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