Home   »  Regulations  »  FDA Regulations

Get Updates

FDA Regulations

The agency charged with oversight of cosmetics, the U.S. Food and Drug Administration (FDA), has no authority to require pre-market safety assessment as it does with drugs, so cosmetics are among the least-regulated products on the market. The FDA does not review nor does it have the authority to regulate what goes into cosmetics before they are marketed for salon use and consumer use. In fact, 89 percent of all ingredients in cosmetics have not been evaluated for safety by any publicly accountable institution.

Ironically, most consumers believe the U.S. government regulates the cosmetics industry the same way it regulates food and drugs sold in this country to make sure they're safe. The truth is, no one's minding the store when it comes to shampoo, skin moisturizers, baby products, lipstick or any other personal care product.

The FDAs own Web site explains its limitations:

FDA's legal authority over cosmetics is different from other products regulated by the agency .... Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives.

The emerging evidence on the body burdens of chemicals in the American people, as well as the new science on how small exposures to these chemicals can add up to harm, suggest that there is no health-based rationale for the difference in regulatory powers between the different FDA divisions.

According to FDA, "[a] change in FDA's statutory authority over cosmetics would require Congress to change the law." To discourage congressional legislation, the cosmetics industry trade group (then the Cosmetic, Toiletry, and Fragrance Association, now the Personal Care Products Council), created a system of voluntary self-regulation in 1976 through the Cosmetic Ingredient Review Panel.

The Fox Guarding the Hen House

The Cosmetic Ingredient Review (CIR), the industry's self-policing safety panel, falls far short of compensating for the lack of FDA oversight. According to its Web site, the CIR "thoroughly reviews and assesses the safety of ingredients used in cosmetics in an open, unbiased, and expert manner, and publishes the results in the peer-reviewed scientific literature."

Yet in its more than 30-year history, the CIR has reviewed the safety of only 11 percent of the ingredients used to formulate personal care products, and through June of 2008 has found only nine ingredients to be unsafe for use in cosmetics.

This panel operates in a vacuum of guidance from FDA when it comes to the safety of personal care products. Words on labels like "natural," "safe" and "pure" have no definition in law and no relationship to the hazard inside the packaging. Acceptable levels of risk are entirely at this panel's discretion.

To the detriment of public health, the CIR doesn't look at the effects of exposures to multiple chemicals linked to negative health impacts; the cumulative effect of exposures over a lifetime; the timing of exposure, which can magnify the harm for the very young and other populations; or worker exposures, in both beauty salons and manufacturing plants.

Voluntary self-regulation of the cosmetics industry in the United States is not working. Consumers deserve a government that protects them from unsafe chemical exposures in the cosmetics they use every day.

More Information

The FDA and lead in lipstick

U.S. federal reform efforts

Factsheet: FDA regulatory shortcomings

FDA authority over cosmetics

Sourcewatch: What is the CIR?

FDA: Make Condoms Even Safer
Even though condoms are critical to safe sex, some popular brands release cancer-causing chemicals called nitrosamines.

The FDA and Brazilian Blowout
Since 2007, scientists and the FDA have known that Brazilian Blowout hair products contain dangerously high levels of formaldehyde.

The FDA and Lead in Lipstick
It took two years of pressure for the FDA to release information to the public about its analysis of lead in lipstick.

Letter to Dr. Linda Katz, Director of the FDA Office of Cosmetics and Colors
Letter to Dr. Linda Katz, Director of the FDA Office of Cosmetics and Colors, Concerning Lead in Lipstick