Last summer I argued for better sunscreens. FDA approval of such products had been seen as imminent for many years.
Since then, what has happened on the sunscreen front? Nothing. Zip. Nada.
Meanwhile, more than 76,000 Americans have been diagnosed with invasive melanoma, the scary skin cancer, and 10,000 more people have died of melanomas that spread to their internal organs. Better sunscreen, adopted years ago, might have spared us some of this loss.
So here I go again.
Better Sunscreen Now!
We all know that we should be using sunscreen to protect our skin from sunburns, aging and, most critically, skin cancer. One problem with this is that the most effective sunscreens are not available in the United States.
There are two kinds of damaging rays from the sun. One, UVB, can cause sunburns and perhaps skin cancer; most American sunscreens block UVB rays pretty well. The SPF number on a sunscreen product — 15, 30, 55, 70 — tells you how much protection it offers from UVB.
The other type is a little different. UVA rays penetrate the skin through windows and car windshields as well as outdoor exposure. UVA is more closely implicated in skin cancer, as well as premature aging of the skin.
Unfortunately, UVA protection is more limited. Early sunscreens only worked against UVB, and we now are advised by dermatologists to use “broad spectrum” sunscreens that protect against UVA as well.
Unfortunately, the term “broad spectrum” does not specify exactly how broad or protective a sunscreen is against UVA.
Only three substances are approved by the Food and Drug Administration for use in “broad spectrum” sunscreens. Many other substances — some said to block a broader range of rays and to protect for much longer than U.S. formulations — have been used successfully in many other countries for many years now.
No one seems to know why the more effective UVA-blocking substances have not been approved here, but the battle has been going on for a long, long time.
Below are some field reports from a quick internet search:
Q. Did anyone hear recently in the news about a sunblock approved in Europe but not here? Plus why it’s supposed to be so good? And why it’s not OK’d by the FDA?
A. There are two new sunscreen ingredients, Tinosorb and Mexoryl, that are superior in UVA protection. They are available in Europe, but they are still in the process of being approved by the FDA. Hopefully, they’ll be approved soon.
July 30, 2004
But nowadays everyone — the American Academy of Dermatology, the Food and Drug Administration (FDA), and, of course, sunscreen manufacturers — agrees that the American consumer deserves access to a sunscreen that’s as effective at filtering UVA as it is at taming UVB. . . .
The sunscreen ingredient that tops many most-wanted lists, including that of Clay J. Cockerell, president of the American Academy of Dermatology, is Mexoryl. The drug, developed by L’Oreal, has been widely used in Europe and elsewhere since 1993.
Mexoryl, which Cockerell said protects against even the longest-wavelength UVA light and can block 75 percent to 90 percent of that light, is widely deemed more effective than any anti-UVA drug available in the United States.
So where does Mexoryl stand in the FDA approval process? The agency doesn’t comment on such matters. Nor does Jennie James, vice president for media relations for L’Oreal USA, shed much light: “All we really say about Mexoryl is that we have initiated a process of discussion with the FDA about Mexoryl and are continuing to work closely with the FDA.”
“Less Than Full Protection”
June 28, 2005
In the absence of new (FDA) rules, consumers are left with sunscreen regulations that date back to the Carter administration — 1978 — when the science of sun protection was much more primitive. The status quo leaves Americans with less-effective sunscreens, doctors and scientists say.
“In the States, we are selling an obsolete generation of sun protection,” said Lionel De Benetti, the president of Clarins Laboratoires, a French cosmetics company. In its European sunscreens, Clarins uses superior ingredients that are not approved for use in the United States, he said, adding, “It’s a bit upsetting.”
To get state-of-the-art sun protection, some consumers seek out sunscreens from Europe that use UVA filters that are not yet approved by the F.D.A. Yu-Chi Lyra Kuo, a graduate student at Princeton University, took the trouble to do the research and now uses European products.
“The sunscreens in North America tend to be very effective at blocking UVB rays, but not UVA rays,” she said.
“UVA Reform: It’s Not PDQ”
New York Times
June 24, 2010
Henry Lim, chairman of dermatology at Henry Ford Hospital in Detroit and a member of the American Academy of Dermatology, says multiple UVA filters still awaiting clearance in the U.S. have been used effectively outside the country for years.
“The U.S. is an island by itself on this one,” he said. “They’re available in Canada, available in Europe, available in Asia, available in Mexico, and available in South America.”
Wall Street Journal
May 13, 2013
The FDA hasn’t helped itself on the public relations front. In 2002 the agency developed a new process to speed approval of chemicals that have long been on the market abroad, and FDA officials declared their intent to approve or deny applications within 180 days. In early 2009—that’s more than 2,500 days later—it had become achingly clear that the FDA was not making those self-imposed deadlines on sunscreen ingredients. Pressed by the industry to get moving, the agency promised to process most of the long-delayed applications by the end of the year. That was four years ago, and we are still waiting.
It’s almost hard to believe that America is home to some of the most outdated sun protection products in the world. It is, and it’s been this way for some time now.
The last time a new sunscreen ingredient was introduced to the US market was in 2002. The Food and Drug Administration regulates sunscreens as over-the-counter drugs, making the process for ingredient approval cumbersome. Eight new OTC sunscreen ingredients have been pending in the FDA’s queue for more than a decade, while countries in Europe and Asia have been enjoying the same ingredients for years and are constantly introducing innovative new options.
“Burned by Bureaucracy”
Why is the FDA stalling on
newer and better sunscreens?
April 23, 2014
“We’ve not heard any real objections to the legislation. We’re optimistic that this is going to be a bill that everybody can get behind and we can get it enacted this summer,” (said Michael Werner, a Washington, D.C. lawyer who advised the PASS (Public Access to Sunscreen) Coalition.
“Critics Want FDA to OK New Sunscreen Ingredients”
June 6, 2014
“Some UV filters actually provide longer and better UVA protection,” said Dr. Stephen Wang a dermatologist at the Memorial Sloan Kettering Cancer Center in Basking Ridge, New Jersey, to Racked. “Sunscreens offer certain spectrums of protection. “The ingredients waiting to be approved can deliver better protection. The US currently has three [ingredients providing] UVA protection whereas there are a lot more available in Europe and Asia.”
“Why You Shouldn’t Be Buying Your Sunscreen in America”
July 16, 2014
The New England Journal of Medicine dipped a cautious toe in the water last week, releasing a perspective article for a comment period that ends today (July 15, 2015). It surveys the damage UVA rays cause as well as the yearslong efforts to allow sales of better products and then says this:
“It’s no surprise that the FDA would act cautiously given the scientific advice it’s received and a legal structure that essentially provides it with just one tool: authorizing extensive marketing of multiple products and formulations. Understanding the FDA means recognizing that the framework for over-the-counter products is not designed to promote innovation, even innovation with potential public health benefits.”
There is a lot more blah-blah-blah about process and then this conclusion:
“After all, the ultimate goal is to make meaningful progress against this public health problem.”
Exactly, I say. When is the FDA going to start taking this situation seriously?