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The U.S. Deserves Better Sunscreen Filters · The Science of Skin

• 0:09
  SPEAKER_00: Hello and welcome to Skincare Confidential, a podcast supporting the Science of Skin Care Summit, an annual educational event occurring September 5th through the 7th in 2025 in Austin, Texas.
• 0:23
  SPEAKER_00: My name is Dr.
• 0:24
  SPEAKER_00: Ted Lane.
• 0:24
  SPEAKER_00: I am a board-certified dermatologist and your host for today's episode.
• 0:29
  SPEAKER_00: But it is my pleasure to introduce you to someone you probably haven't heard of before, but is very important in the skincare industry.
• 0:36
  SPEAKER_00: His name is Carl DeRuiz.
• 0:38
  SPEAKER_00: Now, Carl is the senior head of regulatory and business development in beauty and care for DSM North America.
• 0:47
  SPEAKER_00: But what I'm most interested in why I've asked Carl to be on today is because his company, DSM, is involved in bringing a brand new filter, a sunscreen filter, to the United States.
• 1:01
  SPEAKER_00: Carl, we haven't had a new filter.
• 1:04
  SPEAKER_00: Well, I can't even remember.
• 1:05
  SPEAKER_00: How long has it been since we've had a new filter, Carl?
• 1:08
  SPEAKER_01: Well, you know, you have to think back a long, long time.
• 1:10
  SPEAKER_01: And thanks for having me.
• 1:11
  SPEAKER_01: Um we we haven't had a new UV filter in the United States in 26 years, um, which is an awfully long time considering that uh we have the least number of filters available for the formulation of sunscreens ingredients as compared to the rest of the world.
• 1:28
  SPEAKER_00: Yeah.
• 1:28
  SPEAKER_01: Where you know uh so it's been a long time.
• 1:31
  SPEAKER_01: And I've been working on this tirelessly, on and off, since uh actually 1997.
• 1:37
  SPEAKER_01: And um regulations have changed, um procedures have changed, and and FDA um is is currently actually reviewing a new filter uh which I've introduced um as part of the new regulatory process that was instituted um in 2021.
• 1:54
  SPEAKER_00: Okay, so let's go back.
• 1:55
  SPEAKER_00: So so a lot to unpack there.
• 1:57
  SPEAKER_00: So exactly correct, right?
• 1:58
  SPEAKER_00: We have 16 UV filters that are approved in the United States.
• 2:04
  SPEAKER_00: There are 27, for example, in the EU.
• 2:07
  SPEAKER_00: Okay.
• 2:07
  SPEAKER_00: So we are far behind, right, Carl?
• 2:10
  SPEAKER_01: Yeah, and it's important to realize not all those 16 filters are used.
• 2:13
  SPEAKER_01: Um the way you look at it right now, in terms of the regulations, FDA has approved two filters, which are minimal filters, as generally regarded as safe and effective.
• 2:25
  SPEAKER_01: And um, while there are a total of 16 of those 16, not all of them are used by industry for one reason or another uh in terms of um either smell or compatibility.
• 2:37
  SPEAKER_01: And and it's always it boils down to maybe a total of seven filters, of which FDA is requiring more testing for of those that haven't been approved.
• 2:47
  SPEAKER_01: Very complicated situation.
• 2:49
  SPEAKER_00: So so just to expound on that, right?
• 2:51
  SPEAKER_00: There in 2021, the CARES Act, which came out of COVID, right, came out and said, okay, look, sunscreens are regulated regulated as OTC drugs, but in in particular for these different filters that you have, you have to go back and and do some more testing on all the filters because there's this allow, probably in my view, um baseless concern about these filters having endocrine disruption and or other deleterious effects on the body.
• 3:22
  SPEAKER_00: And I think the the FDA was responding to these concerns saying, hey, we need to get more testing done on these filters, except for zinc oxide and titanium dioxide, which is, as you mentioned, the two that are generally recognized as safe and effective, or grass.
• 3:36
  SPEAKER_00: And those two are essentially approved, right?
• 3:38
  SPEAKER_00: The rest are allowed to be marketed and used as long as there is progress being made on their testing, especially inhuman toxicology testing.
• 3:48
  SPEAKER_01: That's correct.
• 3:49
  SPEAKER_01: And and um, you know, this whole process goes back to 1972 in terms of the sunscreen monograph.
• 3:57
  SPEAKER_01: And um, the latest iteration, of course, is the 2021 CARES Act, which reformed OTC uh regulations.
• 4:04
  SPEAKER_01: And um now FDA is requiring, based upon their testing of off-the-shelf sunscreen products, showing that they're uh have an absorption level of about 0.5 nanograms per mil, which they believe is the level at which further testing is required.
• 4:20
  SPEAKER_01: The crazy thing about it is that we've used this on humans since the monograph began in 78, and it's been globally, all these filters have been globally utilized.
• 4:30
  SPEAKER_01: Yet FDA is now, because of the fact uh uh of their taking products off the shelf and and doing NV2 penetration tests indicating a level above 0.5 nanograms.
