GOVER NMENT & POL ICY INSIGHTS
Sunscreen Safety Lack of mandatory standards leads to widely VARIABLE PRODUCTS BRITT E. ERICKSON, C&EN WASHINGTON
S HU TTE RSTOC K
time, EWG has created a Web-based IT’S THAT TIME of year again. As database (cosmeticsdatabase.com/ vacationers head to the beaches and sunscreens) of more than 100 recswimming pools, many of them will ommended sunscreens to help concarry along a bottle of sunscreen. But sumers find the best protection. with so many choices out there, it is FDA regulates sunscreens as overhard to know which one will provide the-counter drugs. The agency has the best protection against sunburn approved 17 active ingredients, most and skin cancer. The Food & Drug of which it approved in the 1970s. AcAdministration is doing little to help cording to EWG, only four of those consumers sort through the dizzying ingredients—Mexoryl SX, avobenarray of sun protection products curzone, titanium dioxide, and zinc rently on the market. oxide—offer full UV-A protection. In Most people are familiar with the contrast, the European Union has approved at least 29 active ingresun protection factor (SPF) rating, which tells you how protected dients in sunscreens. you will be from ultraviolet-B rays (wavelengths 290–320 nm). It’s Getting additional active ingredients approved by FDA, howevgenerally thought that the higher the SPF number, the better the er, takes time and can be frustrating for sunscreen manufacturers. protection. UV-A rays (wavelengths 320–400 nm), however, can They say they have alternatives that offer better sun protection, also cause serious skin damage and may lead to melanoma, the but FDA is dragging its feet in approving them. Some of the chemideadliest form of skin cancer. SPF values tell the consumer nothing cals have been under review by FDA for years. In the EU, on the about how much protection they are getting from UV-A rays. other hand, sunscreens are considered cosmetics, and therefore Last August, FDA proposed a new rating system for sunscreens. the approval process is quicker and less onerous. In addition to the SPF value, the agency wants to add a four-star FDA also appears to be dragging its feet when new information rating system for UV-A protection. Almost a year later, FDA has not raises safety concerns about active ingredients in sunscreens that moved on finalizing the regulation. are already on the market. Take, for example, oxybenzone, also This month, the Environmental Working Group, a nonprofit known as benzophenone-3. FDA approved the use of the chemiorganization that has been pushing FDA to toughen its sunscreen cal in the 1970s. Research conducted since then by the National regulations for years, released a study that calls into question the Toxicology Program suggests that it can negatively affect the liver, safety and efficacy of many sunscreens on the market. Out of 952 kidney, and reproductive organs. Numerous studies have also indibrand-name sunscreens sold in the U.S., EWG found that four out cated that it acts as an endocrine disrupter in laboratory animals. of five of them offer inadequate protection or contain ingredients In 2001, Margret Schlumpf and colleagues at the University of Zuthat raise safety concerns. Furthermore, one out of seven offers no rich’s Institute of Pharmacology & Toxicology rocked the industry UV-A protection. EWG also found that nearly half of all sunscreens when they reported estrogenic activity from five frequently used tested lack chemical stabilizers to prevent active ingredients from sunscreen ingredients, including benzophenone-3. rapidly breaking down in the presence of sunlight. Consumers who want to avoid these organic chemicals in sunThe sunscreen industry and some dermatologists were up in screens have few alternatives. They can opt for one that contains arms about the EWG report, contending that sunscreen products titanium dioxide or zinc oxide, both of which provide UV-A protecon the market are safe and effective and that the levels of active tion. But most of these inorganics-based sunscreens on the market ingredients are too low to cause health concerns for people or today contain nanoscale forms of the metal oxides, which also raise wildlife. John Bailey, chief scientist of the industry group Persafety concerns. Scientists have been calling for more sonal Care Products Council, issued the following environmental, health, and safety research of nanostatement: “Sunscreen products have been thorNearly half of materials for several years. oughly studied and tested, and used safely for more FDA has its work cut out for it. Until it figures than 30 years.” all sunscreens out a better way to regulate sunscreens, the best the In those 30 years, FDA has failed to set mandatolack chemical agency can do is offer the following guidance: Limit ry safety standards for sunscreens, EWG countered. stabilizers to exposure to direct sun between 10 AM and 4 PM, and The agency has issued only draft guidelines that it prevent active wear protective clothing such as long sleeves, long encourages manufacturers to follow voluntarily. ingredients pants, and a big hat. That surely makes me want to go EWG also pointed out that FDA violated a congresfrom rapidly have fun in the sun. sional mandate that required the agency to finalize its sunscreen safety standards by May 2006. “We’re breaking down Views expressed on this page are those of the author still waiting,” Jane Houlihan, vice president for in the presence and not necessarily those of ACS. research at EWG, said in a statement. In the meanof sunlight. WWW.C E N- ONLI NE .ORG
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