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Is Soap a Cosmetic?

Questions and Answers

I get this question all the time so it is worth my time to address this issue. Under the FDA Guidelines SOAP IS NOT A COSMETIC.  Below is the FDA’s stance on soap.

A cosmetic is a product, except soap, intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.
Sec. 201(i) FD&C

What’s the regulatory definition of soap?

Whether a product is a “soap” in the traditional sense, or is really a synthetic detergent, helps determine how the product is regulated. So, let’s take a look at how “soap” is defined in FDA’s regulations;

To meet the definition of soap in FDA’s regulations, a product has to meet three conditions:

  1. What it’s made of: To be regulated as “soap,” the product must be composed mainly of the “alkali salts of fatty acids,” that is, the material you get when you combine fats or oils with an alkali, such as lye.
  2. What ingredients cause its cleaning action: To be regulated as “soap,” those “alkali salts of fatty acids” must be the only material that results in the product’s cleaning action. If the product contains synthetic detergents, it’s a cosmetic, not a soap. You still can use the word “soap” on the label. 
  3. How it’s intended to be used: To be regulated as soap, it must be labeled and marketed only for use as soap. If it is intended for purposes such as moisturizing the skin, making the user smell nice, or deodorizing the user’s body, it’s a cosmetic. Or, if the product is intended to treat or prevent disease, such as by killing germs, or treating skin conditions, such as acne or eczema, it’s a drug. You still can use the word “soap” on the label.

Here are some examples what would be considered a cosmetic by the FDA:

Here are some examples of products marketed as cosmetics:

  • Makeup
  • Moisturizers
  • Hair dyes, permanent waves, straighteners, and removers
  • Perfumes and colognes
  • Nail care products

As defined in section 201(i) of the FD&C Act, a cosmetic is a product, except soap, intended to be applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance.

In short, one may say that a cosmetic is a product intended to exert a physical, and not a physiological, effect on the human body.

When Might Soap be Considered a Cosmetic?

Lotions, soaps, and other cleansers may be regulated as cosmetics or as other product categories, depending on how they are intended to be used. If a product is intended to affect the way a person’s body works, or to treat or prevent disease, it’s a drug, but sometimes it is both a cosmetic and a drug depending on its claims. Drugs must meet different requirements.

Cleansing products, many of which are marketed as “soap,” may be cosmetics or drugs regulated by FDA, or consumer products regulated by the Consumer Product Safety Commission, depending on how they are made or how they are intended to be used. For example, soaps and cleansers marketed as “antibacterial” are drugs.

If you market you soap using terms like “will moisturize your skin” then your soap we become a “cosmetic”.

 




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