• 4:41
  SPEAKER_01: They indicate, well, now well, if if industry must uh for those ingredients that are in our grass uh conduct further testing, which includes dermal um uh penetration tests, uh carcinogenicity testing in animals, which are long-term studies, and developmental reproductive toxicity studies in animals as well, in order to ascertain whether or not the data derived from both uh animal studies and then also human studies, because you're also now under the mandate to conduct uh maximum usage trials, which are basically pharmacokinetic trials, to see uh what the absorption is on a variety of different formulations that are anticipated to be on the market for each single ingredient.
• 5:26
  SPEAKER_01: So this all results in in a in a program that industry is now facing, which involves uh a very complicated series of tests that are required in order to keep these products continue on the market.
• 5:42
  SPEAKER_01: Um and and and FDA has indicated, well, if you show that you're making progress and you commit to doing the testing, we'll renew um what's called the deferral from rulemaking every year for each of the ingredients that are being supported so that they can continue to be used in the United States.
• 6:01
  SPEAKER_01: In the meanwhile, the rest of the world marches on using in silico, um in vitro testing, and and modern toxicological methods to approve new filters which are much more efficient.
• 6:13
  SPEAKER_01: Uh we use less, they're they're more bread spectrum, they have less environmental profiles as compared to those that have been used now for almost half a century, if not more than half a century.
• 6:25
  SPEAKER_01: So it's it's a very difficult situation for public health in the United States.
• 6:28
  SPEAKER_01: And if what's happening is people are going to into the internet.
• 6:32
  SPEAKER_01: When they go uh borough, they they they shop for products which are approved elsewhere.
• 6:36
  SPEAKER_01: They like the feel, the texture, and they've all they'll only use what they like.
• 6:41
  SPEAKER_01: If they don't like it, they're not going to use it.
• 6:43
  SPEAKER_01: People of color at a disadvantage in terms of a lot of these filters which are approved, you know, they're white casts.
• 6:49
  SPEAKER_01: Um, they cast a white chain, and people don't like it.
• 6:52
  SPEAKER_01: And as a result, they don't use it.
• 6:54
  SPEAKER_01: What happens?
• 6:55
  SPEAKER_01: Public health suffers because people will not use the product that's there to protect them against skin cancer and and and photo aging.
• 7:04
  SPEAKER_01: So it's it's a it's a really difficult situation.
• 7:06
  SPEAKER_01: And it's even more compounded because a lot of these consumer products with tests uh which sell sunscreens uh are global uh companies and they have non-animal testing policies.
• 7:18
  SPEAKER_01: And here's a kicker.
• 7:20
  SPEAKER_01: In most of the world, sunscreens are cosmetics and they're subject to animal bans, test test bans.
• 7:25
  SPEAKER_01: In the United States, they're drugs and they're subject to FDA's animal testing policies.
• 7:29
  SPEAKER_01: So you have this uh conflict going on that uh is currently putting at risk a lot of the ingredients that are currently available in terms of will they or will not will they not be supported given non-animal testing approaches which are um global in nature and which are um you know supported by consumers and in society as a whole.
• 7:50
  SPEAKER_01: Yet FDA has not yet embraced you know uh the these these um these modern toxicological methods, new approach methods.
• 7:59
  SPEAKER_00: It's a conundrum, isn't it, especially for these multinational corporations who, as you as you say, have have really kind of restricted themselves to non-animal testing correctly, in my view.
• 8:08
  SPEAKER_00: And yet if they want to get one of these new filters, I mean if they're not new, one of these filters from the EU, which we know have long UV protection, which is exactly what we need for uh, you know, reduction in the incidence of skin cancer, not only for the health, but also the beauty of the skin.
• 8:24
  SPEAKER_00: We absolutely need longer spectrum, more broad spectrum filters.
• 8:28
  SPEAKER_00: They are available, but because of the corporate policies, correct corporate policies, it's very difficult for these companies to get them approved in the United States.
• 8:37
  SPEAKER_00: So to your point, we're at a we're at a fork in the road.
• 8:40
  SPEAKER_01: Yeah, and there's no incentive to do these tests because basically those companies that do the testing and stand up to do the right thing are then undercut by other companies who will not do the testing and then will manufacture these ingredients on the basis of United States pharmacopure purity uh standards, um, and then we'll sell them at a cost lower than that of the companies that have done the testing simply because they have not invested in the testing.
• 9:08
  SPEAKER_01: So it's an uneven playing field, and there's no recognition at all by FDA that this is a commodity business.
• 9:14
  SPEAKER_01: You know, um there's no for the existing filters, they've been used for many, many, many years.
• 9:20
  SPEAKER_01: There's no patents, there's nothing to protect on the USP grade, and they're so basically companies buy the lowest cost ingredient in order to maximize sales as long as they meet the purity and standards and standards of USP, which is you know the foundation for all OTC drugs.
