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EWG to FDA: Sunscreen Regs Good Step, Not Enough

EWG to FDA: Sunscreen Regs Good Step, Not Enough

Wednesday, September 21, 2011

The Environmental Working Group has submitted comments to the U.S. Food and Drug Administration about the agency’s efforts to ensure the safety and effectiveness of sunscreens. The sunscreen rulemaking process began in 1978, but the FDA did not finalize rules until June 2011.

EWG, which produces an annual review of the best and worst sunscreens on the market, has long urged the FDA to issue comprehensive regulations. EWG’s comments highlight specific ways in which the final rules fall short of protecting public health. They also weigh in on several issues the FDA left unresolved, including whether to cap SPF values at 50+ and how to regulate spray sunscreens.

EWG supports the FDA’s new labeling requirements because they will help consumers make more informed decisions. By banning overly broad claims like “waterproof” and “sweatproof,” for example, the rules will promote more effective sunscreen use. However, EWG believes the FDA set too weak a standard for products to qualify as “broad-spectrum.” Sunscreens that meet the FDA’s low standard will give consumers a false sense of protection from the sun’s harmful rays. Sunscreen makers in Europe follow more stringent guidelines that only a fraction of U.S. sunscreens would meet.

EWG calls on the FDA to do more to ensure that consumers are not faced with undue health risks when using sunscreens. For example, the FDA should investigate the safety of new active ingredients used in sunscreens in other markets that have not reached the American consumer. These ingredients could prove to be valuable tools in the fight to prevent skin cancer but have yet to be approved by the FDA for use in products sold in the U.S.

As for those issues still under FDA review, EWG believes that the FDA should cap the labeling of SPF values at 50+ because higher values have no proven clinical benefits. EWG also supports the FDA’s plan to study the safety and effectiveness of sunscreen sprays, which may present unique risks when inhaled.

EWG’s letter to FDA is available here.