New Sunscreen Monograph

FDA Issues New Guidelines For Sunscreen Labeling.

The Food and Drug Administration's long-awaited announcement yesterday of significant changes to sunscreen labeling was widely reported both by television and print media. The changes will empower consumers to make better decisions in choosing a product to prevent sun damage as well as reduce overall confusion about sunscreens.

        The CBS Evening News (6/14, story 9, 0:30, Pelley) reported, "The government put out new rules today for sunscreens. From now on, the gold standard will be broad-spectrum protection. Manufacturers may put that on the label only if the sunscreen protects [against] ultraviolet B which causes burning and ultraviolet A which causes wrinkling." Both forms of UV rays "cause skin cancer, and only sunscreens with an SPF 15 or higher may claim to lower the risk of cancer."

        On NBC Nightly News (6/14, lead story, 2:50, Williams), chief medical editor Nancy Snyderman, MD, explained, "One of the biggest changes is this, a drug facts label showing ingredients and differentiating between products that protect against cancer from those that only prevent sunburn." The FDA's Janet Woodcock, MD, was shown saying, "We've heard from many surveys that we've done this really helps people access information. So we're adding the drug facts box just like is found on other OTC drugs."

        On ABC World News (6/14, lead story, 3:20, Sawyer), correspondent Lisa Stark pointed out why the change is so important. "Despite the explosion of sales of sunscreens, there's also been an explosion of skin cancer," as evidenced by the fact that "cases of the most deadly kind of skin cancer, melanoma, increased 45% between 1992 and 2004," particularly in young people. Ronald Moy, MD, president of the American Academy of Dermatology, was shown saying, "Now, melanoma's the most common form of cancer for young adults in their late 20s."

        In a follow-on analysis piece on ABC World News (6/14, story 2, 1:15, Sawyer), chief health and medical editor Richard Besser, MD, explained that the action taken by the FDA on sunscreen labeling was "done five years ago" by European regulators. Besser suggested that consumers looking for sunscreen should examine "the UVB number. I recommend 30, at least. That will protect you against that. But for UVA, you need to go to" a list put together by Consumer Reports specifically for products "tested for UVA. By next year you'll be able to trust the labels for everything."

        The AP (6/15, Perrone) reports that beginning next summer, if sunscreens do not protect against both UVA and UVB rays, "or the sun protection factor is below 15," then sunscreens must "carry a warning: 'This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.'" The AP quotes AAD's Moy as saying, "For the first time, the FDA has clearly defined the testing required to make a broad-spectrum protection claim in a sunscreen and indicate which type of sunscreen can reduce skin cancer risk."

        Bloomberg News (6/15, Larkin) reports, "Lawmakers have urged the FDA for more than a decade to revise sunscreen labels to address cancer-causing UVA rays that penetrate deeper into skin cells and aren't blocked by window glass." Unfortunately, "'twenty percent of Americans will develop skin cancer in their lifetime,' said" Moy at yesterday's press conference at FDA's headquarters. "Ultraviolet exposure is the most preventable risk factor for skin cancer."

        The Los Angeles Times (6/15, Maugh) reports that the FDA "has been considering such regulations since 1978 and released some proposed rules in 2007, but subsequently concluded that the labeling system under consideration would be too confusing for consumers."

        The Washington Post (6/15, Stein) reports that "the agency is barring the use of the term 'sunblock' as well as claims that sunscreens are 'waterproof' or 'sweatproof,' saying those terms are inaccurate." Under the new guidelines, "sunscreen makers will only be allowed to claim that products are 'water-resistant' and will have to specify whether they work for 40 or 80 minutes." Sunscreens "that do not must carry warnings advising people to use a water-resistant product if they are going to be exposed to water or sweat."

        On its front page, the New York Times (6/15, A1, Harris, Subscription Publication) reports that FDA "regulators said they had yet to decide whether to end an SPF arms race in which manufacturers are introducing sunscreens with SPF numbers of 70, 80 and 100, even though such lotions offer little more protection than those with an SPF of 50." In fact, the FDA "had proposed allowing manufacturers to use SPF numbers no higher than 50, but that remains only a proposal (pdf) for which the agency will seek further comment." Nevertheless, many dermatologists are enthusiastic about the new rule. "Now, we'll be able to tell patients which sunscreens to get," said Henry W. Lim, MD, a spokesman for the American Academy of Dermatology.

        USA Today (6/15, Szabo) reports that currently, "the American Academy of Dermatology recommends both adults and children use a sunscreen with an SPF of at least 30." It is important to use enough of the product, too. Dermatologist Henry W. Lim, MD, explained that "the average person needs about one ounce of sunscreen – enough to fill a shot glass – to cover the body." Most people use considerably less.

        Also covering the story are the UK's Financial Times (6/15, Rappeport, Subscription Publication), the Wall Street Journal (615, D1, Dooren, Subscription Publication), the Wall Street Journal (6/15, Hobson, Subscription Publication) "Health Blog," the Washington Post (6/15, Petri) "ComPost" blog, the Star-Ledger (6/15, Todd), the CNN (6/14, Willingham) "The Chart" blog, the Columbus Dispatch (6/15, Jacobson), the NPR (6/14, Thrasybule) "Shots" blog, WebMD (6/14, DeNoon), HealthDay (6/14, Reinberg), MedPage Today (6/14, Walker), and Reuters (6/14). An FDA webcast of the press conference announcing the rule is available for viewing here.

        Myrtle Beach Dermatologist Says FDA Rule Is Insufficient. On its website, WPDE-TV Myrtle Beach, SC (6/14, Theis) reports, however, that a local dermatologist "says the dermatologist community was disappointed with the outcome of the regulations released today. 'Many doctors were hoping for more clarity in the muddled confusion of SPF, oxides, and other ingredients that often can confuse consumers,'" says Dr. Robert Bibb of Waccamaw Dermatology. He adds that doctors wanted a measurement system on sunscreen labels enabling consumer to understand a product's effectiveness in blocking UV-A rays. "SPF is B-rays only," he notes.

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