Hair where
hair oughtn't be, according to the current dictates of American
fashion, raises many an eyebrow. And so, for cosmetic reasons,
millions of women, and a growing number of men, spend millions
of dollars each year on products and services that promise
smooth, silky skin free of "unsightly," "excessive"
body hair.
For do-it-yourselfers, a variety of home-use
hair removal products are available over the counter. These
include shaving creams, foams, and gels; waxes; chemical
depilatories; and electrolysis devices. Professionals at
beauty and skin care salons and in dermatologists' offices
provide waxing, electrolysis, and, most recently, laser
treatments to remove hair. On April 3, 1995, FDA cleared
the first laser for this use.
The cost, safety, effectiveness, and ease
of use of the various methods, as well as the area and amount
of hair growth to be treated, are some factors to weigh
in choosing a method and deciding whether to go to a professional.
Often, different methods are better suited for different
areas.
FDA's Office of Cosmetics and Colors in
the Center for Food Safety and Applied Nutrition regulates
chemical depilatories, waxes, and shaving creams and gels.
(The Consumer Product Safety Commission regulates razors.)
These products, says John E. Bailey Jr., Ph.D., acting director
of the office, are classified as cosmetics, defined as substances
applied to the body to alter the appearance, promote attractiveness,
cleanse, or beautify.
The agency's Center for Devices and Radiological
Health regulates electrolysis equipment and lasers.
Shaving
Shaving is by far the most common method
of hair removal for both men and women. Men have been shaving
their beards and mustaches for thousands of years, but cosmetic
hair removal in women was relatively uncommon until after
World War I. Now, many American women routinely shave their
legs and underarms.
A clean razor with a sharp blade is essential
for a safe and comfortable shave. Skin should never be shaved
dry; wet hair is soft, pliable, and easier to cut. Contrary
to what many believe, shaving does not change the texture,
color, or rate of hair growth.
Depilatories
"Depilatories act like a chemical razor
blade," Bailey says. Available in gel, cream, lotion,
aerosol, and roll-on forms, they contain a highly alkaline
chemical--usually calcium thioglycolate--that dissolves
the protein structure of the hair, causing it to separate
easily from the skin surface.
"It's very important to carefully follow
the use directions for depilatories and to do a preliminary
skin test both for allergic reaction and sensitivity,"
Bailey says. "Hair and skin are similar in composition,"
he explains, "so chemicals that destroy the hair can
also cause serious skin irritations--possibly even chemical
burns--if left on too long."
"The concentration of calcium thioglycolate
is generally kept as weak as possible to avoid skin irritation,
yet strong enough to work in a reasonable amount of time,"
says Stanley R. Milstein, Ph.D., special assistant to the
cosmetics and colors director. "Contact with the skin
is kept to somewhere between 4 and 15 minutes, depending
on how fine or coarse the hair is."
Consumers should be sure to read the product
label and select the formulation appropriate for the intended
use, because skin sensitivity varies on different parts
of the body. Some depilatories are for use only on the legs,
for example, while others are safe for more sensitive areas,
such as the bikini line, underarms and face.
Depilatories should not be used for the
eyebrows or other areas around the eyes, or on inflamed
or broken skin. To minimize the chance of skin irritation,
they should not be applied more often than recommended on
the product label.
Although cosmetics are not subject to premarket
approval, FDA can take action against products that are
found to cause harm.
"If we find an adverse reaction is
occurring under recommended use conditions, and not because
of misuse by the consumer, we can pursue any number of actions,
depending on the severity and prevalence of the problem,"
says Bailey.
For example, he says, "A depilatory
might cause second- or third-degree burns, and possibly
scarring, if its formula is too strong or if an inactive
ingredient in the product heightens its effect. In that
case, FDA may, after evaluating the problem, initiate regulatory
action such as seizure or injunction against the product
or the firm to stop further manufacture."
Tweezing and Waxing
While depilatories remove hair at the skin's
surface, "epilatories," such as tweezers and waxes,
pluck hairs from below the surface. Waxing and tweezing
may be more painful than using a depilatory, but the results
are longer lasting. Because the hair is plucked at the root,
new growth is not visible for several weeks after treatment.
