Antiperspirant Awareness: It's Mostly No Sweat (cont.)
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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