By Sally C. Pipes
Just in time for the beginning of summer, the Food and Drug Administration has approved a new sunscreen ingredient for the first time in more than a quarter-century.
Bemotrizinol is a next-generation ultraviolet filter already widely used in other nations. The FDA fully approved the ingredient for use in the United States this month.
It’s progress, but it does not address the deeper problem. The FDA still regulates sunscreen as if it were a high-risk drug rather than a low-risk cosmetic product. That regulatory posture keeps the latest in sunscreen technology off the U.S. market and deprives Americans of some of the most effective tools available for preventing skin cancer.
The public-health consequences may not be visible immediately, but they’re real. More Americans are diagnosed with skin cancer each year than all other cancers combined. Melanoma alone kills nearly 20 Americans every day.
Because their governments regulate sunscreen as a cosmetic, most European and Asian consumers have long had access to ultraviolet filters that provide broader protection against UVA radiation, which is associated with skin aging and skin cancer.
Those newer filters also allow manufacturers to produce lighter, smoother formulations people are more likely to wear every day — not just during trips to the beach.
American consumers, by contrast, have largely been stuck with older ingredients that allow UVA rays to penetrate more deeply into the skin.
The FDA’s arduous approval process deserves blame.
Securing regulatory approval for a new drug can require years of toxicology studies and clinical research. Funding those efforts can take millions of dollars. The company seeking approval for bemotrizinol spent 20 years and roughly $18 million securing FDA authorization.
That level of scrutiny may make sense for experimental drugs with potentially dangerous side effects. It makes far less sense for topical sunscreen ingredients that have been used safely overseas for decades.
Consider Tinosorb M, a next-generation sunscreen filter that has been available abroad for years. The ingredient provides protection against both UVA and UVB radiation. Yet it remains unavailable in the United States, largely because of the FDA’s cumbersome approval process.
The FDA argues that its cautious approach protects public health. But excessive regulatory caution carries risks of its own.
George Mason University economist Alex Tabarrok has described this phenomenon as the “invisible graveyard” of FDA regulation — the lives lost not because unsafe products reached the market but because safe and beneficial ones did not.
Regulators are finally recognizing that the current framework is outdated. But approving one new sunscreen ingredient after a quarter-century drought is not enough.
What is needed is a broader modernization of how sunscreen is regulated in the United States.
Congress took a step in that direction last year by enacting the SAFE Sunscreen Standards Act, which directs regulators to establish clearer, more flexible standards for evaluating sunscreen ingredients and permits the use of real-world evidence from other countries to determine safety and effectiveness.
Lawmakers should go further. Reclassifying sunscreen as a cosmetic product — and thereby subjecting it to a more sensible regulatory burden — would help bring newer and more effective sunscreens to American consumers far more quickly.
In the fight against skin cancer, regulatory delay is not a neutral act. When public officials keep better sunscreens off the market for decades, Americans are left relying on yesterday’s protection against today’s risks.
Sally C. Pipes is president, CEO and Thomas W. Smith Fellow in Health Care Policy at the Pacific Research Institute. Her latest book is “The World’s Medicine Chest: How America Achieved Pharmaceutical Supremacy — and How to Keep It.” Follow her on X @sallypipes. This piece was originally published in the South Florida Sun Sentinel.