How The FDA Defines Soap

Not every product marketed as soap meets FDA's definition of the term. FDA interprets the term "soap" to apply only when:

• 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 [21 CFR 701.20].

If a cleanser does not meet all of these criteria ...
If a product intended to cleanse the human body does not meet all the criteria for soap, as listed above, it is either a cosmetic or a drug. For example:

If a product:

• consists of detergents or
• primarily of alkali salts of fatty acids and
• is intended not only for cleansing but also for other cosmetic uses, such as beautifying or moisturizing,
  it is regulated as a cosmetic.

If a product:

• consists of detergents or
• primarily of alkali salts of fatty acids and
• is intended not only for cleansing but also to cure, treat, or prevent disease or to affect the structure or any function of the human body,
  it is regulated as a drug.

If a product:

• is intended solely for cleansing the human body and
• has the characteristics consumers generally associate with soap,
• does not consist primarily of alkali salts of fatty acids,
  it may be identified in labeling as soap, but it is regulated as a cosmetic.

Maria Schasteen is the owner of Aroma-essence.com and publisher of the Aromatherapy Tip of the Week.