Antiperspirant Awareness: It's Mostly No Sweat
By Carol Rados
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."
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