• 9:37
  SPEAKER_01: So it it's very complicated, and there's so many moving parts to this that um uh you know we've we've been kind of advocating with Congress to change the laws and recognize this and have been making incremental progress and along with other in the industry.
• 9:50
  SPEAKER_01: And um we will continue to do this to see if we can, you know, change the laws to allow for, you know, these new alternative toxological methods that are used globally, even by the EPA in the United States, to regulate chemicals in the environment and industry.
• 10:06
  SPEAKER_01: And and yet FDA is kind of stuck in this uh 1970s um world where you know animal testing is is a gold standard.
• 10:15
  SPEAKER_01: Um and and and and change is definitely needed.
• 10:19
  SPEAKER_01: Um the good thing is that we're the only company that has uh invested in bringing a new filter to the market, and FDA is under an O TC monograph whatever requests uh application, which basically gives FDA all the information that they require, all the must studies of pharmacokinetics, the penetration, the carcinogen studies, the developmental reproductive toxicity studies that were done mostly in the 1990s and early 2000s, where these ingredients were introduced into the rest of the world.
• 10:53
  SPEAKER_01: Um and and and right now they are reviewing uh Bimotrizanol, Parcel Shield, or dinosaur best, as it's also known as a trained name.
• 11:02
  SPEAKER_01: Um, and we're currently on schedule to get an approval or a recognition, well, a determination of generally regarded as safe and effective by March 7th of 2026.
• 11:14
  SPEAKER_01: So um it's been a long, long, long, long road.
• 11:17
  SPEAKER_01: And um at least we have some indication that FDA may be open to accepting this new fee filter based upon the review, which is currently on the going.
• 11:27
  SPEAKER_01: So at least one, but I don't expect there'll be there'll be any other filters introduced if the if the regulations are are not changed in the United States.
• 11:37
  SPEAKER_00: Yeah, so so just to backtrack a little bit, so Bematrisinol or BEMP BEMT is uh known across the pond as Tinasorb, right?
• 11:46
  SPEAKER_01: Uh What's a trade name is Tinasorb.
• 11:49
  SPEAKER_01: Trade name for Tennasorb.
• 11:50
  SPEAKER_00: Yeah.
• 11:51
  SPEAKER_00: Parcel Shield.
• 11:52
  SPEAKER_00: Okay.
• 11:53
  SPEAKER_00: And it's been used for 20 years, I think.
• 11:56
  SPEAKER_01: It was first approved in Europe under the um European sunscreen um regulations in 2000.
• 12:02
  SPEAKER_00: 2000, so 24 years, 25 years almost.
• 12:04
  SPEAKER_00: Okay.
• 12:05
  SPEAKER_00: Yeah.
• 12:05
  SPEAKER_00: All right.
• 12:06
  SPEAKER_00: So it has a very long history of use, probably a very long safety history as well.
• 12:10
  SPEAKER_00: Uh used XUS.
• 12:13
  SPEAKER_00: And here we are 25, maybe 26 years later, and in hopefully, God willing, fingers crossed, you know, salt over the shoulder, knocking on wood, what else do we need to do?
• 12:25
  SPEAKER_00: Uh we'll get this approved for use in the United States, and we will finally have a chemical long UV blocking broad spectrum filter that, as you mentioned so correctly before, will be great for public health, in particular those with with skin of color who in in in whom it is difficult to find you know correctly shaded sunscreens to match their natural skin tone because we have so many issues with the white cast.
• 12:55
  SPEAKER_00: And so not only for those of us who who are not happy, you know, who have lighter skin tones who aren't happy with the mineral sunscreens and the way they feel and look and that the the overall experience with them, but also for those of us with darker skin tones, it will make it a lot easier to use these sunscreens and know that we're getting the broad spectrum coverage, right?
• 13:14
  SPEAKER_01: Yeah, that's correct.
• 13:15
  SPEAKER_01: And and the fact is that there will be three grass ingredients titanium dioxide, zinc oxide, and BMT.
• 13:22
  SPEAKER_01: And then um the rest of the filters are are still subject to testing.
• 13:26
  SPEAKER_01: And whether or not they're supported, it's a question mark.
• 13:30
  SPEAKER_01: And uh probably not all, maybe a few, but that even reduces the number of filters more.
• 13:37
  SPEAKER_01: But at least having B Motrizenol uh together with the uh organ the mineral filters allows for more um aesthetically pleasing um that are shearer.
• 13:47
  SPEAKER_01: And and you know, if if if it is your your selection to only use grass ingredients, then you have options in that area that go beyond what's available today, while you can still use the other ingredients, which are very important.
• 13:58
  SPEAKER_01: And the crazy thing is there's only one UVA filter, and that's Avobenzone, right?
• 14:03
  SPEAKER_01: And and that's still requiring further testing, despite having sent FDA tons of information that has been generated worldwide and data reviewed by experts uh in the field by um in in in development of reproductive, carcinogenicity, et cetera, which I've indicated real, you know, there really is no concern um given there's no genotoxicity with these ingredients.
