Sunscreen Innovation Act reaches the White House
The act aims to streamline the sunscreen approval regulatory process, enabling the FDA to approve new ingredients far more efficiently.
The current system for the approval of OTC sunscreens is long-winded and bureaucratic, demanding that ingredient providers supply a significant amount of paperwork.
If signed into law by President Obama, the Sunscreen Innovation Act will help provide Americans 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.
CosmeticsDesign.com USA spoke to regulation law expert Angela Deisch, who was recently made a shareholder at the Kronick Moskovitz Tiedemann & Girard practice, in Roseville, California, about the bill earlier in the month. She revealed 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.
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.
