Latest / Skin Anarchy / Behind the Scenes of Beauty: Regulatory Compliance, Testing, and Safety Measures with Validated Claim Support

Transcript

Behind the Scenes of Beauty: Regulatory Compliance, Testing, and Safety Measures with Validated Claim Support · Skin Anarchy

0:08
SPEAKER_00: Hi guys, welcome back to Skincare Anarchy.
0:11
SPEAKER_00: This is your host, Ekta, and I have such a wonderful guest today because we're gonna get to talk about a lot of the things that have been buzzing in the beauty and cosmetic industry lately that have to do with a lot of regulation, making sure things are safe, you know, that we're purchasing as consumers.
0:26
SPEAKER_00: There's a huge shift happening right now in the beauty world.
0:30
SPEAKER_00: And so my guest today is truly very well versed in everything that's been going on, but also he is the founder of his own endeavor and company that's really moving things forward in this direction.
0:40
SPEAKER_00: So without further ado, I want to introduce you guys to Brian Ecclefield.
0:43
SPEAKER_00: Welcome to the show, Brian.
0:44
SPEAKER_00: I'm so excited to host you.
0:45
SPEAKER_01: Hi, Dr.
0:45
SPEAKER_01: Ecta.
0:46
SPEAKER_01: Thank you very much for the introduction.
0:48
SPEAKER_00: Yeah, no, I'm really excited, Brian, because I know you have a lot of knowledge in this area.
0:52
SPEAKER_00: And I know we were talking about for everyone listening before the interview about Makro, which is a set of guidelines that are being introduced by the FDA.
0:59
SPEAKER_00: And I want Brian to tell us all about that later.
1:02
SPEAKER_00: But Brian, I want to get started by learning all about you and your background because I know it's truly impressive and everything that led up to before you started the company.
1:10
SPEAKER_01: Yeah, absolutely.
1:11
SPEAKER_01: So I've spent the last 14 years involved behind the scenes developing in vivo clinical studies.
1:18
SPEAKER_01: And my focus has always been on helping international or domestic brands building personal care claims or cosmetic claims.
1:26
SPEAKER_01: So that pretty much boils down to a combination of biophysical instrumentation, expert clinical grading, subjective perception, and then clinical before and after photography.
1:39
SPEAKER_01: So somewhere pairing those four elements, I'll put together custom portfolios of clinical or claim support for either Lux Beauty or niche startup or major multinational brands in some cases.
1:53
SPEAKER_01: And basically validated claim support in its name defines what we do.
1:59
SPEAKER_01: We were founded back in 2019 as what I like to call an alternative to the CRO status quo, CRO being clinical research organization.
2:12
SPEAKER_01: And our place is really in the customer service forward, very small uh boutique organization space.
2:20
SPEAKER_01: We're really big on designing these studies from the ground up.
2:24
SPEAKER_01: We're not held by any major multinational conglomerate lab or investment house, which is big in the industry right now.
2:33
SPEAKER_01: And our biggest thing really is that the customer service aside.
2:38
SPEAKER_01: So every clinical study that gets developed at VCS is basically handheld by myself and my business partner, Jane Turvorin.
2:47
SPEAKER_01: We together started VCS from the ground up.
2:50
SPEAKER_01: It's all either friends and family or SBA 7A startup funds.
2:56
SPEAKER_01: It's been quite a process.
2:58
SPEAKER_01: So we started fundraising and planning a couple of years ago, officially launched the company in 2019.
3:04
SPEAKER_01: And now we're doing just about 100 individual custom tailored skincare or hair care clinicals over the course of a calendar year.
3:13
SPEAKER_00: Wow.
3:13
SPEAKER_00: That's impressive.
3:15
SPEAKER_00: I like that you guys aren't owned by anybody.
3:17
SPEAKER_00: That's really cool to me.
3:18
SPEAKER_00: I mean, I think that with the way that the landscape is like in general, I think with clinical trials and clinical data, it's very difficult to tell like what are the cookie cutter studies from the ones that are truly novel.
3:29
SPEAKER_00: So I think that's phenomenal that you're doing that.
3:31
SPEAKER_01: I think that's one of the biggest things that can help a startup or luxury beauty brand too, is just knowing that every company and every product are distinctly individual from their formulation through how they get positioned on the market.
3:46
SPEAKER_01: And I don't really think there's anyone better to have that discussion with somebody who wants to differentiate a new cutting edge, unique product.
