How the 2020 CARES Act Finally Unclogged US Sunscreen Approvals
The reason no new filter appeared for decades wasn't just science - it was a broken approval mechanism, and a wonky 2020 law finally fixed it.
Bemotrizinol is the first new active ingredient advanced under the streamlined OTC monograph order process created by the 2020 CARES Act, which replaced slow notice-and-comment rulemaking with a faster administrative-order, user-fee-funded framework; the FDA finalized the proposed order within roughly seven months of issuing it.
Regulatory lawyers explain that before the CARES Act, the old rulemaking process effectively stalled new sunscreen actives, and the new administrative-order pathway is what allowed bemotrizinol to move forward.
Questions we get a lot
What is the CARES Act monograph order process?
The 2020 CARES Act created a streamlined administrative-order process for over-the-counter drug monographs, replacing the older, slower notice-and-comment rulemaking. It is funded by user fees and is designed to move faster. Bemotrizinol is the first new sunscreen active advanced under this process.
Why did the old system block new sunscreen filters?
Under the prior rulemaking framework, new sunscreen actives could stall for years without a clear path to approval. Legal analysts describe the CARES Act process as the fix that finally enabled progress. Bemotrizinol's advancement is cited as proof the new pathway can work.
How fast did the FDA move on bemotrizinol?
Reporting indicates the FDA finalized the proposed order within roughly seven months of issuing it, a notably quick turnaround compared with the prior system. That speed is attributed to the CARES Act administrative-order process. It illustrates how the new framework can compress timelines.
r/SkincareScience: 'If the science on these filters was settled abroad, why did it take a 2020 law for the US to even consider one?'