L’Oreal Holds Washington Briefing on Sunscreen Legislation

Written by 1938

On May 20^th I had the opportunity to attend a Washington briefing sponsored by The Hill newspaper, the Public Access to Sunscreens Coalition advocacy group and L’Oreal USA Inc. The discussion centered on legislation calling for an acceleration of the FDA’s review of sunscreen active-ingredient time-and-extent applications.

Currently, U.S. consumers do not have access to the latest sunscreen technology as other countries due to a backlog of sunscreen ingredient approvals. The industry wants to alleviate the current 12-year delay and streamline the sun care ingredient review process so U.S. consumers can gain access to the most effective and innovative sunscreen products.  Not surprisingly, the last Over-The-Counter (OTC) sunscreen ingredient to be approved was in the 1990s. Since that time, eight new sunscreen applications have been filed and are still awaiting review.

A bipartisan group of  Members of Congress introduced the bicameral Sunscreen Innovation Act (H.R.4250/ S.2141) in March.  During the briefing all parties agreed the legislation could ride the wave of momentum it  has garnered and pass this year.

Details of  The Sunscreen Innovation Act (H.R.4250/ S.2141)

• 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
• 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 information or request additional information
• The FDA will concur (approve) or deny the Committee’s recommendation
• 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
• The Act requires that the current sunscreen backlog be reviewed within 8 months and new submissions be reviewed within 11 months
• FDA is would be required to submit reports to Congress regarding the progress of the program 12 months following enactment and every two years thereafter

Political Obstacles

With every House and a number of Senate seats up for election in November, it seems that everyone involved is moving quickly to secure passage of both bills by August. Once you get into September of an election year it’s harder for Congress to come together on issues and campaigning commitments take more of a member’s time and attention. However, because the bills have bi-partisan support their chance of passage is more likely compared to the controversial draft legislation being debated to overhaul the outdated FDA Cosmetics Act.

• Briefing Notes

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1938

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