Following on from senate approval for the Sunscreen Innovation act in October, the bill has finally been signed by the President which aims to streamline the sunscreen approval regulatory process, enabling the FDA to approve new ingredients far more efficiently.
Until now the system for the approval of OTC sunscreens has been long-winded and bureaucratic, demanding ingredient providers supply a significant amount of paperwork.
The Act will ultimately help to provide Americans with access to the latest sunscreen ingredients, some of which have been widely available for 15 years in Europe, Asia and Latin America.
That process takes around a year to secure approval but because of the lengthy process a considerable backlog has built up, which means approval is now taking much longer than that.
What does this now mean for sunscreen makers?
The current regulatory system for sunscreens was established in 2002, promulgating a two-part process which classifies such active ingredients under the OTC drug monograph system.
The backlog of ingredients includes eight that have been waiting approval for years - amiloxate, 10%; bemotrizinol, 10%; bisoctrizole, 10%; *diethylhexyl butamido triazone, 3%; drometrizole trisiloxane, 15%; ecamsule, 10%; enzacamene, 4%; *octyl triazone, 5%.
“If the Sunscreen Innovation Act is passed, we will hopefully see these pending requests either granted or denied within the next year and a half. That, as you can imagine, is beneficial to all as more options for active ingredients will be available for use,” regulation law expert Angela Diesch told CosmeticsDesign-Europe.com, back in September.
Founding member of the PASS Coalition, L’Oréal USA had also released a statement prior to passing of the Bill.
“L’Oréal commends the House of Representatives for its unanimous passage of the Senate version of the Sunscreen Innovation Act (S.2141), which will provide American consumers greater access and choice when it comes to the latest and effective sunscreen products available," said chief communications officer, Kristina Schake.