Cosmetics Overview from the
Campaign for Safe Cosmetics, 2009
In recent years, ingredients used to make consumer products
(including cosmetics) have come under increased scrutiny for
their possible effects on human health and on the environment.
This is in part fueled by information on the Internet about the
chemicals in consumer products, including cosmetics.
This document is a brief overview of cosmetics, how they are
regulated, and what is (and is not) known about their possible
health effects, as part of the American Cancer Society's role in
informing and educating people about cancer, its possible
causes, and commonly encountered concerns about cancer. The
American Cancer Society does not maintain lists of the
individual chemicals that may be used in cosmetics or have
position statements about either ingredients or products. A
discussion of web sites on these issues is provided later in
this document. Susan B. Komen and National Breast Cancer
Coalition also will not tell consumers about chemicals in daily
What are cosmetics?
According to the US Food and Drug Administration (FDA), the
law defines cosmetics as "articles intended to be rubbed,
poured, sprinkled, or sprayed on, introduced into, or otherwise
applied to the human body... for cleansing, beautifying,
promoting attractiveness, or altering the appearance." This
includes skin moisturizers, perfumes, lipsticks, fingernail
polishes, eye and facial makeup, shampoos, permanent waves, hair
colors, toothpastes, and deodorants, as well as any component of
a cosmetic product. It does not include products used solely as
Cosmetics are different from drugs, which are defined as
"articles intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease" and "articles (other than
food) intended to affect the structure or any function of the
body of man or other animals."
This difference is important when it comes to federal
oversight of these products, which is described below in the
section, "How are
Do cosmetics cause health problems?
Cosmetics include a wide range of products. Some of these can
cause health problems in some people, such as skin or eye
irritation or allergic reactions. These types of problems are
usually short-term and go away if use of the product is stopped.
But whether cosmetics or certain ingredients in them cause more
subtle or long-term health problems is still a matter of current
debate. Uncertainty exists because many products and
ingredients, although unlikely to cause serious problems, have
not been thoroughly tested. Even when ingredients in cosmetics
have been tested, the results may not always be simple or clear
cut. In addition, little information is available to the public
on which ingredients are absorbed by the body and to what
How can products be tested for safety?
The ingredients in cosmetics are routinely tested for acute
health problems such as skin and eye irritation and allergic
reactions. Much less information is available on whether
long-term effects can result from the absorption of ingredients
It is more difficult to test the ingredients in cosmetics for
harmful long-term health problems such as cancer. It is not
feasible to test every combination and dose of these ingredients
in the actual products, which in any case frequently change.
Therefore, scientists must resort to other types of tests --
typically at much higher doses and through different routes of
exposure than people would normally have -- to try to determine
the potential of a chemical to cause cancer.
Scientists get much of their data about whether something might
cause cancer from lab studies using cell cultures and animals.
Because there are far too many substances (natural and manmade)
to test each one in lab animals, scientists use knowledge about
chemical structure, other types of lab tests, and other factors
to select chemicals for testing. They can often get an idea
about whether a substance might cause problems by looking at its
chemical structure and comparing it to similar chemicals.
Virtually all substances known to cause cancer in humans also
cause cancer in lab animals. But the reverse is not always true
-- not every substance found to cause cancer in lab animals is
known to cause cancer in people. There are different reasons for
First, most lab studies of potential carcinogens
(cancer-causing substances) expose animals to doses that are
much higher than common human exposures. This is so that cancer
risk can be detected in relatively small groups of animals. But
doses are very important when talking about toxicity. For
example, taking a couple of aspirin may help with your headache,
but taking a whole bottle could put you in serious trouble. It's
not always clear that the effects seen with very high doses of a
substance would also be seen with much lower doses.
Second, there may be other differences between the way
substances are tested in the lab and the way they would be used,
such as the route of exposure. For example, applying a substance
to the skin is likely to result in much less absorption of the
substance than would be seen if the same substance is swallowed,
inhaled, or injected into the blood. The duration and dose of
the exposure also help determine the degree of risk.
Finally, the bodies of lab animals and humans don't always
process substances in the same way, and a substance that may
cause harm to one may not have the same effect on the other. As
an example of this type of difference, you may like chocolate,
but you probably know that it could make your dog very sick.
By themselves, lab studies provide only a limited picture
about whether a substance would cause long-term health problems
in humans under normal use.
(population-based) studies: Epidemiologic studies look at
human populations to determine which factors might be linked to
cancer. While these studies provide useful information, they
also have their limitations. Humans do not live in a controlled
environment. People are exposed to numerous substances at any
one time, including those they encounter at work, school, or
home; in the food they eat; and in the air they breathe. It's
very unlikely people truly know exactly what they've been
exposed to or that they would be able to remember all of their
exposures if asked by a researcher. And it is usually many years
(often decades) between exposure to a carcinogen and the
development of cancer. Therefore, it can be very hard to single
out any particular exposure as having a definite link to cancer.
By combining data from both types of studies, scientists do
their best to make an educated assessment of a substance's
cancer-causing ability. But often there simply isn't enough
information to be certain one way or the other.
Federal and international agencies who designate the level of
evidence that a substance causes cancer typically classify an
exposure as being either a
known human carcinogen,
probably carcinogenic to humans, or
possibly carcinogenic to
humans. Not surprisingly, most chemicals that make these lists
fall into the possibly carcinogenic category, meaning there is
potential for cancer but no strong evidence of this in humans.
How are cosmetics regulated?
