Cosmetic Safety : Allergic Reactions, What's Natural?

by Food and Drug Administration (FDA)

(Page 2 of 3)

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."

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.