|| Beauty Care Business and Professional Network
U. S. Food and Drug Administration
May - June 1998
Clearing Up Cosmetic Confusion
by Carol Lewis
Cosmetics run the gamut from eye shadow to deodorant sprays.
consumers' concerns and questions are just as varied as the
"Consumers are so confused by the products out there because
all do so many different things," says Lynn Reniers, a licensed
cosmetologist with Elizabeth Arden. "So it's important to send
with a very clear understanding of product usage."
When FDA surveyed 1,687 consumers ages 14 and older in 1994
their use of cosmetics, many of the responses pertained to
perceptions about cosmetic labeling claims. For example, many
expect a product to prevent or slow the formation of wrinkles if
such a claim on its packaging. And nearly half of those surveyed
felt that a
product claiming to be "natural" should contain all natural
do these products live up to their labeling claims?
Not necessarily. John Bailey, Ph.D., director of FDA's Office
Cosmetics and Colors, says, "Image is what the cosmetics industry
through its products, and it's up to the consumer to believe the
Behind the image, however, are real products, and consumers
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
The regulatory requirements governing the sale of cosmetics
as stringent as those that apply to other FDA-regulated products.
the Federal Food, Drug, and Cosmetic (FD&C) Act, cosmetics and
ingredients are not required to undergo approval before they are
the public. Generally, FDA regulates these products after they
released to the marketplace. This means that manufacturers may
ingredient or raw material, except for color additives and a few
prohibited substances, to market a product without a government
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
ingredients and register their manufacturing establishments
agency's voluntary reporting program. According to FDA's Office
Cosmetics and Colors, however, only about 35 to 40 percent of
manufacturers currently participate in the program.
But some regulations do apply to cosmetics. In addition to
Act, the Fair Packaging and Labeling Act requires an ingredient
on every cosmetic product offered for sale to consumers. In
these regulations require that ingredients be listed in
descending order of
quantity. Water, for example, accounts for the bulk of most
products, which is why it usually appears first on these
Although companies are not required to substantiate
claims or conduct safety testing, if safety has not been
product's label must read "WARNING: The safety of this product
"Consumers believe that 'if it's on the market, it can't hurt
Bailey. "And this belief is sometimes wrong."
FDA's challenge comes in proving that a product is harmful
conditions of use or that it is improperly labeled. Only then can
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
the human body for cleansing, beautifying, promoting
altering the appearance without affecting the body's structure or
functions. This definition includes skin-care creams, lotions,
sprays, perfumes, lipsticks, fingernail polishes, eye and facial
permanent waves, hair colors, deodorants, baby products, bath
bubble baths, and mouthwashes, as well as any material intended
as a component of a cosmetic product.
Products that intend to treat or prevent disease, or
structure or function of the human body are considered drugs.
that make therapeutic claims are regulated as drugs and
must meet the labeling requirements for both. A good way to tell
buying a cosmetic that is also regulated as a drug is to see if
ingredient listed is an "active ingredient." The active
ingredient is the
chemical that makes the product effective, and the manufacturer
have proof that it's safe for its intended use. For products that
drugs and cosmetics, the regulations require that active
listed first on these products, followed by the list of cosmetic
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
marketed, they must be scientifically proven safe and effective
therapeutic claims. If they are not, FDA considers them to be
and can take regulatory action.
Reading Is Believing
The ingredient list on a cosmetic container is the only place
consumer can readily find out the truth about what he or she is
Consumers can check the listing to identify substances they wish
And becoming familiar with what cosmetics contain can help
some of the alluring appeal showcased elsewhere on the
"Our best friend is the ingredient label," says beauty
14-year veteran consumer reporter Paula Begoun. "And spending the
to read it may be all that is needed to protect ourselves from
But the ingredient list, although a mandatory requirement on
cosmetics, is also the most difficult part of the label to
admits that most of us don't recognize the names of the
because there are thousands available to chemists creating a wide
of products. But there's no way to change that, he says, and
identify the substances that are used.
Consumers can, however, obtain specific information about a
cosmetic ingredient in various references, such as the
Cosmetic Ingredient Dictionary and Handbook, published by the
Toiletry, and Fragrance Association, available at most public
libraries or at
the Office of the Federal Register, 1100 L St., N.W., Washington,
FDA recognizes the association as a reliable source of substances
been identified as cosmetic ingredients, as well as their
Cosmetic ingredient declaration regulations apply only to
products intended for home use. Cosmetic samples and products
exclusively by beauticians in salons and labeled "For
Professional Use Only"
are not required to include the ingredient declaration. However,
products must state the distributor, list the content's quantity,
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
irritation. There is no list of ingredients that can be
guaranteed not to
cause allergic reactions, so consumers who are prone to allergies
pay careful attention to what they use on their skin.