• 14:28
  SPEAKER_01: But yeah, FDA is still saying, well, this is the approach, this is the these are the studies that are required, and you have to go through the list and and provide them all um before we can make a determination.
• 14:40
  SPEAKER_01: And that's where we are right now, unfortunately.
• 14:42
  SPEAKER_00: Carl, we were having a discussion a few weeks ago about what what how DSM will benefit from the approval uh of this of this filter and and review that with us because honestly, at this point, it's almost a public health service that this company is doing.
• 14:57
  SPEAKER_01: It is.
• 14:57
  SPEAKER_01: You know, we're we're kind of a Dutch Swiss company and kind of crazy.
• 15:01
  SPEAKER_01: Um I think uh or you know, right now, um the the investment in this in in ingredient over the last 26 has been, you know, well since we've we've taken we we approached FDA in 2018 indicating, well, you guys reviewed this back in uh the under the time and extent application and then under the Sunscreen Innovation Act and uh provided comments in terms of what was necessary, we want to fill the data gaps.
• 15:27
  SPEAKER_01: And since 2018, we we had to file an IND uh because you can't do uh tests on humans on unapproved new drugs in the US.
• 15:35
  SPEAKER_01: We've conducted all the clinical studies, we've we've we've done two uh metabolism studies in animals, which are required by FDA in order to do a risk assessment and a marginal safety assessment.
• 15:46
  SPEAKER_01: Uh and as a result, we've bent to almost$7 million in that period of time and now provided that.
• 15:55
  SPEAKER_01: In addition to, under the Omar, this is now a fee-based review.
• 16:02
  SPEAKER_01: We provided$537,000 fee for them to review what they've already reviewed twice before, and then are now reviewing in uh in 17.5 months.
• 16:12
  SPEAKER_01: So this is absolutely insane if you if you if you ask me, but it is the way, the only way.
• 16:16
  SPEAKER_01: And we're committed to this as you know, um as DSM Ferminich.
• 16:20
  SPEAKER_01: Um and and we believe in public health, and this is something that um I've been working on half my life at least, and I I firmly believe it.
• 16:29
  SPEAKER_01: And DSM also believes that it's necessary because if nobody does it, public health will suffer.
• 16:35
  SPEAKER_01: So we'll do it, and we're almost there.
• 16:37
  SPEAKER_01: We're almost at, you know, uh at the goalposts.
• 16:40
  SPEAKER_01: Um and and we're still sending FDA um information uh requests data almost monthly.
• 16:49
  SPEAKER_01: Um and I think we're gonna be in a good position because basically they need to show Congress that they can approve a filter in the United States.
• 16:55
  SPEAKER_01: And we've done more studies on a UV filter than any other company on the planet.
• 17:04
  SPEAKER_01: You know, it's it's tantamount and NDA for an onology drug.
• 17:09
  SPEAKER_01: Um and it's kind of crazy if you look at what the indications are in terms of uh on on the OTC um drug label and the usage as compared to the RX drug.
• 17:20
  SPEAKER_00: Once it's finally approved, what kind of exclusivity will DSM have for partial?
• 17:25
  SPEAKER_01: Well, we're hoping that under the new Omar regulations, FDA has advised us that the company, the first to first introduce a new OTC uh active ingredient, will get 18 months' exclusivity uh having done the clinical studies, um, which is not the case in NDAs, but it is for OTCs.
• 17:44
  SPEAKER_01: So if that's the case, then we'll have 18 months exclusivity, which is really nothing.
• 17:48
  SPEAKER_01: Right.
• 17:48
  SPEAKER_01: Uh because it takes 18 months to really create an OTC drug product given the stability test and the formulation uh requirements, SPF testing, and and and everything uh in order to get to market.
• 18:01
  SPEAKER_01: So, you know, the uh and the thing is FDA had never done this before, so we don't really know how this is gonna work out because they don't know either.
• 18:09
  SPEAKER_01: So we're setting a lot of precedence here, right?
• 18:12
  SPEAKER_01: Uh this is something that had never done been done before.
• 18:14
  SPEAKER_01: And they're really happy because you know um they they can tutor horn and say, hey, you know, we're doing something new.
• 18:19
  SPEAKER_01: And and it is important uh for public health, and that's why we're committed.
• 18:23
  SPEAKER_01: So um, once this uh date comes on the 7th, uh we actually have a couple meetings before that period of time.
• 18:30
  SPEAKER_01: Uh we have uh a meeting in June where we'll have a debrief on everything that we've submitted.
• 18:36
  SPEAKER_01: And then what happens is this since this is a public rulemaking, none of the data is protected, so it's all available for anybody who wants it for free online on usgov.com.
• 18:46
  SPEAKER_01: And that's another problem in terms of uh being production or confidentiality, but we won't go there.
• 18:53
  SPEAKER_01: Um then uh basically FDA will issue what's called a proposed rule, and that will be published in the Federal Register, and that will be subject to public comment, right?
• 19:02
  SPEAKER_01: So the public in general will have 30 days, I think, or 45 days, I can't remember, uh, to comment on what they have indicated.
