In a landscape where sunscreen innovation has stalled for over 25 years—yes, you read that right—things might finally be shaking up. The CARES Act, signed in 2020, has changed the game. Gone is the old monograph system, replaced by a new administrative order process. This means the FDA now has a deadline to issue a revised sunscreen order—18 months after September 27, 2021. It’s about time, right?
The new process is designed to speed up approvals for new sunscreen ingredients. No more endless waiting for something, anything, to hit the shelves. The law demands clear timelines and effective dates for these orders. Of course, there’s a catch: ingredient approvals can be deferred for up to a year if studies are, you know, “progressing satisfactorily.” So, fingers crossed!
The new process promises faster sunscreen ingredient approvals, but delays could still linger if studies take their time. Fingers crossed!
Sunscreen ingredients are still treated like drugs, though, meaning they must undergo rigorous safety and efficacy testing. Remember the Sunscreen Innovation Act (SIA) from 2014? It aimed to create a streamlined review for nonprescription ingredients. Timelines were set—existing applications in 8 months, new ones in 11.
But the SIA ended in 2022, leaving us with the CARES Act’s administrative order process. The FDA still needs to determine if ingredients are Generally Recognized as Safe and Effective (GRASE). Good luck with that!
The U.S. sunscreen market has been stuck in a time warp. Only two new UV filters have been approved since the ’90s. That’s right, two. And eight more have been waiting for clearance for over a decade. Meanwhile, other countries enjoy effective sunscreen options that we can only dream about. U.S. sunscreens may be less effective than those available in the EU, leading to frustration among medical professionals who find the strict requirements outdated. The FDA’s cautious approach ensures thorough evaluation for potential risks like skin irritation and hormone disruption, which, while protective, has contributed to the stagnation of new products.
Now, the FDA has issued a proposed order, inviting public comments. It’s a step forward, but how far will it actually take us? The SAFE Sunscreen Standards Act is also in the mix, aiming to modernize and ease approvals. Can we finally get some decent sunscreen on the market? Here’s hoping!
