Statements on Introduced Bills and Joint Resolutions
Floor Speech
STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS -- (Senate - August 01, 2008)
By Mr. DODD (for himself, Mr. Reed, Mr. Kerry, Mr. Carper, Mrs. Clinton, and Mr. Biden):
S. 3425. A bill to make effective the proposed rule of the Food and Drug Administration relating to sunscreen drug products, and for other purposes; to the Committee on Health, Education, Labor, and Pensions.
Mr. DODD. Mr. President, I rise today along with Senators Jack Reed, John Kerry, Tom Carper, Hillary Rodham Clinton, and Joe Biden to introduce the Sunscreen Labeling Protection Act of 2008, or the SUN Act. I thank them for their support of this legislation and have enjoyed working with them on the issue of sunscreen labeling. This is an issue I have been working on for more than a decade. I also want to thank the many outside organizations who support this legislation including the American Cancer Society, the Melanoma Research Foundation, and many others as well as the leading U.S. manufacturers of sunscreen, Banana Boat and Hawaiian Tropic.
As we head into yet another steamy, sweltering summer locally in Washington, DC, and as Americans throughout the country hit the outdoors to enjoy a relaxing time at beaches, backyard barbeques and parks, we cannot forget how important it is to protect our skin from the sun's damaging rays.
However, I am profoundly disappointed to report that yet another summer is passing us by without adequate sunscreen labeling to protect consumers from harmful ultraviolet radiation, including UVA and UVB. Americans are being left in the lurch by the inaction of the Food and Drug Administration, which has failed to issue comprehensive and consistent standards for measuring and labeling sunscreen products for their protective value and for guarding against false claims on sunscreen products.
Americans may be surprised to learn that the Sun Protection Factor, SPF, number on the sunscreen they buy at their local convenience store or supermarket measures only the level of UVB protection provided by the sunscreen. It does not include a measure of the level of UVA protection. UVB has long been associated with sunburn while UVA has been recognized as a deeper penetrating radiation that contributes to skin cancer. While many products claim to offer UVA protection, that claim is not backed by enforceable, FDA-recommended standards by which those claims can be substantiated.
The FDA's standards for sunscreen testing and labeling lag 30 years behind our knowledge of the dangers of sun exposure. Research tells us that individual risk of melanoma, the most serious form of skin cancer, is associated with the intensity of sunlight that a person receives over a lifetime. In 2008, it is estimated there will be more than 1 million new cases of skin cancers and 62,480 new cases of melanoma, the deadliest form of skin cancer. Tragically, there will be as many as 8,420 deaths from melanoma this year.
Many sunscreen products carry claims that they protect against cancer-causing UVA rays, but without FDA action to set standards for testing and labeling, these claims can't be validated. Indeed, an analysis released earlier this summer found that many sunscreen products have misleading labels that make unsubstantiated claims.
Senator Jack Reed of Rhode Island and I, along with many of my colleagues on both sides of the aisle, have repeatedly urged the FDA--for over a decade now--to follow through with its development of standards. We have written letters to the FDA dating back more than ten years, we have made phone calls, we have asked questions at hearings, and we even directed the FDA to issue final labeling for UVA and UVB in the fiscal year 2006 Agriculture Appropriations bill.
The American Cancer Society, the American Academy of Dermatology, and numerous other organizations speak of the value of using sunscreen to protect our skin from damaging UVA and UVB rays as an important step in preventing skin cancer. For years, we have heard their repeated cries for industry-wide standards that will help Americans protect themselves from a preventable cause of cancer. And still there is no final action by the FDA.
The public deserves better. If you take one look at the startling numbers of Americans who will be diagnosed with skin cancer this year and who will likely die from this disease, it is clear that the public must know that what they read on the label of a sunscreen product represents a scientifically valid claim of protection from both UVA and UVB radiation.