• 19:09
  SPEAKER_01: It's a proposed rule to include BMO Trizon all at 6% under the OTC monograph.
• 19:14
  SPEAKER_01: And here's all the data and what does the public think?
• 19:16
  SPEAKER_01: And then the public has, I think, 30 days to respond in terms of what they think.
• 19:21
  SPEAKER_01: Um and then FDA gets to review all that data and make a determination.
• 19:26
  SPEAKER_01: And that's how that's the next step.
• 19:27
  SPEAKER_01: So that that's where we're still going towards.
• 19:30
  SPEAKER_01: Um and and you know, and and and the data package which we submitted includes not only pharmacokinetics, clinical toxicology, uh, but also includes environmental uh assessments, right?
• 19:41
  SPEAKER_01: So fully loaded.
• 19:43
  SPEAKER_01: You know, and nothing has been done to this extent ever.
• 19:47
  SPEAKER_01: And and I can't see it ever being done again given the time it's taken to do this.
• 19:53
  SPEAKER_01: But um once that's done, FDA will issue a final rule uh on the date, and from that date it will be allowed to be marketed.
• 20:01
  SPEAKER_01: But then you need to kind of do an NDC listing before you can import it, and then companies can use it in their products.
• 20:08
  SPEAKER_01: So it'll take another month or so before companies can begin to really um generate final products.
• 20:14
  SPEAKER_01: So it'll be sometime in 2026, uh knocking on wood.
• 20:18
  SPEAKER_01: Um but FDA is very, very excited that we have stepped up in in our doing this and have indicated it to us because nobody has.
• 20:27
  SPEAKER_01: And it's it's it's it's a way for them to show that their new program um is working, even though um it may be short-lived in terms of the number of ingredients.
• 20:38
  SPEAKER_01: But uh, you know, as I said, you know, the the world marches on and new ingredients are being introduced, including our we are uh introducing new molecules on on a fairly rapid pace globally as well, which is a lot more easy to do than than in the United States.
• 20:54
  SPEAKER_00: Yeah, you know, I work in the pharmaceutical environment as well, and and there are drugs that are approved in 30 to 40 countries outside of the U.S.
• 21:02
  SPEAKER_00: that have no issues with their label, nothing on their label that would worry anybody in the US.
• 21:09
  SPEAKER_00: They have contents on the label that are worrisome.
• 21:12
  SPEAKER_00: And so it it really hampers these drugs in the United States in terms of how how widely they're used.
• 21:18
  SPEAKER_00: And yet outside the US, they're used as first line because they just don't have the same warnings or precautions or content on their important safety information or even black box warnings that are available that that that XUS do not have.
• 21:32
  SPEAKER_00: So there's definitely a difference in the way the FDA handles the approval of both uh drugs and and uh OTC drugs and and you know, and even going on to beauty care products as well.
• 21:44
  SPEAKER_00: Um so so uh just to kind of uh level set this, we have a Dutch switch company who has invested seven million plus plus twenty plus years to improve the health of the American public.
• 21:58
  SPEAKER_00: Is that about right?
• 22:00
  SPEAKER_01: That is correct.
• 22:00
  SPEAKER_01: We we have stepped up as the only company to do this, uh relying on past data generations by um by my former company um in in in 1990s and 2000s, which was Cebagai, which was bought by BSF.
• 22:14
  SPEAKER_01: And and that data didn't go anywhere, but it's in the public docket.
• 22:18
  SPEAKER_01: And utilizing that data along with all the new data that was generated by DSM that came about as a result of um the CARES Act and and the um the guidances that FDA issues for Must Studies and grass determinations and safety and efficacy studies, that whole pile of paper or electronic data is now being reviewed by FDA for the first time to get this approved.
• 22:47
  SPEAKER_01: And it's exciting because you know it's always, you know, it's scary to be the first, but somebody has to do it.
• 22:54
  SPEAKER_01: And I think we're doing it.
• 22:56
  SPEAKER_01: And we're not gonna make a killing on this at all.
• 23:00
  SPEAKER_01: The question of whether we did conduct some animal testing is gonna be looming for those companies who have animal testing policies.
• 23:07
  SPEAKER_01: Sure.
• 23:08
  SPEAKER_01: But then if you look at the benefit to humanity in terms of doing two small dermal and normal metabolic studies in in rats, what that means in terms of the potential to prevent skin cancer in humans, you know, and the and the hurt and anguish that comes about of families and people that have to go through that, it's incomparable.
• 23:32
  SPEAKER_01: I mean, you it it does you know, I'm definitely in animal testing, uh I've developed policies against it, but in this case, I think there's there's there's a good reason for doing it.
• 23:43
  SPEAKER_01: Um the the the risk uh the benefits outweigh the risks by a mile, if not more.
• 23:51
  SPEAKER_01: Um so we're hoping that companies will at least the small companies are are very open to this.
• 23:56
  SPEAKER_01: Uh they're much more um pragmatic, much more fast moving.
• 24:00
  SPEAKER_01: And I think several large companies too.
• 24:02
  SPEAKER_01: But once it takes hold, I think, you know, you'll have three grass ingredients, the grass status will will probably be prominent in terms of being vetted by FDA uh under the gold standard.
• 24:14
  SPEAKER_01: Um nothing else has been vetted to this extent ever.
• 24:17
  SPEAKER_01: And not even the the mineral filters, uh, you know, they they just FDA said, well, they're not absorbed, so they're good to go.
• 24:23
  SPEAKER_01: Uh, you know, and this one has has all the data behind it.
• 24:26
  SPEAKER_01: Even in those, you know, we've even gone to Australia and Canada looking at, you know, their uh databases where they collect adverse events um from uh from from products and in addition to the the clinical study that we have uh done in dermal and and and pharmacokinetic, we we see no indication of any um adverse events at all.
• 24:50
  SPEAKER_00: Um so even additional safety information then besides what you've already submitted to the FDA, we have the post-marketing adverse event reporting that's required in certain countries and showing that when used on thousands upon thousands upon thousands of people, we just don't see any increased safety signals or issues that have arisen.
• 25:08
  SPEAKER_00: So yet another set of data that should give people uh more security in the safety of this novel UV filter that again has been out and being used in X US for 20 plus years.
• 25:22
  SPEAKER_00: So I I just think, Carl, I uh this is one of the most exciting things that's happened in dermatology in a long time, quite frankly, to to finally have a new filter that is again a long UV filter that covers a spectrum that's chemical, so it doesn't leave that white gene and have some of the other issues related to the minerals, mineral filters is um it is truly something that's going to be revolutionary for us and and it's just so sorely needed.
• 25:45
  SPEAKER_00: So that's that's also why I wanted to highlight all the work you and DSM are doing.
• 25:49
  SPEAKER_00: But but if we can just spend a couple of minutes talking about DSM, because it's one of those companies that's kind of in the background of dermatology and and and health and beauty that that the consumer certainly and probably most dermatologists don't really know about, but is as a contract manufacturer, you supply the novel ingredients that are used in many of the formulations that that are are available today.
• 26:10
  SPEAKER_01: Yeah, well, yeah, we we we not only uh we generate we we innovate and and we go we create molecules.
• 26:18
  SPEAKER_01: Okay, so we're the science behind the product, right?
• 26:22
  SPEAKER_01: Um and one of the areas we focus is on UV filters.
• 26:27
  SPEAKER_01: Obviously, we we have a whole palette of global UV filters, which are used throughout the world.
• 26:32
  SPEAKER_01: Um, and and and it's a very large stable of products which are not available in the United States.
• 26:37
  SPEAKER_01: We also manufacture those which are used currently under the OTC monograph, but we go beyond that.
• 26:43
  SPEAKER_01: We we're into skincare, we're into fragrances as well, and that's firmage.
• 26:46
  SPEAKER_01: But um we we make uh a lot of different things in terms of peptides.
• 26:52
  SPEAKER_01: We design peptides, we have peptide libraries where we can create new peptides targeting different things.
• 26:57
  SPEAKER_01: We're involved in synolytics, um, and we target innocent cells to rejuvenivate aging skin.
• 27:03
  SPEAKER_01: And this is a uh a new um ingredient, um, Edo Well Youth, which has won numerous uh awards throughout the world uh last year and this year, and it and it looks to be uh a mover and shaker in terms of you know um being um an option now, which um can be used to um further reduce um skin aging, you know, lines and wrinkles in a very short period of time.
• 27:29
  SPEAKER_01: Um we make vitamins, we're the largest manufacturer of vitamins in the world.
• 27:33
  SPEAKER_01: Okay.
• 27:34
  SPEAKER_01: Uh we made um we make um the vitamin C, the vitamin B, uh all the different vitamins, which uh right now vitamin B3 niacinide is very hot.
• 27:47
  SPEAKER_01: And we're we're selling that and making that um to the highest degrees of purity, um, looking at sustainable practices um in manufacturing, everything that we do.
• 27:58
  SPEAKER_01: We use a lot of um natural ingredients, uh we use biotechnology, moving away from our organic synthesis, um, and taking into account sustainable beauty.
• 28:08
  SPEAKER_01: We're even now moving into what I call design to market, which we're designing formulations specifically tailored to briefs that were provided by companies, and we're looking at indie brands, derms.
• 28:20
  SPEAKER_01: Okay, and we're we're we have three levels.
• 28:23
  SPEAKER_01: We have a basic, uh, intermediate, uh advanced formulation where we will put together a formula with manufacturing options that are tailored to meet whatever endpoint you want to meet using uh clinical data that has been generated by us.
• 28:38
  SPEAKER_01: We actually do and invest in clinical data and substantiate our claims.
• 28:42
  SPEAKER_01: Um so we go beyond just the molecule.
• 28:45
  SPEAKER_01: We we do the science, the regulatory, the clinical work, we substantiate it scientifically and publish the results, and we support everything we do in that nature, whereby uh a simple manufacturer will only either put it together and utilize other people's or companies' data too to uh substantiate what needs to be done.
