The FDA Finally Approved a New Sunscreen Ingredient. It Only Took Over 25 Years.
The FDA's burdensome regulatory process has throttled sunscreen innovation.
The U.S. has led the world in several innovations in recent decades: the iPhone, Facebook, and artificial intelligence. But when it comes to sunscreen, Americans have been living in the Dark Ages compared with Europe and Asia.
That could be changing. This week, the Food and Drug Administration (FDA) added bemotrizinol (BEMT) to its list of permitted active sunscreen ingredients, updating the list for the first time since 1999, according to National Geographic. BEMT, per the FDA, "provides protection against both ultraviolet A and B rays and has low levels of absorption through the skin into the body," and it is safe and effective "for use in sunscreens by adults and children 6 months of age and older." Beginning August 9, BEMT will be sold in the U.S. exclusively by the manufacturer DSM, under the name Parsol Shield, The Hill reports. After 18 months, other manufacturers will be allowed to sell BEMT.
While the approval might be good news for sunscreen consumers, it's long overdue: BEMT has been used in the European Union's sunscreen market since 2000, and it has been approved in Australia, Canada, and several Asian countries. So why has the U.S. lagged so far behind other countries when it comes to sunscreen innovation? Sunscreen ingredients are "treated as over-the-counter drugs," reports Time, whereas "in the E.U., they are considered cosmetics," making the approval process in the U.S. lengthy and costly.
There has been a bipartisan push to remove some of these regulatory hurdles. In 2014, Congress passed the Sunscreen Innovation Act, which was intended to expedite the approval process, but it did not prompt the FDA to approve any new ingredients. In 2020, Congress again tried to modernize the sunscreen ingredient approval process via a provision of the 2020 CARES Act, but it still took six years for BEMT to become the first ingredient approved under the new process, according to the FDA. And last November, as part of a stopgap government funding bill, Congress passed a provision requiring the FDA to draft guidance on how to allow for non-animal testing while still meeting safety standards for sunscreens—meaning there will likely be more pathways for approval in the future. The issue has even united political foes Rep. Alexandria Ocasio-Cortez (D–N.Y.) and Sen. Mike Lee (R–Utah), who have called for an overhaul of the regulatory process.
Given the impact that bad sunscreen can have on people's health, it's important that new sunscreen ingredients are seriously tested for their safety. A 2020 study by FDA researchers demonstrated that some sunscreen active ingredients can be absorbed into the bloodstream. While the study's authors said that the study does not mean people should stop wearing sunscreen, it emphasizes the need to ensure sunscreens are safe for use.
But rather than approving a new ingredient once every 20 years, alternative approval pathways should be considered. One that has been proposed by the Cato Institute's Jeffrey A. Singer would allow for international drug reciprocity, which would enable the U.S. to approve drugs already found safe in other developed countries. Such a policy would have allowed the U.S. to sell products containing BEMT long before 2026. And clearly, there has been a demand for new products, as Americans have turned to a gray market for overseas sunscreens from countries like South Korea.
Some consumers may remain sunscreen skeptics, perhaps opting to brave the sun barefaced or lathering themselves in olive oil and baking to a crisp. But those who want more skin protection options should not be burned by outdated and inefficient regulations.