Almost a year ago, the FDA issued a proposed rule that would set standards for testing and labeling sunscreen that includes UVA and UVB. I applaud this progress. It was a long time in coming. But I must reiterate that until the proposed rule is finalized, consumers and manufacturers lack an enforceable, consistent and comprehensive standard for testing and labeling of sunscreen products.
That is why I am introducing the SUNscreen Labeling Protection Act of 2008, or the SUN Act. This simple, straightforward bill gives the FDA 180 days from the date of enactment to finalize the proposed rule for comprehensive labeling, including formulation, testing and labeling requirements for both UVA and UVB, after which point the proposed rule would become effective.
I cannot emphasize enough the importance of this issue. The public continues to be misled by false claims that cannot be effectively challenged because there are no enforceable FDA standards for measuring and labeling UVA protection.
If the FDA would finalize its proposed rule including UVA and UVB protection, this legislation would not be necessary. But, a year and an entire summer season has nearly passed since the rule was proposed, as have decades of inaction prior to the proposed rule even being issued. All the while, consumers have gone without the information and protection they need which is what makes this legislation so critical.
I urge my colleagues to support this critically important bill.
Mr. President, I ask unanimous consent that letters of support be printed in the Record.
There being no objection, the material was ordered to be placed in the Record, as follows:
CANCER ACTION NETWORK,
July 30, 2008.
Hon. CHRISTOPHER J. DODD,
U.S. Senate, Russell Senate Office Building, Washington, DC.
Dear Senator Dodd: On behalf of the volunteers and supporters of the American Cancer Society Cancer Action Networks SM (ACS CAN), the partner advocacy organization of the American Cancer Society, we want to express our thanks for your leadership in introducing the Sunscreen Labeling Protection Act of 2008 (SUN Act). The SUN Act will direct the Food and Drug Administration (FDA) to issue final regulations related to labeling for sunscreen products.
Skin cancer is the most common of all cancer types with more than one million skin cancer diagnoses each year in the United States. Because exposure to ultraviolet (UV) radiation from the sun is the most important known risk fact for skin cancers, we believe this long-awaited proposal from the FDA will better inform consumers on the value and limits of sunscreen use.
We have provided extensive comments on the FDA proposed rules to ensure that the new regulations will require the most accurate and user-friendly presentation of sun protection possible on sunscreen products. The majority of skin cancers are caused primarily by UVB rays, and we know that UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage. Therefore, it is important to decrease UV exposure by wearing protective clothing, seeking shade whenever possible, and using a sunscreen with a high enough SPF Value to protect against some level of both UVB and UVA rays. ACS CAN believes that by raising the highest labeled sun protection factor (SPF) Value from 30 to 50 and including a UVA protection measure, consumers will be able to better select their protection level.
ACS CAN views cancer prevention as the most important attribute of sunscreens, and there is now convincing evidence that consistent use of appropriate sunscreens will result in the prevention of squamous cell carcinoma of the skin and may lower melanoma risk. Hence it is our strong conviction that all sunscreen packages must note the importance of applying sunscreen before going into the sun and reapplying as needed. We hope the new FDA regulations will help to achieve this by requiring a principle display panel on packages that is simple and easy for consumers to read, so they have clear directions on sun safety to make the most appropriate choice about protection levels.
Again, ACS CAN is encouraged that the SUN Act may finally lead to implementation of new regulations related to sunscreen labeling, and we look forward to working with Congress and the FDA to provide consumers with the most accurate and forthright information regarding sun protection and sunscreen use. If we can ever be of assistance or provide information, please contact Kelly Green Kahn, Associate Director, Federal Relations.
Sincerely,
Daniel E. Smith,
President,
Dick Woodruff,
Senior Director, Federal Relations.
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CITIZENS FOR SUN PROTECTION,
Washington, DC, July 30, 2008.
Hon. Christopher Dodd,
Russell Senate Office Building,
Washington, DC.
