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For Immediate Release

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EWG Asks FDA To Wind Up Study of Vitamin A In Sunscreen

FDA Data Suggest Retinyl Palmitate Is Carcinogenic On Skin Exposed to Sunlight


Working Group (EWG) president Ken Cook today urged the Food and Drug
Administration (FDA) and the National Toxicology Program (NTP) to speed
their analysis of a seminal investigation of possible toxic and
carcinogenic risks of retinyl palmitate, a form of vitamin A added to
many sunscreen products.

In a letter to FDA Commissioner Dr. Margaret Hamburg and NTP's Dr.
Linda Birnbaum, Cook wrote:

"Our review of the publicly available data suggests that your
completion of this assessment could not be more urgent. The data show
that tumors and lesions developed as much as 21 percent more rapidly in
lab animals coated in a retinyl palmitate (RP)-laced cream (at
concentrations of 0.1 percent to 0.5 percent), compared to control
animals treated with an RP-free cream. Both groups were exposed to the
equivalent of nine minutes of bright sunlight each day for up to a year.
The differences are statistically significant and dose-dependent (EWG

The dramatically accelerated development of tumors and lesions in
retinyl palmitate-treated animals, compared to untreated animals, has
potentially significant implications for public health, which is why EWG
raised concerns about the chemical in our 2010 review of sunscreen
products (EWG 2010). Sunscreen makers have added retinyl palmitate and
related forms of vitamin A to 41 percent of sunscreens on the market
this year, according to EWG analysis of ingredient labels for nearly 500

According to a press report, a dermatologist who, EWG has
determined, is a paid consultant for the sunscreen industry, dismissed
the FDA-NTP findings on grounds the study tested the chemical on mice.
But scientists throughout the world who assess human carcinogenicity
risks consider the government scientists' methodology to be the gold
standard for research.

Cook wrote:

"We are concerned that sunscreen industry consultants are attempting
to downplay the relevance of the federal study. First, according to
recent media reports, they disregard FDA's body of research on retinyl
palmitate. As well, they misstate the basic purpose of laboratory
toxicity studies that rely on non-human animals. For instance, a
dermatologist who consults for a wide range of prominent sunscreen
companies was quoted as saying that it was "very premature to even cast
doubt about the safety of this chemical," on grounds that rodent studies
are not applicable to humans."

As the FDA points out, "testing for photocarcinogenicity in humans is
unethical; animal testing has been used as a surrogate." As you well
know, FDA, NTP and other scientific institutions are working to develop
sorely needed non-animal methods for toxicity testing. Until reliable
non-animal models are available, animal tests are established,
state-of-the-art methods for evaluating toxicity."

The FDA has published some of the data generated by the study on its
website but not its own assessment and conclusions. The agency has said
that it expects to publish these aspects of its work sometime in 2011.
An EWG analysis of the FDA data, described in EWG's 2010 Sunscreen
Guide, concluded that the data suggested that retinyl palmitate, when
applied to test animals' skin and exposed to sunlight, accelerated the
development of skin lesions and tumors. EWG called for more research on
retinyl palmitate and advised consumers to avoid products containing
the compound as long as scientists have not determined that it presents
no health risks.

The Environmental Working Group is a community 30 million strong, working to protect our environmental health by changing industry standards.

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