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.