Antiperspirants Don't Cause Cancer

by Food and Drug Administration (FDA)

Offensive body odor is against the law in libraries in San Luis Obispo County, Calif. A code of conduct, officials say, is necessary to ensure that one person's right to use a public library doesn't infringe on the rights of another and law enforcement officers have the authority to remove library patrons who smell bad.

An extreme measure? Perhaps. But social awareness, coupled with the availability of dependable personal care products, may be a more practical way to hold body odor at bay.

The agency defines antiperspirant as a drug product applied topically that reduces the production of sweat (perspiration) at the site where it is applied. Antiperspirants, according to the Food and Drug Administration, can safely and effectively reduce sweat for up to 24 hours, if formulated and tested properly. And for most, this means protection against both wetness and odor.

The FDA issued a final rule in June 2003 establishing conditions under which over-the-counter (OTC) antiperspirants are generally recognized as safe and effective (GRASE), and are not misbranded. The final rule establishes allowable ingredients and labeling for the products.

In October 2004, the agency reopened the record on this final rule to consider one manufacturer's request to double the length of time — from 24 hours to 48 hours — during which an OTC antiperspirant is considered to be effective. The request in this case, called an enhanced duration claim, applies to the testing and labeling of this particular claim.

Matthew R. Holman, Ph.D., an FDA scientist in the Division of Over-the-Counter Drug Products, says that the agency needs scientific evidence that extended duration products work. "Manufacturers have to back up such claims with studies," he says. The FDA must be satisfied that the testing is valid for 48 hours.

Under the Federal Food, Drug, and Cosmetic Act, the FDA legally defines products by their intended uses. Therefore, drugs are defined as products intended for treating or preventing disease or for affecting the structure or any function of the body. Antiperspirants are considered drugs because they affect the function of the body by reducing the amount of sweat that reaches the skin.

But different laws and regulations apply to each type of product. Some products, for example, must comply with the requirements for both drugs and cosmetics. This happens when a product has two intended uses, for example, when an antiperspirant is also a deodorant. Cosmetics are defined as substances that cleanse, beautify, promote attractiveness, or alter the appearance, without affecting the body's structure or function. Deodorants are regulated as cosmetics because they promote attractiveness only by masking odor, not by reducing sweat.

Unlike drugs, neither cosmetic products nor cosmetic ingredients are reviewed or approved by the FDA before they are marketed. But the agency urges manufacturers to do any necessary testing to prove that their products are safe. And cosmetic makers must put a warning statement on the front labels of those products that have not been safely tested. The agency can take action against cosmetic products found to cause harm after they are on the market.

Why People Sweat

Whether the extra heat comes from hardworking muscles in the gym, from over-stimulated nerves due to stress, or from high air temperatures and humidity, sweating is the body's way of naturally regulating its temperature.

During extended, vigorous activity, a person can lose several quarts of fluid through the evaporation of perspiration. A pea-sized bead of sweat can cool about one quart of blood 1 degree Fahrenheit, according to the Mayo Clinic, and only about 1 percent of the body's sweat is produced under the arms.

Sweat itself is odorless. It's the bacteria that live on the skin and break down the sweat that cause the unpleasant odor. Keeping underarms dry and smelling good are big business. According to the Mintel Group, a marketing and research organization in Chicago, Americans spent an estimated $1.7 billion in 2004 on antiperspirants and deodorants. These products, designed for both men and women, include aerosols, sprays, pumps, roll-ons, solid sticks, gels, and creams. The FDA refers to these various forms of application as "dosage forms."

Given the amount of money people spend on personal hygiene products, it would seem that an offensive body odor shouldn't be much of a problem. However, according to Gray's Anatomy, most people have several million sweat glands distributed over their bodies, providing plenty of opportunity for odors to develop.

There are two types of sweat glands. The eccrine glands, which we are born with and which are the most numerous, produce most of the sweat in the underarms. These glands open directly onto the surface of the skin. Apocrine glands, which are triggered by emotions, develop in areas abundant in hair follicles, such as the scalp, underarms, and genitals. These glands only begin to secrete sweat after puberty, and have little, if anything, to do with temperature regulation.

The sweat glands are located in the middle layer of skin called the dermis, which is also made up of nerve endings, hair follicles, and blood vessels. A sweat gland is a long, coiled, hollow tube of cells. Sweat is produced in the coiled part in the dermis, and the long part is a duct that connects the gland to the opening, or pore, on the skin's outer surface. When the sweat gland is stimulated, the cells secrete perspiration that travels from the coiled part of the gland up through the straight tube and out onto the skin's surface.

The American Academy of Dermatology (AAD) says that perspiration is 55 percent to 60 percent fluid, mainly water. Perspiration also contains salt (sodium chloride), as well as trace amounts of other substances, such as ammonia, calcium, chloride, copper, lactic acid, phosphorous, and potassium. These substances, called electrolytes, help to regulate the balance of fluids in the body. The most abundant electrolytes are phosphorous and sodium, which cause sweat to sting the eyes and give sweat its salty taste.

The loss of excessive amounts of salt and water from the body can quickly dehydrate a person and can lead to circulatory problems, kidney failure, and heat stroke. So, although it's literally cool to sweat, it's also important that people drink fluids when exercising or when outside in high temperatures.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.