Document ID: FDA-2008-N-0138-0012
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-03-21T04:00Z

FOR IMMEDIATE RELEASE: Thursday, February 8, 2007

Contacts: Kevin Donegan or Marisa Walker, Breast Cancer Fund, (415)
346-8223; Stacy Malkan, Campaign for Safe Cosmetics, (510) 848-5343
x105; David Steinman, author, “Safe Trip to Eden,” (310) 403-6995
Sheila Huettl, Freedom Press, (323) 208-2629.

Cancer-causing Chemical Found in Children’s Bath Products and Major
Brand Personal Care Products

WASHINGTON—A hidden cancer-causing petrochemical has been found in
dozens of children’s bath products and adults’ personal care
products, in some cases at levels that are more than twice FDA’s
lenient recommended maximum.

Laboratory tests released today revealed the presence of 1,4 dioxane in
products such as Hello Kitty Bubble Bath, Huggies Baby Wash, Johnson’s
Baby Shampoo, Scooby-Doo Bubble Bath and Sesame Street Bubble Bath. The
tests also found the carcinogen in Clairol Herbal Essences shampoo, Olay
Complete Body Wash, Sunlight dishwashing liquid and many other brands.

1,4 dioxane is a petroleum-derived contaminant considered a probable
human carcinogen by the U.S. Environmental Protection Agency, a
clear-cut animal carcinogen by the National Toxicology Program and a
possible human carcinogen by the U.N. International Agency for Research
on Cancer. It is also on California’s Proposition 65 list of chemicals
known or suspected by the state to cause cancer or birth defects.
Because it is a contaminant produced during manufacturing, FDA does not
require it to be listed as an ingredient on product labels.

The problem of 1,4 dioxane contamination in personal care products is
highlighted in a new book, “Safe Trip to Eden: Ten Steps to Save the
Planet Earth from the Global Warming Meltdown,” by David Steinman. The
laboratory results were jointly released today at the National Press
Club by Steinman and the Campaign for Safe Cosmetics, a coalition of
U.S.-based health and environmental groups working to protect cosmetics
consumers from toxic chemicals and hold companies accountable for the
safety of their products.

“Regrettably, 1,4 dioxane contamination is just the tip of the
iceberg,” said Jeanne Rizzo, R.N., executive director of the Breast
Cancer Fund, a founding member of the Campaign for Safe Cosmetics.
“Because the FDA does not require cosmetics products to be tested for
safety, companies can put unlimited amounts of toxic chemicals in
cosmetics.”

Steinman said parents should be outraged that companies are willing to
spend a significant amount of money on entertainment licensing
agreements that entice children but won’t spend pennies to remove
contaminants such as 1,4 dioxane.

“Consumers who have young children, as I do, have the right to expect
the highest purity in children’s products,” Steinman said. “I call
on American consumers to say no to dangerous petrochemicals in their
children’s cosmetic and personal care products.”

Contrary to what many consumers may believe, the FDA does not review or
regulate cosmetics products or ingredients for safety before they are
sold to the public and has no legal authority to require safety
assessments of cosmetics.

More/

Add One/ Cancer-causing Chemical Found in Personal Care Products

Devra Lee Davis, a noted epidemiologist and director of the Center for
Environmental Oncology at the University of Pittsburgh Cancer Institute,
said that the combined effects of very low levels of hidden contaminants
in personal care products, food, air and water have lifelong effects
that scientists are just now beginning to understand. “The usual
regulatory approach of assessing risk one chemical at a time does not
account for that mixture,” Davis said. “We must lower exposures to
controllable agents that we know or suspect cause cancer.”

The FDA has been measuring 1,4-dioxane levels since 1979, but because
the agency has little authority or enforcement capacity over the
cosmetics industry, it has worked with manufacturers on a voluntary
basis only to reduce levels. In 2000, the FDA recommended that cosmetic
products should not contain 1,4 dioxane levels at concentrations greater
than 10 ppm (parts per million); yet some 15 percent of products tested
exceeded even these lenient guidelines.

More than two dozen products were tested at Steinman’s request by West
Coast Analytical Service, an independent testing laboratory specializing
in trace chemical analysis.

Product								1,4 dioxane concentration

Baby & Children’s Consumer Products

Gerber Grins & Giggles Gentle & Mild Aloe Vera Baby Shampoo	8.4 ppm

Hello Kitty Bubble Bath						12 ppm*

Huggies Baby Wash Shampoo					4.0 ppm

Huggies Natural Care Baby Wash Extra Gentle and Tear Free	4.2 ppm

Johnson’s Baby Shampoo						5.3 ppm/6.1 ppm

Johnson’s Kids Tigger Bath Bubbles					5.6 ppm to 7.9 ppm

Johnson’s Kids’ Shampoo Watermelon Explosion			10 ppm*

L’Oreal Kids Orange Mango Smoothie Shampoo			2 ppm

Rite-Aid Tearless Baby Shampoo					4.3 ppm

Scooby-Doo Bubble Bath from Kid Care				3 ppm

Sesame Street Wet Wild Watermelon Bubble Bath			7.4 ppm

Adult Consumer Products

Clairol Herbal Essences Rainforest Flowers				23 ppm*

Olay Complete Body Wash with Vitamins (normal skin)		23 ppm*

Suave Naturals Passion Flower 					2 ppm

Steinman’s book explains what Americans can do today to be “green
patriots” and curb the nation’s dependency on foreign oil. The new
laboratory results reveal the health risks posed by the same
petrochemicals that are part of what he calls the nation’s growing oil
addiction.

Women and girls use an average of 12 personal care products daily,
according to a 2004 survey conducted by the Campaign for Safe Cosmetics.

# # #

Founding members of The Campaign for Safe Cosmetics include: Alliance
for a Healthy Tomorrow, Breast Cancer Fund, Commonweal, Friends of the
Earth, Women's Voices for the Earth, Environmental Working Group,
National Black Environmental Justice Network and the National
Environmental Trust. For more information and background on the
campaign, and a link to the Environmental Working Group’s “Skin
Deep” database of cosmetics product safety, visit
www.safecosmetics.org. To learn more about “Safe Trip to Eden: Ten
Steps to Save the Planet Earth from the Global Warming Meltdown” by
David Steinman, call Sheila Huettl (323) 208-2629.

* Exceeds or is at upper limit of FDA voluntary guidelines