• 29:04
  SPEAKER_01: So, you know, we're all we're we're very deeply um embedded within the skincare industry in terms of you know making sure that you have skin wellness, and skin wellness is now kind of the new buzzwords with advanced ingredients, and we have market leadership in different types of products, hydrotic acid, you know, um UV filter protection, uh pentabitin, vitamins, um, and then the combination of these ingredients which create synergistic effects, which helps you target different skin problems in a way that you can't really get to with one product on the market, or you have to buy two products.
• 29:43
  SPEAKER_01: But it's really exciting uh because you know, we're into barrier repair, we're into microbiome, you know, all these cutting-edge stuff, which you know consumers don't really understand, but we're creating the the the runway whereby we can now start launching products in those areas and really facilitating um skincare in a way that hasn't been done before is beyond fillers, right?
• 30:05
  SPEAKER_01: We're using the actual skin mechanisms um to do it.
• 30:08
  SPEAKER_00: Let me let me just jump in.
• 30:09
  SPEAKER_00: So, I mean, uh the agenda of our conference is essentially everything that you guys are doing, as you mentioned, everything.
• 30:14
  SPEAKER_00: Um, you know, in regards to the vitamins in particular, we don't have a lot of time here, but in in regards to the vitamins, I mean, one of the issues that the consumer has with vitamins is of course we just don't know there's no regular regulation uh in regards to to these vitamins and supplements.
• 30:29
  SPEAKER_00: And and how do we know that what we are purchasing actually contains the active ingredients and they aren't tainted with other possibly harmful ingredients as well?
• 30:37
  SPEAKER_00: Knowing the the high standards that DSM has for all of the product manufacturing, is there a way for the consumer to determine which products are which vitamins, for example, are made by DSM and which ones are not?
• 30:49
  SPEAKER_01: Well, I mean, um I I think being transparent, you know, is kind of something that we're very uh much uh in tune with.
• 30:58
  SPEAKER_01: And and the fact is that, you know, for a vitamin V B3, vitamin C, vitamin E, you know, uh vitamin D, we do have safety data and we do not.
• 31:10
  SPEAKER_01: Um and we have levels that are levels of the ingredients that are approved either for leave-on or rinse off, where we support based upon the risk assessment and safety assessments.
• 31:20
  SPEAKER_01: Everything that we do is substantiated from a regulatory safety point of view.
• 31:25
  SPEAKER_00: Oh, yeah.
• 31:25
  SPEAKER_01: So it's compliant with regulations, especially Omar now in the United States.
• 31:30
  SPEAKER_00: How would the consumer know, though, if that vitamin is made by your company or another?
• 31:34
  SPEAKER_01: Aaron Powell Well, I think the trade name, you know, what happens is on the label you have the inky name, right?
• 31:40
  SPEAKER_00: Uh-huh.
• 31:40
  SPEAKER_01: So the inky name is a standardized name which is only pertinent to that ingredient in terms of form and cast number, et cetera.
• 31:48
  SPEAKER_01: So there's no way to really know about who manufactures it because a lot of the the company that's making the product does not necessarily reveal it because one, they can get it cheaper, and maybe that company may not have the same standards, but it's still an inky name, right?
• 32:06
  SPEAKER_01: So uh I think one of the things that we're trying to do under this design to market is that we have now a way to communicate to customers what that data is, and and maybe have a library by which derms can can present it to the patients or in general consumers, what is the safety behind it?
• 32:24
  SPEAKER_01: And it's important for people to know that because you look at allergens, you look at all the different things, you know, impurities, you know, which are which are which are harmful potentially.
• 32:34
  SPEAKER_01: And and you can make decisions based upon the quality.
• 32:37
  SPEAKER_01: And it's our mission basically to to incorporate things at the highest level of purity.
• 32:43
  SPEAKER_01: And in many cases, we'll have ingredients which are much more pure than those other ones being um uh marketed and and sold for the cosmetics industry.
• 32:53
  SPEAKER_01: And I think a lot of that's gonna change in the next year because, at least in the United States, given that uh the uh we now have um uh a new regulation for cosmetics, which is gonna institute GMPs, right?
• 33:06
  SPEAKER_01: Good manufacturing practices.
• 33:07
  SPEAKER_01: They've already instituted the safety uh substantiation portion of it.
• 33:11
  SPEAKER_01: But once you start getting into the GMP, you're gonna start seeing that there's going to be a lot of companies that are gonna go out of business simply because they can't manufacture to the level of purity that's required on the GMP or or or or or or demonstrate that the product has been done there.
• 33:27
  SPEAKER_01: So there's gonna be a lot of help that's gonna be required.
• 33:30
  SPEAKER_01: We're we're gonna be there to to help them.
• 33:32
  SPEAKER_01: The fact that all of our ingredients are produced on the GMP because they're European based is important because they're already compliant with GMP, right?
