H.R. 4250, the "Sunscreen Innovation Act"

On March 13, 2014, Rep. Ed Whitfield (R-KY) and Rep. John Dingell (D-MI) introduced H.R. 4250, the Sunscreen Innovation Act.  H.R. 4250 sets up a system under which sunscreens that have been marketed continuously for at least five years in the United States or elsewhere, and that meet certain other conditions, would be eligible for review by an FDA advisory committee.  After the advisory committee issued its recommendation, FDA would have 45 days to affirm or deny the recommendation.  If FDA did not deny an approval recommendation within 45 days, the sunscreen would automatically be approved as generally recognized as safe and effective. The bill also provides an appeals process for situations in which the company disagreed with the FDA determination.

On July 28, 2014, the bill passed the House by a voice vote.