The FDA is Limiting Your Access to the World's Best Sunscreen

Jezebel


The FDA is Limiting Your Access to the World's Best Sunscreen 
By Madeleine Davies

May 28, 2013



Ah, Europe. Not only does it get the fancy old castles, the Eurovision competition and Louis Garrel, but now it has the world's best sunscreen, too. Just how good is this white gold? So good that Americans are eschewing U.S. brands like Coppertone (that chubby naked baby couldn't rule forever) and instead having European brands shipped into the country or brought back in with them from their European vacations.

And what makes the European brands so special (other than their cool aloofness, all-black wardrobe and preference for Gauloises cigarettes)?

Well, for one thing, they're much better at preventing skin cancer and sun damage.

Sunscreens created abroad are allowed to use eight additional ingredients that, thanks to the FDA, are still under review in the U.S. While it makes sense that the FDA would want to test out products before making them widely available across the country, they're dragging their heels — some of the sunscreen ingredients have been awaiting approval for a whole decade despite being deemed safe and showing no health problems for people in the places where they are widely used.

Henry Lim, chairman of dermatology at Henry Ford Hospital in Detroit and a member of the American Academy of Dermatology, tells the Wall Street Journal, "The U.S. is an island by itself on this one. They're available in Canada, available in Europe, available in Asia, available in Mexico, and available in South America."

By limiting sunscreen ingredients, the FDA has also limited our UV protection. While broad spectrum sunscreens have become increasingly available in the U.S., the current legal ingredients only provide three UVA filters (the factor that blocks sun rays from penetrating skin), none of which are terribly long lasting. Ecamsule, Tinosorb S and Tinosorb M are the three most effective ingredients in long lasting UVA protection, but all three still have pending TEA applications. (The TEA process "allows the FDA to approve the ingredients if they have been used for at least five years abroad and have proved effective and safe.")

There has been some hesitation from U.S. dermatologists to recommend foreign sunscreens because "a paucity of research and concerns that some may be highly allergenic or affect estrogen levels."

However, from the WSJ:

No such concerns have been cited for Tinosorb or Mexoryl, several doctors said. The filters have been used effectively outside the U.S. for a long time, according to Dr. Lim. The lack of UVA filters in the U.S. "does limit the ability of sunscreen manufacturers to manufacture good, broad-spectrum sunscreens," he said.

Sonya Lunder, a senior analyst for the Environmental Working Group, a nonprofit advocacy group in Washington, D.C., said "not all the of the European sunscreen chemicals are good or better. But there are a handful that really stand out to us as worthy of consideration and would result in improvement for sun protection."

Give us our damn Tinosorb, FDA! Summer is coming and most of us can't afford a quick sunscreen run to France.


European Sunscreen Roadblock on U.S. Beaches

Wall Street Journal (Subscription)

European Sunscreen Roadblock on U.S. Beaches 
By Sumathi Reddy



May 28, 2013

Karen Spear needed a passport to discover the sunscreens she wanted.

Ms. Spear, a school psychologist in New York who has suffered from past overexposure to the sun, said she was looking for extra protection for her skin. She finally got what she needed on trips to the Caribbean and Europe.

"I noticed that the consistency was better and nicer and not as expensive and gooey as the ones you buy in the States," she said. "It is definitely much better than any of the sunscreens bought from the drugstores or cosmetic companies."

After doing some research and consulting with her dermatologist, Ms. Spear learned of the key ingredient, Tinosorb S. About a year ago her son ordered online a European sunscreen, Avène Emulsion SPF 50+, not available in the United States. At $18, she found the price reasonable.

She is part of a group of attentive U.S. consumers savvy enough to find certain kinds of sunscreen despite regulations that make a purchase tougher than a trip to the corner pharmacy.

Eight sunscreen ingredient applications have been pending before the U.S. Food and Drug Administration for years—some for up to a decade—for products available in many overseas countries. The applications were filed through the federal TEA process (time and extent application), which allows the FDA to approve the ingredients if they have been used for at least five years abroad and have proved effective and safe. A spokeswoman for the FDA said federal law prevents the agency from disclosing information about applications under review.

New labels that first surfaced in December are appearing on U.S. sunscreens for the first time when people most notice them, as summer gears up. They're designed to help consumers find "broad-spectrum" products that protect from both ultraviolet B and A rays. But some say U.S. brands are limited by the lack of long-range UVA filters, or sunscreen ingredients, not allowed by the federal government.

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." 

The newly formed PASS Coalition, short for Public Access to Sunscreens, is urging the FDA to act on the eight pending applications for sunscreen ingredients. PASS members include chemical companies and others with applications before the FDA. 

"In the U.S. we only have three UVA filters that can extend the range of the UVA protection to the long range," said Steven Wang, director of Dermatologic Surgery and Dermatology at Memorial Sloan-Kettering Cancer Center in New Jersey. Dr. Wang has had a consulting relationship with some companies that make sunscreen, including L'Oréal, OR.FR +1.75% the Paris-based cosmetic and beauty company, and is a member of PASS.

Both UVA and UVB rays contribute to skin cancer, but the damage caused by UVA rays is harder to measure. UVA filters block the rays from the sun that penetrate deep into the skin, causing collagen to break down, resulting in wrinkles. They also are a possible cause of melanoma, the deadliest of skin cancers, and may impact the immune system.

Of the eight pending TEA applications, doctors say ecamsule (also known as Mexoryl SX), Tinosorb S and Tinosorb M are the most effective, all offering long-range UVA protection.

