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FDA’s new sunscreen rules arm dermatologists withgood information for patients about making sun-safe choices

Many U.S. dermatologists were thrilled to hear about the Food and Drug Administration’s new rules for sunscreens when they were announced on June 14. Indeed, in an unprecedented partnership, the FDA invited American Academy of Dermatology President Ronald L. Moy, MD, and Henry W. Lim, MD, the chair of the Academy’s Council on Science and Research, to join Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in announcing the new rules. “We are proud to have worked with the Academy and its esteemed leadership to announce our new sunscreen rules and to join forces to get this important information out to the public,” Dr. Woodcock said. “We would be delighted to continue working with the AAD and look forward to future collaborations to educate consumers about sun protection.” >>>

After the announcement, dermatologists participated in hundreds of media interviews to help print and broadcast reporters provide context for the news. In the wake of this frenzy, though, dermatologists may find themselves wondering how to explain the new rules during patient visits. What are the rule’s most important changes to the current standards? How should dermatologists tell their patients to incorporate the new rules, and resulting label changes, into their sun-protection behavior? And, with the rules not scheduled to take effect until summer of 2012, and summer of 2013 for smaller manufacturers, how should dermatologists advise their patients in the meantime?

Broad spectrum defined

According to Dr. Lim, the most important change in the new rules is the definition of the term “broad spectrum.” “For the first time, the FDA has put out a very clear guideline as to what a broad-spectrum sunscreen should be and how it should be tested so a consumer will know what broad spectrum means and so physicians know what to recommend to consumers and how to advise them,” Dr. Lim said. “That type of rating has been available in many parts of the world but it has not been available in the United States until now.”[pagebreak]

Dr. Woodcock explained that the FDA has determined “that sufficient data are available to establish a standard broad-spectrum test procedure that measures UVA radiation protection in relation to the amount of UVB radiation protection.” This designation, she said, “will give consumers better information on which sunscreen products offer the greatest protection from both UVA and UVB exposure.” Dr. Woodcock noted that the new rule also allows sunscreens that pass the FDA’s tests for providing “Broad Spectrum” protection and SPF protection of 15 or higher to include the claim on their label that they decrease the risk of skin cancer and early skin aging, when used with other sun-protection measures.

Darrell Rigel, MD, clinical professor of dermatology at New York University Medical Center, hailed the change. “The most important way the new labeling will make a difference is that the term broad spectrum will have meaning,” he said. “In the past it had no real meaning; sunscreen manufacturers could put it on a bottle but it didn’t mean anything and there was no easy way to tell patients what to look for without telling them a brand — you couldn’t tell them what to look for in one.”

Now, noted Mary Maloney, MD, chief of dermatology at the University of Massachusetts Medical School, the label will tell patients how important broad-spectrum protection is. “There will be a statement right on the bottle that if sunscreen doesn’t provide broad-spectrum protection against both UVA and UVB, it may prevent sunburn but not skin cancer,” she said. “That’s going to start getting the message out that UVA protection is desperately important to prevent skin cancer and give people a standard. It’s up-front about broad spectrum being important to prevent skin cancer.” And Dr. Lim noted that the broad-spectrum information will be very clearly marked in the same line as the SPF rating — “so the consumer will be able to clearly see as they look for the SPF if a sunscreen is broad spectrum or not.”

Waterproof no more

Another very important change, according to David J. Leffell, MD, David Paige Smith Professor of Dermatology and Surgery and deputy dean for clinical affairs at Yale School of Medicine, is the fact that the new rules no longer allow the use of the term waterproof, instead allowing the label to indicate if a sunscreen is water resistant for 40 minutes or 80 minutes. “This has been a source of great confusion for patients and the fact that there is now the expectation that sunscreen needs to be reapplied every two hours reinforces what dermatologists have been saying all along,” Dr. Leffell said.[pagebreak]

Ali Hendi, MD, a Mohs surgeon and attending physician at Georgetown University Hospital who recently discussed the new rules with Judy Woodruff on the PBS NewsHour, agreed. “The terms that are a little misleading have been eliminated from the labeling of sunscreen products sunblock, sweatproof, and waterproof. Those things don’t really exist,” he said. Products cannot claim to provide all-day protection anymore, either. “Some products now say they offer 12- or 24-hour protection; those were really misleading to consumers and made them think that if they put it on they were good for a whole day at the beach,” Dr. Hendi said. “Now the products have to mention that the protection is good for up to two hours and has to be reapplied after that. That’s probably one of the most common misuses of sunscreen — consumers put it on and think they’re good for the whole day.”

