in cosmetic products, hence a product containing it must be a drug.
    Also, Renova claims a certain efficiency of it’s product and supports that with clinical trials. Olay neither makes specific promises (beside the reduction of fine wrinkles, which might even be a result of simple moisturizing and nothing else) nor is the product clinically tested. B3 which is used in Olay doesn’t show the risks that come with the use of retinoic acid.
    With that we are back to the intent and consumer expectations. The expectation a consumer has from Renova are probably different than from Olay.

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    The prescription version of tretinoin is Renova Cream. So the remaining question is, how is Renova a drug product designed to get rid of fine lines and wrinkles from sun damage different than Olay which also gets rid of fine lines and wrinkles?

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    Perry, Tretinoin is just another term for retinoic acid, but not a finished product, hence it’s sort of difficult to compare it to the Olay product.
    Now, products containing retinoic acid are drugs because of their intended purpose which usually is the treatment of a medical condition – acne.
    Also, as far as I know, retinoic acid isn’t even allowed in cosmetics.

    P.S. I agree, great debate !

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    Harald – Thanks for the discussion. It has made me really think through the issue.

    Certainly the Olay product complies with the letter of the law (e.g. they qualify their claims by saying stuff like “reduce the appearance of wrinkles” rather than saying “reduces fine lines and wrinkles”) but not the spirit or intent of the law.

    Products that treat wrinkles are drugs as evidenced by the FDA Monograph for Tretinoin. If they both treat wrinkles, how is the Olay anti-wrinkle product different than the prescription Tretinoin product?

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    Perry, I don’t think that reversing wrinkles can be seen as a change in the skin’s structure. Especially, because there might be a number of reasons why the wrinkles are diminished.
    First, we are talking about fine wrinkles. Just moisturizing the skin can improve those. Even if other mechanisms play a role, the basic structure of the skin doesn’t change. Apparently this Olay product complies with regulations, therefore this discussion seems to be more about whether or not you agree with current regulations and this is an entirely different issue.
    The FDA defined drugs in a particular way, hence anything that doesn’t fit the description is not a drug for regulatory purpose. But the definition of “drug” is not universal. Other countries might have other definitions, hence a product like the one we are discussing here, might very well be considered a drug somewhere else.

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    Hi Perry,
    Maybe the easiest way is to look at the definition of a drug, according to the FDA and check whether a given cosmetic products fits into this definition.
    “The FD&C Act defines drugs, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)].”
    As for the Olay product, I can’ see how it would fit this description of a drug. True, B3 might reduce fine wrinkles (which is the purpose they added it to the product I assume), but neither has anything to do with disease, nor does it affect any structure/function of the body.
    Beside that, we also need to know in which concentration is B3 used in this formulation. Is it sufficient to do anything at all ? Are there any regulatory limitations to how much B3 can be used in a cosmetic formulation and if so, is Olay within this limit ?

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      Well, I would suggest that reversing wrinkles is affecting the structure of the skin. And it’s specific to how it works (e.g. increasing collagen and elastin synthesis in skin cells). This is why I questioned why a product like this isn’t considered a drug.

      Whether it does anything when delivered from a topical treatment is a different question. It probably doesn’t.
      There are no regulatory limitations on B3 in a skin cream so in this regard Olay would be perfectly fine to include it.

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    Let’s look at a product like Olay Age Defying Anti-Wrinkle product.

    They claim they “Replenish skin’s moisture overnight” and are “Proven to reduce the appearance of fine lines and wrinkles. Olay intense moisture with Vitamin E replenishes skin without added oil — leaving skin soft and smooth.”

    In their formula, they include Niacinamide. Why? Because they know that it will have an effect on skin cell metabolism as indicated by this research.

    This should be a drug don’t you think?

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    Why would you formulate a moisturizer that contains in ingredient that does things you don’t really care for in an moisturizer ? There are 1000s of raw materials on the market that should be sufficient to tailor a formulation precisely to ones needs. With that many choices, I don’t believe that we have to put up with undesired properties of a finished product.
    Still, some rare exceptions might be lurking out there somewhere. Do you have any real life case in mind where you wanted a particular product performance and couldn’t get it without adding an unwanted property ?

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    Hi Perry, I don’t really see this dilemma as long as the intended use is clear.
    In your example, if my intent isn’t to color gray hair and I neither want to claim this feature nor do I want to surprise my customer with colored hair, then I probably wouldn’t choose this particular ingredient with such a side effect.
    Look at a banana for example. The intended or primary use is certainly for nutrition. Nevertheless, as a side effect you also get a vitamin and potassium boost, although most people wouldn’t eat a banana for that particular reason.
    The same is true for cosmetics and unless it’s done on purpose with the intention to cheat the customer in some way, I don’t really see any ethical problem here.
    Perhaps we should look at this issue based on a real life examples.

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      Hello Harald,

      What do you think about a cosmetic like a moisturizer that is designed to improve the appearance of your skin? Say this moisturizer includes an ingredient that is supposed to affect the production of collagen and elastin.

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    Hey Perry,
    I don’t think that there is that much of a dilemma about what is or is not a cosmetic product.
    The FDA is pretty clear about that: “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance”.
    So the key is the “intended use”. The intended use, according to the FDA is established through product labels, advertising, consumer expectation of what the product is supposed to do, ingredients used, etc.

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      @Harald – It still seems like an ethical dilemma to me if you know your cosmetic is doing one thing but you aren’t claiming that it does. For example, if you made a hair conditioner and included an ingredient that was supposed to restart melanocytes to color gray hair, that seems like a drug to me even if you don’t claim it.

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