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.
Allergic
Reactions
Do the preservatives
themselves pose any safety risk?
According
to a study of cosmetic reactions conducted by the North American
Contact Dermatitis Group, preservatives are the second most common
cause of allergic and irritant reactions to cosmetics. Fragrances
are number one. Although the study is more than 10 years old,
the results can still be considered valid today, says Harold R.
Minus, M.D., an associate professor of dermatology at Howard University
Hospital. (For more information on this study, see "Cosmetic
Allergies" in the November 1986 FDA Consumer.)
People who
have had allergic reactions to cosmetics may try hypoallergenic
or allergy-tested products. These are, however, only a partial
solution for some and no solution at all for others.
"Hypoallergenic
can mean almost anything to anybody," says Bailey.
"Hypo"
means "less than," and hypoallergenic means only that
the manufacturer feels that the product is less likely than others
to cause an allergic reaction. Although some manufacturers do
clinical testing, others may simply omit perfumes or other common
problem-causing ingredients. But there are no regulatory standards
on what constitutes hypoallergenic.
Likewise,
label claims that a product is "dermatologist-tested,"
"sensitivity tested," "allergy tested," or
"nonirritating" carry no guarantee that it won't cause
reactions.
FDA tried
to publish regulations [in 1975] defining hypoallergenic to mean
a lower potential for causing an allergic reaction," says
Bailey. "In addition, we were going to require that companies
submit information to FDA establishin g that in fact their products
were hypoallergenic." However, two cosmetic manufacturers,
Almay and Clinique, challenged the proposed regulations in court,
claiming that consumers already understood that hypoallergenic
products were no panacea against allergic reactions. In July 1975,
the U.S. District Court for the District of Columbia upheld FDA's
regulations, but the two companies appealed. On Dec. 21, 1977,
the U.S. Court of Appeals for the District of Columbia reversed
the district court's ruling.
What's
'Natural'?
Like hypoallergenic,
"natural" can mean anything to anybody.
"There
are no standards for what natural means," says Bailey. "They
could wave a tube [of plant extract] over the bottle and declare
it natural. Who's to say what they're actually using?"
Revlon, Inc.,
uses natural plant extracts in its New Age Naturals cosmetics
line, says Dan Moriarity, Revlon's director of public relations.
"But the base formulas are the same as our conventional products,"
he says. In addition, because these products contain fragrances,
they don't fit Revlon's definition of hypoallergenic, he explains.
Anyone who
has ever had poison ivy knows that "natural" and "hypoallergenic"
are not necessarily interchangeable terms. For example, some manufacturers
of cosmetics marketed as natural products use naturally occurring
vitamins E and C as preservatives. But, according to Alexander
Fischer, M.D., author of Contact Dermatitis, "Topical vitamin
E is a potent sensitizer which can produce both delayed allergic
contact dermatitis and immediate allergic hives."
In addition,
natural doesn't mean pure or clean or perfect either. According
to the cosmetic trade journal Drug and Cosmetic Industry, "all
plants [including those used in cosmetics] can be heavily contaminated
with bacteria, and pesticides and chemical fertilizers are widely
used to improve crop yields."
Safety
Testing
Whether driven
by altruism, liability, or the bottom line, most companies see
the need for safety testing. But safety testing can rarely be
mentioned without bringing up the controversy surrounding the
use of animals for those tests.
Many companies
have begun to label their products with statements indicating
that no animals have been used in testing.
"As far
as we know," says Neil Wilcox, D.V.M., director of FDA's
Office of Animal Care and Use, "what these companies do is
use, for the most part, old reliable ingredients that have been
proven safe [based on past animal data and a history of safe use]
and then test the final product on people."
"There's
kind of a fine point here," says CTFA's McEwen. "These
companies that say they don't test on animals are skirting the
issue. Practically every ingredient that's used in cosmetics was
at some point tested on animals. Probably a statement like 'no
new animal testing' would be more accurate."
But what if
a company wants to use a new ingredient?
Unlike drugs,
FDA does not require pre-market approval for cosmetics. However,
if a safety problem with a cosmetic product arises after it's
been marketed, FDA can take action to obtain the manufacturer's
safety data on the product. Because there is not yet enough information
on alternatives to animal testing to validate their use in ensuring
human safety, FDA, at this point, would only accept animal safety
data.
The most widely
used, and possibly most controversial, animal test, the Draize
Eye Irritancy Test, involves putting drops of the substance in
question into the eye of an albino rabbit. Investigators then
note if any redness, swelling, cloudiness of the iris, or corneal
opacity occurs. In addition, the ability of the eye to repair
any damage is noted.
"Draize
may be impossible to replace with a single alternative test,"
says Sidney Green, Ph.D., a toxicologist with FDA's Center for
Food Safety and Applied Nutrition.
He explains
that because the Draize test measures three different areas of
the eye, replacing Draize will probably take a combination of
alternative tests, "but we've not seen that combination yet."
Wilcox explains
that for FDA to approve other methods, those methods will have
to produce test results that can be reproduced in other labs.
In addition, databases will have to correlate historical animal
test results with newer lab results.
"Database
development and cooperation [between industry and FDA] is pivotal
to the validation process," says Wilcox.
The cosmetics
industry has taken one step towards database development--the
Cosmetic Ingredient Review. The basic purpose of the review is
to gather information from the scientific literature and from
company files on the safety of cosmetic ingredients and make that
information publicly available.
FDA's division
of toxicological review and evaluation is currently evaluating
two alternatives for the Draize eye test. One is Eytex, manufactured
by Ropak Corp., Irvine, Calif., a chemical assay that produces
opacity similar to that of an animal cornea upon exposure to irritants.
The other is vertebrate cell cultures from humans and mice.
But until
alternatives have been scientifically verified, the option for
animal testing must be available for new ingredients and new products,
says Wilcox. "No one wants to think of animals being used
for anything other than kindness and human companionship,"
he says. "But it's important that we continue to recognize
the risk to human health if unreliable tests are used."