Talking to patients

When patients ask about the new rules, what can dermatologists tell them? “I explain that they are designed to simplify the selection and purchase of sunscreen,” Dr. Leffell said. “I think that most dermatologists have always explained what broad spectrum means, and that one should look for a sun-protection product that provides protection against UVA and UVB waves. I also use the new rules as an opportunity to emphasize the fact that sunscreen needs to be reapplied every couple of hours while active outdoors.”

Dr. Lim added that dermatologists should tell patients to look for a sunscreen with an appropriate SPF. “As dermatologists we recommend at least SPF 30 and broad spectrum,” he said. “We also need to tell patients that the use of sunscreen is just one of the photoprotective measures; full photoprotection is the entire package of seeking shade, wearing appropriate clothing, wearing hats, using sunscreen on exposed areas, and putting on sunglasses.” Patients should also know that sunscreen should be applied 15 to 20 minutes before exposure and has to be applied very generously, Dr. Lim said. “The rule of thumb is that covering an adult requires an amount the size of a shot glass or a golf ball.”[pagebreak]

Zoe Draelos, MD, chair of the Academy’s Council on Communications, said that the new rules will lead to new questions from patients — because they will give manufacturers of products that contain sunscreens new opportunities to make claims about those products. “Dermatologists need to know that anti-aging claims are being made based on the sunscreen ingredient present in [a cosmetic or anti-aging product’s] formulation,” she said. “A lot of times people will say, This is an anti-aging product,’ and then they’ll go on to talk about the caviar extract. People need to realize that the sunscreen is the most important ingredient in there in terms of photoprotection. I think dermatologists need to inform their patients who come in wondering if they should buy a $300 jar of cream that provides anti-aging benefits that the sunscreen in that formulation is what’s providing the anti-aging protection; then consumers will need to make an informed decision based upon the information their dermatologist provides. It depends on what their goals are — they may like the smell, they may enjoy the feel, but they need to be informed so they can spend their money wisely and make quality purchases,” she said. “In the current marketplace, the most potent anti-aging ingredient is sunscreen.”

In the interim

The new sunscreen labeling rules are not scheduled to take effect until the summer of 2012, with smaller manufacturers given an extra year to comply. What should dermatologists advise their patients to do in the meantime?

“Dermatologists should tell their patients that they should continue to look for SPF 30 and broad-spectrum sunscreens but keep in mind that until the rule is implemented broad spectrum could mean a sunscreen that would pass the new FDA test but could also mean one that might not; the requirement for broad spectrum right now is very weak,” Dr. Lim said. “As long as there is a sunscreen agent that has a filter to absorb some of the UVA spectrum it can currently be called broad spectrum, but we know that all UVA filters are not the same; some are better than others. Right now, unfortunately, the consumer will not be able to tell if a sunscreen would pass the new guidelines. Generally I tell patients to look for sunscreens from the larger manufacturers. Many of them anticipated stricter guidelines on broad-spectrum coverage and have been making very good broad-spectrum sunscreens that would have passed the new FDA test. That doesn’t mean the small brands are not good, but there is more variance.”

Dr. Leffell added, “I tell patients to buy a quality sunscreen that provides UVA and UVB protection. I specify the ingredients such as avobenzone, zinc oxide, and the traditional UVB sunscreen ingredients. I make a special point of emphasizing that patients, as consumers, should be suspicious of claims that sound unreasonable. In essence, the new guidelines reflect what dermatologists have already been telling their patients.”[pagebreak]

In addition, Dr. Draelos said, patients should be reminded that they need a product that they find aesthetically pleasing so that it ends up on their skin and doesn’t stay in the bottle. If it does, she said, patients need to be reminded to throw away old sunscreens, as they are over-the-counter drugs and are expiration-dated. “Old sunscreen does not provide optimal protection — why would you settle for suboptimal protection? A lot of people have the same sunscreen bottle for three years and still use it — if that sunscreen is expired you need to throw it away and purchase a new one.”

Looking at the bigger picture, Dr. Draelos said, “What we really need to do is impress upon people that investing in your future with sunscreen is one important part of protecting your skin from the sun and providing for healthy skin for life. They should use it up long before it expires — but people don’t.” The message dermatologists need to convey to patients, she said, is that a healthy life is lived with a healthy dose of prevention, and using sunscreen is an investment in the prevention of skin cancer and the maintenance of healthy skin.

“The battle against UV radiation and tanning and sun exposure that we as dermatologists are fighting is in its infancy,” Dr. Hendi said. “Where we are now compares with where physicians and the public health community were 30-40 years ago in the fight against tobacco companies. It’s an ongoing battle of public awareness and education. With the help of the new guidelines from the FDA we’ve definitely made a stride in the right direction.”



