Bipartisan U.S. Lawmakers Introduce "SAFE Sunscreen Standards Act" to Reform FDA Approval Process

Bipartisan U.S. legislators have proposed the "Supporting Accessible, Flexible, and Effective Sunscreen Standards Act" (hereinafter referred to as the SAFE Sunscreen Standards Act), to reform the way the Food and Drug Administration (FDA) evaluates and approves over-the-counter (OTC) sunscreen ingredients.

Overview of the New Legislation

On June 3, 2025, Republican representatives Dave Joyce, John Joyce, Debbie Dingell, and Deborah Ross from Pennsylvania proposed the SAFE Sunscreen Standards Act. This bipartisan legislation aims to amend Section 505G of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and establish new standards to evaluate the safety and efficacy of these ingredients, thereby modernizing the FDA's sunscreen ingredient review process.

The bill also endorses non-animal testing methods and requires the FDA to update its administrative orders for pending sunscreen ingredients. In addition, the bill also requires the U.S. Department of Health and Human Services (HHS) to issue an annual report on FDA progress and adoption of alternative testing.

The SAFE Sunscreen Standards Act directly addresses the long-standing industry concerns over FDA delays in approving new UV filters. Although the U.S. Congress passed the Sunscreen Innovation Act (SIA) in 2014 to expedite the approval process, the FDA has not approved any new sunscreen active ingredients since 1999, meaning no new sunscreen filters have been approved since the 1990s, resulting in American consumers being unable to access new UV filters provided by other regions.

Skin cancer remains the most common cancer in the U.S., yet regulatory stagnation has kept American sunscreen formulations behind international standards. The bill aims to bridge these gaps by updating the evaluation assessment framework based on current scientific and ethical standards.

Regulatory and Market Opportunities

The SAFE Sunscreen Standards Act may open up a faster pathway for UV filtering products that have been approved abroad, especially in the European Union and Asia-Pacific regions.

APAC markets (e.g., China, Japan, South Korea) have long been at the forefront of innovation and approval of sunscreen ingredients in the world. Currently, the U.S. permits only 16 UV filters, while the EU has approved 48 types. If this bill is passed, advanced filters approved in the Asia-Pacific regions such as Bemotrizinol will be more likely to be included in the U.S. OTC monograph, creating market expansion opportunities for suppliers.

In addition, the new regulations advocate for the use of non-animal, safety-efficient, and internationally accepted testing methods (under strict animal testing restrictions), may make Asia-Pacific laboratories and raw material suppliers more competitive. However, it is necessary to prepare in advance since that the application for supplementary materials cannot be quickly responded to and still needs to be rectified.

The bill requires the FDA to publish annual implementation reports and make them public, which can further enhance regulatory transparency. For non-U.S. companies, it is beneficial to grasp the approval process and challenges, making the development of international compliance strategies more efficient. According to Article 5 of the bill, the Secretary of Health and Human Services (HHS) will be required to submit annual reports to the House Energy and Commerce Committee and Senate Health, Education, Labor, and Pensions (HELP) Committee, detailing "the implementation of evidence and testing standards for sunscreen active ingredients, as well as the progress of the FDA in allowing non-clinical trials to replace animal testing in considering sunscreen active ingredients.

The opportunities and challenges brought by this regulation coexist. On the one hand, for some Asia-Pacific manufacturers, it enables them to enter the world's largest sunscreen market earlier, improve R&D returns, and accelerate the introduction of new products. On the other hand, it is necessary to establish a timely evidence system that meets FDA requirements, including real-world data (RWD), clinical trials, or alternative models, and to pay attention to further restrictions on animal testing in the U.S.

These reports aim to enhance people's understanding of the agency's handling of sunscreen ingredient assessments under an updated framework, and the bill has been submitted to the committee for review, awaiting further action. Cosmetics and personal care industry stakeholders should closely monitor their progress and prepare for possible adjustments to FDA review procedures and formulation regulations.