“Cosmeceutical”

Consumers and manufacturers sometimes have questions about the term “cosmeceutical.”

The term “cosmeceutical” has no meaning under the law. While the Federal Food, Drug, and Cosmetic Act (FD&C Act) does not recognize the term “cosmeceutical,” the cosmetic industry uses this word to refer to cosmetic products that have medicinal or drug-like benefits.

A product can be a drug, a cosmetic or both. The FD&C Act defines drugs as those products that cure, treat, mitigate or prevent disease or that affect the structure or function of the human body, if a product makes such claims it will be regulated as a drug. Cosmetics are intended to beautify, promote attractiveness, alter appearance or cleanse; they are not approved by FDA for sale nor are they intended to effect structure or function of the body. hypoallergenic

More resources:

• Cosmetic Labeling and Label Claims: An introduction to cosmetic labeling requirements
• Cosmetics Q&A: Personal Care Products: A quick look at how different “personal care products” are labeled
• Is It a Cosmetic, a Drug, or Both? (or Is It Soap?): Information on the legal differences between cosmetics, drugs, and soap 
• Warning Letters Address Drug Claims Made for Products Marketed as Cosmetics: Warning Letters issued by FDA citing unapproved drug claims

July 6, 2017. This document is current and is updated only when necessary.

ResourcesForYou

• Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)
• Warning Letters Address Drug Claims Made for Products Marketed as Cosmetics