FDA Road Block: Sunscreen upgrade needed
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.
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 to 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.
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.
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