Some beauty products on the market offer some rather amazing claims. How are we to know which ones are truly classified as drugs or are just considered cosmetics? And, then there are those combined products known as cosmeceuticals. How are they different?
The differences between these three products can be confusing and the line is sometimes not so clear. The FDA separates drugs and cosmetics by “intent” of use.
- Drugs are "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" (1)
- Cosmetics are "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" (1)
What is a cosmeceutical?
The FDA does not recognize cosmeceuticals as a real product category. A product can be a drug, a cosmetic or a combination of both. But the FDA does not regulate cosmeceuticals in any way.
Common over-the-counter drugs we use on our skin would be products like topical cortisone, antifungal cream, acne products that contain benzoyl peroxide, and even sunscreen.
Cosmetics include lipsticks, eye shadow, moisturizers, toothpaste, regular shampoos, hair dye, fingernail polish and deodorant. Because cosmetics cannot make a “clinical” claim, the FDA does not test them for efficacy.
However, when cosmetics cross over that line and make claims that sound as though they are acting like drugs, then the FDA steps in and warns them to change their labeling.
Otherwise, a manufacturer would need to show proof (clinical studies) that their product can actually produce the action that only drugs are able to do. The product would then have to go through the drug approval process.
Terminology becomes the defining factor. Products marketed as cosmetics have to use wording that makes them sound like cosmetics. The Beauty Brains explained this in several examples using retinol products as a model.
Retinol products claim to: