Tuesday, January 23, 2018
Health

Dermatologists and skin cancer groups urge FDA to act on new sunscreen ingredients

Few items that beachgoers use this Fourth of July weekend are as distinctly American as their bottles, tubes and cans of sunscreen. But that shouldn't be a point of pride, according to a coalition of dermatologists, cancer research groups and sunscreen makers.

Sunscreens sold in the United States are missing some of the latest and most effective ingredients for blocking the type of ultraviolet rays associated with premature aging and serious skin cancer, says the Public Access to Sunscreens Coalition, called PASS for short.

Those ingredients, though widely used in European and Asian countries, have been held up for years at the Food and Drug Administration. Federal law treats sunscreen as an over-the-counter drug, meaning new formulas must undergo rigorous and costly scrutiny before they hit store shelves.

Now the coalition is making a public push for the FDA to get moving. The centerpiece of their efforts is proposed federal legislation, called the Sunscreen Innovation Act, which would give FDA a timeline for acting on sunscreen applications.

"Everybody agrees that the process is broken down," said Wendy Selig, president of the Melanoma Research Alliance, which is part of the PASS coalition.

• • •

It's difficult to pinpoint the reasons for the delays. FDA officials have cited staffing shortages and a lengthy rule-writing process. In 2002, the agency set up what was intended to be a streamlined process for sunscreens, allowing officials to approve ingredients if they have been used for at least five years abroad and have proven effective and safe.

But no ingredients have been approved through that process. Eight applications are pending, some dating to 2003.

FDA spokeswoman Andrea Fischer said Americans have many effective products from which to choose. Still, she said, the agency is committed to acting on the applications as soon as possible.

She pointed to the FDA's notifications to three applicants earlier this year that their scientific evidence is lacking. In other countries, sunscreen is treated as a cosmetic and the safety data that is available from its use there doesn't always meet the FDA requirements.

"The FDA recognizes the public health importance of sunscreen use and has prioritized reviewing the safety and effectiveness of additional sunscreen ingredients as quickly as possible given the agency's resources," Fischer said.

The FDA has methods for fast-tracking approvals of drugs for serious or life-threatening conditions. Selig noted that in just the last four years, there have been at least six new drugs approved for melanoma, the deadliest skin cancer. But there has not been one new sunscreen ingredient approved in that time.

"It's the same agency," she said.

• • •

Dr. James Spencer, a St. Petersburg dermatologist, said American sunscreens are good at protecting against ultraviolet B rays, which are primarily responsible for sunburns and can cause skin cancers. Protection from UVB is what people shop for when they select sunscreen by its SPF rating.

But he and other dermatologists say sunscreens here have limited ingredients that filter the deeper-penetrating ultraviolet A rays. UVA rays, which can pass through window glass, cause premature aging and are also associated with melanoma.

Four of the eight pending applications with the FDA are for ingredients that fight UVA rays, according to the Environmental Working Group, a consumer organization that puts out an annual report on sunscreens.

The best UVA filter in the United States is avobenzone, which is less effective than several products safely used in Europe for years, said Dr. Mary Lien, a dermatologist who practices at several Tampa Bay area hospitals, including Moffitt Cancer Center. Another kind of chemical UVA filters used in the United States, the benzophenones, have caused allergic reactions in some people, she added.

Certain physical blockers like titanium oxide also work against UVA rays but are impractical for daily use because they deposit a chalky film that few users except lifeguards will tolerate.

In recent years, the FDA has toughened up labeling standards to help consumers pick the best "broad spectrum" sunscreens, those that protect against both UVA and UVB rays. For instance, the agency now requires that sunscreens pass a test before they can be labeled broad-spectrum. Critics, including the Environmental Working Group, say that test isn't stringent enough.

European countries, for instance, require that sunscreens offer UVA protection that is at least a third as potent as the UVB protection measured by SPF. The group estimates that about half of the 456 American sunscreens it evaluated this year would be too weak to be sold on the European market.

