American sunscreens are often perceived as less effective, not as long-lasting, or cosmetically elegant compared to sunscreens from other parts of the world, like Europe and Asia. This is largely due to the FDA’s clunky, lengthy, and expensive monograph process for approving a new ingredient, compared to Europe and Asia, where UV filters are regulated as a cosmetic rather than an over-the-counter (OTC) drug. In June, a new piece of legislation was introduced in the House that aims to bring American sunscreen standards up to speed with the rest of the world.

Introduced by Congressman Dr. John Joyce (PA-13), Congresswoman Debbie Dingell (MI-06), Congressman Dave Joyce (OH-14), and Congresswoman Deborah Ross (NC-02), the Supporting Accessible, Flexible and Effective (SAFE) Sunscreen Standards Act is a bipartisan effort seeking to modernize the FDA's regulation of OTC sunscreen ingredients. The bill directs the US Food and Drug Administration (FDA) to establish clearer and more flexible evaluation standards, which will hopefully accelerate the introduction of potentially safer and more effective sunscreen ingredients in the US.

“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 Congresswoman Dingell in a statement announcing the introduction of the bill. “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.”

The Congressman from Pennsylvania, a melanoma survivor, understands the critical need for effective sunscreen. Skin cancer is the most common form of cancer in the United States, with more people diagnosed each year than all other cancers combined.

“It’s high time for the Food and Drug Administration to start a new chapter in skin health and embrace new advancements that will expand access to cutting-edge sunscreens for all Americans,” said the Congressman from Ohio.

Congressman John Joyce is a board-certified dermatologist who practiced medicine in Pennsylvania for over two decades before being elected to Congress in 2018. He continues to utilize his medical background to inform his legislative decisions, particularly concerning healthcare policy and has personally witnessed the benefits of sunscreens in preventing 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,” he said in a statement. “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.”

Key Details of the SAFE Sunscreen Standards Act

The SAFE Sunscreen Standards Act aims to modernize the evaluation of sunscreen safety and effectiveness by broadening the scope of acceptable scientific data. It proposes to allow the FDA to consider real-world evidence, observational studies, and non-traditional scientific data, in addition to traditional clinical trials, when assessing safety and effectiveness. Additionally, the act incorporates non-animal testing alternatives, aligning with modern research practices and ethical standards.

The act also requires the FDA to update its final administrative order on pending sunscreen ingredients, considering historical data and reinforcing sunscreen's role in cancer prevention. Finally, the act aims to increase transparency and reporting in these efforts. It mandates annual reports to Congress on the progress of implementing new standards, the number of applications reviewed under the new process, and the FDA's use of non-animal testing methods. These reports would also be publicly posted on the FDA website within seven days.

The beauty industry is holding its breath, eagerly awaiting the approval of new sunscreen filters. DSM-Firmenich has been working with the FDA to secure approval for PARSOL Shield (bemotrizinol) via an OTC Monograph Order Request (OMOR) since 2018. If approved, PARSOL Shield would become the first new sunscreen active ingredient added to the US OTC monograph in nearly 25 years.