FDA Regulation and Future Availability

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New Humans Memories of the Future, the first exhibition to fill the new museum's entire recently expanded campus, brings together the work of more than two hundred artists from around the world to consider what it means to be human in the face of major social and technological change tickets or become a member today at newmuseum. org Hey, it's Flora and you're listening to Science Friday The FDA recently approved a sunscreen ingredient that's been used in Europe and Asia for years. It's called BMatrizenol, also known as BEMT. And this is a big deal because it's the first new sunscreen ingredient approved in the U.S In over two decades, meananwhile, skin cancer has become the most common cancer in the US Here to get into the chemistry of Sunblock is AJ Aday, a chemistry PhD candidate studying sunscreen at UCLA. She's also the founder of Sula Labs, which tests sunscreen and other cosmetics formulations Hey J, welcome to Science Frid Thank you for having me. I'm excited to chat Me too. Is this approval big news in your world Oh, for sure. I think over two decades, as you said, has been the last time that there's been a UV filter approval in the United States. So this fundamentally changes the landscape a bit. Well, how is BeMatrizenol different from other sunscreen ingredients Yeah, so BMT is actually the first UV filter that has been approved that is an organic UV filter that is generally recognized as safe and effective. So I say organic very intentionally because there are two UV filter classes that are allowed in the United States in organic UV filters, so that would be zinc oxide and titanium dioxide. And then there are organic UV filters. and those are ones like homocylate, octicyle, oxybenzonee, Avaenzone. So BEMT would fall under the organic class And it would be the first and only one that contains this generally recognized, safe and effective status. Do this new ingredient Fe different, look different, go on differently So It definitely has an advantage over zinc oxide and titanium dioxide in that it goes on the skin a little bit more transparently. than you would expect from inorganic filters. So that's a great advantage, but I would say the biggest advantage is actually in how efficiently it protects the skin from Harmful UV damage. Say more Yeah, so are a lot of UV filters already allowed in the United States, but a lot of them really skew towards UVV protection, which is useful because sun protection factor really narrowly measures the ability for a sunscreen to protect you from UVV rays What's great about BMT is that it actually very efficiently absorbs both UVB and UVA rays, which would make it more of a broad spectrum filter And it's exciting because typically you have to combine several different UV filters and sunscreens to get a broad spectrum claim Whereas with BMT, you can do so a little bit more efficiently without taking up so much of the sunscreens's real estate. Now the only other UV filter that does absorb broad spectrum is ABAenzone allowed in the United States But the thing about AAenzone is that it does require other UV filters to stabilize it. So this is really the most efficient UV filter as far as that And what's the difference between UVA and UVB light So UVB light, particularly, I think we associate more with sunburn Whereas UBAI, we associate more with photoaging, skin darkening, more of those cosmetic concerns that you see You know, there's some concern about the chemicals in sunscreen Is BEMT anyy safer or is it chemistry any different? Yeah, to pass any UV filter in the United States, it requires a lot of toxicological evidence And it requires evidence of understanding how a filter could interact with human biology. What's great about BMT is that it's actually a lot larger of a molecule than other UV filters that we've seen. And so it's well beyond a limit that one would be concerned for extreme biological absorption profiles or exposure that could be harmful to the human skin or human body. So that's also a really great advantage because the you know tooxicity risk profile is significantly lower than one would expect. You mentioned that the EMT doesn't leave as much of that. Wh past on the skin. What gives sunscreen that white color So, you know, that that can be kind of a deterrent for a lot of people for wearing sunscreens It all comes down to light scattering. Any color that we can see is a consequence of something reflecting visible light. And so what's really great about zinc oxide and titanium dioxide is that they can absorb UV, but they also scatter light in such a way that we can see the color white And that also can be caused by aggregation and agglomerates of these zinc oxide titanium dioxide minerals, particles. in such a way that larger aggregates scatter more visible light thoseose are inherently pigments as well. That's why we see zin oxide and titanium dioxide also in paints and coatings And they just so happen to also absorb