On March 13, 2014, Rep. Ed Whitfield (R-KY), Rep. John Dingell (D-MI), Sen. Jack Reed (D-RI), and Sen. Johnny Isakson (R-GA) introduced the bipartisan, bicameral Sunscreen Innovation Act in both Chambers of Congress in an effort to improve sunscreen protection, promote sunscreen use, and ensure U.S. consumers have access to the safest, most effective sunscreens available.  As of July 15th, the measure is one step closer to becoming law as the House’s version, H.R. 4250, passed the Energy & Commerce full committee.

As skin cancer rates continue to climb, the bill 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, but have had their applications pending before the FDA for a decade or more.

Current Process

In 2002, the FDA created the Time and Extent Application (TEA) process to streamline the review of products on the market. In addition, the agency made active ingredients with a five-year history of extensive and safe over the counter use in another country eligible for fast-track review.  Likewise, 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.

Proposed Process

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:

  • Eligibility. Under the proposal, existing FDA eligibility requirements will be maintained where 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);  and pending ingredient submissions already deemed eligible by FDA will be considered eligible for the new review and approval process.
  • Transparency.  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 information from the public and will communicate with the application’s sponsor to clarify or request additional information.  The FDA will then concur or deny the Committee’s recommendation.
  • Predictable and Reasonable Timeframe.  Increase 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.
  • 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.

What To Expect

According to the American Cancer Society, more than 3.5 million cases of 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.  With these numbers expect champions of the bill to increase outside pressure encouraging Congress to act swiftly to pass a bill that will aid consumers is preventing skin cancer and allows manufactures to bring to market the best quality products possible. Industry leaders have been actively lobbying for the passage of the bill via The PASS Coalition (Public Access to Sunscreen). You can learn more about the coalition and join the grassroots advocacy effort on their website here.

1938 is the online magazine blog for Well-Kept Beauty, formally entitled Primer.

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