119-hr3686

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3686 Introduced in House

    (IH) ]

<DOC>

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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