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May 28, 2010
4:34 PM

CONTACT: Environmental Working Group (EWG)

EWG Public Affairs: 202.667.6982.

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

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

WASHINGTON - May 28 - Environmental 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 2010).  

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 products."  

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 mission of the Environmental Working Group (EWG) is to use the power of public information to protect public health and the environment. EWG is a 501(c)(3) non-profit organization, founded in 1993 by Ken Cook and Richard Wiles.


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