DEAR SENATOR DODD, On behalf of the Citizens for Sun Protection, an organization of parents, cancer survivors, healthcare professionals, business advocates and community leaders, joined together to advocate for stronger standards for sunscreen protection, I am writing you to express our strong support for the Sunscreen Labeling Protection Act of 2008 (SUN Act). This legislation would provide for the enactment within 180 days of the sunscreen standards rule that was first proposed by the Food and Drug Administration (FDA) in August 2007, and has yet been acted upon. We applaud your leadership in advancing federal sunscreen standards to protect Americans against cancer-causing UVB and UVA rays.
The delay in upgrading U.S. sunscreen standards, which has dragged on for now close to 20 years, can no longer be tolerated. Several other countries, including the European Union, already have strong sunscreen standards that provide protection from both UVA and UVB rays for their citizens. Your legislation will assure that the FDA issues final standards for UVA and UVB protection within 180 days of enactment and thus provide Americans with vitally important protection against skin cancer, premature aging, and skin damage.
A comprehensive FDA rule would require that sunscreen manufacturers properly label products so consumers will know the level of protection provided in the sunscreen they use for themselves and their families. Today, the average American using sunscreens that are commercially available in this country mistakenly believes that the product is providing equal protection for both UVB and UVA exposure. In reality Sun Protection Factor designations only apply only to UVB rays, those that primarily cause sunburn, and do not protect against UVA rays which cause skin cancer and other skin damage.
Compelling facts drive the need for change: According to the American Cancer Society one million new cases of skin cancer will be diagnosed in the United States this year and over 10,000 Americans will die from the disease. Every year the FDA proposal is delayed leaves our citizens at increased risk. It is critical to the health and welfare of the U.S. public to have access to strong, protective sunscreens they can trust. On behalf of the Citizens for Sun Protection, I wish to once again affirm our strong support for the SUN Act. We applaud your efforts to establish strong standards and an accurate labeling system for UVA and UVB protection in the United States.
Sincerely,
Robert F. Hurley,
Executive Director.
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ENVIRONMENTAL WORKING GROUP,
Washington, DC, July 30, 2008.
Hon. CHRISTOPHER J. DODD,
Chair, Subcommittee on Children and Families, Committee on Health, Education, Labor and Pensions, U.S. Senate, Washington, DC.
DEAR MR. CHAIRMAN: As the summer sun is upon us, we are again reminded of the need to ensure that sunscreens protect consumers from the damaging rays of both ultraviolet A (UVA) and ultraviolet B (UVB) radiation. The Food and Drug Administration first proposed to set safety standards in 1978, yet failed to act. That is why EWG supports the Sunscreen Labeling Protection Act of 2008, The SUN Act, which would require FDA to finalize sunscreen safety standards within 6 months, ending 30 years of delay.
The need for these standards is clear. A recent EWG study found that 85 percent of sunscreens that we tested do not offer enough protection from UV rays, are made with potentially harmful ingredients, or have not been tested for safety. Many products on the market present obvious safety and effectiveness concerns, including one of every seven that does not protect from UVA radiation. Overall we identified 143 products that offer very good sun protection with ingredients that present minimal health risks to users. Many sunscreens: lack UVA protection; break down in the sun; make questionable product claims, i.e. ``waterproof''; contain nano-scale materials that raise questions; and absorb into the blood.
These problems are aggravated by the fact that FDA has not finalized comprehensive sunscreen safety standards, called the ``Sunscreen Monograph,'' they began drafting 30 years ago. It took FDA 29 years to propose a Sunscreen Monograph. It has been nearly a year and it has yet to finalize the Monograph. EWG hopes it will do so quickly, but after 30 years of delay, we must ensure consumers get the protections they believe they are getting.
We commend you for your continued leadership in this area and the introduction of The SUN Act. We look forward to working with you to ensure its quick passage.
Sincerely,
RICHARD WILES
Executive Director.
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