UV really well I love your gusto for this subject. Yeah, I mean, like you said, I'm a PhD candidate and you know, this is my field of work. Thank you This is your actual thesis. Yeah, quite literally. suunnscreen whitecast, biological interactions, like this is I could go on forever It's really fascinating. Thank you, AJ No problem, thank you for having me AJ Aday, a chemistry PhD candidate studying sunscreen at UCLA Given the benefits of BEMT and that it's been used across the world for many, many years, why didn't the FDA approve it sooner? And what does this sunscreen tail tell us about FDA approvals and how our system for regulating drugs works Here with some answers is health journalist Michael Scoturo, who's been following sunscreen formulations and regulation for years and most recently wrote about it for KFF News. Michael, thanks for being here. They shouted me So why did it take so long to get this ingredient approved I think the main reason is that it's expensive to bring a new drug through the FDA because in the United States Sunscreen chemicals are considered over the counter drugs in France or in Korea or in many places around the world. sunscreens and sunscreen chemicals are considered cosmetics And so they don't really have to be subjected to animal tests But in the US, the FDA defines sunscreen as an OTC, an over the counter drug, which is kind of like or cough syrup or anything that you might buy like a Walgraens or a CVS. And those are things that have to go through Traditionally an animal testing process So DSM, the company that manufactures this chemical had to submit that data. And so That's hard, right? Because it's very expensive. It costs them about eighteen million dollars to bring this new chemical through the FDA And Congress has tried in like two laws now to sort of nudge the FDA in the direction of alternative testing methods And they're they're not quite convinced because for this new New ish, right? This new for us in the US, but widely used globally this D EMT was still subjected to animal tests Why is sunscreen regulated like a drug That's a good question. I think it's because the FDA is concerned about the potential toxicity of a product that people use every day. People are putting a lot of this on their bodies And I think their position would be that they have to really be certain that that some of these drugs don't cause reproductive harm or They have a low level of toxicity in the body. I mean, we put a lot of things on our body every day like lotion and cosmetics So does the rationale go beyond that Well, So in writing about this over the last two years, I kept hearing that the FDA is very proud of its record in the nineteen sixties of having been one of the only regulators globally to have prevented phalidamide from being sold in the U.S That's the drug that caused egregious harm to fetuses in many countries and led to people being born with birth defects And so they have always been very very over cautious And I think that in this case they might be over correcting At the same time, I mean, there There is this sort of anti sunscreen movement in the U. S right now W there skepticism around the safety of sunscreen. How does this story fit in with that I think the sunscreen controversy kind of started in twenty nineteen around then, because the FDA did test did tests on several sunscreen ingredients that have been sold for for a while have been considered to be safe to be in sunscreens but they basically found that in some certain chemicals were appearing in very, very small amounts in the human bloodstream And I think they reclassify these drugs as And It's very complicated, notot grasset, it's like not generally recognize as safe and effective for use in sunscreens. So it's a really complicated way of saying that they needed more data to know whether these chemicals were safe. they were not necessarily saying They're not safe They were just saying, we would like more data because we don't really know. And it u And it made people really wonder like, well, can they trust these things? So there there were about twelve chemicals were that were in this that were moved into this not Crosset So not considered not generally recognized as safe and effective for use in sunscreens category. But the industry has begun to has over the last few years phased out those chemicals, Essentially four are still widely used. in sunscreens. So it's just to say it's very complicated. The FDA They've let these chemicals exist in a kind of gray area because they said, again, they're not generally recognized as safe and effective for use in sunscreens but you can still use them Okay, That's what I mean That's very confusing. It is a gray area. Right. And I'll say this, like if you look at this like this I'm in Germany right now and I purchased this sunscreen. And on the front of the packaging of this sunscreen says like it says, this is free of microplastic, it's free of octinosate It doesn't have home satellite because it's no longer used in Europe. So