Fine Print: Is Your Product a Cosmetic or a Drug?
What this decision could mean for your beauty package.
By Holly C. Young and Marcus TiradoHirschhorn + Young Graphics
As members of the beauty industry, we tend to think that our products have nothing to do with drugs. However, one ingredient—or even a few words in a marketing claim—can cause FDA to classify a beauty product as an over-the-counter (OTC) drug. And, as we all know, labeling regulations for OTC drugs are much stricter than those for standard cosmetics. Let’s examine U.S. labeling regulations for cosmetics versus OTC drugs.
First, you must decide whether your product is an OTC drug or a cosmetic. To do so, you must identify your product’s intended use. FDA will call a product a “cosmetic” if the product is “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)]. Personal care products that fall into the cosmetics category include moisturizer, cleanser, deodorant, fragrance, makeup, and hair care products.
OTC drugs are classified 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)]. Personal care products that fall into this category include sunscreens, antidandruff and anti-acne products, antiperspirants, and skin protectors.
Once you have determined which category your product falls under, the next challenge is figuring out how to label your package. These renderings illustrate what is required on your product’s principal display panel (PDP) and additional panels, depending on whether your product is a cosmetic or an OTC drug.
As you can see from the illustration, there are considerable differences between labeling regulations for OTC drugs and for cosmetic products. It is incredible how something as simple as a single ingredient or a few words in a marketing claim can change the entire fate of your label.
Also, be aware that the regulations discussed above apply only to products marketed in the United States. We suggest reviewing the fine print of the regulations for each country you sell your products in, as there is no global standard for the labeling of cosmetics or OTC drugs.
So, do you want your product to be perceived by the customer as a drug or as a cosmetic? Decide which is better for your brand image and retail sales. The answers are up to you.
About the Authors
Deciphering the fine print of labeling regulations can be a challenge for any beauty brand. The authors of CPC Packaging’s new Fine Print column are here to help.
Holly C. Young
Holly C. Young is president of Hirschhorn + Young Graphics, an award-winning design firm that provides production art and packaging design services for the beauty industry. The firm places an emphasis on U.S., international, and over-the-counter (OTC) graphic regulatory compliance.
Young is the coauthor of Simplified FDA/OTC Label Requirements Guidelines. She is a favorite speaker at many trade association events such as HBA and Cosmoprof North America.
Marcus Tirado
Marcus Tirado, regulatory specialist, gained vast knowledge of global regulations, package design, and prepress production working in the dietary supplement and OTC industries. His experience with labeling regulations ensures that packages meet FDA and FTC graphic regulations.