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Testimony highlights the urgent need for innovation in sunscreen standards to combat the fastest-growing cancer in America—skin cancer.
April 2, 2025
By: TOM BRANNA
Chief Content Officer
Carl D’Ruiz MPH represented DSM-Firmenich Beauty & Care as well as the Personal Care Products Council at an Energy and Commerce Health Subcommittee hearing on FDA OTC sunscreen regulations and OMUFA 2 reauthorization. D’Ruiz’s testimony highlighted the urgent need for innovation in sunscreen standards to combat the fastest-growing cancer in America—skin cancer. With 6.1 million adults treated annually at a cost of nearly $9 billion, the importance of effective sunscreens cannot be overstated. Ruiz noted that unfortunately, due to regulatory barriers, Americans lack access to the most innovative, safe, and effective sunscreens available globally.Key points from D’Ruiz testimony included:• Innovation: It’s been over 25 years since FDA approved a new UV filter. DSM-Firmenich is the only company in the US sponsoring the approval of Bemotrizinol (Parsol Shield).• Regulatory Process: FDA testing requirements must be modernized to match international standards.• OTC Monograph Reform: Streamlining regulatory frameworks and aligning US standards with global practices is crucial.• Consumer Confidence: Limited options and outdated testing methods are eroding trust in sunscreens.• OMUFA Program: Enhancing drug review processes to support innovation and affordability.• HHS Layoffs: Addressing challenges in product approval and consumer safety.
Organizations represented at the meeting included DSM-Firmenich, Personal Care Products Council, the Consumer Healthcare Products Association, the American Cleaning Institute, the Environmental Working Group, and the Melanoma Research Foundation, all advocating for improved sunscreen regulations and innovation.“Reauthorizing OMUFA will provide FDA with the resources to sustain and evolve the system, ensuring timely feedback, guidance, and regulatory clarity needed to support innovation and consumer access,” said D’Ruiz. “This program is designed to improve innovation while maintaining the FDA ‘gold-standard’ of safety.”D’Ruiz pointed out OTC medications, including sunscreens, are vital as they allow nearly 9 out of 10 Americans to treat common ailments and prevent skin cancer, saving the healthcare system billions annually. Safe, reliable and affordable OTC drugs enable consumers to manage their health effectively without needing to visit a healthcare provider.
DSM-Firmenich is taking the lead in public health as the only company to sponsor FDA’s acceptance of a new sunscreen, Parsol Shield (Bemotrizinol), under OMUFA’s OMOR Tier 1 process.
“Our aim is to obtain a successful reauthorization of OMUFA, taking into account the improvements needed to bring new sunscreen actives that protect Americans from skin cancer to the monograph,” said D’Ruiz.For more information and to watch the recording of the hearing, visit https://lnkd.in/eyg-cfR6
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