FDA Approves First New Sunscreen Ingredient in Nearly 30 Years
The FDA has approved bemotrizinol (BEMT), a new sunscreen ingredient that has been available in Europe and Asia for years, marking the first new sunscreen ingredient approved in the US since the late 1990s. The approval came after Congress ordered the FDA to overhaul its sunscreen approval process in 2020, which had previously classified sunscreens as over-the-counter drugs rather than cosmetics. The approval is significant because it addresses concerns about chemical sunscreen ingredients and may help reverse declining sunscreen use in the US.
The FDA has approved bemotrizinol (BEMT) as a new sunscreen ingredient, the first to gain approval in the United States since the late 1990s, despite being available in Europe and Asia for years. The delay in US approval was due to the country's unique regulatory framework that classifies sunscreens as over-the-counter drugs rather than cosmetics, a more stringent classification than in other regions. Congress mandated an FDA overhaul of the sunscreen approval process in 2020, leading to DSM Nutritionals' 2024 application for bemotrizinol approval. The ingredient's approval comes amid growing consumer concerns about chemical sunscreen ingredients potentially seeping into the bloodstream and causing adverse health effects, concerns that intensified after 2019 FDA safety assessments. Proponents, including the Environmental Working Group and dermatologists, view the approval as significant because it offers broader UV protection, better cosmetic appeal, and potentially lower systemic absorption compared to existing chemical sunscreen options.
What's missing
The article does not provide independent dermatological or toxicological assessment of bemotrizinol's actual safety profile compared to existing ingredients, nor does it explain what specific data the FDA reviewed to approve it. Additionally, there is limited information about the practical differences consumers will experience or the cost implications of this new ingredient.
How coverage differed
Vox frames this as a positive development for consumer health and innovation, emphasizing the long regulatory delay and the role of advocacy groups. The article acknowledges the sunscreen backlash and safety concerns about chemical ingredients, presenting bemotrizinol as a solution to these concerns rather than questioning whether those concerns are scientifically justified.
What different sources said
- VoxLeft
The US just got its first new sunscreen in almost 30 years
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