What is the Difference Between a Cosmetic and a Drug?

drug or a cosmetic_

We love the products we make. We love them so much that we want to share with our friends and family. Some eventually decide to sell to the public, and that is where the trouble often starts. Some of those products may be drugs rather than cosmetics.

What classifies a product as a drug or a cosmetic?

In the USA, according to the FDA, the difference lies in intended use. Will the consumer purchase the product to treat a disease or condition or to make her or himself look better? If the product will treat or cure a skin condition, whether it be eczema or sunburn or an insect bite, it is a drug. The FD&C Act defines drugs in part, by their intended use, 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)].

If, on the other hand, the product is meant to moisturize or otherwise improve the appearance of the skin, it is a cosmetic. The FDA (FD&C Act) defines cosmetics by their intended use, as “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)].

I know. Your Bug Bite Stick works well for soothing the hurt and itch of insect bites. Your friends and family report that it is magical. Your soap for treating eczema has helped your children and your best friend’s children. Your Pain Balm heals scratches and minor burns.

Still, these products are considered drugs by the FDA and are required to undergo clinical testing to prove that they work prior to selling. If not, they are still considered drugs, but unapproved drugs.

Cosmetics, on the other hand, are only meant to cleanse or make the person look better. Cosmetic makers are required to manufacture safe products that are not mislabeled or adulterated, are not required to conduct clinical testing.

Get it straight from the FDA here: https://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm#Definedrug

If you are somewhere besides the US, your regulations will differ, of course, so follow your country’s regulations.

Until next time, may your days be filled with bubbles and wax.

Beth Byrne for Making Soap, Cosmetics & Candles Magazine