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                     Clearing Up Cosmetic Confusion

         This article originally appeared in the May-June 1998
          FDA Consumer. The version below is from a reprint of
     the original article and contains revisions made in May 1998.

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

"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.

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

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

"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 productso 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

- 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

- 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

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

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

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


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

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

Do not use on infants and children.


Prohibited Ingredients

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

       mercury compounds
       vinyl chloride
       halogenated salicylanilides
       zirconium complexes in aerosol cosmetics
       methylene chloride
       chlorofluorocarbon propellants
       methyl methacrylate monomer in nail products


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 (

Publication No. (FDA) 98-5017