Cosmetic Safety More Complex Than at First Blush

by Food and Drug Administration (FDA)

The European cosmetic known as ceruse was used faithfully — and fatally, because it was mainly white lead — by wealthy women from the second century until well into the 19th century to make their faces look fashionably pale.

Nothing on the market today approaches ceruse's deadliness. But many consumers wonder about the eye makeup, lipsticks, foundations, and nail products that are on the shelves. Are there any risks in using these cosmetics? Are long lashes, even skin tone, and brightly colored nails worth any risk at all?

Serious injury from makeup is a "pretty rare event," says John E. Bailey, Ph.D., director of FDA's Office of Colors and Cosmetics. "We don't see it happen that often."

Even one of the most serious problems, eye infections from a scratch on the eyeball with a contaminated mascara wand, has become rare. January 1989 was the last time an infection of this type was reported to FDA.

In 1994, FDA headquarters received approximately 200 reports of adverse reactions to cosmetics. Skin-care products and makeup accounted for about 65. Of those, at least 22 concerned products containing the chemical alpha hydroxy acid (AHA), used in so-called "skin peelers." Most of the 65 reports were either allergic reactions or skin irritations. The other complaints were about hair products, soaps, toothpastes, and mouthwashes.

Although industry probably received about 50 reports for every one made to FDA, says Bailey, the problems reported to the companies are along the same lines — allergies and skin irritation.

The agency can't do much about isolated allergic reactions or irritation problems. It's up to the individual to avoid the product that caused the reaction and any other products that contain the offending ingredient. (See "Contact D ermatitis: Solutions to Rash Mysteries" in the May 1990 FDA Consumer.)

But that doesn't mean reporting the problem isn't important.

"We look for clusters," says Bailey. "If we see we're getting a number of complaints for the same product, then that is cause for concern."

Unlike reports of allergic or irritation reactions, even one report of an acute injury, usually caused by a contaminated product, results in quick action by the agency. "We'll inspect the establishment, talk to the consumer, talk to the doctor, collect samples, and analyze them to determine the extent of contamination," says Bailey.

Moldy Oldies

Contaminated makeup is the result of either inadequate preservatives or product misuse. But contamination doesn't necessarily translate into serious injury for the user.

"Cosmetics are not expected to be totally free of microorganisms when first used or to remain free during consumer use," according to a 1989 FDA report on contamination of makeup counter samples in department stores. The report was based on a survey which found that over 5 percent of samples collected were seriously contaminated with such things as molds, other fungi, and pathogenic organi sms.

Every time you open a bottle of foundation or case of eye shadow, microorganisms in the air have an opportunity to rush in. But adequately preserved products can kill off enough of the little bugs to keep the product safe.

Occasionally, however, a product will be seriously contaminated. According to FDA data, most cases of contamination are due to manufacturers using poorly designed, ineffective preservative systems and not testing the stability of the preservatives during the product's customary shelf life and under normal use conditions.

Driving and Making Up Don't Mix

Consumers must take an active role in keeping product contamination and potential infection to a minimum once they take a product home, says Gerald McEwen, Ph.D., vice president for science for one of the cosmetic industry's trade associations, The Cosmetic, Toiletry and Fragrance Association.

"You need [to follow] good personal hygiene — clean hands, clean face," he says. "And common sense."

One of the riskiest things a woman can do is put on mascara while she's driving, says McEwen. "You hit a bump and you scratch your eyeball," he explains. "Once you've scratched your eyeball, you have all kinds of possibilities of contamination. We're not talking about disease germs here. We're talking about normal bacteria that are all over the air. Those get into that kind of a cut, and without proper medical attention you can go blind."

Testing the Testers

There's something else that is definitely taboo when using makeup — sharing.

"Never share, not even with your best friend," says Irene Malbin, CTFA' s vice president of public relations. Sharing cosmetics means sharing germs, and the risk, though small, isn't worth it, says Malbin.

Shared-use cosmetics — the testers commonly found at department store cosmetic counters — are even more likely to become contaminated than the same products in an individual's home, according to the 1989 FDA report.

FDA followed its 1989 report on makeup testers with a survey of corresp onding unopened retail packages. The survey found only negligible contamination, and the agency concluded that the preservatives couldn't handle the challenge of constant use.

"At home, the preservatives have time — usually a whole day — to kill the bacteria that is inevitably introduced after each use," says Bailey. "But in a store, there may be only minutes between each use. The preservatives can't handle it."

If you really want to test a cosmetic before you buy, "you should insist — must insist — on a new, unused applicator," says CTFA's Malbin. She says that some companies use cotton swabs for that purpose.

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.