A Quiet U.S. Sunscreen Market
Source：The New York Times
From：Taiwan Trade Center, New York
U.S. sunscreens are perceived as lagging behind the rest of the world due to regulatory hurdles and a lack of recent innovation. The American sunscreen market is regulated by the Food and Drug Administration (FDA), which has not approved new active ingredients for many years. This regulatory inertia has hindered the introduction of more advanced and effective sunscreen formulations. In contrast, countries in Europe and Asia have embraced a wider array of sunscreen ingredients and formulations, leading to more diverse and sophisticated options for consumers. This disparity in regulatory approvals and innovation has left many Americans seeking superior sun protection solutions abroad. After discussing the particularities of sunscreen regulations in the U.S., this article will explore the government’s attempts to simplify the FDA approval process for sunscreen ingredients and how this issue has risen to a level of awareness among everyday people.
In the United States, sunscreen is regulated differently than in major skincare hubs like South Korea, Japan, and the European Union. While these countries consider sunscreen a cosmetic product, the U.S. classifies it as an over-the-counter drug under the jurisdiction of the FDA. This distinction means that any sunscreen marketed to Americans must gain FDA approval, as it claims to prevent sunburn, reduce the risk of skin cancer, and counter early skin aging. However, the FDA has not approved new active sunscreen ingredients for over two decades, leaving many Americans feeling that the rest of the world has surpassed the U.S. in developing innovative sunscreen formulations. While the FDA currently permits the use of 14 sunscreen filters, the European Union has approved more than 30. To give an example, the ultraviolet-filtering compounds amiloxate, enzacamene, and octyl triazone – which have been used in foreign-made sunscreens for decades – have all remained in the FDA's regulatory pipeline since at least 2003. This regulatory disparity has drawn attention and frustration, especially from skincare influencers promoting exciting foreign products that are unavailable in the U.S.
To respond to this issue, two initiatives have been made in the past few years. The first one was in November 2014 when President Barack Obama signed the Sunscreen Innovation Act (SIA) into law. Its primary purpose was to expedite the approval process for new sunscreen ingredients. The SIA required the FDA to review and make decisions on pending sunscreen ingredient applications within a specified time frame (usually within a year), aiming to encourage the development and introduction of more advanced and effective sunscreen formulations. However, despite the SIA's intentions, progress in approving new sunscreen ingredients has been slower than expected. The CARES Act, which stands for the Coronavirus Aid, Relief, and Economic Security Act, was signed into law in March 2020 in response to the COVID-19 pandemic. While the primary focus of the CARES Act was to provide economic relief and address various aspects of the pandemic, it also made changes to the approval process for over-the-counter drugs, including sunscreens. Under the CARES Act, the FDA asked manufacturers for more information on new sunscreen filters, essentially requiring additional data for their approval but not outright denying them. This change aimed to facilitate the introduction of new sunscreen ingredients into the market, although it didn't lead to an immediate influx of new options.
According to Representative Alexandria Ocasio-Cortez of New York, who noted a lack of attention to the issue since the Sunscreen Innovation Act was signed in 2014, Congress holds the responsibility for enhancing sun protection for Americans. She expressed optimism about growing public awareness and is actively trying to generate political momentum through her various platforms. Influencers are more and more expressing their appetite for fresh formulations, and new targeted sunscreen brands have recently appeared on the market (e.g., Black Girl Sunscreen), reflecting a trend of Americans seeking alternative sunscreen options beyond what's traditionally available.