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Cosmetics Overview from the Campaign for Safe Cosmetics, 2009

Introduction

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 used products.

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 soaps.

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 cosmetics regulated?"

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 extent.

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 in cosmetics.

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.

Lab studies: 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 this.

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.

Epidemiologic (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 food.

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 important respects:

  • 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 allergic reactions.
  • 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 (cancer-causing) effects.
  • 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 health problems:

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 Skin Deep.

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 exposure.

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.

Additional resources

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: Overview

National organizations and web sites

In addition to the American Cancer Society, other sources of information include*:

Food and Drug Administration (FDA)
Center for Food Safety and Applied Nutrition
Web site: www.cfsan.fda.gov/~dms/cos-toc.html

This web site contains information on cosmetics from the Food and Drug Administration, the federal agency responsible for overseeing cosmetics in the United States.

Cosmeticsinfo.org
Web site: www.cosmeticsinfo.org

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.

Skin Deep
Web site: www.cosmeticsdatabase.com

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.

References

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.

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