Rising rates of skin cancer: The cost of FDA’s inaction on novel sunscreen products

A decade after Sen. Jack Reed (D-R.I.) authored the Sunscreen Innovation Act, which became law in 2014, Americans are still waiting for newer, more effective sunscreen products due to the Food and Drug Administration’s chronic inaction.

Ten years ago, Republicans and Democrats came together to pass this legislation with the promise of overcoming regulatory obstacles and ushering in a new era of sun protection. As Reed stated, “Americans shouldn’t have to wait decades for access to the most advanced, effective sunscreens as they try to better protect themselves from skin cancer.”

But the FDA has failed to deliver on that promise. Bureaucratic red tape continues to leave Americans without access to the most innovative sun protection that is widely available to consumers in other parts of the world.

For more than two decades, people across Europe, Asia, and Canada have had access to sunscreens that provide protection against the full spectrum of ultraviolet rays, while older versions here in the U.S. often fail to efficiently block out ultraviolet A (UVA) rays that are known to cause cancer and age the skin. Newer agents also help produce more cosmetically elegant sunscreens that don’t leave a white cast, which encourages people of all skin tones to utilize this lifesaving preventative tool.

The result of these delays is that skin cancer rates in the U.S. remain stubbornly high. In fact, skin cancer is the most common type of cancer — with more diagnosed in the U.S. than all other cancers combined. The country now has some of the highest skin cancer incidence globally.

One of the most disheartening aspects of these statistics is that it’s one of the few cancers where the direct cause is known, and the risk of developing it can easily be lowered by protection from the sun’s ultraviolet rays. The sun’s UV intensity has also been increasing over the past 20 years, making for an even greater need for better protection.

Despite this, over this past decade of FDA inaction, the U.S. has continued to see one American die every hour from melanoma.

It doesn’t have to be this way. Other countries now empower their citizens with the latest tools to combat rising skin cancer rates, including nearly twice as many sunscreen ingredients that better absorb or block UV radiation. Governments in these countries remain focused on the core issue: protecting the body’s largest organ — skin — against a known carcinogen – UV radiation.

The U.S. somehow has it backward. The FDA has not approved a single new sunscreen ingredient since the 1990s. Instead of approving new ingredients, the agency has befuddlingly chosen to move in the other direction. It insists on testing and retesting existing ingredients that have been used for decades for hypothetical and unproven risks, even though tens of millions of Americans have used sunscreen daily for decades with none of those hypothetical problems ever seen.

In addition, the FDA also relies on tests that lack common sense and bear no resemblance to real-world conditions, like feeding rats sunscreen ingredients and exposing them to levels that any human being wouldn’t reach even after applying sunscreen every day for 277 years.

The FDA needs to return to the facts and real-world evidence. Using sunscreen lowers the risk of getting skin cancer. Nearly all dermatologists agree that sunscreen is safe, and research demonstrates its ability to cut melanoma rates by more than half when used as directed. To put it simply, Americans need better access to the newer safe and effective sunscreens, and not be limited to the products currently available to them.

With one in five Americans being diagnosed with a largely preventable cancer, it is essential to safeguard and increase access to the most effective sun protection available. The FDA needs to align itself with the efforts of the major national medical and scientific organizations to combat skin cancer by advancing — not hindering — innovation that can help save lives.

Darrell Rigel, M.D., is a clinical professor of dermatology at the NYU Grossman School of Medicine, a consultant dermatologist at the Cooper Clinic in Dallas, and the former president of the American Academy of Dermatology, the American Academy of Dermatology Association, the American Society for Dermatologic Surgery, and the American Dermatological Association. These views expressed here are the author’s alone and not necessarily official positions of these organizations.