Sunscreen Innovation Act

3/14/2024, 12:48 PM

Congressional Summary of HR 4250

(This measure has not been amended since it was reported to the House on July 24, 2014. The summary of that version is repeated here.)

Sunscreen Innovation Act - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to establish a process for the review and approval of over-the-counter (OTC) sunscreen active ingredients.

Allows any person to request that the Secretary of Health and Human Services (HHS) determine whether an OTC sunscreen active ingredient or combination of ingredients is safe and effective.

Requires the Secretary to review any request regarding a sunscreen active ingredient or combination of ingredients that has been in use and that is not included in the stayed sunscreen monograph published by the Food and Drug Administration (FDA).

Directs the Secretary to invite the sponsor of the request to provide data and other information on the safety and efficacy of the sunscreen active ingredient or combination of ingredients. Requires the Secretary to determine whether the provided information is sufficient to conduct a review, and if so, file the request, and if not, explain to the sponsor why the provided information is insufficient.

Requires the Director of the Center for Drug Evaluation and Research to complete a review of a filed request and determine the safety and efficacy of the sunscreen active ingredient or combination of ingredients within 300 days for new requests or a shorter timeframe for requests pending before enactment of this Act. Directs the Commissioner of Food and Drugs to make the determination if the Director does not make a determination in the allowed timeframe.

Allows sunscreen active ingredients that are determined to be safe and effective to be used in OTC sunscreen products.

Directs the Comptroller General (GAO) to report on the progress of the Secretary in establishing this process and the role of the Commissioner of Food and Drugs in issuing determinations on pending requests. Requires the Secretary to report on the decisions made about the safety and efficacy of sunscreen active ingredients, the amount of time between submission and decision for each request, the cost of the review process, and recommended improvements to the review process.

Current Status of Bill HR 4250

Bill HR 4250 is currently in the status of Bill Introduced since March 13, 2014. Bill HR 4250 was introduced during Congress 113 and was introduced to the House on March 13, 2014.  Bill HR 4250's most recent activity was Received in the Senate. as of July 29, 2014

Bipartisan Support of Bill HR 4250

Total Number of Sponsors
1
Democrat Sponsors
0
Republican Sponsors
1
Unaffiliated Sponsors
0
Total Number of Cosponsors
34
Democrat Cosponsors
8
Republican Cosponsors
26
Unaffiliated Cosponsors
0

Policy Area and Potential Impact of Bill HR 4250

Primary Policy Focus

Health

Potential Impact Areas

Congressional oversightConsumer affairsDrug safety, medical device, and laboratory regulationHealth promotion and preventive careMusculoskeletal and skin diseases

Alternate Title(s) of Bill HR 4250

Sunscreen Innovation ActTo amend the Federal Food, Drug, and Cosmetic Act to provide an alternative process for review of safety and effectiveness of nonprescription sunscreen active ingredients and for other purposes.Sunscreen Innovation ActSunscreen Innovation ActSunscreen Innovation Act
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