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:
- Fight fine lines and wrinkles: “Fighting” is a cosmetic term versus “removing”.
- Smoothe mottled or rough skin: “Smoothes” is also a cosmetic term.
- Aid mild to moderate acne: “Aids” does not mean “treats”. Since retinol has many of the same properties as retinoic acid, which is a prescribed drug, the manufacturers can claim this.
- Alleviate the appearance of age spots: “Alleviates” is also not the same claim as “removes”.
How about products that are both a cosmetic and a drug?
Examples of products that can be both a cosmetic and a drug are dandruff shampoos that contain coal tar or salicyclic acid, sunscreens mixed with moisturizers, toothpaste with fluoride in it, and deodorants that also contain antiperspirants.
And what about soaps? Are they cosmetics since they are used for cleansing?
Soaps are not regulated by the FDA unless they are mixed with moisturizers or deodorant, in which case they are considered to be cosmetics.
If they contain antiperspirant, antibacterial or anti-acne cleansers, they must comply with FDA drug standards. True old-fashioned soap is regulated by the Consumer Product Safety Commission.
Sources:
Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?). U.S. Food and Drug Administration. Web. Feb 23, 2014.
http://www.fda.gov/cosmetics/guidancecomplianceregulatoryinformation/ucm...
Soap. What It Is and How It Is Regulated.
http://www.fda.gov/Cosmetics/ProductandIngredientSafety/ProductInformati...
When does a cosmetic become a drug? Beauty Brains. Web. Feb. 23, 2014.
http://thebeautybrains.com/2014/02/21/when-does-a-cosmetic-become-a-drug
Cosmetic Drug or Cosmeceutical – What is the Difference? Chemistcorner.com. Web. Feb. 23, 2014. http://chemistscorner.com/cosmetic-drug-or-cosmeceutical-–-what-is-the-difference/
Michele is an R.N. freelance writer with a special interest in woman’s healthcare and quality of care issues. Other articles by Michele are at www.helium.com/users/487540/show_articles
Edited by Jody Smith