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Is this Product a Cosmetic, Drug, or Soap?

The U.S. Food and Drug Administration (FDA) classifies products based on their intended use, and different laws and regulations apply to the different categories of products. Generally, approval processes and marketing regulations are stricter for drugs, and the law that defines the different categories is the Federal Food, Drug, and Cosmetic Act (FD&C).1

Understanding the differences between products being labeled or approved as a drug versus a cosmetic product versus a soap can be important as it impacts what the product should or shouldn’t be used for. Sometimes manufacturers may try to advertise a product a certain way to make it sound more appealing to the consumer, but what the product is actually approved for does not match what the brand is promising. For those living with a chronic condition like atopic dermatitis, products that promise to help with some of the more challenging physical symptoms certainly will draw patients in. A look at the differences between these product categories as defined by the Federal Food, Drug, and Cosmetic Act.

What is a cosmetic?

The FD&C defines a cosmetic as any product that is intended to be rubbed, poured, sprinkled, sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. Common products that are classified as cosmetics include:

What is a drug?

The FD&C defines a drug as any article that are used to diagnose, mitigate, treat, or prevent disease, as well as articles (other than food) that are intended to affect the structure or function of the body. The category of drug applies to those products that are used to in the treatment of animals and humans. Some drugs are available over-the-counter, while others require a doctor’s prescription.1

What is a soap?

Soap is a special category. While “soap” is a commonly used word, the term only officially applies to products that meet certain characteristics:

  • The majority of the ingredients consist of an alkali salt of fatty acids and the detergent ingredients are due to the alkali-fatty acid compounds, and
  • The product is labeled as soap.

Other products that do not meet these criteria and may be labeled as a cleanser may be classified as a cosmetic or a drug, depending on their intended use.1

Can a product be both a cosmetic and a drug?

Some products are classified as both a cosmetic and a drug, such as products that have two intended uses. Some examples include:

  • Antidandruff shampoo – as a shampoo, it cleanses the hair and is a cosmetic, but as an antidandruff treatment, it is also classified as a drug
  • Antiperspirants – the deodorant portion of the product is a cosmetic (as it enhances the smell of the body), while the antiperspirant compounds are a drug
  • Toothpastes with fluoride – toothpastes clean the teeth and freshen the mouth (cosmetic), and fluoride helps prevent cavities (drug)1

So the next time you are shopping for over-the-counter products take an extra second to read the label. What is the intended use of that product? Don’t be fooled by clever marketing campaigns that may be walking a fine line and potentially violating the law by marketing a cosmetic with a drug claim or the other way around and marketing a drug as if it were a cosmetic.

  1. U.S. Food and Drug Administration. Available at https://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm. Accessed 9/22/17.

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