Mt. Vernon Register-News

Features

April 24, 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
Features
  • cleaning supplies Don't judge mothers with messy homes

    I was building shelves in my garage when a neighbor girl, one of my 4-year-old daughter's friends, approached me and said, "I just saw in your house. It's pretty dirty. Norah's mommy needs to clean more."

    July 25, 2014 1 Photo

  • Has the ipad lost its swag?

      The company reported this week that sales of its sleek, pricey tablet were down 19 percent from last quarter and 9 percent year-over-year. CEO Tim Cook tried to reassure investors that Apple's new partnership with IBM to sell its devices to IBM's corporate customers will help make iPads ubiquitous in the workplace. "This isn't something that worries us," he said of the iPad sales decline. But the numbers are disappointing no matter how you spin them.

    July 24, 2014

  • Darth Vader is polling higher than all potential 2016 presidential candidates

    On the other hand, with a net favorability of -8, Jar Jar is considerably more popular than the U.S. Congress, which currently enjoys a net favorability rating of -65.

    July 23, 2014

  • Hospitals let patients schedule ER visits

    Three times within a week, 34-year-old Michael Granillo went to the emergency room at Northridge Hospital Medical Center in Los Angeles because of intense back pain. Each time, Granillo, who didn't have insurance, stayed for less than an hour before leaving without being seen by a doctor.

    July 22, 2014

  • Wal-Mart to cut prices more aggressively in back-to-school push

    Wal-Mart Stores plans to cut prices more aggressively during this year's back-to-school season and will add inventory to its online store as the chain battles retailers for student spending.

    July 21, 2014

  • Your chocolate addiction is only going to get more expensive

    For nearly two years, cocoa prices have been on the rise. Finally, that's affecting the price you pay for a bar of chocolate - and there's reason to believe it's only the beginning.

    July 18, 2014

  • web_starbucks-cof_big_ce.jpg Starbucks sees more Apple-like stores after Colombia debut

    This week Starbucks opened its first location in Colombia — a 2,700-square-foot store with a heated patio, concrete columns, mirrors on the ceiling and walls of colorful plants.

    July 17, 2014 1 Photo

  • Screen Shot 2014-07-16 at 11.16.48 AM.png VIDEO: Comcast apologizes after customer service call goes viral

    Comcast issued an apology after one of its representatives kept a customer captive on the phone for nearly 20 minutes, demanding to know why he was choosing another cable provider.

    July 16, 2014 1 Photo

  • 20110929_bowling.jpg Why fewer people go bowling

    Like other industries facing tough economic times, America's bowling centers are trying to reinvent themselves.

    July 15, 2014 1 Photo

  • Almost half of the world actually prefers instant coffee

    Americans' taste in coffee might be getting more high-end _with a growing fixation on perfectly roasted beans, pricier caffeinated concoctions, and artisan coffee brewers - but it turns out a surprisingly big part of the world is going in the opposite direction: toward instant coffee.

    July 14, 2014

Twitter Updates
Facebook
Stocks