Consumer Group Pushes FDA To Review Sunscreen Ingredient
Published March 27, 2008
The Environmental Working Group is calling on FDA to investigate the safety of the sunscreen ingredient oxybenzone because of allergic reactions, hormone disruptions and environmental damage possibly linked to the chemical. EWG says the agency should immediately publish a final version of its sunscreen monograph, but FDA has more than 2,800 comments on the draft monograph to review first.
EWG requests that FDA review new sunscreen chemicals used in Europe that the group says protect against sun exposure better than sunscreen ingredients, including oxybenzone, used here.
Oxybenzone has been associated with changes in the liver, kidney and reproductive organs of animals used in clinical studies, according to the Centers for Disease Control and Prevention. But oxybenzone has not been associated with adverse health affects in humans and acute toxicity is low.
The CDC published a study March 21 that shows exposure to oxybenzone was prevalent in Americans 6 and older. The study was published in the journal Environmental Health Perspectives.
"Furthermore, little is known about the potential hazards associated with recurring or ecological exposures to these synthetic substances," the CDC report states. It says studies have show oxybenzone has been found in surface and drinking water.
EWG conducted its own review of 910 sunscreens last year and found nearly 600 sunscreens sold in the U.S. contained oxybenzone. On a scale of 1 to 10 indicating the "health hazard" extent of sunscreen ingredients, EWG gave oxybenzone a 7 rating, based on its association with photoallergic reactions. The skin also absorbs the chemical in significant amounts, EWG claims.
"These studies are the latest in a long list of reasons the Food and Drug Administration must thoroughly review the safety of all chemicals used in sunscreens Americans use every day," says EWG senior scientist Rebecca Sutton, in a statement. "FDA must do what it promised 30 years ago: Enact permanent, enforceable federal safety standards for sunscreens so consumers can get the best and safest sun protection."
EWG has praised elements of FDA's proposed monograph, including a new standard for Ultraviolet A protection and specific methods to measure sunscreens' water resistance.
Lawmakers have also pushed the agency to quickly issue a final sunscreen regulation, a move the Personal Care Products Council fears could lead the agency to overlook industry's concerns with key aspects of the rule. The council is urging FDA to revise the proposed testing and labeling requirements for UVA protection, the rating system for UVA protection and the types of claims that would be allowed.
Oxybenzone, which absorbs and dissipates UV in sunscreens, is also used in fragrances and cosmetics. FDA last reviewed it for safety in the 1970s.
