Host: Captain Catherine Chew
Pharmacist: Lieutenant Commander Lindsay Wagner
CAPT Chew: Is it a drug, a cosmetic, or both? This is a question consumers may ask their pharmacist.
Hi, I’m Captain Catherine Chew, and this is Drug Info Rounds, brought to you by the pharmacists in FDA’s Division of Drug Information.
Here at FDA’s Division of Drug Information, we are asked many questions that can be answered by understanding the definitions of a drug and a cosmetic. For this reason, I have asked my colleague, Lieutenant Commander Lindsay Wagner, to explain the key differences between a drug and a cosmetic.
LCDR Wagner: Whether a product is regulated as a drug, a cosmetic, or both under the law is determined by a product's intended use. Drugs are defined as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and as articles intended to affect the structure or any function of the body of man or animals. Cosmetics on the other hand, are defined 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. Some examples of cosmetic products include skin lotions, perfumes, lipsticks, fingernail polishes, eye and face makeup, cleansing shampoos, hair dyes, and deodorants.
CAPT Chew: When is it possible for a product to be both a drug and a cosmetic?
LCDR Wagner: A product may be both a drug and a cosmetic if it has both intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Therefore, an antidandruff shampoo is both a cosmetic and a drug.Other examples of products that are both a cosmetic and a drug are deodorants that are also antiperspirants and lotion, creams, and makeup marketed with sun-protection claims. Such products must comply with the requirements for both cosmetics and drugs.
It’s important to know that the FDA does not recognize the term "cosmeceutical." A product can be a drug, a cosmetic, or both, but the term "cosmeceutical" has no meaning under the Federal Food, Drug, and Cosmetic Act.
CAPT Chew: If a drug, cosmetic, or dual designation is determined by intended use, there must be specific criteria that establish this.
LCDR Wagner: To establish a product’s intended use, FDA may consider a variety of direct and circumstantial evidence. This includes any claim or statement made by or on behalf of a manufacturer that explicitly or implicitly promotes a product for a particular use and any circumstances surrounding the distribution of the product or the context in which it is sold. For example, FDA may consider the following to establish intended use:
- Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials. Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic. Some claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or any function of the human body. For example, claims that products restore hair growth, reduce cellulite, treat varicose veins, or regenerate cells are generally drug claims.
- Consumer perception, which may be established through the product's reputation. In other words, asking why the consumer is buying it and what the consumer expects it to do.
- Inclusion of ingredients that have a well-known therapeutic use. An example of this is fluoride in toothpaste.
CAPT Chew: This video is only an introduction to some important differences between the laws and regulations for cosmetics and drugs. If you have questions about cosmetic laws and regulations, call FDA’s Food and Cosmetics Information Center, or use the inquiry form on their website. If you have questions about drug laws and regulations, call or email FDA’s Division of Drug Information.