Getting burned – Part 1: SNEWS uncovers sunscreen confusion, misinformation and FDA inaction

For nearly two generations, the alarms about the risk of sun exposure have been sounded so loudly that you’re practically a pariah if you don’t slop on the sunscreen before you head out to hike, bike or simply bask in its rays.

And for nearly those same two generations, the U.S. Food and Drug Administration has sat immobilized on basic regulations to cover labeling, ingredients and warnings about what’s in all those tubes, bottles and sticks we so religiously stock on our shelves, pack into our pockets and slather on our skin. Despite counting on the creams, sticks and sprays to keep us healthy, we have been left at risk — unprotected, uneducated, mislead, and at the mercy of manufacturers’ and marketers’ ethics.

Since 1978, the FDA has dilly dallied over passage of a final, all-encompassing rule about do’s and don’ts for sunscreen manufacturers in the $2.2 billion industry, and the Wild Wild West created has put us all in danger – with sunburns, freckles and wrinkles the least of the worries. Think unsafe chemicals penetrating the skin, cancerous skin lesions and skin tumors. Most people are tootling happily along assuming we, our families and customers are protected from all of the above, when perhaps that’s not likely the case at all. And by the time you find out – think skin cancer and beyond – it’s too late.

“Isn’t it time for the FDA to take control of the sunscreen industry and really regulate it to assure we have a quality, safe, effective product?” asked Sancy Leachman, director of the melanoma and cutaneous oncology program at Huntsman Cancer Institute in Salt Lake City, Utah. “People can’t tell if they’re being told the truth or not.”

Leachman should know. Under her direction, the institute in Utah works with the pale-skinned, outdoorsy population there of Northern European ancestry that has some of the highest rates of cancer in the world. Plus, many of her patients have a highly risky form of hereditary melanoma that means you have a three in four chance of developing cancer. Those kinds of patients aren’t just worried about aging skin and an occasional unsightly burn. Exasperated by the lack of information and understandable labeling, she undertook a huge project in 2004 – an in-depth spreadsheet of all the sunscreen brands she could find in her area from Albertson’s to Walgreens. With several hundred types broken down by price, protection rating and ingredients, it’s a gold mine – and it was out-of-date before it was done, she said with a sigh.

“It’s very difficult to stay educated,” she admitted, “and I have a lot of chemistry background…. Not only do the products change but the ones kept in stock change.”

Digging deeper

Over the last eight months, SNEWS® has dug deep into many hundreds of pages of FDA documents, sorted through chemical names, poured over spreadsheets and databases, sifted through court documents, spoken to manufacturers, advocates, non-profits and scientists, and read reports and surveys. And we have found that the concoctions we ourselves squirt on our exposed skin to protect ourselves from burns and, we hope, cancer, may not be worth the plastic they come in.

Let’s be clear from the start: This is not to damn every sunscreen brand that’s out there. In fact, most of them commonly found in the outdoor and specialty sports industry try to abide by what are considered safe guidelines for effective protection. But without clear FDA oversight even ethical companies find they have to compete against the less-ethical, less-expensive brands and are relegated to using ambiguous claims – albeit not necessarily risk-producing ones — and labeling that fudges just a smidgen.

“I think we do a really good job of making accurate claims, but there is so much ambiguity in what words mean…. I have to cringe when I put some of this stuff on the labels, as I’m sure many of us do,” said John Bercaw, director of product development and marketing for Beyond Coastal. “While all of our products and I’m sure those of many others are very good, you can call marketing B.S. on some of it. You’re just trying to get something to resonate with people so they take the extra second to look at your product.”

That’s not a simple task when some brands are a fraction of the cost of others, and they’re all floating in a colorful sea of bottles, tubes and tubs on a drugstore shelf. It’s not easy for a specialty store to stock and sell a three- or four-ounce bottle that may cost $14 to $20 when a bottle of a drugstore brand that’s double or triple the size may cost a half or quarter that amount. A quick, comparative glance at the label – eyeglasses at the ready — and, gosh darn, all those unpronounceable and serious-sounding chemical names sound sort of the same, the reassuring claims are identical, and it looks just as official and effective, so why not pay less?

Why not? You may not be getting what you think you are. Because nobody is really there to look over the manufacturers’ shoulders and say, “Hey, you didn’t put in enough of x or y to protect from those cancer-causing UVA rays that you say you are…. How come you say that goop is waterproof when that’s not even a valid claim?… And, wait, organic? The ingredients are all chemicals, and there’s nothing really organic about them.”

