PASS Coalition Supports Move to Speed Approval of New UV Filters, Looks to Canada

Contact the Author
Save
This item has been saved to your library.
View My Library
(click to close)
Save to My Library
Title: PASS Coalition Supports Move to Speed Approval of New UV Filters, Looks to Canada
PASSx sunscreensx UV filtersx Canadax FDAx
  • Article
  • Keywords/Abstract
  • Related Material

In March 2014, the Public Access to SunScreens (PASS) Coalition published its support of a proposed Sunscreen Innovation Act to speed the U.S. Food and Drug Administration's (FDA's) review of Time and Extent Applications (TEA) for new UV filters. In a related blog post, PASS followers congratulated the group and agencies involved, and urged Canadian regulators to do the same.

On March 13, 2014, U.S. Senator Jack Reed (D-RI) and U.S. Representative Ed Whitfield (R-KY) introduced the “Sunscreen Innovation Act,” S. 2141 and H.R. 4250, respectively, aimed at amending existing legislation in order to include a process for the FDA's review of potential sunscreen active ingredients—within given time constraints.

Most recently, the FDA had determined amiloxate and diethylhexyl butamido triazone were eligible for the TEA program back in 2003 and 2006, respectively. The new Act requires new submissions to be reviewed within 11 months, and that the current backlog of six TEAs for sunscreen actives be reviewed within 8 months. Moreover, as proposed, the FDA would be required to submit reports to Congress regarding its progress.

Unrelated to the TEA program, the proposed Act also requires the FDA to issue determinations regarding testing and labeling of sunscreen sprays, and the labeling of sunscreen drug products with SPF levels above 50.