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U. S. Food and Drug Administration
FDA Consumer
September 1996

Hair Today, Gone Tomorrow

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 ch emicals 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 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 "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 o f 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 supp orting 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 entered the "laser age" last year when FDA cleared the ThermoLase Softlight laser, manufactured by Thermotrex Corporation, based in San Die go.

"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 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.