Published on March 22, 2014

FDA hasn't approved any new sunscreen ingredients in 15 years

By Beth Reese Cravey, The Florida Times-Union

In her 20s, Jacksonville resident Ximena Bailey paid little attention to how much time she spent in the sun.

But in her 40s, she was diagnosed for the first time with skin cancer. Now 70, the native of Ecuador has undergone multiple surgeries to remove cancerous and non-cancerous patches on her head, arms and chest, the latest just two years ago.

Bailey has checkups every six months and is vigilant about protecting herself from the sun.

And she would like a word with the federal Food and Drug Administration, which has not expanded its list of approved sunscreen ingredients in 15 years, despite rising U.S. cases of skin cancer.

“They need to get in touch with reality,” she said. “Things are happening to us. Don’t stay behind.”

Sunscreens made outside the U.S. contain the latest ingredients to protect against harmful ultraviolet rays. U.S. sunscreens do not because they are considered over-the-counter drugs, which require FDA approval. The agency has not approved new sunscreen ingredients since 1999 because of a backlog, according to a Washington Post report.

Eight new sunscreen ingredient applications that have been in use for years in Europe, Asia, South America and elsewhere are currently awaiting FDA review, according to the Post.

“The FDA’s criteria are the weakest in the modern world. Half of the U.S. sunscreens that meet the FDA rules would not make it to store shelves in Europe,” according to the Environmental Working Group, a Washington, D.C.-based advocacy group that focuses on public health and environmental issues.

FDA officials blame the backlog on a complex and lengthy rule-writing process, as well as some applications lacking safety data, according to the Post. Also, differing standards mean that an ingredient considered safe in another country might not automatically get a thumbs-up from U.S. regulators.

A coalition of dermatologists, sunscreen ingredient companies and advocacy groups has been lobbying to streamline the approval process. Legislation to accomplish that was recently introduced in the House and Senate.

“It is certainly time for the U.S. to accelerate the backlog of blocking agents,” said Troy Guthrie Jr., medical director of Research and Education at Jacksonville’s Baptist Cancer Institute, who is leading several clinical trials for melanoma, which is the most deadly skin cancer.

The FDA “tends to be slow … very deliberate,” he said, but the need for improved sunscreen rises as the number of skin cancer cases rises. The disease “in most patients … is associated with sun exposure and UV ray toxicity,” he said.

Skin cancer is the most common form of cancer in the U.S., with more than 2 million people diagnosed annually.

Over the past 30 years, more people have had skin cancer than all other cancers combined, according to the Skin Cancer Foundation, and the incidents of melanoma have increased by about 2.8 percent per year since 1981. One in five Americans will develop skin cancer, which is curable if found early.

“Fortunately, it can be prevented through regular and appropriate use of sunscreens. This much needed and long overdue legislation is a key step for the approval of critical and innovative ingredients to be used in future sunscreens,” Steven Wang, a board-certified dermatologist at Memorial Sloan Kettering Cancer Center and member of the Public Access to SunScreen Coalition, said in a news release.

The importance of effective sunscreen — and public education about how best to use it — cannot be underestimated, said Jacksonville resident Michael A. Altes.

“I think it is vitally important to inform the public that skin cancer can, and does, kill,” he said. “I have had several friends die from melanoma. Even the current therapies in testing cannot cure, only delay, the disease.”

For years, skin cancer was mostly attributed to severe sunburn in childhood. But the latest research shows it can stem just as much from chronic sun exposure as an adult, said William Sumner, a surgical oncologist at St. Vincent’s HealthCare in Jacksonville.

And the increasing incident numbers stem at least in part from demographics and the aging population, he said.

“More people are at an age when it occurs,” he said.

Until more effective sunscreen ingredients come along, the public should use what’s available. The higher the SPF, the more waterproof, the more frequently applied, the better, Sumner said.

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