FDA process bogs down progress for sunscreens in the US

The cutting edge of sunscreen isn't in the US, and fingers are pointing at a mired-down FDA approval process as the main culprit.

The cutting edge of sunscreen isn't in the US, and fingers are pointing at a mired-down FDA approval process as the main culprit. National Cancer Institute photo

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The tourists flocking to the French Riviera or Spain’s Costa del Sol this summer will slather on sunscreen containing the latest ingredients for protecting against the sun’s most harmful ultraviolet rays.

But American beachgoers will have to make due with sunscreens that dermatologists and cancer-research groups say are less effective and have changed little over the past decade.

That’s because applications for the newer sunscreen ingredients have languished for years in the bureaucracy of the Food and Drug Administration, which must approve the products before they reach consumers.

“We have a system here that’s completely broken down, and everybody knows that it has broken down,” said Wendy Selig, president of the Melanoma Research Alliance, the largest private funder of melanoma research.

Her group and others, along with dermatologists and sunscreen manufacturers, have joined forces to make a public push for the FDA to approve at least some of the backlogged applications.

The agency has not expanded its list of approved sunscreen ingredients since 1999. Eight ingredient applications are currently pending, some dating to 2003. Many of the ingredients are designed to provide broader protection from certain types of UV rays and were approved years ago in Europe, Asia, South America and elsewhere.

The FDA noted that U.S. consumers “have access to a great number of sunscreen products,” but said in a statement to The Washington Post that it recognizes the public health importance of sunscreen and has prioritized its review of the long-pending applications. The agency said “it is proceeding as quickly as practicable given available review resources and competing public health responsibilities.”

In the meantime, advocates for newer sunscreens have grown increasingly frustrated.

“These sunscreens are being used by tens of millions of people every weekend in Europe, and we’re not seeing anything bad happening,” said Darrell Rigel, clinical professor of dermatology at New York University and past president of the American Academy of Dermatologists. “It’s sort of crazy. . . . We’re depriving ourselves of something the rest of the world has.”

Even some FDA officials have expressed frustration about how the applications have become mired in a complex regulatory regime, adopted more than a decade ago, that was originally intended to simplify approvals for over-the-counter products used in other countries for at least five years.

“This is a very intractable problem. I think, if possible, we are more frustrated than the manufacturers and you all are about this situation,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, told lawmakers in November when asked about the agency’s sluggish over-the-counter reviews.

Part of the hold-up, she said, is that the agency must undertake a lengthy rule-writing process before it can add to the list of active ingredients approved for sunscreens. In addition, the FDA has found some applications lacking in safety data. And differing standards mean that an ingredient considered safe in Canada or Japan, for example, might not automatically get a thumbs-up from U.S. regulators.

Since last year, a group of dermatologists, sunscreen ingredient companies such as BASF and advocacy groups such as the Prevent Cancer Foundation have lobbied lawmakers and rallied public support for changes to the approval process. Last week, a bipartisan group of lawmakers in Congress introduced legislation aimed at speeding up the FDA reviews. The FDA itself has planned a public meeting later this month to seek input about overhauling its process for evaluating over-the-counter products.

Selig, of the Melanoma Research Alliance, noted that the FDA has approved multiple new treatments in recent years for melanoma, the most deadly type of skin cancer, which kills nearly 10,000 Americans each year. If patients deserve access to the latest advancements in treating a disease, she said, why not also allow them access to every possible product that could help prevent it?

“We’re basically saying that the American people should make due with what was the most innovative science from 10 to 12 years ago,” she said. “Ask someone if they want to buy automobile technology from 12 years ago, or computer technology from 12 years ago.”

Both UVA and UVB types of ultraviolet radiation from the sun can contribute to skin damage, premature aging and cancer. While UVB light primarily is responsible for causing sunburn, UVA rays penetrate the skin more deeply, potentially damaging cells and contributing to the development of skin cancers.

In the United States, the UVA filters most commonly found in sunscreen include chemicals such as oxybenzone and avobenzone. Those ingredients are effective, dermatologists say, but they either protect against only certain UVA rays or break down too quickly. Other UVA filters such as zinc oxide don’t break down as quickly but cover the skin in a white gunk that only a lifeguard could like.

The pending applications at FDA include chemical filters such as Tinosorb S, Tinosorb M and Mexoryl SX (also known as ecamsule), which experts say offer stronger UVA protection and could allow manufacturers to create sunscreen formulations that last longer and feel better on consumers’ skin, making them more likely to use them.

L’Oreal received FDA approval in 2006 to use ecamsule, which had been approved in Europe in the early 1990s, in a handful of high-priced U.S. products. But because those products went through the traditional drug-approval process and were for specific formulations, the company can’t currently expand the use of ecamsule into other products.

Some doctors and industry officials also worry that the FDA’s failure to act on the applications could chill future sunscreen innovations.

“It definitely hurts how we approach development of new UV filters,” said Al Pearce, a personal care senior marketing manager for BASF, which owns several of the pending applications at FDA. “The U.S. market is one of the largest markets in the world. If it’s not open to new innovation, it’s extremely limiting.”

Even as the sunscreen ingredient applications have remained in a regulatory purgatory, the FDA has taken other action on sunscreens. In 2011, it announced long-awaited rules meant to cut back on misleading labels and give consumers clearer information.

For instance, only products that meet FDA standards for protecting against both UVA and UVB rays can be labeled as providing “broad spectrum” protection. In addition, the new rules barred the use of the terms “sun block,” “sweatproof” and “waterproof,” because the agency said such claims overstate the effectiveness of the sunscreens.

The agency said manufacturers could label their products “water resistant” but also must say how long the sunscreen remained effective in water. It also proposed limiting the maximum sun protection factor on labels to “50+,” saying there wasn’t sufficient data to show that products with higher SPF values provide greater protection.

But when it comes to finally allowing new sunscreen ingredients to reach the market, the wait continues in the United States. Eleven months ago, in a congressional hearing, FDA Commissioner Margaret Hamburg told lawmakers that sorting out the sunscreen issue was “one of the highest priorities.”

Rigel, the New York dermatologist, hopes that’s still true.

“I want the ultimate, perfect sunscreen for my patients,” he said. “No such perfect sunscreen exists yet. But these ingredients would help us get closer to that goal.”

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