New sunscreen rules in brief

Under the sunscreen rules announced by the FDA on June 14:


  • Sunscreens must pass broad-spectrum UVA testing and have at least an SPF 15 to include the claim that they protect against skin cancer and premature aging on their label. The broad-spectrum test is a pass/fail test based on the critical wavelength value of 370 nm.
  • Sunscreens can claim to be water resistant for either 40 minutes or 80 minutes; “waterproof,” “all-day protection,” and “sweat proof” claims will no longer be allowed, nor will use of the term “sunblock.”
  • Sunscreens that do not pass the critical wavelength test and do not have at least an SPF 15 will have a warning in the drug labeling stating that the product will only protect against sunburn and not skin cancer or premature aging.



Proposed rules on sprays, SPF limits

In addition to announcing a final rule establishing broad-spectrum and water-resistant standards for sunscreen labels on June 14, the FDA also published a proposed rule that would limit the level of SPF that could appear on a sunscreen label to 50 and a notice of proposed rulemaking seeking additional data regarding sunscreens in spray form. Zoe Draelos, MD, said the latter is an important issue for dermatologists to educate patients about.

“One of the things dermatologists have known for a long time is that if you don’t apply an even coat of sunscreen in sufficient amounts you get insufficient sun protection,” Dr. Draelos said. “If you spray on the sunscreen you get little droplets on the skin but you don’t get a complete film. Unless you rub, that discontinuous film will not provide optimal sun protection.”

Are sunscreen ingredients safe?

The announcement of new rules for sunscreens on June 14 followed by less than a month the Environmental Working Group’s May 23 release of its 2011 report regarding sunscreens, which recommended that consumers avoid products that contain retinyl palmintate and oxybenzone. The report was still on the minds of reporters — the first question for Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, following the announcement was about the safety of sunscreen ingredients. Are they safe? It may be a question patients bring to their dermatologists.

They should feel confident addressing the question, according to Ali Hendi, MD. “Any small potential risk of using a sunscreen product is far smaller than the known risk of excess sun exposure and sun damage from UV radiation,” he said. “The products being marketed today have been used for many years and the FDA doesn’t have any reason to believe that they are not safe for consumer use. The studies the Environmental Working Group looked at were animal studies with a flawed design. They fed the active sunscreen ingredients to lab animals; of course, if you use a product in a manner that it’s not intended to be used, there will be ill consequences. But there’s no evidence that any of the products on the market today are dangerous to humans when used topically.”

A letter published in the July 2011 issue of Archives of Dermatology from Steven Q. Wang, MD, Henry W. Lim, MD, and Mark E. Burnett did the math to show the difficulty of extrapolating from feeding oxybenzone to rats to suggesting that its topical application causes problems for humans. In the letter, “Safety of Oxybenzone: Putting Numbers into Perspective,” they wrote that “both the application regimens and time periods” necessary to produce systemic oxybenzone levels equal to those studied in rats are “essentially unobtainable.” Using generous application figures, the authors found that it would take a U.S. woman who applied sunscreen every day on her face, neck, hands, and arms 277 years to apply enough to potentially lead to absorption sufficient to cause systemic issues. The authors acknowledged that they were not endorsing the “extrapolation of data from immature rats to humans” but said they “hope that this analysis helps to place into perspective the doses reported by the in vivo study from which inappropriate conclusions have been drawn and considerable controversy has developed.”

Darrell Rigel, MD, agreed. “The [EWG] report this year is nothing new. The reality is that report is like a book report; they review a bunch of things out of context,” Dr. Rigel said. “The experiment is done every weekend every summer when tens of millions of Americans are using sunscreen. If there were a problem we’d see the things they’re predicting happening and we’re not.”

The American Academy of Dermatology responded to the EWG report. “Contrary to recent reports, available scientific literature and decades of public use does not support a link between oxybenzone in sunscreen and hormonal alterations, or other significant health issues in humans,” Academy President Ronald Moy, MD, said. “The FDA has approved oxybenzone in sunscreen for use on children older than six months, and dermatologists continue to encourage protecting children by playing in the shade, wearing protective clothing, and applying broad-spectrum sunscreen.”

FAQs on retinyl palmitate, oxybenzone, and nanontechnology for use with media and patients can be found in the Academy’s online media relations toolkit at www.aad.org/member-tools-and-benefits/media-relations-toolkit/dermatology-issues-in-the-news.




 

Related Resources

New sunscreen rules in brief
Proposed rules on sprays, SPF limits
Are sunscreen ingredients safe?