• 33:40
  SPEAKER_01: And you know, we're using USB standards for testing in terms of making sure that we use the methods that are currently on the pharmacopoeia uh to generate uh what is necessary in order to people have people have peace of mind when they use the ingredient.
• 33:54
  SPEAKER_01: And you know, the companies selling this product will will use that as a competitive advantage as well.
• 34:00
  SPEAKER_01: Yeah.
• 34:01
  SPEAKER_01: And communicating that is another issue in terms of the social media part of it, uh which is going currently going crazy.
• 34:08
  SPEAKER_01: But we're involved there as well, um, and trying to bring out uh a little more a little bit more balance with regards to what is true and what is a misconception.
• 34:19
  SPEAKER_01: And I think um that's something that's really important too.
• 34:22
  SPEAKER_01: But you know, we try to do what we can in in many different ways using different approaches.
• 34:26
  SPEAKER_01: You know, it can be web-based, it can be social media based, it can be technical uh presentations, it can be papers, all this all contributes to to the foundation of supporting the ingredients in the way that they should be approved, uh supported and and approved uh for use.
• 34:42
  SPEAKER_00: Well, you know, just just to highlight that, I think we we have been for most of what we were talking about, we've been uh throwing shade on the FDA.
• 34:50
  SPEAKER_00: But uh for for to be to be clear though, this the recent act that that is kind of mandating the good manufacturing pro uh practices for these uh supplements and for skincare as well and and for beauty uh is really important.
• 35:08
  SPEAKER_00: Adverse event reporting is also including in that included in that.
• 35:11
  SPEAKER_00: So I think that the whole level of safety is going to be elevated because of that.
• 35:17
  SPEAKER_00: Uh, and that is something that we definitely need to give give kudos to the FDA uh to recognize that we are behind uh as a nation, behind the EU and in many of these uh safety acts and and finally catching up.
• 35:33
  SPEAKER_00: But Carl, look, I I can't thank you enough for for your time and and honestly, just wanted to highlight the great work that DSM is doing, not only for for BEMT and and bringing a new filter that's sorely needed to the United States, but also as I dive dived more into the into the website and talking with you about what DSM is doing, uh it's just really interesting uh for improving safety and that that design to market idea is also really uh I find that fascinating.
• 36:04
  SPEAKER_00: And and certainly if I was a a Derm or someone interested in developing my own line, partnering with a company like DSM seems like a no-brainer to me.
• 36:13
  SPEAKER_01: No, we're we're more than happy, you know, to to share our technology, our expertise, our knowledge.
• 36:19
  SPEAKER_01: And I think that's a whole thing, right?
• 36:20
  SPEAKER_01: Um we have over 100 scientists in Switzerland uh uh doing innovation.
• 36:26
  SPEAKER_01: We have safety studies, and we can substantiate what we sell, whereas by I don't know if many other companies except for a few of the larger ones can do that.
• 36:37
  SPEAKER_01: But you know, having all that in terms of ammunition to put forward to developing new formula stands is great.
• 36:45
  SPEAKER_01: And then having third-party uh endorsements of the product and approvals in terms of vegan, halal, you know, um eco, uh all those add credibility and transparency is what the customer wants.
• 36:57
  SPEAKER_01: They want to know that they're buying something that they can feel as though it's it's safe and they don't have to worry about uh anything uh bad happening.
• 37:07
  SPEAKER_01: And that can be for the entire family, right?
• 37:09
  SPEAKER_01: It's not just for for adults but children as well.
• 37:12
  SPEAKER_01: Absolutely.
• 37:13
  SPEAKER_01: And that's our mission.
• 37:14
  SPEAKER_01: And um, you know, I think now we're we're kind of moving away from you know just offering this to the the large mega computer uh consumer companies and now offering to the smaller companies who might not have had that opportunity before.
• 37:30
  SPEAKER_01: And the terms as well, because they're the front line in terms of preventing disease and offering patients um solutions to skincare issues.
• 37:37
  SPEAKER_00: Well, you know, again, thank you, Carl.
• 37:40
  SPEAKER_00: So so this is uh skincare confidential.
• 37:42
  SPEAKER_00: Uh and and again, the idea for this podcast is to give our listener a 360-degree view of the skincare industry and and what better way than highlighting companies, contract manufacturing companies such as DSM, who are really investing in the health of our nation and and really improving the safety of of all of beauty and and and health care.
• 38:04
  SPEAKER_00: So uh I really appreciate what DSM is doing.
• 38:06
  SPEAKER_00: And when I found out more about it, I I wanted to highlight that on Skincare Confidential.
• 38:10
  SPEAKER_00: So thank you again, Carl.
• 38:11
  SPEAKER_00: Uh my name is Dr.
• 38:12
  SPEAKER_00: Ted Lane, and uh thank you so much for listening.
• 38:15
  SPEAKER_00: Please, if you've enjoyed this episode, subscribe, uh, give us five stars and refer us to to to a friend as well.
• 38:21
  SPEAKER_00: We appreciate you listening.
• 38:23
  SPEAKER_00: Thank you.