Issue Date: July 21, 2008
IT'S THAT TIME of year again. As vacationers head to the beaches and swimming pools, many of them will carry along a bottle of sunscreen. But with so many choices out there, it is hard to know which one will provide the best protection against sunburn and skin cancer. The Food & Drug Administration is doing little to help consumers sort through the dizzying array of sun protection products currently on the market.
Most people are familiar with the sun protection factor (SPF) rating, which tells you how protected you will be from ultraviolet-B rays (wavelengths 290–320 nm). It's generally thought that the higher the SPF number, the better the protection. UV-A rays (wavelengths 320–400 nm), however, can also cause serious skin damage and may lead to melanoma, the deadliest form of skin cancer. SPF values tell the consumer nothing about how much protection they are getting from UV-A rays.
Last August, FDA proposed a new rating system for sunscreens. In addition to the SPF value, the agency wants to add a four-star rating system for UV-A protection. Almost a year later, FDA has not moved on finalizing the regulation.
This month, the Environmental Working Group, a nonprofit organization that has been pushing FDA to toughen its sunscreen regulations for years, released a study that calls into question the safety and efficacy of many sunscreens on the market. Out of 952 brand-name sunscreens sold in the U.S., EWG found that four out of five of them offer inadequate protection or contain ingredients that raise safety concerns. Furthermore, one out of seven offers no UV-A protection. EWG also found that nearly half of all sunscreens tested lack chemical stabilizers to prevent active ingredients from rapidly breaking down in the presence of sunlight.
The sunscreen industry and some dermatologists were up in arms about the EWG report, contending that sunscreen products on the market are safe and effective and that the levels of active ingredients are too low to cause health concerns for people or wildlife. John Bailey, chief scientist of the industry group Personal Care Products Council, issued the following statement: "Sunscreen products have been thoroughly studied and tested, and used safely for more than 30 years."
In those 30 years, FDA has failed to set mandatory safety standards for sunscreens, EWG countered. The agency has issued only draft guidelines that it encourages manufacturers to follow voluntarily. EWG also pointed out that FDA violated a congressional mandate that required the agency to finalize its sunscreen safety standards by May 2006. "We're still waiting," Jane Houlihan, vice president for research at EWG, said in a statement. In the meantime, EWG has created a Web-based database (cosmeticsdatabase.com/sunscreens) of more than 100 recommended sunscreens to help consumers find the best protection.
FDA regulates sunscreens as over-the-counter drugs. The agency has approved 17 active ingredients, most of which it approved in the 1970s. According to EWG, only four of those ingredients—Mexoryl SX, avobenzone, titanium dioxide, and zinc oxide—offer full UV-A protection. In contrast, the European Union has approved at least 29 active ingredients in sunscreens.
Getting additional active ingredients approved by FDA, however, takes time and can be frustrating for sunscreen manufacturers. They say they have alternatives that offer better sun protection, but FDA is dragging its feet in approving them. Some of the chemicals have been under review by FDA for years. In the EU, on the other hand, sunscreens are considered cosmetics, and therefore the approval process is quicker and less onerous.
FDA also appears to be dragging its feet when new information raises safety concerns about active ingredients in sunscreens that are already on the market. Take, for example, oxybenzone, also known as benzophenone-3. FDA approved the use of the chemical in the 1970s. Research conducted since then by the National Toxicology Program suggests that it can negatively affect the liver, kidney, and reproductive organs. Numerous studies have also indicated that it acts as an endocrine disrupter in laboratory animals. In 2001, Margret Schlumpf and colleagues at the University of Zurich's Institute of Pharmacology & Toxicology rocked the industry when they reported estrogenic activity from five frequently used sunscreen ingredients, including benzophenone-3.
Consumers who want to avoid these organic chemicals in sunscreens have few alternatives. They can opt for one that contains titanium dioxide or zinc oxide, both of which provide UV-A protection. But most of these inorganics-based sunscreens on the market today contain nanoscale forms of the metal oxides, which also raise safety concerns. Scientists have been calling for more environmental, health, and safety research of nanomaterials for several years.
FDA has its work cut out for it. Until it figures out a better way to regulate sunscreens, the best the agency can do is offer the following guidance: Limit exposure to direct sun between 10 AM and 4 PM, and wear protective clothing such as long sleeves, long pants, and a big hat. That surely makes me want to go have fun in the sun.
Views expressed on this page are those of the author and not necessarily those of ACS.
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