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U. S. Food and Drug Administration
Hair Today, Gone Tomorrow
by Marian Segal
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 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 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
"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 ch emicals that destroy the hair can
also cause serious skin irritations--possibly even chemical burns--if left on
"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
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
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 wax ed.
"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
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
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
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
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 o
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
"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
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)
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 supp
"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."
Hair removal entered the "laser age" last year when FDA cleared the
ThermoLase Softlight laser, manufactured by Thermotrex Corporation, based in San
"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
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 somew hat
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.