Defining Soap, Cosmetics, and Drugs

Did you know that there are certain rules that need to be followed when labeling your handmade products?  I touched on labels briefly back in the Reading the Labels post, but let's figure out which label actually should be used.

There are three main categories that handmade bath and body products could potentially fall into:  soap, cosmetic, or drug.  Let's take a look at each.  For my purposes today, I am using the FDA's definitions of each, as they are the government agency that oversees these categories.


This one seems like a big fat DUH, right?  Wrong.  

The FDA defines a true soap as:

  • a product in which the bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compounds, and
  • the product is labeled, sold, and represented solely as soap

Products that meet this definition of what soap is are then regulated by the Consumer Product Safety Commission (CPSC) rather than the FDA.  True soaps are exempt from the FD&C (Food, Drug & Cosmetic) Act, and are not required to be labeled with the ingredients.  However, you will find that most soap makers do include ingredient labels because they are very proud of the ingredients they use to make their soaps.  

This definition of soap means that soap makers are not allowed to make any sort of claims about their soap!  About the only thing that can be claimed is that "it cleans."  You may be able to say that it smells good and/or looks pretty, but this basic definition is very narrow.


The FDA defines cosmetics by their intended use, such 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 common products that fall into this category are lotions/moisturizers, make up (lipsticks, nail polishes, foundations, eye shadows, etc), perfumes, shampoos, hair colorants, deodorants, and more.  

"Intended use" is generally determined by claims made about a product, including product labels, catalog and/or online product listings, customer reviews, and more.  Because of this, soap makers have to be very careful about any claim they might make about their products.  

Cosmetics do not require FDA approval (with the exception of any colorants) before being placed on the market.  In regards to colorants, the FDA has compiled a list of approved colorants/color additives to be used in cosmetics.  You can find that list here.  

Cosmetics should be labeled as per the cosmetic labeling requirements.  These are the labeling guidelines that I follow for my products.  


Drugs are the most stringently controlled category.  Drugs are defined by their intended use by the FDA as: 

  • articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease
  • articles (other than food) intended to affect the structure or any function of the body of man or other animals

You may have noticed by now that some products can fall into more than one category!  In these cases, makers should comply with the requirements for both categories.  

Drugs must be approved by the FDA before being sold.  If you wish to market your products as a drug, as defined by the FDA, you should follow their requirements for testing and registration.  These can be found on their website

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