New legislation proposed in the US could see better sunscreens become available to millions of Americans.
A fresh bill has been introduced aiming to modernise the regulation of sunscreen ingredients in the country, which lags far behind Europe and Asia.
The Supporting Accessible, Flexible and Effective (SAFE) Sunscreen Standards Act has been put forward by Congressman Dr John Joyce (PA-13), Congresswoman Debbie Dingell (MI-06), Congressman Dave Joyce (OH-14), and Congresswoman Deborah Ross (NC-02).
In the US, sunscreens are regulated by the US Food and Drug Administration (FDA).
The bipartisan bill proposes amending the Federal Food, Drug, and Cosmetic (FD&C) Act to streamline the FDA’s review process of the effectiveness and safety of new ingredients for nonprescription sunscreens.
Sunscreens are categorised as over-the-counter (OTC) drugs by the FDA, meaning any new UV filter must undergo a full New Drug Application (NDA) – a process akin to pharmaceutical approval.
No new sunscreen filters have been approved for use in the US since 1999.
Eight modern filters submitted under the 2014 Sunscreen Innovation Act have yet to receive full approval.
The FDA has a list of 16 approved active ingredients for use in sunscreens, while the European Union, which classifies sunscreen as a cosmetic product, has 48 allowed UV filters.
“We know sunscreen is an incredibly effective, affordable tool to prevent the most common cancer in our country, yet America still lacks the same sunscreen technology that many other nations are using,” said Representative Dingell.
“We should be making it as easy as possible for people to get the best sunscreen available.
“This bill will allow for the FDA to approve new, advanced sunscreen ingredients to better protect Americans from dangerous sun exposure and reduce their risk of skin cancer.”
Representative Dr John Joyce said: “As a physician legislator and a board-certified dermatologist, I have seen firsthand the benefits of sunscreens to help prevent melanoma and other skin cancers.
“It is very disappointing that the FDA has ignored Congressional intent and continues to stall the approval of new sunscreen ingredients despite legislation to streamline this process.
Through the introduction of the bipartisan SAFE Sunscreen Standards Act, we can ensure that the FDA quickly approves new sunscreen ingredients, giving the American public access to the best skin protection available.”
What does the new bill propose?
Representative Joyce outlined the proposals of the SAFE Sunscreen Act as follows:
Improves Regulatory Standards:
- Directs the FDA to establish clearer, more flexible standards for evaluating sunscreen ingredients
- Allows the use of real-world evidence, observational studies, and nontraditional scientific data—not just standard clinical trials—to determine safety and effectiveness
- Incorporates non-animal testing alternatives to align with modern research practices and ethical standards
Places an Administrative Order on Sunscreens:
- Requires the FDA to update its final administrative order on pending sunscreen ingredients to:
- Consider historical data on ingredients already used safely in the U.S
- Reinforce that sunscreen is a proven cancer prevention tool
- Use the new evidence and testing standards established in this bill
Increases Transparency and Reporting:
- The Secretary of Health and Human Services must submit annual reports to Congress detailing:
- Progress on implementing new standards
- How many applications were reviewed under the new process
- FDA’s use of non-animal testing methods
- These reports must also be publicly posted on the FDA’s website within 7 days
Commenting on the bill, the Consumer Healthcare Products Association (CHPA) said: “This is a smart, targeted solution that will open the door to sun protection products that have long been used safely and effectively around the world, giving Americans even greater options to protect themselves against skin cancer.
“CHPA commends the co-chairs of the Congressional Skin Cancer Caucus for their leadership in advancing legislation that takes an important step in helping ensure Americans have access to the best sun protection available."
How has US sunscreen regulation progressed?
Recent years have seen some movement in US sunscreen regulation, albeit at a slow rate.
In 2019, the FDA issued a proposed rule on sunscreens, which proposed to revise the requirements for sunscreen active ingredients; maximum SPF levels; broad spectrum requirements; and dosage forms, among other things.
The proposed rule also included updates on how sunscreens are labelled.
In 2014, former President Barack Obama signed the Sunscreen Innovation Act, giving the FDA five years to approve or deny the use of new sunscreen ingredients, so they wouldn’t stay in the review process for an inordinate period of time.
Five years later, the FDA reaffirmed that two sunscreen ingredients – titanium dioxide and zinc oxide – were safe but asked for more information about 12 other ingredients manufacturers were using in sunscreens.
In 2021, the FDA said it needed more time to determine if 12 of the 16 UV filters used in sunscreens were considered safe and effective.
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act), meanwhile, was signed into law in March 2020 in the US.
It amended the Federal Food, Drug, and Cosmetic (FD&C Act) to replace the monograph rulemaking process with an administrative order process for issuing, revising and amending OTC monographs, including the 1999 final monograph regulation for OTC sunscreen products.
In September 2021, the FDA posted its deemed final order for sunscreens, which sets the current requirements for marketing OTC sunscreen products.
It also posted a proposed order for sunscreens to amend and revise this deemed final order.