Tweezing is impractical for large areas,
however, because it is such a slow process. Women mostly
use tweezers for shaping eyebrows and removing facial hair.
Waxing, too, is mostly done to shape the
eyebrows and remove hair on the chin and upper lip, says
Brenda Ruffner, a cosmetologist in Rockville, Md., although,
she says, many women also have their legs, underarms, and
bikini line waxed.
"Men usually come in for treatment
on their chest or back," Ruffner says. "I have
male clients who are bodybuilders and want their skin to
look smooth for competitions. And some men are uncomfortable
with the hair on their back or are embarrassed by it,"
she says.
Epilatory waxes are also available over
the counter for home use. They contain combinations of waxes,
such as paraffin and beeswax, oils or fats, and a resin
that makes the wax adhere to the skin. There are "hot"
and "cold" waxes.
With hot waxing, a thin layer of heated
wax is applied to the skin in the direction of the hair
growth. The hair becomes embedded in the wax as it cools
and hardens. The wax is then pulled off quickly in the opposite
direction of the hair growth, taking the uprooted hair with
it.
Cold waxes work similarly. Strips precoated
with wax are pressed on the skin in the direction of the
hair growth and pulled off in the opposite direction. The
strips come in different sizes for use on the eyebrows,
upper lip, chin, and bikini area.
Labeling of over-the-counter
waxes cautions that these products should not be used by
people with diabetes and circulatory problems, who are particularly
susceptible to infection. Waxing--and tweezing as well--can
leave the skin sore and open to infection. Waxes should
not be used over varicose veins, moles, or warts. They should
not be used on the eyelashes, inside the nose or ears, on
the nipples or genital areas, or on irritated, chapped,
sunburned, or cut skin. A small area should be tested for
sensitivity or allergic reaction before treating the entire
area. Some hair removal experts recommend professional waxing
for the best results.Electrical Epilators
Two types of devices
use electric current to remove hair: the needle epilator
and the tweezers epilator.
"Needle epilators introduce a very
fine wire close to the hair shaft, under the skin, and into
the hair follicle," explains Anthony Watson, a materials
engineer in FDA's Center for Devices and Radiological Health.
"An electric current travels down the wire and destroys
the hair root at the bottom of the follicle. The loosened
hair is then removed with tweezers. Every hair is treated
individually."
Needle epilators are used in electrolysis.
Because this technique destroys the hair follicle, it is
considered a permanent hair removal method. The hair root
may persist, however, if the needle misses the mark or if
insufficient electricity is delivered to destroy it.
"Also," Watson adds, "the
stimulus for hair growth in an area is never permanently
removed. For instance, you can't control hormonal changes
that cause new growth. Most people would probably define
permanent as 'never comes back,' but from a medical standpoint
that may not be practical."
Successful electrolysis usually requires
considerable time and money. Mona Wexler, an electrologist
in Bethesda, Md., says she is careful to explain the process
to her clients at their first appointment.
"Electrolysis requires a series of
treatments over a period of time. It's not just a one-,
two- or three-time thing," she says. "For example,
the process for a forearm takes a series of appointments
once a week for about a year. You may have a first clearing
of both forearms in about eight hours of treatment over
two months. After that, you have to catch the hairs that
are coming in on a different cycle of growth. For the best
results, you want to treat each hair during its active growing
stage."
Electrolysis may not always be the best
approach, Wexler adds: "Some men who begin electrolysis
to get rid of the hair on their back soon stop, because
it can be a huge, costly, and very time-consuming job, depending
on the amount of hair."
More often, she says, men are treated for
the area between the eyebrows, around the outside of the
ears, and the shoulders.
"Women mostly come in for facial hair--the
lip, chin, eyebrows, and neck, but I also do a tremendous
amount of body work--bikini line, abdomen, breast, forearms,
underarms," says Wexler.
The major risks of electrolysis are electrical
shock, which can occur if the needle is not properly insulated;
infection from an unsterile needle or other infection control
problem; and scarring resulting from improper technique.
There are no uniform standards governing
the practice of electrology. Only 31 states require electrologists
to be licensed, and, among those, the licensure requirements
vary.
