FDA says it needs more data to rule on safety of sunscreen ingredients
If sunscreen manufacturers, environmentalists, dermatologists and consumers were expecting the U.S. Food and Drug Administration to take a position on the safety of chemical filters in sunscreen products by yesterday, they were likely disappointed. On Friday, the regulatory agency said that it needs more time and data before ruling whether the filters in question, compounds designed to protect users from UVA and UVB rays, are in fact safe.
Instead, the FDA released an announcement that closely mirrored its 2019 proposed rule, in which it deemed only 2 of 16 UV filters used in sunscreens (the minerals zinc oxide and titanium dioxide), as generally recognized as safe and effective (GRASE). Two of the organic chemical compounds - aminobenzoic acid (PABA) and trolamine salicylate - are proposed as not safe and effective for sunscreen use. The other 12 remain under review and are sold under the definition of "Marketed Unapproved Drugs." The agency also opened a 45-day period for public comment.
"The FDA will continue to work with industry and public health stakeholders to make sure that consumers have access to safe and effective sunscreens that are up to date with the latest science," Theresa Michele, director of the office of nonprescription drugs in the FDA's Center for Drug Evaluation and Research, said during a news briefing on Friday regarding the proposed order which had been mandated by Congress with a deadline of Sept. 27 as part of the Cares Act of 2020. The FDA will issue a final order "after we have reviewed and carefully considered all of the comments," Michele said.
According to Wen Schroeder, a consultant and lecturer on the regulation of personal care products, the proposed order means the FDA still needs more data before deciding whether the 12 UV filters in question, including cinoxate, octinoxate and avobenzone, which are in many popular sunscreens, are safe and effective for human use. "This basically means manufacturers have the next 45 days to send data that supports that these UV filters are GRASE, if they want to keep selling them."
Carl D'Ruiz, chair of sunscreen consortium of the Personal Care Products Council, an industry trade group, said his consortium will continue to share its data and scientific evidence with the FDA during the 45-day comment period, in an effort to eventually achieve safe and effective status for the 12 chemical filters. "Looking at the big picture, these filters have been used for quite a long time and there have been no indications globally in terms of severe adverse effects," he said.
Three recent events may have complicated the decision for the FDA. In January 2020, the agency released findings that showed that six chemical UV filters are absorbed more readily into the bloodstream than previously known. It reiterated, however, that "absorption does NOT equal risk" and said that more studies were needed to determine the clinical significance of these findings.
Sunscreen came under scrutiny again in May of this year when independent lab Valisurefound the known carcinogen benzene in 78 sunscreen and after-sun care products. Some experts, including Martyn Smith, a professor of toxicology at the University of California at Berkeley, believed the findings were most likely a result of contamination during manufacturing than ingredients in the sunscreen and that the amounts detected were too small to cause harm. One manufacturer, Johnson & Johnson, issued a recall of five of its sun protection products while CVS paused sales of two of its aloe after-sun products out of what it said was an abundance of caution.
Then, in August, Craig Downs, executive director of Haereticus Environmental Laboratory, submitted a letter to the FDA with co-author Joe DiNardo, a toxicologist who previously worked for the cosmetics industry, asking the agency to remove sunscreen that contains the ingredient octocrylene from the shelves because research he and DiNardo had conducted found that it can degrade into the possible carcinogen benzophenone over time.
Downs, whose earlier research had led Hawaii to ban the sale of oxybenzone-containing sunscreen because it was linked to coral-reef damage, expressed frustration about the FDA's lack of action. "There is no justification for kicking the can when current data in the literature, and what data has been provided to the FDA, does not demonstrate safety and efficacy," he said. "There is very little consumer confidence" in the FDA's generally recognized as safe and effective standard.
Dermatologists also were eager for the FDA to rule on the safety of the sunscreen filters in question, in hopes of putting the public's confidence back into sunscreen. American Academy of Dermatology Association President Kenneth Tomecki, said in a statement on Friday, "we look forward to the completion of the required testing and analysis to help eliminate public confusion about sunscreen ingredients."
Ranella Hirsch, a dermatologist based in Cambridge, Mass., said she fields hundreds of questions on her Instagram account every time sunscreen is in the news. "With so much fear-based misinformation circulating about sunscreen, I'm hopeful that a final order from the FDA will be forthcoming and that by clarifying the safety [of sunscreen] will put minds at ease once and for all," she said.
After the 45-day public comment period, the law stipulates the FDA cannot come out with a final ruling until at least a year after the proposed order, though there is no set deadline for the FDA to initiate a final order.
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