So do our weaker sunscreens result in higher skin cancer rates than other countries? Dr. Steven Wang, director of dermatologic surgery and dermatology at Memorial Sloan-Kettering Cancer Center in New Jersey and a member of the PASS coalition, said that's a difficult question to answer. That's partly because so many people, in every country, aren't using their sunscreen correctly: They don't reapply it nearly enough, he said, or they assume any use at all gives them license to bake.

"People think it makes them invincible," he said.

Jodie Tillman can be reached at [email protected] or (813) 226-3374. Follow @jtillmantimes.

Comments
Free clinics respond as more people head to the ER with dental problems (w/video)

Free clinics respond as more people head to the ER with dental problems (w/video)

Charles Lee had been dealing with an excruciating toothache for days. The pain made it hard to eat or sleep or focus on work. But Lee, 54, didn’t have dental insurance. His job as a delivery truck driver offered only a supplemental policy that was to...
Published: 01/22/18
When you need a breast screening, should you get a 3-D mammogram?

When you need a breast screening, should you get a 3-D mammogram?

When I went to the imaging center for my regular mammogram last year, the woman behind the desk asked me if I’d like to get a "3-D" mammogram instead of the standard test I’d had in the past."It’s more accurate," she said.What do you say to that? "No...
Published: 01/22/18
Expect some pain. That’s what hospitals are starting to tell patients as concern spreads over opioids

Expect some pain. That’s what hospitals are starting to tell patients as concern spreads over opioids

Doctors at some of the largest U.S. hospital chains admit they went overboard with opioids to make people as pain-free as possible, and now they shoulder part of the blame for the nation’s opioid crisis. In an effort to be part of the cure, they’ve b...
Published: 01/19/18
It’s flu season, and how: Here’s what you need to know

It’s flu season, and how: Here’s what you need to know

Cristi Fryberger, a fifth-grade teacher, was headed back for the first day of classes at St. Petersburg Christian School after the Christmas break but didn’t feel well. She left a couple of hours later and went to an urgent care clinic, where a swab ...
Published: 01/19/18
This 66-year-old is about to run seven marathons in seven days on seven continents

This 66-year-old is about to run seven marathons in seven days on seven continents

When Robert Owens’s father was 75, he gave his son some advice. "He said, ‘You know, son, the sad part is when you get old they just put you on a shelf and you become irrelevant. Fight to stay relevant. Fight to stay in the game, otherwise they will ...
Published: 01/18/18
5 things we learned about Trump from his medical checkup

5 things we learned about Trump from his medical checkup

Five things we learned about President Donald Trump from Navy Rear Adm. Ronny Jackson, the doctor who oversaw Trump’s first medical checkup in office. SLEEP Trump doesn’t get much shut-eye. Jackson guessed that Trump snoozes four to five hours a nig...
Published: 01/17/18
A century after the 1918 pandemic, science takes its best shot at flu

A century after the 1918 pandemic, science takes its best shot at flu

WASHINGTON — The descriptions are haunting. Some victims felt fine in the morning and were dead by night. Faces turned blue as patients coughed up blood. Stacked bodies outnumbered coffins. A century after one of history’s most catastrophic disease o...
Published: 01/17/18
A popular school fundraiser is just ‘junk-food marketing to kids,’ experts say

A popular school fundraiser is just ‘junk-food marketing to kids,’ experts say

For 43 years, schoolkids and their parents have clipped the labels from cookie bags and cracker boxes as part of a popular rewards program called Labels for Education.Through this and similar programs — think Tyson’s Project A+ or General Mills’ Box ...
Published: 01/17/18
Pinellas is at the center of a rise in Florida flu outbreaks

Pinellas is at the center of a rise in Florida flu outbreaks

Feeling a little sniffly or scratchy or stuffed up? It may be the flu, and you don’t want to wait around to see a doctor this year. This is not the time to write off flu-like symptoms, Tampa Bay area health officials and doctors warn. The influenza v...
Published: 01/16/18

CDC says ‘There’s lots of flu in lots of places.’ And it’s not going away anytime soon.

A nasty flu season is in full swing across the United States, with a sharp increase in the number of older people and young children being hospitalized, federal health officials said Friday.The latest weekly data from the Centers for Disease Control ...
Published: 01/12/18