"Training requirements vary from as
few as 120 hours to 1,100 hours," says Trudy Brown,
president of the International Guild of Professional Electrologists.
"Some states may require continuing education classes,
others not, and there are no national standards for testing,"
she adds.
Two organizations--the American Electrology
Association and the Society of Clinical and Medical Electrologists--have
certification programs, however, both based on a written
exam, Brown says. A list of licensed and certified electrologists
is available from the International Guild of Professional
Electrologists, 202 Boulevard St., Suite B, High Point,
NC 27262; (800) 830-3247.
Home-use electrolysis
devices work the same way as those for professional
use and carry the same health risks. The risks are not very
great, however, FDA's Watson says, because the voltages
and currents for the home-use devices are not very high.
Neither the home-use nor the professional devices use great
amounts of current, he adds.
The American Medical Association's Committee
on Cutaneous Health and Cosmetics says the success of electrolysis
self-treatment depends largely on the condition of the hair
and skin, the equipment, and the level of skill developed.
The committee recommends limiting self-treatment to readily
accessible areas, such as the lower parts of the arms and
legs. Because working on facial hair requires use of a mirror,
and, therefore, reversed movements, this area is best done
by a professional.
Like needle epilators, tweezers epilators
use electric current to remove hair. The tweezers grasp
the hair close to the skin, and applied current travels
down the hair shaft to the root. And, like needle epilators,
electric shock is possible if the tweezers touch the skin
instead of grabbing the hair. Tweezers epilator manufacturers
can claim permanent hair removal if they can provide supporting
data.
"Tweezers epilators are relatively
new," Watson says, having been brought into the market
only about 20 years ago. "Because they don't use a
needle, they are supposed to be less painful than the older
devices, which have been around for more than a hundred
years," he says.
Needle epilators are exempt from premarket
notification; tweezers epilator manufacturers, however,
must submit to FDA data showing their devices are substantially
equivalent to similar devices already on the market. FDA
is currently reviewing this policy.
"On Aug. 14, 1995, FDA published a
Federal Register notice requesting manufacturers of tweezers
epilators to submit safety and effectiveness data,"
Watson says. "After the information is analyzed, the
agency will decide what kind of clearance will be required
for these devices."
Laser Hair Removal
Hair removal entered the "laser age"
last year when FDA cleared the ThermoLase Softlight laser,
manufactured by Thermotrex Corporation, based in San Diego.
"The Softlight is essentially a standard
dermatological laser similar to others already on the market
for treating skin lesions and removing tattoos," says
Richard Felten, a senior reviewer in FDA's Center for Devices
and Radiological Health.
With the ThermoLase method, a proprietary
topical black-colored solution is applied to the treatment
area before the laser is scanned across it.
"The solution penetrates the hair follicles,
and the black material in it preferentially absorbs the
laser wavelength, which heats and destroys the follicles,"
Felten explains.
Three-month clinical trials of the ThermoLase
process showed at least a 30 percent reduction of hair on
treated areas in 60 to 70 percent of people treated. Manufacturers
must limit claims of laser treatment permanence to results
substantiated by the clinical data. Thermotrex, therefore,
can claim that its laser process causes hair reduction for
up to three months after treatment.
Some side effects can be expected whenever
a laser is used to treat the skin, Felten says. These include
redness, caused by heating the tissue; possibly some darkening
of light-complexioned skin and lightening of dark-complexioned
skin; and a risk of some scarring in some patients.
"Usually the treated area is covered
to prevent infection during the healing period, and then
kept covered with a moist solution for a period of time,"
Felten says, adding that sunlight should be avoided during
healing also, to avoid a change in pigment.
A prescription device, the laser must be
used under a licensed practitioner's direction. At press
time, the Softlight laser was in use at several spas in
San Diego and Dallas and in physicians' private practices,
says ThermoLase's manager of Softlight, Rick Episcopo. Episcopo
says clients may report a stinging in sensitive areas, such
as the upper lip, but mostly a sensation of warmth.
Cosmetic hair removal can be quick and easy
or time-consuming and somewhat uncomfortable. It can be
costly or inexpensive. But, for just about anyone who so
desires, there's a way to get rid of the hair you don't
want.
Marian Segal is a member
of FDA's public affairs staff.
