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Home :: Professional / Government Regulation / FDA Requirements and Programs / Clearing Up Cosmetic Confusion


U. S. Food and Drug Administration
FDA Consumer
May - June 1998


Clearing Up Cosmetic Confusion

by Carol Lewis

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.

Regulatory Authority

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.

Cosmetics are voluntarily registered with FDA by those manufacturers who, in good faith, want to project an image of responsible product development. They may forward data about their ingredients and register their manufacturing establishments through the agency's voluntary reporting program. According to FDA's Office of Cosmetics and Colors, however, only about 35 to 40 percent of cosmetic manufacturers currently participate in the program.

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.

The Fine Line Between Cosmetics and Drugs

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, fluoride toothpastes that fight tooth decay, antiperspirants/deodorants, and sunblocking/tanning preparations, including foundations that contain sunscreens.

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.

Reading Is Believing

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 most public libraries or at the Office of the Federal Register, 1100 L St., N.W., Washington, DC 20408. FDA recognizes the association as a reliable source of 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 and labeled "For Professional Use Only" 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.

They Can Be Irritating

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."

What Lies Behind the Meaning

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.

Some of the more common terms that consumers should be aware of include:

  • Natural: implies that ingredients are extracted directly from plants or animal products as opposed to being produced synthetically. There is no basis in fact or scientific legitimacy to the notion that products containing natural ingredients are good for the skin.
  • Hypoallergenic: implies that products making this claim are less likely to cause allergic reactions. There are no prescribed scientific studies required to substantiate this claim. Likewise, the terms "dermatologist-tested," "sensitivity tested," "allergy tested," or "nonirritating" carry no guarantee that they won't cause skin reactions.
  • Alcohol Free: traditionally meant that certain cosmetic products do not contain ethyl alcohol (or grain alcohol). Cosmetic products, however, may contain other alcohols, such as cetyl, stearyl, cetearyl, or lanolin, which are known as fatty alcohols.
  • Fragrance Free: implies that a cosmetic product so labeled has no perceptible odor. Fragrance ingredients may be added to a fragrance-free cosmetic to mask any offensive odor originating from the raw materials used, but in a smaller amount than is needed to impart a noticeable scent.
  • Noncomodogenic: suggests that products do not contain common pore-clogging ingredients that could lead to acne.
  • Shelf Life (Expiration Date): the amount of time for which a cosmetic product is good under normal conditions of storage and use, depending on the product's composition, packaging, preservation, etc. Expiration dates are, for practical purposes, a rule of thumb, and a product may expire long before that date if it has not been stored and properly handled.
  • Cruelty Free: implies that products have not been tested on animals. Most ingredients used in cosmetics have at some point been tested on animals so consumers may want to look for "no new animal testing," to get a more accurate indication.

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."

Carol Lewis is on assignment with FDA's Office of Public Affairs.


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.
  • Never drive and apply makeup. Not only does it make for dangerous driving, but hitting a bump in the road and scratching your eyeball can cause bacteria to contaminate the cut and could result in serious injury, including blindness.
  • Never share makeup. Always use a new disposable applicator when sampling products at a cosmetics counter. Insist that salespersons clean container openings with alcohol before applying their contents to your skin.
  • Never add liquid to a product to bring back its original consistency. Adding other liquids could introduce bacteria that can easily grow out of control.
  • Stop using any product that causes an allergic reaction.
  • Throw away makeup if the color changes or an odor develops. Preservatives degrade over time and may no longer be able to fight bacteria.
  • Do not use eye makeup if you have an eye infection. Throw away all products you were using when you discovered the infection.
  • Keep makeup out of sunlight. Light and heat can degrade preservatives.
  • Keep makeup containers tightly closed when not in use.
  • Never use aerosol beauty products near heat or while smoking because they can ignite. Hairsprays and powders may cause lung damage if inhaled regularly.

--C.L.


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.)

FDA recommends that consumers take precautions with AHA and BHA products:

  • Test any AHA/BHA-containing product on a small area of skin before applying to a larger area.
  • Avoid the sun when possible.
  • Use an effective sunscreen when using an AHA-containing product, even if you haven't used the product that day.
  • Follow use instructions on the label.
  • Do not exceed recommended applications.
  • Do not use on infants and children.

--C.L.


Prohibited Ingredients

The following ingredients, because of the dangers they impose, are either restricted or prohibited by regulation for use in cosmetics:
  • bithionol
  • mercury compounds
  • vinyl chloride
  • halogenated salicylanilides
  • zirconium complexes in aerosol cosmetics
  • chloroform
  • methylene chloride
  • chlorofluorocarbon propellants
  • hexachlorophene
  • methyl methacrylate monomer in nail products

--C.L.

* Consumers should report cosmetic adverse reactions by calling their local FDA office, listed in the Blue Pages of the telephone book, or FDA's Office of Consumer Affairs at 1-800-532-4440. More information on cosmetics is available by calling the Office of Cosmetics and Colors' automated information line at 1-800-270-8869 or by visiting FDA's Website (www.fda.gov).

FDA Consumer magazine (May-June 1998)


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