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U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Cosmetics Fact Sheet
February 3, 1995
Ordinary soap is solely made up of fats and an alkali. In the past, people
made their own soap from animal fats and wood ashes.
Today there are very few true soaps in the traditional sense on the market.
You might recognize these soaps as products marketed with characteristics such
as "pure". "True" soaps are regulated by the Consumer
Product Safety Commission, not FDA, and do not require ingredient labeling.
Most body cleansers on the market today are actually synthetic detergent
products and come under the jurisdiction of FDA. These detergent cleansers are
popular because they make suds easily in water and don't form gummy deposits.
Some of these detergent products are actually marketed as "soap" but
are not true soap in the common and legal definition of the word.
If a cosmetic claim is made on the label of a "true" soap or
cleanser, such as moisturizing or deodorizing, the product must meet all FDA
requirements for a cosmetic, and the label must list all ingredients. If a drug
claim is made on a cleanser or soap, such as antibacterial, antiperspirant, or
anti acne, the product is a drug, and the label must list all active
ingredients, as is required for all drug products.
The 1979 FDA Consumer article reprinted below provides additional information on
U. S. Food and Drug Administration
ALL THAT LATHERS IS NOT SOAP
by Harold Hopkins
You've been near it all your life, bassinet to bath to boudoir. It was used
behind your ears before perfume was used there. It has removed dirt and grime
from your face, fingers, and knees. If you've said naughty words your mother may
have threatened to wash out your mouth with it. It has cleansed you, made you
smell good, added a glow to your complexion, and helped make you feel fresher.
But what do you really know about soap?
Well, in the first place the product you regard as soap may not be soap at
all, but a synthetic detergent "beauty" or "bath" bar. These
and similar names have been used by copywriters to spare the consumer the awful
knowledge that she is not bathing herself with real soap, but with a synthetic
detergent which, ironically, is for some purposes superior to soap. Some
"soap" bars may consist of soap and synthetic detergent.
Soap, as long as we can remember, has enjoyed an enviable respect in polite
society and this could be at least a part of the reason why Congress placed soap
above the law in enacting the Food, Drug, and Cosmetic Act of 1938. This law
exempted soap from regulation as a cosmetic.
So long as no cosmetic representations are made for soap, other than that it
cleanses, and no claims are made that it will affect the structure or functions
of the body or treat a disease, it is beyond FDA regulation. When such claims
are made the soap must meet all FDA requirements for a cosmetic or a drug or
both, whichever is appropriate. If it's represented as a drug the label must
list all active ingredients; if represented as both a cosmetic and drug or as
only a cosmetic the label must list all ingredients.
For instance, if a soap is labeled as a deodorant soap, FDA considers this to
be a cosmetic claim and the label must, as with other cosmetics, carry a list of
ingredients. If the soap makes a medical claim, such as that it will cure
dandruff, it is considered a drug and must carry required drug labeling and also
meet FDA safety and effectiveness requirements.
Fortunately, plain soap of the noncosmetic, nondrug variety has earned a good
reputation. Apart from the familiar sting from getting soap into your eyes or
the peril of slipping on a bar in the bathtub or shower, common bath and hand
soap is relatively safe. In fact we often use it to remove other substances from
our hands and skin that we think are a lot less safe.
For purposes of excluding ordinary soap from regulation as a cosmetic, FDA
defines it as a product in which most of the nonvolatile matter consists of an
alkali salt of fatty acids and whose detergent properties are due to these
alkali-fatty acid compounds. Our ancestors often made their own soap for
laundering, cleaning, and bathing from animal fats and wood ashes. Today's soap
may contain perfumes, colors, and oils, but if it is represented only as soap
it's out of FDA's regulatory bailiwick.
Ordinary soap is regulated by the Consumer Product Safety Commission under
authority of the Hazardous Substances Act. CPSC's jurisdiction covers most
noncosmetic, nondrug substances used in the home.
If the bar you use for bathing does not claim to be a soap, it's probably a
synthetic detergent product. FDA defines a cosmetic as an article intended to be
used on the body for cleansing, beautifying, promoting attractiveness, or
altering the appearance; thus, a nonsoap product intended for any of these
purposes is automatically classified as a cosmetic.
Soaps and synthetic detergent cleansing agents function in water in somewhat
the same way; that is, they break down the resistance barrier between the water
and the dirt, grime, oil, or other material, allowing it to be wetted and washed
away. Soap works well in soft water, but in hard water, which contains a
relatively high amount of calcium in solution, the calcium and soap react to
form a gummy material called soap scum, which includes dirt and other matter.
This gummy stuff is what forms the familiar ring in the bathtub.
The increasing number of synthetic detergent bars on the market is due
largely to their more efficient functioning in water, regardless of hardness,
and because they don't form gummy deposits as does soap. There are many types of
synthetic detergents, ranging from strong to mild; usually the milder types are
used for personal cleansing. Some of the harsher detergents are capable of
causing eye irritation or injury and manufacturers normally avoid using these in
personal bathing bars. There are consumers who may experience irritation or
allergic skin reactions from some synthetic detergents. Some consumers also may
be allergic to fragrances, colors, or other substances added to either soaps or
synthetic detergent bars.
FDA's file of about 70 reports of adverse reactions during the years 1975
through 1977 from use of bar soaps and synthetic detergent bars that qualify as
cosmetics includes consumer complaints about skin rash, redness, inflammation,
irritation, itching, and burning among the most common problems. The Consumer
Product Safety Commission's file of complaints and injury investigations shows
similar effects on the skin and eye irritations. Consumer complaints about
adverse reactions to synthetic detergent bars and those soaps classified as
cosmetics may be made to any FDA district office or to the Director, Division of
Cosmetics Technology, Food and Drug Administration, 200 C Street, SW,
Washington, DC 20204.
Complaints of adverse reactions from ordinary personal cleansing soap not
classified as a cosmetic or drug should be sent to the Consumer Complaints
Section, Consumer Product Safety Commission, Washington, DC 20207. Complaints
may also be made and information obtained on any current recalls, warnings, or
bans concerning soap by dialing the toll-free CPSC Hotline for Consumers:
800-638-8326; 800-492-8363 for residents of Maryland; 800-638-8333 for residents
of Alaska, Hawaii, Puerto Rico, and the Virgin Islands.
Harold Hopkins is editorial director of FDA Consumer.
U. S. Food and Drug Administration
FDA CONSUMER, February 1979