The act aims to streamline the regulatory process, enabling the FDA to make the approval process for new ingredients far more efficient and effective.
The current system for the approval of OTC sunscreens is long-winded and bureaucratic, demanding that ingredients providers supply a significant amount of paperwork.
Serious approval backlog
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.
"The Senate HELP Committee had previously sought comments on a discussion draft of the H.R. 4250, which was passed in July, and S. 2141, passed on September 17th,” said Angela Diesch who was recently made a shareholder at the Kronick Moskovitz Tiedemann & Girard practice, in Roseville, California.
“Now the House and Senate will have to agree on a single version to send to President Obama for signature - which should not be difficult as the two bills are very similar.”
What does this mean for sunscreen makers?
Diesch goes on to explain that 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,” said Diesch.