119-s2491

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 2491 Introduced in Senate

    (IS) ]

<DOC>

119th CONGRESS
 1st Session
 S. 2491

 To amend the Federal Food, Drug, and Cosmetic Act to improve the 
regulatory review process to determine the safety and effectiveness of 
 nonprescription drugs intended for topical administration, and for 
 other purposes.

_______________________________________________________________________

 IN THE SENATE OF THE UNITED STATES

 July 29, 2025

 Ms. Hassan (for herself and Mr. Marshall) introduced the following 
 bill; which was read twice and referred to the Committee on Health, 
 Education, Labor, and Pensions

_______________________________________________________________________

 A BILL

 To amend the Federal Food, Drug, and Cosmetic Act to improve the 
regulatory review process to determine the safety and effectiveness of 
 nonprescription drugs intended for topical administration, and for 
 other purposes.

 Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

 This Act may be cited as the ``Supporting Accessible, Flexible, and 
Effective Sunscreen Standards'' or the ``SAFE Sunscreen Standards 
Act''.

SEC. 2. TREATMENT OF ACTIVE INGREDIENTS FOR TOPICAL ADMINISTRATION.

 

Section 505G of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355h) is amended by adding at the end the following:
 ``

    (r) Evidence and Testing Standards for Active Ingredients for 
Topical Administration.--
 ``

    (1) Evidence and testing standards for active ingredients 
 for topical administration.--The Secretary shall--
 ``
        (A) in evaluating the generally recognized as 
 safe and effective status of active ingredients used in 
 nonprescription drugs intended for topical 
 administration for purposes of subsection

    (a) , utilize 
 standards that allow for the use of real world evidence 
 (as defined in 

section 505F

    (b) ), as appropriate, as 
 part of a comprehensive evaluation of scientific 
 evidence to demonstrate the safety and effectiveness of 
 such active ingredients, to supplement evidence from 
 traditional clinical trials, provided that such 
 standards allow the Secretary to evaluate whether the 
 benefits of such active ingredients outweigh the risks; 
 and
 ``
        (B) apply subsection

    (b)

    (6)
            (C) to the regulation 
 of active ingredients used in drugs intended for 
 topical administration.
 ``

    (2) Non-animal testing methods for topical active 
 ingredients.--
 ``
        (A) In general.--The Secretary shall consider the 
 types of nonclinical tests described in paragraphs

    (1) through

    (4) of the first subsection

    (z) of 

section 505 
 (as inserted by 

section 3209

    (a)

    (2) of the Health 
 Extenders, Improving Access to Medicare, Medicaid, and 
 CHIP, and Strengthening Public Health Act of 2022 
 (division FF of Public Law 117-328)), or any other 
 alternative to animal testing that the Secretary 
 determines appropriate, in the consideration of drugs 
 intended for topical administration under this section.
 ``
        (B) Guidance.--Not later than 1 year after the 
 date of enactment of this subsection, the Secretary 
 shall issue new draft guidance on how sponsors can use 
 nonclinical testing alternatives to animal testing, as 
 appropriate, to meet safety and efficacy standards 
 under this section for drugs intended for topical 
 administration.
 ``

    (3) Clarification.--Nothing in this subsection shall be 
 construed to alter, supersede, or limit the standards for 
 making determinations of whether a drug is generally recognized 
 as safe and effective under 

section 201

    (p) or the standards set 
 forth under 

section 505 for determining the safety and 
 effectiveness of drugs.''.

SEC. 3. SUNSCREEN FINAL ADMINISTRATIVE ORDER.

 A final administrative order on nonprescription sunscreen active 
ingredients issued under 

section 3854 of the Coronavirus Aid, Relief, 
and Economic Security Act (Public Law 116-136; 21 U.S.C. 360fff-3 note) 
shall--

    (1) account for historical data regarding the safety of 
 sunscreen active ingredients that have previously been accepted 
 for marketing in the United States;

    (2) account for the role of broad spectrum sunscreens with 
 a Sun Protection Factor of 15 or higher in effective skin 
 cancer prevention; and

    (3) incorporate the evidence and testing standards for 
 sunscreen active ingredients detailed in 

section 505G

    (r) of the 
 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355h) (as added 
 by 

section 2).

SEC. 4. REPORTING AND TRANSPARENCY.

    (a) In General.--The Secretary of Health and Human Services (in 
this section referred to as the ``Secretary'') shall, not later than 18 
months after the date of enactment of this Act and annually for 5 years 
thereafter, submit to the Committee on Energy and Commerce of the House 
of Representatives and the Committee on Health, Education, Labor, and 
Pensions of the Senate a report describing, in compliance with 

section 505G
            (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355h
            (d) )--

    (1) the status of implementation of evidence and testing 
 standards for nonprescription drugs intended for topical 
 administration, including--
        (A) the application of evidence or testing 
 standards made under 

section 505G

    (r) of the Federal 
 Food, Drug, and Cosmetic Act (21 U.S.C. 355h) (as added 
 by 

section 2); and
        (B) the number of sunscreen active ingredient 
 requests reviewed using the standards under such 
 

section 505G

    (b) ; and

    (2) the progress of the Food and Drug Administration in 
 allowing nonclinical testing alternatives to animal testing for 
 the consideration of sunscreen active ingredients.

    (b) Publication.--Not later than 7 days after the date on which the 
Secretary submits a report under subsection

    (a) , the Secretary shall 
publish such report on the website of the Food and Drug Administration.
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