Nearly one-quarter of the people questioned in FDA's 1994
survey responded "yes" to having suffered an allergic reaction to
care products, including moisturizers, foundations, and eye
"Because of the almost limitless combinations in all sorts of
and formulations, it is virtually impossible to know if, when, or
anyone's skin will react to any cosmetic," Begoun says. She
consumers to "buy with a healthy dose of skepticism," and to stop
offending product and return it to the place of purchase.
product gives the cosmetics company essential information about
these formulas are working."
What Lies Behind the Meaning
FDA has tried to establish official definitions for the use
terms such as "natural" and "hypoallergenic," but its regulations
overturned in court. So companies can use them on cosmetic labels
mean anything or nothing at all. Most of the terms have
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
- Natural: implies that ingredients are extracted directly
plants or animal products as opposed to being produced
There is no basis in fact or scientific legitimacy to the notion
containing natural ingredients are good for the skin.
- Hypoallergenic: implies that products making this claim
likely to cause allergic reactions. There are no prescribed
required to substantiate this claim. Likewise, the terms
"dermatologist-tested," "sensitivity tested," "allergy tested,"
"nonirritating" carry no guarantee that they won't cause skin
- Alcohol Free: traditionally meant that certain cosmetic
products do not contain ethyl alcohol (or grain alcohol).
products, however, may contain other alcohols, such as cetyl,
cetearyl, or lanolin, which are known as fatty alcohols.
- Fragrance Free: implies that a cosmetic product so
no perceptible odor. Fragrance ingredients may be added to a
fragrance-free cosmetic to mask any offensive odor originating
raw materials used, but in a smaller amount than is needed to
- 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
cosmetic product is good under normal conditions of storage and
depending on the product's composition, packaging, preservation,
Expiration dates are, for practical purposes, a rule of thumb,
product may expire long before that date if it has not been
- Cruelty Free: implies that products have not been tested
animals. Most ingredients used in cosmetics have at some point
tested on animals so consumers may want to look for "no new
testing," to get a more accurate indication.
The list of ingredients, once again, can help consumers
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
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,
likely to try other products with the same recognizable names.
have all the information, you can begin to make your own
what products work best for you.
"There is really very little that's new under the sun,"
"and that certainly applies to cosmetics."
Carol Lewis is on assignment with FDA's Office of Public
Beauty on the Safe Side
Serious injury from makeup is a rare occurrence, according to
Bailey, director of FDA's Office of Cosmetics and Colors. But it
happen. Good common sense and a few precautions can help
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
eyeball can cause bacteria to contaminate the cut and could
serious injury, including blindness.
- Never share makeup. Always use a new disposable
when sampling products at a cosmetics counter. Insist that
clean container openings with alcohol before applying their
- Never add liquid to a product to bring back its original
consistency. Adding other liquids could introduce bacteria that
grow out of control.
- Stop using any product that causes an allergic reaction.
- Throw away makeup if the color changes or an odor
Preservatives degrade over time and may no longer be able to
- Do not use eye makeup if you have an eye infection.
away all products you were using when you discovered the
- Keep makeup out of sunlight. Light and heat can degrade
- Keep makeup containers tightly closed when not in use.
- Never use aerosol beauty products near heat or while
because they can ignite. Hairsprays and powders may cause lung
if inhaled regularly.
Helping the Buyer Beware
Despite many questions about their safety, alpha hydroxy
(AHAs) and beta hydroxy acids (BHAs) have become widely used in
years. AHAs are derived from fruit and milk sugars, and are among
popular ingredients that attract customers with their claims to
wrinkles and age spots, and help repair sun-damaged skin. (See
Hydroxy Acids" in the March-April 1998 FDA
FDA recommends that consumers take precautions with AHA and
- Test any AHA/BHA-containing product on a small area of
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.
The following ingredients, because of the dangers they
either restricted or prohibited by regulation for use in
- 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
local FDA office, listed in the Blue Pages of the telephone book,
Office of Consumer Affairs at 1-800-532-4440. More information on
cosmetics is available by calling the Office of Cosmetics and
automated information line at 1-800-270-8869 or by visiting FDA's
FDA Consumer magazine (May-June 1998)