Comment from Rich Gold
The is a Comment on the Centers for Disease Control and Prevention (CDC) Notice: Preventing Skin Cancer Through Reduction of UV Exposure
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September 4, 2013
Tom Frieden, MD, MPDH
Centers for Disease Control and Prevention
3311 Toledo Rd.
Hyattsville, MD 20782
RE: Preventing Skin Cancer Through Reduction of UV Exposure
[Docket No. CDC-2013-0014]
Dear Director Frieden,
The Public Access to SunScreens (PASS) Coalition would like to thank the Centers for Disease Control and Prevention (CDC) and the Department of Health and Human Services (HHS) for providing an opportunity to identify ways to reduce exposure to ultraviolet (UV) radiation. The PASS Coalition applauds the CDC and HHS for its efforts to address the growing skin cancer epidemic and issue an Office of Surgeon General publication regarding the topic.
The PASS Coalition is a multi-stakeholder coalition formed to advocate for a regulatory pathway to market for new, safe and effective sunscreen ingredients. Specifically, the purpose of the Coalition is to develop reforms that guarantee a predictable, transparent and timely review by the Food & Drug Administration (FDA) of pending Time and Extent Applications (TEAs) for over-the-counter (OTC) sunscreen ingredients. This would provide the same "toolbox" to formulators for the US as is-currently available outside of the US. The goal of the Coalition is to work collaboratively with the FDA, the White House, Congress, healthcare providers, consumer organizations and sunscreen manufacturers to establish a transparent process for pre-market approval of sunscreen components. Our members include: the Melanoma Research Alliance, the Melanoma Research Foundation, the Prevent Cancer Foundation, The Skin Cancer Foundation, the Sun Safe Tee Program, Dr. Harry Fallick, Dr. Elizabeth Hale, Dr. Henry Lim, Dr. Warwick Morison, Dr. Nadim Shaath, Dr. Steven Wang, Ashland Inc., BASF Corp., Beiersdorf, DeWolf Chemical, Inc, Fitz Chem Corporation, L’Oréal USA Products, Inc, McCullough & Associates, Proctor & Gamble and the Suncare Research Laboratories.
Today, skin cancer is the most common form of cancer in the United States. Each year there are more new cases of skin cancer than the combined incidence of breast cancer, prostate cancer, lung cancer and colon cancer. Over the past 40 years, melanoma has increased 800% among young women and 400% among young men. One of the causes in this rise in skin cancer is caused by overexposure to UV radiation. As such, one blistering sunburn during childhood can double an individual's chance of developing melanoma later in life.
Exposure to UV radiation includes both UVA and UVB rays. It was once believed that UVB was primarily responsible for skin cancer, but we now know that both UVA and UVB play important parts. UVA rays, in fact, are the most abundant source of solar radiation at earth's surface and penetrate beyond the top layer of skin, while UVB rays are less abundant at the earth's surface and penetrate less deeply into the skin. Furthermore, UVB rays are most prevalent in summer and during the middle of the day, but UVA rays are equally prevalent year-round. Finally, though UVB rays are the main cause of sunburn, UVA rays are the primary cause of premature skin aging. In short, both UVB and UVA are key factors in skin damage and skin cancer.
An effective way of protecting against UVA and UVB rays is regular use of broad spectrum sunscreen, which protects against both types of rays. Although there are a variety of sunscreen products currently available in the market, American consumers have limited choices when it comes to broad-spectrum sunscreen products. This is attributed to FDA’s decade-long delay regarding eight new sunscreen ingredient applications. This sunscreen technology currently awaiting approval before FDA has been widely available in Europe, Asia, Central and South America, in some cases for over 15 years. Moreover, the lack of a predictable, transparent and timely review process for new sunscreen ingredients in the U.S. is a disincentive to innovation. At a time when cases of skin cancer outnumber the occurrence of all other cancers, and one American dies every hour from melanoma, a lethal form of skin cancer, it is imperative for Americans to have access to the latest safe and effective sunscreen products available. Through greater choice and proper application, sunscreen is a valuable tool needed to battle the public health risks posed by skin cancer.
Therefore, the Centers for Disease Control and Prevention should urge the FDA to clear the 10-year backlog in new sunscreen applications and create a predictable, transparent and timely review process for pre-market approval of new sunscreen ingredients.
Should you have any questions, please do not hesitate to access our website (www.passcoalition.com) for more information or contact Rich Gold at (202) 457-7143 and firstname.lastname@example.org. Thank you.
Public Access to SunScreens Coalition
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Comment Period Closed
Sep 4 2013, at 11:59 PM ET
Tracking Number: 1jx-87f7-yjfc
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Date Posted: Sep 4, 2013
Submitter Name: Rich Gold