FDA urged to limit nanoparticle use in cosmetics and sunscreens
Numerous products such as sunscreens and cosmetics contain
potentially hazardous nanoparticles but lack adequate warning labels of
their possible health effects, two activist groups charged Tuesday.
The groups -- Friends of the Earth and International Center for
Technology Assessment -- formally petitioned the U.S. Food and Drug
Administration, demanding that the agency better monitor and regulate
products containing nanoparticles -- and said they would sue if the
agency does nothing.
Their announcement coincided with the release of a report by the
groups that highlighted the number of personal care products with
nanoingredients, material typically 100 nanometers wide -- far smaller
than a red blood cell -- or smaller.
Tuesday's filing was "the first-ever legal challenge on the
potential human health and environmental risks of nanotechnology and
nanomaterials," the groups claimed in a statement.
"These products pose a clear and present threat," George Kimbrell,
an attorney with the groups, said during the telephone press conference
from Washington. If the FDA doesn't begin to adopt the necessary
monitoring and regulatory actions some time after the 180-day deadline
for response has passed, then the groups plan to sue the agency, he
The term nanoparticle is derived from "nanometer," or a billionth of
a meter. Being so tiny, the particles have exotic physical effects that
allow them to penetrate unusually deeply into the skin and organs, the
groups said. Nanoparticles, they said, are found in some products sold
by cosmetics firms such as Revlon, L'Oreal and Estee Lauder.
Animal studies have shown that some nanoparticles can penetrate
cells and tissues, move through the body and brain and cause
biochemical damage. But whether cosmetics and sunscreens containing
nanomaterials pose health risks remains largely unknown, pending
completion of long-range studies recently begun by the FDA and other
The FDA regulates sunscreens as nonprescription drugs and does not
require extra safety tests for products containing nanoparticles. The
agency has little authority over cosmetics.
FDA spokeswoman Susan Cruzan said Tuesday that the agency has no
evidence that nanoparticles in products pose hazards. Nonetheless, she
said, the agency plans to hold a public meeting in the fall "to gather
information about current development and uses" of nanoparticles.
A top Washington representative of the cosmetics industry defended the use of nanoparticles in products.
"I don't think there's anything to worry about," said John Bailey, a
chemist and former official in the FDA's cosmetics division who is now
executive vice president for the Cosmetic, Toiletry and Fragrance
Association, a trade association in Washington. "All of the safety
questions have been answered" in previous studies, he said.
In a report posted at www.foe.org, the activist groups say
nanomaterials are used extensively in more than 116 sunscreens,
cosmetics and personal care products -- despite a lack of independent
safety assessment and regulation.
"Corporations should stop marketing nano-laced products until these
materials are proven safe and stop treating their customers like guinea
pigs," said Lisa Archer, senior health and environment campaigner with
Friends of the Earth U.S.
Neither Revlon nor L'Oreal responded to phone calls seeking comment.
Estee Lauder spokeswoman Janet Bartucci said the company "will
review the contents (of the activist groups' report) with our
toxicologists and skin biologists."
"We can assure you that consumer safety has always been a top priority at the Estee Lauder companies," she said.