Meanwhile, despite annual sales of sun-protection products reaching into seven digits and continuing to increase, the incidence of skin cancers has also continued to rise. Think 1 million new cases alone of non-melanoma cancer and nearly 69,000 cases of melanoma in 2009.

“The SPF of sunscreens is the biggest fraud in the pharmaceutical field,” said Chris Vaughn, president of the independent sunscreen research lab SPF Consulting. “And you may wonder how come sunscreen sales are ever-increasing and so is skin cancer. What’s up with that?” 

Our Feds at work

It was on Aug. 25, 1978, that the FDA (www.fda.gov) put out a 64-page “Advance Notice of Proposed Rulemaking” as a part of its ongoing review of over-the-counter drug products that it oversees and regulates as part of its duties. According to the paper, the rule would establish conditions for “the safety, effectiveness and labeling of OTC sunscreen drug products.” Comments on the proposed rules were to be received by Nov. 24, 1978. With that, the avalanche of comments and more proposed rules began … and continues today with no end in sight. 

Soon the “proposed rules” morphed into topic-specific proposals: The FDA was not just looking at original active ingredients and labeling, but also at time and extent applications (a way to incorporate new drugs into a proposed rule), the safety of specific ingredients such as avobenzone, the particulars of UVA protection, the ins and outs of the ingredient zinc oxide, and the combined use of sunscreen with insect repellents. As the years passed, there were public meetings, virtual rooms-ful of comments and background submitted for review, plus extensions, delays, stays and more deadlines. The last “final” FDA document on active ingredients and labeling was issued May 21, 1999, but 17 days later its effective date was extended, then stayed, and then delayed, with the last word on the document, called a monograph, now dating back to 2003 in the form of a “delay of a drug fact implementation.”

The proposed rule covering UVA testing and labeling was issued on Aug. 27, 2007, and is still languishing under an extension. That proposal garnered more than 3,000 comments, according to the Personal Care Products Council, a Washington, D.C.-based, advocacy and trade group.

“The newer the area, the more evolving the science,” said John Bailey, chief scientist for the council, an association representing cosmetics manufacturers. Bailey also happens to have worked for the FDA for three decades prior. He pointed out that the government is legally required to read every last comment that is submitted as a part of meetings and the review process. When SNEWS emailed with the FDA in December 2009 to inquire about the process, the delays and the rules (our telephone calls were not returned), we were told succinctly by a spokeswoman that the “FDA is unable to comment or discuss things that are pending.” We were told the rules were pending, and “we are not certain when the final rule will be published.”

Twice a year, the federal government publishes its tentative agenda of work for the next six months in a document called the “Unified Agenda,” which summarizes rules and proposed rules each federal agency expects to issue during the year for inclusion in the Federal Register, which makes them law. In the latest one released Dec. 7, 2009, the FDA noted it planned to have a final rule on sunscreen in May 2010 – this month, which also happens to be Melanoma/Skin Cancer Detection and Prevention Month. So we emailed again with the FDA and, on May 13, 2010, we were told the agency was now targeting October 2010 for a final publication. The spokeswoman pointed to the 3,000 submissions received in 2007 as the reason for the extension.

“Bringing this to closure is something everybody wants,” said Bailey. “At some point, they have to draw a line in the sand and say, ‘OK, we’ll call it final.’”

But without that final word on what brands can and can’t do, label language and promises are the final frontier. Sure, manufacturers say they are toeing the line of the proposed rules, but nobody is really looking over their shoulders and, even if they were, the suggested standards are just that — suggestions.

“Essentially, they’ve been working on this since 1978,” said David Andrews, Ph.D., senior scientist for the independent watchdog Environmental Working Group, which on May 24 issued its controversial 2010 report on sunscreenthat calls into question the protection offered by most products and raises a red flag about a chemical additive called retinyl palmitate that could increase cancer risk. “We are flabbergasted.”

Do manufacturers have much confidence that the FDA will kick itself in the gluteals and get something once and for all passed?

“Let’s put it this way: In 2002, I moved to the U.S. to work for Johnson & Johnson,” said Nic Martens, a Ph.D. biochemist, co-founder of the new SCAPE sunscreen brand and a 20-year veteran of the sunscreen industry who is from Germany and attended the University of Cambridge in England. “At that time, the FDA said it would be ‘imminently approved.’

