[Congressional Record Volume 154, Number 130 (Friday, August 1, 2008)]
[Senate]
[Pages S8037-S8039]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      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

[[Page S8038]]

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 
     NetworksSM (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.
                                  ____



                                  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.
                                  ____



                                  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

[[Page S8039]]

     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.
                                 ______