Is it Soap? Is it a Cosmetic or a Drug?

The FDA regulates cosmetics and drugs.  What determines how a product is classified is the intended used for the product.  The way in which firms market a cosmetic can make it a drug, or how a firm markets a drug can make it a cosmetic.

Cosmetics are 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” [FD&C Act, Sec, 201(1)].  The definition of a Drug is “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)].  Once a product falls within these categories they become subject to strict regulations regarding approval, registration, labeling and good manufacturing practices.

So what is soap?  Soap is a product that is exempt from provisions of the FD&C Act.  It is a product that consists of an alkali salt of a fatty acid and is labeled, sold and represented solely as soap [21 CFR 701.20].  What does all this mean?  Soap does not contain detergents or other synthetic cleansing ingredients.  It consist of common oils or fats (i.e. olive, coconut, avocado, etc.) that have been mixed with an alkaline solution (referred to as lye) which saponify yielding soap with glycerine.  Nothing more nothing less.  Soap can not be made without these ingredients.  Once the fats react with the lye solution, NO lye is left in the product.  It’s simply soap, no regulation needed.

Today, most body cleansing products on the consumer market are actually synthetic detergents.  Did you ever wonder why the package doesn’t just say soap?  Because it’s not.

To learn more visit:  http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074201.htm