[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3686 Introduced in House (IH)]
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119th CONGRESS
1st Session
H. R. 3686
To amend the Federal Food, Drug, and Cosmetic Act to improve the
regulatory review process to determine the safety and effectiveness of
nonprescription sunscreen active ingredients, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 3, 2025
Mr. Joyce of Pennsylvania (for himself, Mrs. Dingell, Mr. Joyce of
Ohio, and Ms. Ross) introduced the following bill; which was referred
to the Committee on Energy and Commerce
_______________________________________________________________________
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 sunscreen active ingredients, 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. FINDINGS.
Congress finds the following:
(1) Skin cancer is the most common cancer in the United
States.
(2) More people are diagnosed with skin cancer each year in
the United States than all other cancers combined.
(3) The United States Surgeon General issued a Call to
Action to Prevent Skin Cancer in 2014 based on finding that
nearly 5,000,000 Americans are treated for skin cancer each
year at a cost that exceeds $8,100,000,000.
(4) It is estimated that the number of new melanoma cases
diagnosed in 2024 will increase by 7.3 percent, with an
estimated 200,340 cases of melanoma diagnosed.
(5) Skin cancer is a deadly disease, and it is expected
that there will be 8,290 deaths from melanoma in 2024.
(6) Skin cancer affects individuals of all ages, and
melanoma is one of the most common cancers in young adults.
(7) In the United States, more than 9,500 people are
diagnosed with skin cancer every day and more than 2 people die
of the disease every hour.
(8) According to the World Health Organization (``WHO''), 4
out of 5 cases of skin cancer can be prevented by adopting sun-
safe practices.
(9) According to the Environmental Protection Agency
(``EPA''), the Ultraviolet (UV) Index in the United States
continues to rise, increasing the risk of melanoma and other
skin cancers for Americans.
(10) The EPA recommends Americans ``Use a broad spectrum
sunscreen with a Sun Protection Factor (`SPF') of at least 30''
to protect against the risks of a rising UV Index.
(11) Congress unanimously passed the Sunscreen Innovation
Act in 2014 to streamline the approval process for sunscreen
active ingredients to improve access to new sunscreens, but no
new sunscreen active ingredients have been approved through the
Food and Drug Administration's over-the-counter approval
process since 1999.
SEC. 3. REGULATIONS ESTABLISHING REQUIREMENTS FOR SUNSCREEN ACTIVE
INGREDIENTS.
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) Regulations Establishing Requirements for Sunscreen Active
Ingredients.--
``(1) Evidence and testing standards for sunscreen active
ingredients.--The Secretary shall establish, through guidance
or regulation, standards for evaluating the safety and efficacy
of sunscreen active ingredients, provided that such standards--
``(A) ensure the safety of consumers based on a
comprehensive evaluation of scientific evidence;
``(B) allow for the use of real-world evidence (as
defined in section 505F(b)), observational studies, and
other scientifically valid approaches in place of, or
to supplement, traditional clinical tests to
demonstrate safety and effectiveness; and
``(C) apply subsection (b)(6)(C) to the regulation
of sunscreen active ingredients in demonstrating a
prima facie safe nonprescription marketing and use.
``(2) Non-animal testing methods for sunscreen 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 deems
appropriate, in the consideration of sunscreen active
ingredients.
``(B) Guidance.--Not later than 180 days after the
date of enactment of this subsection, the Secretary
shall issue new guidance on how sponsors can use
nonclinical testing alternatives to animal testing to
meet safety and efficacy standards for sunscreen active
ingredients.''.
SEC. 4. SUNSCREEN FINAL ADMINISTRATIVE ORDER.
The final administrative order on pending over-the-counter
sunscreen active ingredient submissions 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 demonstrating safe use of
sunscreen active ingredients that have previously been accepted
for marketing in the United States;
(2) emphasize that sunscreen is an effective skin cancer
prevention tool; 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 3).
SEC. 5. REPORTING AND TRANSPARENCY.
(a) To Congress.--The Secretary of Health and Human Services (in
this section referred to as the ``Secretary'') shall, beginning not
later than 1 year after the date of enactment of this Act, annually
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--
(1) the status of implementation of evidence and testing
standards for sunscreen active ingredients, including--
(A) any adjustments to 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 3); and
(B) the number and types of sunscreen active
ingredient applications reviewed using the standards
under such section 505G(r); 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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