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A sea of cosmetics crowds the drugstore shelves, luring you with claims of romance, popularity and beauty. To be happy, you must use these products! Or so the advertisers would have you believe.

Do they work? Will you be the most beautiful, the most successful, and the most radiant person if you use these products? Where does the hype end and the help begin?

Cosmetics are defined in the Federal Food, Drug, and Cosmetic Act as "articles (other than soap) intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions."

Cosmetics can't work miracles, but they can help keep your skin clean and looking moist and soft. They also can temporarily close pores, plump up skin to make it appear smoother, and give you a rosy glow or blush.

Many cosmetic products are designed to protect the skin of people over 30 against dryness and the accompanying wrinkles. But these aren't the concerns of most teens. The biggest skin problem for most teenagers is acne. Some studies show that all adolescents have acne to some degree because when puberty hits, your skin starts secreting more oil. This contributes to blackheads and pimples, which cause your pores to stretch a little bit. Although acne cannot be avoided simply by washing your face, the oils on the surface of your skin can be diminished by frequent washing with cleansers made for that purpose. And there are many treatments available for acne both in over-the-counter and prescription strengths (see "Acne Agony" in the July-August 1992 FDA Consumer).

If, while trying to decrease the oily shine on your face, you make your skin overly dry, or if you're spending a lot of time outdoors in very cold weather, you may want to use a moisturizer. "Teens really should only use a water-based moisture lotion labeled 'non-comedogenic,' which means it doesn't clog pores," says Dr. Barry Leshin, M.D., associate professor of dermatology at the Wake Forest School of Medicine. "Heavier oil-based moisturizers can cause acne cosmetica--an [acne-like] skin condition directly attributed to the use of cosmetics."

What cosmetics can or cannot do for your complexion is determined by the ingredients of the cosmetics and your own complexion. Cosmetics contain ingredients from nature and from the laboratory. Some work well for cleaning, others are good for lubricating--and some don't do very much at all.

It's a good idea to read the labeling on cosmetics to find out what the product contains. Some ingredients, such as alcohol and mineral oil, are fairly common. Others seem more unusual and may require some explanation. Here are some examples.

Overuse of some cosmetics can cause allergies and other skin problems (see "Cosmetic Safety More Complex Than at First Blush," in the November 1991 FDA Consumer). Ingredients such as fragrance and preservatives can cause allergic reactions in some people. Skin reactions, which doctors call contact dermatitis, should be taken seriously. (See "Contact Dermatitis: Solutions to Rash Mysteries" in the May 1990 FDA Consumer.) Even if you've used a cosmetic for years with no problems, you can develop an allergic reaction as you become sensitized to one or more of the ingredients.

Some cosmetics are labeled "allergy-tested" or "hypoallergenic," but products with these claims don't always offer a solution to cosmetic allergies. "Hypoallergenic" means only that the manufacturer feels that the product is less likely to cause an allergic reaction. Before placing this claim on the label, some companies conduct tests, and others simply don't include perfumes or other common problem-causing ingredients in their products. The claim "dermatologist-tested" on some cosmetic products only means that a skin doctor has tested the product to see if it will generally cause allergenic problems. Other label claims that carry no guarantee that they won't cause reactions include "sensitivity-tested" and "non-irritating."

"Natural" ingredients are extracted directly from plants or animal products as opposed to being produced synthetically. Natural ingredients can cause allergic reactions. If you have an allergy to certain plants or animals, you could have an allergic reaction to cosmetics containing those ingredients. For instance, "lanolin," extracted from sheep wool, is an ingredient in many moisturizers and is a common cause of allergies.

Marcia Sheets, a substitute teacher in Sykesville, Md., has tried to use cosmetics for years, but even those claiming to be allergy-free have created problems for her.

"I've had hives and swollen eyes, I've sneezed because of perfumes, and I've had blotchy skin--even from some products that are supposed to be gentle. If you have allergies, you just don't use the stuff. Over the years, I've figured out what I can use and what I can't."

If you have an allergic reaction to a cosmetic, you should stop using all cosmetics until you call your doctor, who will then try to determine which ingredient, or combination of ingredients, caused the reaction.

