When is a cosmetic really a drug?

Innovation from the cosmetic raw material companies always makes me smile. I remember when one particularly “innovative” company would come in for a visit and always show these incredible compounds with mind blowing claims. While I always admired their attempts there was a fundamental thing they did that I found troubling; they would blur the line between cosmetic claims and drug claims.

I still frequently see this with the way both cosmetics and cosmetic raw materials are marketed. So, I thought it would be helpful to go through what is a cosmetic.

What is a cosmetic?

Let me first apologize to our International readers. This article will focus mainly on the US market. However, many of the same principles apply.

According to the FDA a cosmetic is…

“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” [FD&C Act, sec. 201(i)]

And to distinguish cosmetics from drugs, the FDA further defines a drug 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)].

What does this mean?

The key piece to consider is the part in the definition where it states “…articles intended to affect the structure or any function of the body of man…”

So, when companies make claims like…

  • Ingredient will stimulate collagen production
  • Ingredient will inhibit the enzyme tyrosinase
  • Ingredient will prevent premature gray hair

…they are making DRUG claims, not COSMETIC claims. If you use these ingredients in your formulation with the intent that they are going to have the effects claimed, you are no longer making a cosmetic. You are formulating a drug that is regulated differently than cosmetics. (Mostly, it requires more testing and validation).

What is not a cosmetic?

So to simplify the difference between cosmetics and drugs think of it this way.

A cosmetic is a product that is designed to clean or alter the appearance of the skin and hair without affecting metabolic processes. Body wash, skin moisturizers, make-up, etc. are all cosmetics as long as they are not intended to ‘stimulate collagen production’ or otherwise interfere with natural body processes.

When is a cosmetic a drug?

There are some products that are both cosmetics and drugs. This would include products like anti-dandruff shampoos, toothpaste, antiperspirants, sunscreens and anti-acne treatments. These products have to comply with the rules governing both cosmetics and drugs.

Innovation in the cosmetic field is difficult because cosmetic chemists are restricted in what type of effect they can have on the body. If you have created a formula that affects the normal functioning of the body’s cells, then you are no longer formulating a cosmetic, it’s a drug. Until they change the rules, things called cosmecuticals are just marketing fluff.