Is This Product a Cosmetic, Drug, or Soap?

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

Understanding the differences between products labeled or approved as drugs, cosmetic products, or soaps is important. The purpose for which the FDA approves a product affects how the product should or should not be used.

Manufacturers try to advertise products in a way that makes them sound appealing to the consumer. But sometimes, they market a product for a purpose that does not match the purpose the FDA has approved the product for.

For those living with a chronic condition like allergies, products that promise to help with challenging physical symptoms certainly draw patients in. Let's look at the differences between these product categories as defined by the FD&C.

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 cleaning, beautifying, promoting attractiveness, or changing appearance. Common products that are classified as cosmetics include:¹

• Shampoos
• Lotions and other moisturizers
• Perfumes
• Makeup
• Fingernail polish
• Deodorants

What is a drug?

The FD&C defines a drug as a substance used to diagnose, lessen, treat, or prevent disease. Drugs are also substances (other than food) that are intended to affect the structure or function of the body.¹

The category of drug applies to products that are used 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 officially applies only to products that meet all of these criteria:¹

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

Products that meet these criteria are not regulated by the FD&C.¹

A product that does not meet these criteria may be labeled as a cleanser. Cleansers 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. This includes products that have 2 intended uses. Some examples include:¹

• Anti-dandruff shampoo – As a shampoo, it cleans the hair, so it is a cosmetic. But because it treats dandruff, it is also classified as a drug.
• Antiperspirants – The deodorant portion of the product is a cosmetic because it makes the body smell better. But the antiperspirant ingredients make it also a drug.
• Toothpastes with fluoride – Toothpastes are cosmetics because they clean the teeth and freshen the mouth. Fluoride helps prevent cavities, so it is a drug.

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? And do not be fooled by clever marketing campaigns that may be breaking the law with false marketing.