Why sunblock in the U.S. is so much worse than in the E.U.

The U.S. FDA's stringent approval process for sunscreens, classifying them as drugs rather than cosmetics, has resulted in American consumers having access to less effective sun protection compared to Europe and Asia, where regulations are less restrictive and newer, more effective chemical filters like bemotrizinol are widely available; this regulatory lag persists despite skin cancer being more prevalent than all other cancers combined in the U.S., and bipartisan calls for reform from figures like Senator Mike Lee and Representative Alexandria Ocasio-Cortez.

Analysis

The U.S. Food and Drug Administration's classification of sunscreen as a drug, rather than a cosmetic as in many other developed nations, has resulted in a significant regulatory lag, limiting American consumers' access to newer, potentially more effective sunscreen ingredients widely available in Europe and Asia. This stringent approval process, which mandates costly and lengthy procedures including animal testing, has not yielded a new approved sunscreen ingredient since 1999. Consequently, ingredients like bemotrizinol, used for decades in European and Asian sunscreens and demonstrated to offer broad-spectrum UV protection, remain unapproved in the U.S. despite manufacturers like DSM-Firmenich reportedly spending $18 million over two decades to gain FDA clearance. This situation persists even though U.S. skin cancer rates are alarmingly high, with one in five Americans developing the disease by age 70, and skin cancer diagnoses surpassing all other cancer types combined. Notably, the European Union, which classifies sunscreens as cosmetics, imposes stricter UVA protection efficacy standards, which analysis indicates nearly half of American sunscreens fail to meet. Bipartisan political figures have called for reform, and recent statements from Health and Human Services and FDA leadership suggest a potential openness to accelerating drug approvals, presenting a possible catalyst for change in sunscreen regulation.

Key Decisions for Investors

• Investors should closely monitor any developments in U.S. FDA regulatory policy regarding sunscreen ingredients, as a shift towards faster approvals or alignment with international standards could unlock significant market opportunities for companies with advanced UV filter technologies.
• Consider companies like DSM-Firmenich, which have already invested in seeking U.S. approval for ingredients such as bemotrizinol; successful FDA approval would represent a material positive catalyst for such entities.
• Evaluate companies in the personal care and chemical sectors that possess a portfolio of modern sunscreen filters already approved and utilized in European and Asian markets, as they are well-positioned to capitalize on potential U.S. regulatory modernization.