H.R.4250 - Sunscreen Innovation Act 113th Congress (2013-2014)

Bill

Sponsor:  Rep. Whitfield, Ed [R-KY-1] (Introduced 03/13/2014)

Committees:  House - Energy and Commerce

Committee Reports:  H. Rept. 113-558

Latest Action:  07/28/2014 Motion to reconsider laid on the table Agreed to without objection.

Summary: H.R.4250 — 113th Congress (2013-2014)

There is one summary for this bill. Bill summaries are authored by CRS.

Shown Here:

Introduced in House (03/13/2014)

Sunscreen Innovation Act - Amends the Federal Food, Drug, and Cosmetic Act to establish a process for the review and approval of over-the-counter (OTC) sunscreens.

Require the Secretary of Health and Human Services (HHS) to review and determine whether OTC sunscreens are generally recognized as safe and effective and ensure that any sunscreens marketed in the United States are appropriately labeled.

Makes sunscreens that have been marketed for five continuous years in the United States or other countries and in sufficient quantity eligible for review under this Act. 

Establishes a framework for the review and approval by the Food and Drug Administration (FDA) of OTC sunscreens with new active ingredients. Sets forth time frame requirements for review. Requires applications for review to include safety and efficacy data as well as adverse drug experience information.

Directs the Secretary to report on the progress made in issuing timely decisions on the safety and effectiveness of OTC sunscreens.

Requires the Secretary to make determinations on the testing and labeling of aerosol sunscreens and on whether a sunscreen may contain a label indicating a sun protection factor (SPF) greater than 50.