Serious problems from cosmetic use are rare, but sometimes problems arise with specific products. FDA warned consumers last February about the danger of using aerosol hairspray near heat, fire, or while smoking. Until hairspray is fully dry, it can ignite and cause serious burns. Injuries and deaths have occurr ed from fires related to aerosol hairsprays.

Another problem can occur with aerosol sprays or powders: If they are inhaled, they can cause lung damage.

The most common injury from cosmetics is from scratching the eye with a mascara wand. Eye infections can result if eye scratches go untreated. Such infections can lead to ulcers on the cornea, loss of lashes, or even blindness. To play it safe, never try to apply mascara while riding in a car, bus, train, or plane. Sharing makeup can also lead to serious problems. Cosmetics become contaminated with bacteria the brush or applicator sponge picks up from the skin--and if you moisten brushes with saliva, the problem is much more severe. Washing your hands before using makeup will help prevent exposing the makeup to bacteria.

Artificial nails can be a source of problems, especially when not applied correctly. Artificial nails must be completely sealed because any space between the natural nail and the artificial nail gives fungal infection an opportunity to begin. Such infections can lead to permanent nail loss.

Sleeping while wearing eye makeup can cause problems, too. If mascara flakes into your eyes while you sleep, you might awaken with itching, bloodshot eyes, and possibly infections or eye scratches. To avoid eye infections or injury, remove all makeup before going to bed.

Cosmetics run the gamut from eye shadow to deodorant sprays. And consumers' concerns and questions are just as varied as the products themselves.

"Consumers are so confused by the products out there because they all do so many different things," says Lynn Reniers, a licensed cosmetologist with Elizabeth Arden. "So it's important to send them away with a very clear understanding of product usage."

When FDA surveyed 1,687 consumers ages 14 and older in 1994 about their use of cosmetics, many of the responses pertained to consumer perceptions about cosmetic labeling claims. For example, many said they expect a product to prevent or slow the formation of wrinkles if it makes such a claim on its packaging. And nearly half of those surveyed felt that a product claiming to be "natural" should contain all natural ingredients. But do these products live up to their labeling claims?

Not necessarily. John Bailey, Ph.D., director of FDA's Office of Cosmetics and Colors, says, "Image is what the cosmetics industry sells through its products, and it's up to the consumer to believe the claims or not."

Behind the image, however, are real products, and consumers want to know what works and what doesn't.

An understanding of FDA's cosmetic responsibilities can help consumers make wise, rational decisions about the cosmetics they buy.

The regulatory requirements governing the sale of cosmetics are not as stringent as those that apply to other FDA-regulated products. Under the Federal Food, Drug, and Cosmetic (FD&C) Act, cosmetics and their ingredients are not required to undergo approval before they are sold to the public. Generally, FDA regulates these products after they have been released to the marketplace. This means that manufacturers may use any ingredient or raw material, except for color additives and a few prohibited substances, to market a product without a government review or approval.

But some regulations do apply to cosmetics. In addition to the FD&C Act, the Fair Packaging and Labeling Act requires an ingredient declaration on every cosmetic product offered for sale to consumers. In addition, these regulations require that ingredients be listed in descending order of quantity. Water, for example, accounts for the bulk of most skin-care products, which is why it usually appears first on these products.

Although companies are not required to substantiate performance claims or conduct safety testing, if safety has not been substantiated, the product's label must read "WARNING: The safety of this product has not been determined."

"Consumers believe that 'if it's on the market, it can't hurt me,'" says Bailey. "And this belief is sometimes wrong."

FDA's challenge comes in proving that a product is harmful under conditions of use or that it is improperly labeled. Only then can the agency take action to remove adulterated or misbranded products from the marketplace.

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The FD&C Act defines cosmetics as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions. This definition includes skin-care creams, lotions, powders and sprays, perfumes, lipsticks, fingernail polishes, eye and facial makeup, permanent waves, hair colors, deodorants, baby products, bath oils, bubble baths, and mouthwashes, as well as any material intended for use as a component of a cosmetic product.

Products that intend to treat or prevent disease, or otherwise affect structure or function of the human body are considered drugs. Cosmetics that make therapeutic claims are regulated as drugs and cosmetics, and must meet the labeling requirements for both. A good way to tell if you're buying a cosmetic that is also regulated as a drug is to see if the first ingredient listed is an "active ingredient." The active ingredient is the chemical that makes the product effective, and the manufacturer must have proof that it's safe for its intended use. For products that are both drugs and cosmetics, the regulations require that active ingredients be listed first on these products, followed by the list of cosmetic ingredients in order of decreasing predominance.

