OBSERVATIONS YANKEE DOODLING Douglas Kamerow My New Year’s wish is for an effective sunscreen The United States, bastion of high the FDA, but no new sunscreen President Obama 2013 of a lobbying group, the Public technology, may in the next year ingredients have been approved signs bill to Access to Sunscreens Coalition. or two finally catch up to the rest since 1999.2 Despite years of With membership including of the world in the availability of carping by interested parties, help the United various cancer support groups, effective sunscreen preparations. nothing has happened. States close the dermatologists, and (of course) In a rare show of bipartisanship sunscreen gap the major sunscreen and chemical between Republicans and New approved process manufacturers, they set about “to Democrats and of cooperation Hopes were raised in 2002, when establish a regulatory pathway between Congress and the White the FDA introduced a new process for timely pre-market review of House, Congress passed and the to shorten approval time for over new, safe, and effective sunscreen president has now signed into law the counter drugs that have been ingredients.”5 They crafted and the Sunscreen Innovation Act. available elsewhere for at least five lobbied for passage of a new law, years. It allowed manufacturers to applying only to sunscreens, that Types of UV use data on safety and effectiveness would set specific deadlines for The sun’s ultraviolet rays are of from similar countries. This so prompt review by the FDA of these two major types, both deleterious called time and extent application chemicals, the Sunscreen Innovation to human skin and health. UVB (TEA) process was supposed to Act.6 rays cause burning and contribute allow the FDA to approve new The law creates an approval to cancer risk, and UVA rays, ingredients within 3-6 months. schedule specifically for sunscreen penetrating more deeply, cause Nothing has happened, though, ingredients used in over the counter skin aging and also increase and despite the TEA process at Americans have preparations. The FDA must render cancer risk. SPF, the skin protective least eight ingredients are currently needed to go a decision on the eight pending factor number that we’ve all come waiting for an FDA decision.2 abroad to get sunscreen ingredient applications to love and search for on our One of the newer UVA blockers, affordable, effective according to a new, expedited sunscreen’s label, measures only for example, is ecamsule, which sunscreens timeline, with some decisions the sunscreen’s effectiveness in is widely available in European expected in as soon as six months. blocking UVB rays. Thus, it does not sunscreen products. L’Oreal applied New applications must be evaluated tell the whole story. for and received FDA approval for within 10 months. Regulators have been late in a few preparations that include The bill recently passed both appreciating the importance of UVA ecamsule, but they were approved houses of Congress and, amazingly, rays in causing pathology. The Food under new drug approval rules as was quietly signed into law by and Drug Administration, which has complete formulations only. As a President Barack Obama on 26 jurisdiction over such things in the result, ecamsule cannot be used in November. There were no formal US, came out with new regulations other products, by L’Oreal or anyone announcements and no signing only in 2011. At that time the else. The few ecamsule containing ceremony, as he effectively over- FDA mandated several important products that have been approved ruled his own FDA. Maybe by next changes, barring inaccurate in the US cost 3-5 times as much as summer, but surely by summer 2016, terms such as “waterproof” and other sunscreens. we should have some affordable, “sun block” from sunscreen So Americans have needed to go highly effective sunscreens when we labels. They also introduced and abroad to get affordable, effective head for the beach or pool. defined a new label term, “broad sunscreens. New preparations with A small victory to end a dreary year spectrum,” which for the first time better UVA blocking ingredients are on a sunny note. acknowledged the importance widely available throughout Europe, Douglas Kamerow is senior scholar, of ingredients that block UVA the Caribbean, and Australia.3 In Robert Graham Center for policy studies in rays. Only products meeting FDA a recent review, the independent primary care, and associate editor, The BMJ standards for blocking both UVA product evaluation company [email protected] and UVB could be so labelled.1 Consumer Reports was able to find Cite this as: BMJ 2014;349:g7729 So far, so good. But very few only seven US products that did well UVA blocking chemicals have enough against both UVA and UVB thebmj.com been approved by the FDA. Those rays to be recommended.4 ̻ Editorial: Sunscreens, suntans, and skin in use, such as oxybenzone cancer (BMJ 1996;312:1621) ̻ Editorial: Preventing skin cancer (BMJ and avobenzone, may not block Lobby group action 2003;326:114) all wavelengths of UVA rays. Since this is Washington, DC, ̻ Feature: Quality of evidence behind Manufacturers have submitted frustration with the FDA’s lack of FDA approvals varies widely (BMJ other, newer UVA blockers to activity finally led to the creation in 2014;348:g1075) 22 3 January 2015 | the bmj.