In the United States, both cosmetics and drugs are regulated
by the FDA. For drugs, the FDA requires that new products be
shown to be safe and effective before they are allowed to be
sold. This is not the case for cosmetics. The main reason for
this has been that cosmetics are applied to the outside of the
body and the doses absorbed are much less than with drugs or
Except for color additives, the FDA does not have the
authority to require companies to test their cosmetic products
before they are put on the market. The FDA holds cosmetic firms
responsible for confirming the safety of their products and
ingredients prior to marketing. Products that have not been
tested must carry the label, "Warning -- The safety of this
product has not been determined."
The oversight of cosmetics is limited in a number of
- Relatively few ingredients have been thoroughly tested
and reviewed, and the testing that is done mainly looks for
short-term effects such as skin or eye irritation or
- There is no clear definition of safety with respect to
long-term health effects.
- Once a product is on the market, any short-term health
effects are likely to become apparent, but this does not
help to identify any long-term toxic or carcinogenic
- Certain categories of products, such as soaps and hair
dyes, are exempt from some regulations.
- While the FDA does request that some ingredients are
tested more thoroughly, it is not always clear how the
agency determines which ingredients should be evaluated more
thoroughly and what the extent of further evaluation is.
- The FDA has limited staff and resources to oversee the
safety of cosmetics.
Same data, different views
Information about cosmetics is often presented with widely
divergent points of view with respect to the potential for
Innocent until proven guilty?
At one end of the spectrum are those who believe that the
products are adequately regulated and safe. The weakness of this
argument is that there are many gaps in the evidence,
particularly on the extent to which the ingredients in cosmetics
can be absorbed and build up in the body. Further, just because
a substance hasn't been shown to cause a problem doesn't ensure
that it is risk-free. The major reason why most scientists and
regulatory agencies believe that it is very unlikely that
cosmetic ingredients have serious health effects is because of
the low dose exposures, even with regular use.
Better safe than sorry?
At the other end of the spectrum are people who believe that
any evidence that a substance may be linked to cancer,
regardless of the dose or route of exposure, should cause it to
be banned from use, if possible. This is the perspective taken
by some advocacy organizations such as the Environmental Working
Group on the Web site
Particularly controversial are chemicals considered to be
"endocrine disruptors," which can mimic the natural hormone
estrogen. When made by the body or given as a drug, estrogen
affects reproductive organs and can raise the risk of breast and
endometrial cancer. There is considerable controversy about the
effects of much lower exposures to chemicals that mimic estrogen
in the body. Some groups have called for the banning of all such
substances. This is complicated, because certain foods such as
tofu and soy milk contain these compounds naturally.
A main drawback of this perspective is that it is not
possible to completely eliminate any exposure to potentially
carcinogenic compounds. For example, sunlight, naturally
occurring carcinogens in foods, and the reactive chemicals that
our bodies make while metabolizing food cannot be eliminated.
The risk from these can only be managed by behaviors that limit
It's important to have a sense of the difference between the
hazard an ingredient may pose and the risk a person faces from
being exposed to it. Scientists use the term
hazard to describe the
potential of a chemical to cause unwanted health effects. Risk
is used to describe the chances of an unwanted health effect in
a person from normal use of the ingredient. A substance may be
deemed to be potentially hazardous for some reason, but it may
pose very little risk to people during normal use.
More data needed
The American Cancer Society takes seriously its role as a
provider of trusted, credible information on issues related to
cancer. Such information is essential for individuals and
regulatory agencies to make informed decisions about the safety
of consumer products. More information is needed on the extent
to which the ingredients in cosmetics are absorbed and retained
in the body during normal usage, especially in groups such as in
infants and pregnant mothers. Furthermore, the American Cancer
Society supports the need for open and transparent regulatory
oversight of cosmetics and encourages continued and expanded
scientific research of the potential links between cosmetic use
and cancer risk. The need for an effective FDA in ensuring the
safety of our food supply, medicines, and consumer products has
never been greater.
In the meantime, people who are concerned about the possible
health effects of cosmetics may wish to visit the web sites
listed below to learn more about the products and what may be in
them. Concerned individuals may choose to avoid certain products
or to minimize or avoid cosmetic use altogether. Consumers
should be aware that there is no evidence that products labeled
as "natural," "organic," or "green" are in fact safer than
products that do not carry these labels.
More information from your American Cancer Society
The following related information may also be helpful to you.
These materials may be viewed on our web site or ordered from
our toll-free number, at 1-800-ACS-2345 (1-800-227-2345).
- Environmental and Occupational Cancer Risk Factors:
National organizations and web sites
In addition to the American Cancer Society, other sources of
Food and Drug Administration
Center for Food Safety and Applied Nutrition
This web site contains
information on cosmetics from the Food and Drug Administration,
the federal agency responsible for overseeing cosmetics in the
This site, run by the
Personal Care Products Council (a trade association representing
the cosmetics, toiletry, and fragrance industry), contains
information about the safety, testing, and regulation of
cosmetics and personal care products and their ingredients. The
site is divided into 2 main sections -- safety information pages
and an ingredient database.
This web site, created by the
Environmental Working Group (an environmental and public health
advocacy group), allows consumers to look up products of
interest and determine which contain ingredients that have been
associated with cancer, developmental problems, or other health
effects in at least one lab study of animals or in a
population-based study of humans.
*Inclusion on this list does
not imply endorsement by the American Cancer Society.
US Food and Drug Administration. FDA Authority Over
Cosmetics. 2005. Accessed at www.cfsan.fda.gov/~dms/cos-206.html
on February 11, 2009.
US Food and Drug Administration. Is It a Cosmetic, a Drug, or
Both? (or Is It Soap?). 2002. Accessed at www.cfsan.fda.gov/~dms/cos-218.html
on February 11, 2009.
products without harmful chemicals