Examples of products that are both cosmetics and drugs are dandruff shampoos, flouride toothpastes, antiperspirant deodorants, and foundations and tanning preparations that contain sunscreen.

Before products with both a cosmetic and drug classification can be marketed, they must be scientifically proven safe and effective for their therapeutic claims. If they are not, FDA considers them to be misbranded and can take regulatory action.

The ingredient list on a cosmetic container is the only place where a consumer can readily find out the truth about what he or she is buying. Consumers can check the listing to identify substances they wish to avoid. And becoming familiar with what cosmetics contain can help counter some of the alluring appeal showcased elsewhere on the product.

"Our best friend is the ingredient label," says beauty consultant and 14-year veteran consumer reporter Paula Begoun. "And spending the time to read it may be all that is needed to protect ourselves from hurting our skin."

But the ingredient list, although a mandatory requirement on cosmetics, is also the most difficult part of the label to understand. Bailey admits that most of us don't recognize the names of the ingredients listed because there are thousands available to chemists creating a wide variety of products. But there's no way to change that, he says, and still accurately identify the substances that are used.

Consumers can, however, obtain specific information about a cosmetic ingredient in various references, such as the International Cosmetic Ingredient Dictionary and Handbook, published by the Cosmetic, Toiletry, and Fragrance Association, available at many public libraries. FDA recognizes the association as a reliable source of facts on substances that have been identified as cosmetic ingredients, as well as their definitions and trade names.

Cosmetic ingredient declaration regulations apply only to retail products intended for home use. Cosmetic samples and products used exclusively by beauticians in salons are not required to include the ingredient declaration. However, these products must state the distributor, list the content's quantity, and include all necessary warning statements.

Almost all cosmetics can cause allergic reactions in certain individuals. Often the first sign of a reaction is a mild redness and irritation. There is no list of ingredients that can be guaranteed not to cause allergic reactions, so consumers who are prone to allergies should pay careful attention to what they use on their skin.

Nearly one-quarter of the people questioned in FDA's 1994 cosmetics survey responded "yes" to having suffered an allergic reaction to personal care products, including moisturizers, foundations, and eye shadows.

"Because of the almost limitless combinations in all sorts of mixtures and formulations, it is virtually impossible to know if, when, or how anyone's skin will react to any cosmetic," Begoun says. She advises consumers to "buy with a healthy dose of skepticism," and to stop using an offending product and return it to the place of purchase. "Returning the product gives the cosmetics company essential information about how these formulas are working."

FDA has tried to establish official definitions for the use of certain terms such as "natural" and "hypoallergenic," but its regulations were overturned in court. So companies can use them on cosmetic labels to mean anything or nothing at all. Most of the terms have considerable market value in promoting cosmetic products to consumers, but dermatologists say they have very little medical meaning.

The list of ingredients, once again, can help consumers determine if there is any significant difference between products labeled similar to the above, and competing brands that don't make these claims.

Since the cosmetics industry often produces new, reworked versions of old ingredients, a wise consumer will take the time to read the labels to know what's in a product and how to use it safely. After all, consumers are likely to try other products with the same recognizable names. Once you have all the information, you can begin to make your own decisions about what products work best for you.

"There is really very little that's new under the sun," Bailey concludes, "and that certainly applies to cosmetics."

Beauty on the Safe Side

Serious injury from makeup is a rare occurrence, according to John Bailey, director of FDA's Office of Cosmetics and Colors. But it does happen. Good common sense and a few precautions can help consumers protect themselves against hazards associated with the misuse of cosmetics.

Helping the Buyer Beware

Despite many questions about their safety, alpha hydroxy acids (AHAs) and beta hydroxy acids (BHAs) have become widely used in recent years. AHAs are derived from fruit and milk sugars, and are among the popular ingredients that attract customers with their claims to reduce wrinkles and age spots, and help repair sun-damaged skin. (See "Alpha Hydroxy Acids" in the March-April 1998 FDA Consumer.)

Prohibited Ingredients

The following ingredients, because of the dangers they impose, are either restricted or prohibited by regulation for use in cosmetics:

The above Natural Beauty Skincare tips for teens republished for our customers and visitors with thanks to the U.S. Food and Drug Administration.

