Posted by BBN on 6/4/2010
to
Soap
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
