FDA Study: Sunscreen Chemicals Seep Into the Bloodstream
Michael Dorris, 3, has sunscreen applied to his face by his "nana" Roxy Bentley Thursday afternoon. Lewis Geyer / Digital First Media / Boulder Daily Camera / Getty Images
The study, published in the Journal of the American Medical Association Monday, found subjects’ blood had levels of avobenzone, oxybenzone, octocrylene and ecamsule substantially above the 0.5 nanograms per milliliter (ng/mL) point at which testing is required. One of the chemicals, oxybenzone, has been shown to harm coral reefs, and sunscreens containing it have been banned in coral habitats from Hawaii to Key West, Florida.
The study authors said the results should not stop people from using sunscreen, which is an important way to protect against skin cancer.
“The fact that an ingredient is absorbed through the skin and into the body does not mean the ingredient is unsafe. Rather, this finding calls for further testing to determine the safety of that ingredient for repeated use,” Center for Drug Evaluation and Research (CDER) Director Dr. Janet Woodcock and CDER’s Division of Nonprescription Drug Products Director Dr. Theresa M. Michele wrote in an FDA statement about the study.
FDA is committed to improving the overall quality, safety and effectiveness of sunscreens that Americans use. Check out this video from CDER Director Dr. Woodcock on FDA’s efforts to make sure sunscreens are safe & effective: https://t.co/AxUz7CUduz. pic.twitter.com/IHxHrP1lXM
— FDA Drug Information (@FDA_Drug_Info) May 7, 2019
For the study, 24 people were randomly assigned to use one of four commercially available sunscreens: two sprays, a lotion and a cream. They were asked to apply the sunscreens to 75 percent of their body four times a day for four days. Researchers then collected 30 blood samples from the participants over a seven day period. The FDA did not list the brands used in the study.
“It is important to note that each participant in the study applied the equivalent of two standard bottles of sunscreen over four days. This is considerably greater than typical use where it has been estimated that people who use sunscreen go through about one bottle per year per person,” Newcastle University Emeritus Professor of Photobiology, Dermatological Sciences Brian Diffey told Newsweek. “It is important to note there is no evidence from this study that there is any health risk. And even at maximal use, any theoretical risk is almost certainly far smaller than the reduced risk of skin cancer that has been shown to be associated with sunscreen use.”
However, the FDA is doing more research into the safety and effectiveness of sunscreens because they are now being used more frequently, in larger amounts and by more people than previously. When the FDA first began regulating sunscreen in the 1970s, it was mostly used seasonally. Now, it is used daily, Woodcock and Michele wrote.
As part of its investigation, the FDA has proposed a new rule to update sunscreen regulations. The rule requires sunscreen makers to provide the administration with more safety information on 12 active sunscreen ingredients. According to the new rule, active ingredients that are absorbed into the blood at concentrations higher than 0.5 ng/mL like the ingredients in the study, would likely need to be tested to see if they increase the risk of cancer, birth defects or other health impacts.
We rely on sunscreens to help prevent sunburn & to reduce the risks of skin cancer & early skin aging caused by the sun. Check out this video from Dr. Woodcock that explains FDA’s efforts to make sure sunscreens work & are safe https://t.co/GgNrQqNL85
— FDA Commissioner (@FDACommissioner) May 6, 2019
Environmental Working Group senior scientist David Andrews told Reuters he thought the additional testing was a move in the right direction.
“For years the sunscreen chemical manufactures have resisted common sense safety testing for their ingredients and now FDA is proposing that these common ingredients must undergo additional testing to stay on the market,” Andrews said.
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