Alpha Hydroxy Acids for Skin Care

Smooth Sailing or Rough Seas?

Baby boomers and others who once sought the sun's rays with little thought of skin damage are now paying the price--billions of dollars annually for cosmetics containing alpha hydroxy acids (AHAs). Derived from fruit and milk sugars and served up in creams and lotions, AHAs attract customers with their supposed ability to reduce wrinkles, spots, and other signs of aging, sun-damaged skin. Some scientific evidence suggests they may work.

But are these products safe? Since 1989, the Food and Drug Administration has received more than 100 reports of adverse reactions in people using AHA products. Their complaints included severe redness, swelling (especially in the area of the eyes), burning, blistering, bleeding, rash, itching, and skin discoloration.

FDA believes reactions from AHAs are probably even more widespread. Past experience suggests that for every adverse reaction report the agency receives, the manufacturer receives 50 to 100. "This would translate into approximately 10,000 adverse reactions being received for AHA-containing products," says John Bailey, Ph.D., acting director of FDA's Office of Cosmetics and Colors.

Also, their relative newness (they've been widely available only since about 1992) means that their long-term effects are unknown. An industry-sponsored study found that people who use AHA products have greater sensitivity to sun, raising the specter of greater risk of photoaging and skin cancer.

"There are many unanswered questions in front of us," Bailey says. "AHAs are unlike anything else ever introduced onto the cosmetic market on such a wide scale. They are not your traditional cosmetics."

In spring 1997, the National Toxicology Program of the National Institute of Environmental Science accepted FDA's proposal to study AHA safety. While FDA awaits the results, expected by the year 2000, the agency is cautioning consumers to take extra care with AHA products: for example, avoiding the sun when possible, otherwise using adequate sun protection, and reporting adverse reactions immediately to doctors or FDA directly.

"These are very, very popular products," Bailey says. "Very little about the process restricts their sale. And it's a somewhat alarming idea to put acids on the skin. It raises obvious safety questions."

AHA cosmetics are believed to have derived from the "chemical peels" that dermatologists and plastic surgeons have used for years. The peels, typically trichloroacetic acid, phenol, resorcinol, and salicylic acid, help remove undesirable signs of skin aging, such as discoloration, roughness and wrinkling. The chemicals cause the skin to lose its outer layer, or peel off, revealing a fresher-looking layer of skin. Known as chemical exfoliation, the procedure is done in doctors' offices so that doctors can control the process and prevent deep skin burns from the highly acidic solutions.

Cosmetic manufacturers began to market similar but milder versions of these chemical peels containing AHAs for salon and at-home use around 1989. They quickly caught on, and by 1992, mass marketing had begun. Today, says Lisa Berger, a cosmetic sales manager for a Hecht Co. department store in Washington, D.C., "every [cosmetic company] has AHA products. There used to be only three product lines; now there are 20."

The AHAs used most often in cosmetics are glycolic acid and lactic acid, although there are others, and many are used in combination. Increasingly, says Zoe Draelos, M.D., a dermatologist in High Point, N.C., manufacturers are using poly-AHAs, which have larger molecules, and ingredients such as salicylic acid. According to Draelos, who consults for several large U.S. cosmetic companies, these products may produce less skin irritation.

Typically, AHA products sold to consumers have an AHA concentration of 10 percent or less. The concentration of AHA products used by trained cosmetologists may run between 20 and 30 percent, while those used by doctors can range from 50 to 70 percent.

Though sold to consumers mainly in face and body creams and lotions, AHAs also can be found to a lesser degree in other cosmetics, such as shampoos and cuticle softeners. Available everywhere, from discount pharmacies to fine department stores, the products typically range in price from a few dollars to as much as $60 a bottle.

Some in the cosmetic industry have suggested that AHA products are more than simple cosmetics, coining the term "cosmeceutical" to describe them instead.

Under the 1938 Federal Food, Drug, and Cosmetic Act, cosmetics are defined as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance." Drugs are defined as products intended for treating or preventing disease and affecting the structure or any function of the body. They are subject to premarket review and approval; cosmetics are not.

