The Cost of Caution: FDA Regulation and the Delay of Advanced Sunscreen Ingredients

With the massive and slow moving bureaucracy at the Food and Drug Administration (FDA), it is a reasonable question to ask if the FDA really does care about scientific and evidence-based practices, or if they only care about lengthy bureaucratic processes that halt innovation and stifle new products from coming to the market. In June 2026, the FDA approved a new ingredient to be used in sunscreen products. This is a significant milestone for the FDA because it is the first sunscreen ingredient that has been allowed since the late 1990s. The ingredient that was approved is bemotrizinol. However, while bemotrizinol is making headlines, it is not a new sunscreen ingredient; bemotrizinol has been used in sunscreen products in Europe for over two and a half decades. The FDA’s prolonged approval process for sunscreen ingredients demonstrates how excessive regulation can delay consumer access to products that have already accumulated decades of safety and efficacy evidence abroad.

In response to years of criticism, the United States has created a initiative through the Trump Administration’s Make America Healthy Again (MAHA) Strategy Report to bring new sunscreen ingredients to the U.S. market that are commonly used overseas. With this new initiative, the FDA hopes to automate and streamline some of the processes that have remained stagnant for the last two and a half decades. Moreover, the groundwork for this effort was already established through the CARES Act (Coronavirus Aid, Relief, and Economic Security Act), which was enacted in 2020 and included a provision to streamline the process for over-the-counter drugs, which includes including sunscreen.

The reason why sunscreen has such such a bureaucrat system compared to other countries is because the United States and the European Union (EU) differ when it comes to categorizing sunscreen. The FDA considers sunscreen to be a drug, while the EU considers it to be a cosmetic product. These differences are a major reason why it took the FDA nearly 27 years to approve a new sunscreen ingredient, as it had to undergo the FDA’s drug approval process, unlike in the EU. This is why bemotrizinol was available decades earlier in the EU than in the United States. The irony that many dermatologists point out is that the stricter “drug” classification, meant to protect consumers, has actually made U.S. sunscreens worse than those available elsewhere because better ingredients cannot get through the approval process quickly enough. Americans are stuck using older chemical filters with more safety concerns, while newer, arguably safer filters remain in regulatory limbo.

While the different classifications on whether a sunscreen is a drug or a cosmetic tool many developed countries have undergone their own regulatory testing to ensure that these ingredients are safe for consumers regardless of it being labeled as a cosmetic product. In the EU countries use regulors like the scientific committee on consumer Safety (SCCS), a branch of European Commission to approve ensure that ingredients are safe to use for consumers. This begs to ask the question why is the FDA must be so insistent on redundant testing for ingredients with years of evidence behind it. This does not only waste money for companies that have to foot the bill to undergo the testing from the FDA, as in the case of bemotrizinol which cost nearly 20 million dollars, but it also wastes taxpayer dollars who fund the FDA. The FDA solution for this simple problem should be to adopt a regulatory reliance model that gives substantial weight to trusted foreign approvals. Scientific rigor does not require bureaucratic duplication; in many cases, duplication simply delays consumer access to safer and more effective products as can be seen with sunscreen ingredients. From overseas manufacturing inspections to multinational clinical trials, the FDA already relies on foreign scientific evidence in numerous contexts. Yet, when it comes to sunscreen ingredients with decades of real-world safety data, the agency has historically insisted on redundant reviews.

With the new provisions that were brought about by MAHA, the FDA was able to approve of bemotrizinol. However, there are still ingredients that are used overseas that have years of evidence-based positive outcomes that need to be approved. Mexoryl XL, Mexoryl SX, and Tinosorb M should be next in the queue for approval. In the case of Mexoryl SX, it has received limited FDA approval through a product-specific New Drug Application, but it has not been broadly incorporated into the FDA sunscreen monograph, meaning it cannot be freely used. All these ingredients have a long list of benefits and 25 to 28 years of evidence-based research and real-world results supporting their safety and effectiveness, which begs the question as to when the FDA will stop its bureaucratic duplication of testing that has already been done, and follow suit with other countries and allow new sunscreen ingredients.