Article by: Kelly Dobos
When developing products we often walk a fine line in terms of formulating for efficacy and marketing claims. It is important to understand the regulatory and legal implications of the decisions we make.
Cosmetic or Drug?
In the United States, the Federal Food, Drug and Cosmetic Act defines cosmetics as “article intended to be rubbed, pour, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body… for cleansing, beautifying, promoting attractiveness, or altering the appearance.” Examples include blush, lipstick, nail polish, shampoo, and toothpaste.
But once the product claims venture into diagnosis, treatment, or prevention of disease and alleges to affect the structure or any function of the body, the product is a drug. Drugs are subject to stringent regulations, labeling (actives are called out from other ingredients) and testing requirements, which result in the investment of both time and money.
Products can be both cosmetic and drug if the intended use meets both definitions. Moisturizers with sunscreens, moisturizing hand sanitizers, and anti-dandruff shampoos all fall into this category. These cosmetic/drug combinations are subject to the regulations for both drugs and cosmetics. They are considered OTC or Over the Counter drugs.
True soaps represent an additional category and are regulated by the Consumer Products Safety Commission, not the FDA. True soaps are made purely of fat and alkali. Soaps made with any other ingredient or claim any other benefit like moisturization or deodorizing are cosmetics.
One other classification of products is cosmeceuticals. The oft-controversial but significant contributor to our field, dermatologist Dr. Albert Kligman, coined the term cosmeceutical almost 30 years ago. He defined cosmeceuticals as topically applied products that do have a physiological effect on the skin. The industry was quick to respond because the potential regulation of cosmetics as drugs could cripple innovation due to time and cost. Kligman, however, intended to draw attention to the potential biological effects of all cosmetics that did not just merely camouflage or add color. In fact he said it was “scientifically silly to pretend that cosmetics did not do anything” and that cosmetics might actually be doing a lot of good.
The term cosmeceutical is not recognized as part of the Federal Food, Drug, and Cosmetic Act. But whether you agree or disagree, this term has become part of our consumer’s vernacular. The controversy and conversation the term has created remains, in my mind, one of Kligman’s great contributions to cosmetic science.
Further information can be found on the FDA’s website.