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Several Studies Raise Concerns Over Potential Link Between Retinyl Palmitate (RA), A Common Sunscreen Additive, and Skin Cancer; FDA Has Been Reviewing the Data Since July 2009 But Has Yet to Provide Ruling

As Summer Gets Underway and Beach Season is Here, Schumer Urges the FDA to Act Swiftly in Their Final Assessment of the Data

Schumer: Time is of the Essence and the FDA Needs to Provide Guidance and Reassurance to Consumers

Today, U.S. Senator Charles E. Schumer called on the Food and Drug Administration (FDA) to immediately address recent reports suggesting a possible link between skin cancer and a common chemical found in sunscreens. Studies from the National Center for Toxicological Research (NCTR) and the National Toxicology Program (NTP) have suggested a possible link between skin cancer and retinyl palmitate, a common ingredient found in sunscreen products. While the research has been completed since July 2009, the FDA has yet to issue a final assessment or guidance on the data. Schumer says that considering the serious implications of the studies and the fact that consumers use sunscreen products to protect themselves from UV rays and skin cancer, consumers deserve to hear the FDA’s evaluation of the data immediately. In light of the delays, Schumer is pushing the FDA to promptly address these studies and also announce a timeline for new sunscreen regulations.


Schumer was joined at the event by Chuck Bell of the Consumers Union and concerned parents.


“With the recent reports suggesting a possible link between skin cancer and a common chemical found in sunscreens, the FDA must act now to protect consumers in New York and across the nation,” Schumer said. “Summer is here, people are soaking up the sun and the FDA needs to immediately provide guidance and reassurance to consumers. When it comes to the health and safety of the public, there is no room for delay.”


“Consumers need to be able to have confidence in the safety of sunscreens that they use,” said Chuck Bell, Programs Director of Consumers Union, publisher of Consumer Reports.  “We have also been very concerned about the safety of retinyl palmitate, and we strongly share Sen. Schumer’s concerns about its safety.  We urge the FDA to expedite and complete its investigation of possible toxic and carcinogenic risks of this ingredient, and promptly advise the public of its findings and recommendations.”


Retinyl palmitate is an ingredient found in most of the 500 most popular sunscreen products. Scientists at both the NCTR and the NTP have been working diligently over the last decade at the FDA’s request in order to determine whether this Vitamin A derivative, retinyl palmitate, is safe to use in sunscreen products. In one study, tumors and lesions developed up to 21 percent faster in lab animals coated in retinyl palmitate-laced cream than animals treated with a cream that did not contain RP. While these studies have been completed for almost a year now, the FDA has not issued an assessment of ruling on either of them.


A new study indicates that instances of non-melanoma skin cancer are increasing at an alarming rate, making the need to get all the facts and information out to the public all the more imperative. Two separate reports in an academic journal, the Archives of Dermatology, indicate that both new diagnoses and a history of non-melanoma skin cancer appear to have become increasingly common, and the disease affects more individuals than all other cancers combined. Currently, non-melanoma skin cancer is the most common malignant disease in the United States, and the initial reports may just be the tip of the iceberg. Media reports indicate that the Journal of the American Medical Association (JAMA) along with a host of other academic journals will soon publish their own reports on incredible rise in non-melanoma skin cancer occurring in the U.S.


There were approximately 129,400 occurrences of non-melanoma skin cancer in upstate New York in 2006.  Of those approximately 3,465 were in Rockland, 11,080 were in Westchester and 1,157 were in Putnam.  The estimates were obtained by using nation-wide skin cancer statistic from the recent study in the Archives of Dermatology that said approximately 1.166%  of Americans had non-melanoma skin cancer in 2006. 


As the summer season begins, Schumer is urging the FDA to work to make public their reviews and assessments of the data as soon as possible so as not to undermine consumer confidence in the protective value and safety of sunscreen products. Schumer is also a co-sponsor of Senator Chris Dodd’s (D-CT) and Jack Reed’s (D RI) bill to require the Food and Drug Administration (FDA) to strengthen labeling and testing standards for sunscreen products.  The bill is called the Sunscreen Labeling Protection (or SUN) Act.



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