“Is it possible they will approve it? Yeah, potentially,” he said. “Do I believe they will approve it? No.”

But, he goes on to plead to no one and everyone all at once, “Just adopt something and give consumers a chance.”

The ABCs

After decades of pale, China-white skin being a sign of a good health and a well-to-do lifestyle, the pendulum swung in the other direction in the 1960s when deep bronze glows meant you were wealthy enough to afford leisurely vacations and recreation in the sun. As more and more people took to sun-bathing and tanning, so too did science evolve, linking exposure to ultra-violet radiation to skin cancer. In the 1960s, the so-called Sun Protection Factor (SPF) was introduced in the United States and, in the late ‘70s, was adopted into draft regulations by the FDA. But the concept of SPF was quickly misunderstood by the public as a multiplication of how many hours you could stay in the sun safely – thus, an SPF of 15 was falsely interpreted as meaning you were safe for 15 times the length of time you could normally stay in the sun without burning. We’ve seen top journalists for major news agencies and websites state this quite incorrectly.

Here’s the real SPF scoop, according to the American Cancer Society: Wearing a sunscreen of 15 means you would get the equivalent of one minute of UVB, the rays that burn (memory tickler: “B” for burn), for every 15 minutes in the sun. One hour in the sun wearing an SPF 15 is, therefore, like spending four minutes in the sun unprotected. So you still get exposure to big, bad, burning UVB rays, you just get a few less. Note the scale is non-linear, so SPF 30 doesn’t double the protection of 15, nor does an SPF of 45 triple it. SPF 15 sunscreens filter out about 93 percent of UVB rays, while SPF 30 sunscreens filter out about 97 percent, and SPF 50 sunscreens about 98 percent. Most experts agree that anything over 30 doesn’t give you that much more protection, and the FDA a few years ago considered prohibiting any sunscreen from claims over 30, but current draft regulations propose a limit of 50 due to manufacturer outcry.

In another widespread myth, people think the SPF factor rates overall protection from the sun, including from cancer. In fact, SPF has utterly nothing to do with more highly cancer-inducing UVA rays (there’s your “A” of ABC) but only the burning UVB rays. In theory, if you use a higher SPF sunscreen that blocks mostly UVB, you could in fact be multiplying your trouble. How so?

“You don’t get the warning of a burn to tell you to get out of the sun, and you think you’re fine,” said Mark Masthay, Ph.D., chair of the chemistry department at the University of Dayton, Ohio, and a photochemist who has published research on the effects of UV light. “But you’re also accumulating huge UVA exposure.”

Recent research actually suggests that if you get a lopsided ratio of UVA to UVB – that is, a whole heck of a lot of UVA but very little UVB – you could actually be increasing your cancer risk. You could end up with what Masthay called a “super charge” of cancer-risk-inducing UVA exposure.

“I am very anxious,” Masthay added, “about those protecting themselves only from UVB.”

With the lack of labeling information, there is actually no surefire way to know if the lotion or potion you have chosen will protect you from getting The Big C, a.k.a., Cancer. And if you’re diligent about protecting your skin from searing, you may never get the red flag of a burn. Your first warning? As much as 20 or 30 years later when your doctor sits you down for a talk you never want to have: how to treat your cancer.

–Therese Iknoian 

In our story’s second part to run May 28 in SNEWS, our exclusive, in-depth, three-part investigation of the world of sunscreen will explain what some of the fine print on sunscreen tubes and bottles means – and doesn’t mean – and lay out details about some of the key active ingredients allowed for use in the United States. In our third part, to run May 31, we’ll pull together answers to a lot of questions about claims, marketing and ingredients, give a list of resources you can turn to for furthering your education, and offer tips to help retailers look for the right information when making buying decisions. 

1. Getting burned – Part 1: SNEWS uncovers sunscreen confusion, misinformation and FDA inaction (May 26, 2010)
2. Getting burned – Part 2: SNEWS reveals how sunscreen chemical ingredients really work — or don’t (May 28, 2010)
3. Getting burned – Part 3: SNEWS looks at sunscreen marketing hyperbole, offers tips for retail buyers (May 31, 2010)
4. Getting burned – resources: SNEWS offers summaries of FDA actions on sunscreen, ingredients and resources (May 31, 2010)
5. SNEWSitorial: We are getting burned by the FDA’s inability to take action on sunscreen and the unethical claims of some manufacturers (June 4, 2010)