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Home :: Professional / Government Regulation / FDA Requirements and Programs / Cosmetic Safety

U. S. Food and Drug Administration
FDA Consumer
November 1991; revised May 1995

Cosmetic Safety:
More Complex Than at First Blush

by Dori Stehlin

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."

Dori Stehlin is a staff writer for FDA Consumer.

The Meaning of Makeup

Draize test
an animal test used to determine the effects of different substances on the eyes

any natural or synthetic substance or substances used solely to impart an odor to a cosmetic product

* fragrance-free
products so labeled may still contain small amounts of fragrances to mask the fatty odor of soap or other unpleasant odors

* hypoallergenic
cosmetics that are less likely to cause allergic reactions

in vitro
from the Latin meaning "in glass," in vitro tests do not involve the use of living vertebrate animals

a natural extract of sheep wool used as a moisturizer, which is a common cause of allergic reactions but is rarely used in pure form

* natural
ingredients extracted directly from plants or animal products as opposed to being produced synthetically

* non-comedogenic
products so labeled do not contain common pore-clogging ingredients that could lead to acne

parabens (methyl-, propyl-, and butyl-)
the most widely used preservatives in the United States, commonly used in shampoos, foundations, facial masks, hair-grooming aids, nail creams, and permanent wave products

propylene glycol
the most common moisture-carrying vehicle in cosmetics other than water.

(* There are no official, government definitions for these terms.)


Beauty on the Safe Side

Besides never putting on makeup while driving, consumers should follow other precautions to protect themselves and the quality of their cosmetics:
  • Keep makeup containers tightly closed except when in use.
  • Keep makeup out of sunlight; light can degrade preservatives.
  • Don't use eye cosmetics if you have an eye infection, such as conjunctivitis, and throw away all products you were using when you first discovered the infection.
  • Never add any liquid to bring the product back to its original consistency. Adding water or, even worse, saliva could introduce bacteria that could easily grow out of control. "If it has lost its original texture and consistency," says McEwen, "the preservatives have probably broken down."
  • Never share.
  • Throw makeup away if the color changes or an odor develops. Preservatives can degrade over time and may no longer be able to fight bacteria.
"We don't have a hard and fast rule on [when to throw cosmetics out]," says McEwen. McEwen says makeup can be kept indefinitely as long as it looks and smells all right and the consistency doesn't change. "It would be difficult to have any kind of bacterial growth and not have it be noticeable," he explains.

However, Janice Teal, a microbiologist who heads the product and package safety division of Avon Products, Inc., disagrees. "Even after the preservatives have stopped working, you may not be able to see or smell anything different," she says.

She agrees with McEwen that there is no absolute date for discarding various products, but says Avon recommends that consumers throw mascara away after three months. They can keep other makeup products a few months longer.

"Mascara is our biggest concern because of the wand," she says. "Normally, the eye is a good barrier to bacteria, but one slip and that wand can scratch the cornea and introduce all kinds of bacteria."


Regulating Cosmetics

The Federal Food, Drug, and Cosmetic Act defines cosmetics as "articles other than soap which are applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance."

FDA has classified cosmetics into 13 categories:

  • skin care (creams, lotions, powders, and sprays)

  • fragrances

  • eye makeup

  • manicure products

  • makeup other than eye (e.g., lipstick, foundation and blush)

  • hair coloring preparations

  • shampoos, permanent waves, and other hair products

  • deodorants

  • shaving products

  • baby products (e.g., shampoos, lotions and powders)

  • bath oils and bubble baths

  • mouthwashes

  • tanning products
It is against the law to distribute cosmetics that contain poisonous or harmful substances that might injure users under normal conditions. Manufacturing or holding cosmetics under insanitary conditions, using non-permitted colors, or including any filthy, putrid or decomposed substance is also illegal.

Except for color additives and a few prohibited ingredients, a cosmetic manufacturer may use any ingredient or raw material and market the final product without government approval. The prohibited ingredients are:

  • biothionol

  • hexachlorophene

  • mercury compounds (except under certain conditions as preservatives in eye cosmetics)

  • vinyl chloride and zirconium salts in aerosol products

  • halogenated salicylanilides

  • chloroform

  • methylene chloride
Manufacturers must test color additives for safety and gain FDA approval for their intended use.

Cosmetic firms may voluntarily register their manufacturing plants with FDA, file cosmetic formulas, and report adverse reactions.

Cosmetics sold to consumers must bear labels that list ingredients in descending order of predominance. Trade secrets (as defined by FDA) and the ingredients of flavors and fragrances do not have to be specifically listed.



Consumers and their dermatologists should report cosmetic adverse reactions to:

Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Colors and Cosmetics
200 C St., S.W.
Washington, DC 20204
(202) 205-4494

Copyright © 1998-1999 All rights reserved.
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