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.