"The term 'cosmeceutical' is not recognized by law," Bailey says. "These products, depending on their intended use, would be regulated either as cosmetics, drugs, or both as cosmetics and drugs."

FDA has a particular concern about AHAs because, unlike traditional cosmetics, AHAs seem capable of penetrating the skin barrier. In reviewing the limited data on AHAs, FDA concluded in a 1996 report that certain formulations of AHA products can affect the skin in a manner similar to that of chemical peels--that is, increasing cell turnover rate and decreasing the thickness of the outer skin. The effect depends on the product's pH level (a measure of its acidity), the AHA concentration, and the AHA vehicle cream, as well as how the product is used (for example, frequency of use and where on the skin it is applied).

An additional concern arose as FDA prepared its 1996 report on AHA safety: Some people who had reported adverse reactions cited increased sun sensitivity. In addition, one industry-sponsored study found that participants whose skin was exposed to 4 percent glycolic acid twice daily for 12 weeks developed minimal skin redness with 13 percent less ultraviolet (UV) radiation exposure than normal. Three participants developed minimal redness with 50 percent less UV exposure than normal.

Another study that looked at the effects of glycolic acid on production of sunburn cells (markers for UV-induced skin damage) found that people who received the AHA product in the presence of UV radiation experienced twice the cell damage in areas where the AHA had been applied than those who were treated with the non-AHA product.

FDA's concern is that people who are sensitive to sunlight may be particularly susceptible to UV rays, which can damage the skin and, over a long period, can cause skin cancer.

In 1997, the Cosmetic Ingredient Review Panel--the cosmetic industry's self-regulatory body for reviewing and addressing safety of cosmetic ingredients--concluded that the AHA's glycolic acid and lactic acid and their related chemical compounds are safe for use in products intended for consumer use when:

For AHA products used by trained cosmetologists, the Cosmetic Ingredient Review Panel concluded that formulations of glycolic acid and lactic acid at concentrations of 30 percent or less and a pH of 3.0 or greater intended for only "brief" use at one time followed by thorough rinsing and daily use of sun protection are safe.

The panel's conclusions actually serve as guidelines for cosmetic manufacturers, Bailey says. "This means that each manufacturer of an AHA product should conduct appropriate testing on their products to measure whether or not the product increases the sensitivity of the user to UV radiation and, if so, should add sun protection to their product and warn consumers to take extra steps to protect themselves at all times."

Meanwhile, FDA continues to study AHA safety. Later this year, scientists with the National Toxicology Program and FDA will use hairless mice to study the effect of AHAs on the risk of cancer associated with sunlight and UV radiation. The study will run for about three years.

Depending on the outcome of FDA's investigation, Bailey says, the agency may or may not take action against AHA products. "The absence of action by FDA to date doesn't mean that there won't be any in the future."

Considering the questionable safety status, FDA and dermatologists advise consumers who use AHA products to follow these precautions:

If you have an adverse reaction, see a dermatologist. A dermatologist can tell you whether an adverse reaction is from the product or is an indication of an underlying disease, such as skin cancer. Dermatologists also can recommend appropriate skin-care products, and they will report your case, keeping your name confidential, to FDA's adverse reaction monitoring program.

You also can report your adverse reaction yourself to FDA. Reports can be made to local FDA offices, listed in the Blue Pages of the phone book or to FDA's Office of Consumer Affairs at 1-800-532-4440.⁺ Have the label and any other packaging information on hand. Be prepared to give the name of the product, the name and address of the manufacturer or distributor, and any identifiable product code numbers. Also be prepared to state where and when you bought the product, if you can remember, and whether you saw a doctor. "We'd like to know about it even if it's only a mild reaction," Bailey says.

Bailey adds that these precautions are important until AHAs' safety is better known. "We are told that AHAs are here to stay," he says. "But they are not reviewed for safety before they are put on the market. And we don't have enough information to say that they are safe."

Ingredient Terms

Here are some ingredient terms that indicate a cosmetic contains alpha or beta hydroxy acids.

* From a chemist's perspective, salicylic acid is not a true BHA. However, cosmetic companies often refer to it as a BHA and, consequently, many consumers think of it as one.

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Beauty on the Safe Side

Helping the Buyer Beware

Prohibited Ingredients

Alpha Hydroxy Acids for Skin Care

Smooth Sailing or Rough Seas?

Ingredient Terms

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