FDA View on Difference Between Drugs and Cosmetics

FDA View on Difference Between Drugs and Cosmetics

The FDA’ s view on what constitutes the definition of a drug compared to a cosmetic is a longstanding one. A cosmetic is not supposed to either have or to claim physiological effect. This is a reasonable work in definition in so far as it goes. You can pick holes in it if you put your mind to it, but it gets the essence of how most people think of the difference. It has in any case not been something that the FDA gave a lot of attention to.

But they seem to be taking it a lot more seriously in recent years. For example in May they issued an informative ruling against a company, based in Canada, which gives quite a good guide to their current thinking.

The ruling starts with a bit of boilerplate that makes clear what they are thinking.

“these product are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or any function of the body.”

They then explain how they discovered that a claim was being made.

“FDA has reviewed the website, www.xxx.com and determined that various formulations of xxxx are being marketed as a hyaluronic acid based dermal filler used, for example, to treat wrinkles, add contour to facial features, enhance the lips, and to eliminate the appearance of aging.”

So being outside the US didn’t help, and making the claim online was sufficient to trigger an action.

The company was told that the product had to be taken off the market until a drug license had been obtained.

So the take home message is that the FDA are interested in protecting the borderline between drugs and cosmetics and are prepared to take action to defend it.


photo credit: Friday Night in the East Village via photopin (license)

2 thoughts on “FDA View on Difference Between Drugs and Cosmetics”

  1. Hm… I am a bit confused, so the Canadian company gets penalized for marketing their product “as a hyaluronic acid based dermal filler used, for example, to treat wrinkles, add contour to facial features, enhance the lips, and to eliminate the appearance of aging”. But isn’t that what all cosmetic companies with hyaluronic acid in their formulations claim their products do (treat wrinkles, contour facial features and reduce signs of aging)? I mean, half the drug store shelves are filled with jars and tubes that promise exactly that. Or am I missing some fine nuance of English language (am a native Germany speaker). Or is the legislation here in Germany somehow radically different and what is considered medical drugs in the USA is a cosmetic product here? (not that I believe any of those claims can ever come true to a degree visible to human eye)

    I love your blog, I think I read every single entry, it’s just in this post I don’t understand what makes the claims of that Canadian company so much different from all the other usual claims of cosmetic companies who have no problems selling their products in drug stores.

    1. Hello Jana, thanks for taking the time to comment and for your kind words.

      Your point is a good one, in that there isn’t anything very unusual about the claims being made. But the phrasing is a little stronger than usual. A few years ago I don’t think they would have had any trouble, but the FDA seems to be being a bit more strict than they used to be. That was the point I was trying to make.

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