WASHINGTON, DC -- In an effort to improve sunscreen protection, promote sunscreen use, and ensure U.S. consumers have access to the safest, most effective sunscreens available, U.S. Senators Jack Reed (D-RI) and Johnny Isakson (R-GA) and U.S. Representatives Ed Whitfield (R-KY) and John Dingell (D-MI) have introduced the bipartisan, bicameral Sunscreen Innovation Act in both Chambers of Congress.

As skin cancer rates continue to climb, this legislation seeks to expedite the U.S. Food and Drug Administration’s (FDA) approval process for active ingredients in sunscreens that have long been approved for use in places like Europe, Canada, and other countries.  Some of these sunscreen ingredients have been safely used overseas for years, but have had their applications pending before the FDA for a decade or more.  The Sunscreen Innovation Act also seeks to shed some light on the FDA’s approval process by requiring the agency to periodically report to Congress on the progress of the program. 

Any product marketed in the U.S. as a sunscreen is considered an over the counter (OTC) drug and must contain active ingredients that have been approved by the FDA.   In 2002, the FDA created the Time and Extent Application (TEA) process to streamline the review of products that have been on the market “to a material extent and for a material time” in other countries.  The FDA made active ingredients with a five-year history of extensive and safe OTC use in another country eligible for what was supposed to be fast-track review.  The FDA indicated it would “strive to complete TEA evaluations in 90-180 days.”  However, since that time, the FDA has not approved a single sunscreen ingredient through the TEA process.

“The FDA must do its due diligence to ensure the safety of these products and they should do it in a timely manner.  It’s important for people to protect themselves from the sun and Americans shouldn’t have to wait decades for access to the most advanced, effective sunscreens.  By streamlining its review process, the FDA can help consumers better protect themselves from skin cancer and this legislation aims to do just that. We want Americans to follow safe sun practices and benefit from the latest advances in sun care products and research,” said Senator Reed.

“As a melanoma survivor, I believe it’s essential that Americans have access to safe and effective sunscreen. Too often, technological advancements that have the ability to improve the quality of health care and prevent disease are held back by an overly rigid regulatory process. I am pleased to join with my bipartisan colleagues in the Senate and House to introduce the Sunscreen Innovation Act to clear away the bureaucratic hurdles that have stood between American consumers and the new and innovative sunscreen products that are already available in many other countries.  Additionally, I am grateful to FDA Commissioner Margaret Hamburg for agreeing this morning to work with us to move forward on improving the sunscreen approval process,” said Senator Isakson.

“With skin cancer being by far the most common form of this terrible disease, it’s important that consumers have access to the latest breakthroughs in sunscreen technology. Our legislation will expedite and improve the sunscreen application process at the Food and Drug Administration so that Americans can have access to the same sunscreen products that have been used safely in other parts of the world for years” said Congressman Whitfield.

“Skin cancer is a major public health crisis in this country, and we must focus on preventive measures such as developing and bringing to market more effective sunscreens.  I’m pleased to be a co-sponsor of the Sunscreen Innovation Act, which reforms the broken approval process for sunscreen ingredients at FDA.  I want to thank my colleagues, Representative Whitfield and Senators Reed and Isakson, for their leadership on this issue and look forward to continuing our work together,” said Congressman Dingell.

Skin cancer is the most common cancer in the United States.  Most cases of melanoma, the deadliest kind of skin cancer, are caused by exposure to ultraviolet (UV) light.

According to the American Cancer Society, more than 3.5 million cases of basal and squamous cell skin cancer are diagnosed in this country each year.  And the American Academy of Dermatology reports that current estimates show that one in five Americans will develop skin cancer in their lifetime.

The Sunscreen Innovation Act (S. 2141 and H.R.4250, respectively) will amend the Food Drug & Cosmetic Act to ensure all sunscreen ingredients receive a transparent review within a predictable timeframe.  Key aspects of the bill include:

  • Determining eligibility: Under the proposal, existing FDA eligibility requirements will be maintained; an ingredient must be used safely for at least five years in at least one country.  Eligibility determinations will be made by the FDA Division of Nonprescription Regulation Development (DNRD).  Pending ingredient submissions -- already deemed eligible by FDA -- will be considered eligible for the new review and approval process. 
  • Ensuring a transparent review:  After a finding of eligibility, the ingredient application will be submitted to the existing FDA Nonprescription Drugs Advisory Committee (NDAC), for a safety and effectiveness recommendation.  During the review process, the Advisory Committee will receive data from the public and communicate with the application’s sponsor to seek clarifying or request additional information.  The FDA will concur or deny the Committee's recommendation.
  • Ensuring a predictable and reasonable timeframe: The Sunscreen Innovation Act will spur further innovation in sunscreens in the U.S. by ensuring that all submissions are reviewed within a predictable timeframe of 11 months or less depending on whether it is a new or existing submission.
  • Enhancing FDA Accountability: FDA is required to submit reports to Congress regarding the progress of the program 12 months following enactment and every two years thereafter.