Ecamsule is a proprietary ingredient of L'Oréal. In 2006 the company received FDA approval through the new-drug application process to use ecamsule in three currently marketed products, said Rebecca Caruso, a spokeswoman for L'Oréal USA. Two are moisturizers and one is a sunscreen that retails for $35.99.

But the approval was specific to the formulations, meaning the company doesn't have the flexibility to use the ingredient in other products. L'Oréal has two pending TEA applications. In Europe—where more products with ecamsule are available—it has been widely used in a variety of products since 1991.

Ms. Caruso called ecamsule "highly effective," adding, "We look forward to its approval by the FDA so that it can be made more broadly available for use in sunscreen formulations."

Julie Russak, a dermatologist in Manhattan and clinical instructor at Mount Sinai School of Medicine, said it's understandable why the FDA would be cautious in approvals for new sunscreen ingredients because of a paucity of research and concerns that some may be highly allergenic or affect estrogen levels.

"I know patients bring sunscreens with them from Europe and it's very hard for us to give recommendations because we really don't have much data" on such products, Dr. Russak said.

No such concerns have been cited for Tinosorb or Mexoryl, several doctors said. The filters have been used effectively outside the U.S. for a long time, according to Dr. Lim. The lack of UVA filters in the U.S. "does limit the ability of sunscreen manufacturers to manufacture good, broad-spectrum sunscreens," he said.

Sonya Lunder, a senior analyst for the Environmental Working Group, a nonprofit advocacy group in Washington, D.C., said "not all the of the European sunscreen chemicals are good or better. But there are a handful that really stand out to us as worthy of consideration and would result in improvement for sun protection."

In the U.S., the main chemical UVA filters are benzophenones, such as oxybenzone, and avobenzone. Chemical filters largely work by absorbing the sun's rays. 

Experts say oxybenzone has a number of shortcomings. It can cause allergic reactions and studies have found that it is absorbed and detected in the blood stream and could possibly affect some hormone levels. It also only absorbs only a shorter form of UVA rays.

Meanwhile, avobenzone can break down in sunlight, experts say, and reduces the potency of octinoxate, a UVB filter common in the U.S., when combined with it.

Inorganic or mineral-based UVA filters titanium dioxide and zinc oxide, which don't break down as easily in sunlight and generally are not allergenic, are better options, according to Lawrence Gibson, professor of dermatology at the Mayo clinic in Minnesota. These are physical blockers which protect the skin by either deflecting sun rays or reflecting them away from the skin, like a mirror.

But their large particle size makes them heavier in application, resulting in a whitish, chalky appearance that consumers find unappealing. Efforts to make the particles smaller have worked, but have raised safety concerns because they can penetrate the skin and potentially interact with cells. The studies have not been conclusive and most dermatologists still recommend such products.

New sunscreen labels in effect this year require a pass-fail test for UVA and UVB protection.

But critics like the Environmental Working Group say the test that products must pass to receive the "broad spectrum" label is weak. Ms. Lunder noted that in Europe the standards are more rigid: UVA protection has to be one-third of the SPF.



Public Access to SunScreens Coalition Concerned that FDA Has No Clear Timeline for Sunscreen Ingredient Approvals at FDA Budget Hearing

FDA Commissioner Hamburg Indicates Issue is a Priority, Yet Some Sunscreen Applications Have Been Pending for Ten Years

(Washington, DC) -- On Friday, April 26th, the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration (FDA), and Related Agencies held a hearing with FDA Commissioner Margaret Hamburg regarding the Fiscal Year 2014 budget request for FDA.

During this hearing, Subcommittee Ranking Member Sam Farr (D-CA) shared a compelling, personal story about his brother-in-law, who was an avid outdoorsman diagnosed with melanoma that ultimately proved fatal (hearing video available at C-Span beginning at 28m35s).  Ranking Member Farr expressed his concern that FDA had not acted upon any of the eight pending sunscreen ingredient applications that have been pending for over a decade and asked Commissioner Hamburg to explain the delay in taking action on these applications.

While the Public Access to SunScreens (PASS) Coalition was encouraged to hear that the FDA considers sunscreen safety a priority, the Coalition was concerned that Commissioner Hamburg had no details as to when the decade-long delay would be addressed, and new sunscreen ingredients would be approved.

The PASS Coalition thanks Congressman Farr for sharing his personal story and expresses its condolences for his family loss to melanoma.  We appreciate Ranking Member Farr pressing the FDA to address the growing skin cancer epidemic in the United States by ensuring Americans have access to the latest effective sunscreens.  According to the Skin Cancer Foundation, over 75,000 new cases of invasive melanoma will be diagnosed in the U.S. this year and nearly 10,000 people will not survive melanoma in 2013.  The American people need access to safe and effective broad-spectrum, photostable UV screens to protect themselves against the harmful effects of the sun.  The PASS Coalition looks forward to continuing to work with the FDA to seek a timely regulatory pathway to market for new and effective sunscreen ingredients in the United States.

The PASS Coalition is a multi-stakeholder coalition of public health organizations, dermatologists, sunscreen ingredient companies, and concerned citizens who will work collaboratively with the (FDA), the White House and Congress to establish a timely and transparent framework for approval of the next generation of UV active filters for Over-the-Counter (OTC) sunscreens.

The current membership of the PASS Coalition includes: The Skin Cancer Foundation, Prevent Cancer Foundation, Melanoma Research Foundation, Dr. Harry Fallick, Dr. Henry Lim, Dr. Nadim Shaath, Dr. Steven Wang, Beiersdorf, L'Oréal USA Products, Ashland Inc., BASF Corporation, DeWolf Chemical, Fitz Chem Corporation, McCullough & Associates.