The Ottumwa Courier

Southeast Iowa

April 25, 2014

American sunscreens need an upgrade

NEW YORK — The last time a new sunscreen ingredient came on the U.S. market, the Y2K bug was threatening to destroy our way of life. Intel had just introduced the Pentium III processor, featuring an amazing 500 MHz of computing power. The Honda Insight was about to become the first hybrid electric vehicle sold in the United States. Newt Gingrich had just resigned his speakership, and Sasha Obama had not been born. The Oxford English Dictionary accepted the word "bling." Ricky Martin was on top of the charts with "Livin' La Vida Loca," and he was still in the closet. The point is, unlike a lot of things, American sunscreens haven't changed in a long time.

The FDA deserves a huge amount of blame for this problem. Europeans and Canadians enjoy a more diverse and modern set of choices in sunscreen. Some of the ingredients that have been evaluated and approved for use abroad have been stuck in the FDA pipeline for more than a decade. Dermatologists, sunscreen manufacturers and skin cancer foundations have formed the PASS Coalition to prod the agency and Congress to make these ingredients available to Americans.

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.

In the FDA's defense, U.S. law treats sunscreen as an over-the-counter drug, a category of products that receives heavy scrutiny. Europe views sunscreen as a cosmetics product, and therefore can approve new products with less safety and efficacy data. This put the FDA in an awkward position. When the agency developed the fast-track process more than a decade ago, it may not have realized how much of the safety data normally collected during the drug approval process would be missing for some of the sunscreens already in use abroad.

The manufacturers pushing for approval for new sunscreen ingredients bear a portion of the blame as well. Some of them have failed to furnish basic data to the FDA. For example, the agency typically asks makers of new sunscreen ingredients to show that the chemical doesn't penetrate beyond the skin or have systemic effects. The company seeking approval for amiloxate, one of the ingredients stuck in FDA purgatory, has produced only expert opinion and animal studies on this point. The agency, however, argues that rat skin isn't entirely comparable to human skin and has demanded human studies. (Representatives of these manufacturers claim that the FDA requested this information only recently, many years into the process.)

The FDA's final defense is the same argument that most federal agencies make, with justification: It is understaffed, and it's difficult for a small group of people to analyze the evolving science of skin cancer and toxicology while at the same time issuing a stream of rules and collecting and responding to public comment.

Even if you accept all of these arguments, though, the math just doesn't add up. The FDA created this system itself and promised to fast-track the decisions. It's difficult to fathom how an evaluation and rulemaking process that was designed to take no more than six months could end up consuming more than a decade.

In the meantime, the question for consumers is this: Is it worth going underground to seek out these fancy foreign sunscreens?

It's very difficult to conduct a risk-benefit analysis. The problem with FDA-approved sunscreens is that they are mostly limited to protection against short-wave ultraviolet B rays. That made sense back in the 20th century, when most people thought the more plentiful but less powerful ultraviolet A rays played little or no role in skin cancer. Recent research, however, suggests otherwise. The only U.S. sunscreens that filter UVA well are products like zinc oxide, of lifeguard nose fame, but few people want opaque white creams on their faces.

The filters approved in Europe and Canada are better at blocking UVA. Ecamsule, for example, absorbs light waves best at 344 nanometers, which is squarely in the UVA range. Sunscreens that combine the old filters with the new ones provide broader protection against the sun.

How much safer are you with a broad-spectrum sunscreen? No one knows for sure. Researchers have had a difficult time proving that any sunscreen prevents melanoma. That's because there are so many confounding or unmeasurable factors. The fair-skinned people who are most likely to use sunscreen are also the most likely get skin cancer, which gives the false impression that sunscreen is associated with skin cancer. As with most cancers, cumulative lifetime exposure increases the risk of skin cancer, and it's hard to document accurately how much time someone spent in the sun or how often they used sunscreen as a child. Most experts strongly suspect that sunscreen protects against melanoma, but the data is a work in progress.

I suppose it bears mentioning that buying unapproved sunscreens from foreign retailers online and having them shipped into the United States is technically illegal for both the seller and the buyer - even if products containing proven UVA filters like ecamsule, Tinosorb S, and Tinosorb M are widely available on the Internet.

The question of whether to break the law is especially pressing if you have a family history of skin cancer: People with a first-degree relative who had melanoma have a 50 percent greater chance than others of getting the disease themselves. And they shouldn't have to wait. If the FDA finds that these sunscreen ingredients aren't safe enough, we need to know. And if they are safe, we should be able to buy them. You can't escape the conclusion that the FDA is failing us badly when it comes to sun protection.

     

 

1
Text Only
Southeast Iowa
  • Stuff the Bus photo United Way stuffs the bus for Operation Backpack

    OSKALOOSA — United Way of Mahaska County staff stuffed a bus with donated school supplies Tuesday morning to benefit needy students around the county.This is the third year for the Stuff the Bus program that the United Way has sponsored.“It’s a schoo

    July 31, 2014 1 Photo

  • Red Rock Dam 2.jpg North Tailwater to close Aug. 4

    The North Tailwater area near the Red Rock Dam will be closed to the public beginning Aug. 4 to enable construction of hydroelectric facilities at the Dam. The closure will extend until construction of the project is completed in the spring of 2018.

    July 31, 2014 1 Photo

  • Sunburn isn't the only sign of summer that can leave you itchy and blistered

    You've got a rash. You quickly rule out the usual suspects: You haven't been gardening or hiking or even picnicking, so it's probably not a plant irritant such as poison ivy or wild parsnip; likewise, it's probably not chiggers or ticks carrying Lyme disease; and you haven't been swimming in a pond, which can harbor the parasite that causes swimmer's itch.

    July 31, 2014

  • Centerville man violates sex offender registry

    A Centerville man with multiple felony convictions in Monroe County was recently sentenced in the Appanoose County Courthouse for OWI and sex offender violation.

    July 31, 2014

  • Fairfield stabbing suspects' trials separated FAIRFIELD — The three people accused of dragging a man into a Fairfield apartment before robbing and stabbing him have had a judge grant their requests to separate their trials. Dawn Dunn, Dustin Roll and Brett Hedblade are each charged with willful

    July 30, 2014

  • Brownsworth takes over helm at Van Buren hospital KEOSAUQUA — Ray Brownsworth officially started as Van Buren County Hospital’s new chief executive officer on Monday. Employees were introduced to and visited with their new administrator during a morning coffee session. Brownsworth was previously the

    July 30, 2014

  • streetscape July 29.jpg Paving may begin late next week

    The Third Street project in Knoxville is about three weeks behind, but paving may begin late next week. 

    July 30, 2014 1 Photo

  • Supervisors wrestle with staffing woes KEOSAUQUA — Van Buren County Supervisor Chairman Bob Waugh says he wants county supervisors to help alleviate staffing problems within the county treasurer’s office. In May, supervisors opted not to replace a vacancy within the treasurer’s office. Va

    July 30, 2014

  • Muscatine named Blue Zones community MUSCATINE — Muscatine has been named a certified Blue Zones Community. Certification recognizes Muscatine’s community transformation through successful implementation of the Blue Zones Project. Community leaders, volunteers and organizations througho

    July 30, 2014

  • Former Centerville teacher drowns in Creston

    A long-time Centerville Community School District teacher and coach has been identified as the man dive teams recovered from a southeast Iowa lake on Tuesday morning.

    July 30, 2014

Obituaries
Record
Facebook
AP National