Fresh sunscreen ingredients stuck in FDA backlog

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European sunbathers tend to wear less on the beach than their American counterparts, but they may be better protected when it comes to sunscreen.

Skin cancer is the most common form of cancer in the United States, yet federal regulators have not added anything new to its list of approved sunscreen ingredients in 15 years.

Meanwhile, many of the ingredients that provide broader protection - from both the UVA and UVB types of ultraviolet radiation - are available in Europe, Canada and countries in Asia.

But they haven't seen the light of day in the U.S.

"Right now we have a backlog of newer sunscreen ingredients that are pending with the FDA that would be very valuable, as there are newer and better sunscreens being used all over the world," said Dr. Latanya Benjamin, a pediatric dermatologist at Packard Children's Hospital and assistant professor of dermatology and pediatrics at Stanford.

Eight sunscreen ingredients are pending before the U.S. Food and Drug Administration, many of them for years and even more than a decade.

The frustration over the regulatory delays has been heating up as summer approaches. Members of Congress are pushing the Sunshine Innovation Act, introduced in March by Sen. Jack Reed, D-Rhode Island, and Rep. Ed Whitfield, R-Kentucky. The act is designed to speed up the approval process by setting a timetable - approval within 11 months - while maintaining the same safety standards.

'Intractable problem'

The FDA, for its part, has acknowledged the delays. A spokeswoman said regulators have "prioritized reviewing the safety and effectiveness of additional sunscreen ingredients as quickly as possible given the agency's resources."

During a congressional committee hearing in November, Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, called the sunscreen ingredient delay an "intractable problem." "If possible we are more frustrated than the manufacturers and you are about this situation," she said.

Sunscreens makers in the U.S. are limited to only 17 chemicals that have been approved by the FDA, including just three chemicals that screen UVA rays. Meanwhile, European companies can choose among 27 chemicals approved under European Union standards, including seven expressly designed to filter UVA radiation.

Both UVA and UVB are associated with skin cancer. UVA rays play a bigger role in aging, but UVB rays are considered more responsible for burning and thus pose the greater cancer risk. Experts recommend "broad spectrum" sunscreens to cover both types, although the protection sold in the U.S. does a better job of screening out UVB.

"Most of the U.S. sunscreens have done a good job in UVB spectrum. What we're trying to get is a better ingredient that covers the far UVA range," Benjamin said.

Cancer on the rise

Rising rates of skin cancer over the past 30 years are driving the concern. More than 2 million Americans are diagnosed each year with skin cancer, and 90 percent of non-melanoma cases are associated with harmful sun exposure, studies have shown.

The rate of melanoma, the most deadly form of cancer, increased 2.7 percent per year from 2006 to 2010 among white people, according to the American Cancer Society. Anyone can get the disease, but the risk is higher in people with light skin.

As the FDA continues to be bogged down in regulatory processes, consumers have to struggle with figuring out how to best protect themselves absent some of the latest and potentially greatest tools.

The promising ingredients getting the most attention are currently available in Europe. They include ecamsule, also known as Mexoryl, and Tinosorb, and health experts believe they may be better than anything currently available in this country. They block both UVA and UVB rays and are more stable, meaning they don't break down in sunlight as quickly as the American products.

In 2006, the FDA approved a petition by L'Oreal to use a form of Mexoryl in the United States, but only in a single La Roche-Posay sunscreen product and only at a sun protection factor or SPF level of 15. The agency did not approve the chemical for widespread use.

Product concerns

Currently, the main UVA blockers available in the United States are avobenzone (also known as Parsol 1789) and oxybenzone (also known as benzophenone-3). But experts say avobenzone has been known to degrade in sunlight and cause allergic reactions, and both chemicals may be associated with hormonal disruptions.

"We have concerns about the fact people put these (products) all over their bodies, multiple times a day for multiple days in a row," said Sonya Lunder, a senior analyst with the Environmental Working Group, a nonprofit advocacy group in Washington, D.C.

Last week, the group released its eighth annual guide to sunscreen, which includes information about the products' chemical ingredients.

The guide recommends consumers be wary of high sun protection factor, or SPF, claims because they may be misleading and create a false sense of security. SPF is a measure of sunscreen's ability to protect against sunburn; theoretically, higher numbers mean more time can be spent in the sun without getting burned. The guide also cautions against products with vitamin A and oxybenzone, which the group described as toxic.

The recommended 7

Consumer Reports last week also released its sunscreen review. The magazine recommended seven of the 20 sunscreens it reviewed and found that only two products provided the SPF protection on the label.

For patients who are particularly concerned about exposure to potentially harmful ingredients, Dr. Maryam Asgari, a Kaiser dermatologist, recommended the use of physical rather than chemical blockers.

Physical blockers, such as zinc oxide and titanium dioxide, protect the skin by deflecting the rays. They offer good broad spectrum coverage, but tend not to be as resistant to water and sweat.

Asgari said she recommends physical blockers, but would like to see some of the newer unapproved ingredients get past the FDA logjam. If some don't meet the safety standards, at least they won't remain in limbo.

"I'm all for getting those past the review process. It would be nice to know, one way or another," she said.