3:54
SPEAKER_00: Yeah.
3:54
SPEAKER_00: And I think what one of my big questions then would be like, what is that?
3:57
SPEAKER_00: I mean, how long does the process take for you guys?
3:59
SPEAKER_00: Like if I was a brand, I came to you about one of my formulas.
4:02
SPEAKER_00: I mean, how long does the initial because I know with like in the academia world, IRBs can take forever.
4:07
SPEAKER_00: You know what I mean?
4:07
SPEAKER_00: Stuff like that.
4:08
SPEAKER_00: It's just a long, long process.
4:10
SPEAKER_00: But I'm just curious in terms of timeline, especially for smaller brands, what's that like?
4:14
SPEAKER_01: Sure.
4:15
SPEAKER_01: So usually when we start speaking to a brand representative for the first time, we could go back and forth for the best part of a month, figuring out what the study design is going to look like, what the lead sort of game-winning claims are gonna be, at least the top couple of major claims that they're they're looking to achieve.
4:32
SPEAKER_01: So let's say the study design phase will be about a month long.
4:35
SPEAKER_01: And on top of that, we're usually booked anywhere from six weeks to eight weeks out.
4:40
SPEAKER_01: So one month to design, about another month to get that recruitment in place, and then whatever the duration of the study is.
4:47
SPEAKER_01: So if we're talking about an anti-aging eight-week study, you can top, you drop two months in there.
4:52
SPEAKER_01: If we're talking about a medical claim, like a hair regrowth study, that could end up being a six-month process to get into antigen, intelligent ratios, and all the rest of it.
5:00
SPEAKER_01: The nice thing about our space is it's almost always expedited at IRB based on the subject or participant risk category.
5:09
SPEAKER_01: So the IRB really coincides into that um study design and recruitment phase.
5:15
SPEAKER_01: We could really get all of that done up front within that first couple weeks.
5:19
SPEAKER_00: Wow.
5:19
SPEAKER_00: Wow, that's really awesome.
5:20
SPEAKER_00: I'm glad that you have that way of like cutting down time because I know people are always launching new products, and I always wonder about that.
5:27
SPEAKER_00: You know, like where does the testing timeline really come in in terms of like a new formulation or something brand new?
5:32
SPEAKER_00: And a lot of brands, I've talked to some founders, they're like, no, we have to wait on testing and all these things.
5:37
SPEAKER_00: And you know, I've always been curious how long that takes, but that sounds pretty speedy.
5:41
SPEAKER_00: So it's amazing.
5:42
SPEAKER_01: As long as someone comes to us and has a couple of their ducks in a row, it can happen relatively quickly.
5:48
SPEAKER_01: But there are, of course, all the other elements running in the background.
5:52
SPEAKER_01: So they're probably doing patch testing, toxicology, container compatibility, and storage for obvious reasons.
5:59
SPEAKER_01: We can't get started until a product is is at its final formula.
6:05
SPEAKER_01: So you don't want to do clinical efficacy until you're sure that something is shelf life stable and that it's non-irritating.
6:12
SPEAKER_01: So it's it is important to plan out ahead of time.
6:15
SPEAKER_01: I think realistically, to come to the table assuming that your study was going to start in two to three months is pretty reasonable.
6:22
SPEAKER_01: And smaller ingredient supplier and active studies on you know five or 10 subjects for sort of pilot initial data, those can happen considerably quicker.
6:33
SPEAKER_01: But on average, I think two to three months is a fair expectation for a start.
6:38
SPEAKER_00: That's pretty good.
6:38
SPEAKER_00: I like that.
6:39
SPEAKER_00: That's really cool.
6:40
SPEAKER_00: So, I mean, I guess if you are a small brand, it's very doable, it's very like time friendly.
6:44
SPEAKER_00: That's really cool.
6:45
SPEAKER_00: That's that's good to hear because I think right now, one of my biggest debate points that I've noticed coming up with just my own questions, you know, as a consumer for brands, is like who are you testing with and why?
6:56
SPEAKER_00: Because some people will immediately get things done and others won't.
6:59
SPEAKER_00: So it's nice to know that you guys are like a one-stop shop.
7:02
SPEAKER_00: You don't cut corners and you don't compromise, but you're still able to get it done really quickly, which I think is very valuable.
7:08
SPEAKER_00: I mean, from where I'm standing.
7:09
SPEAKER_00: I can imagine as an entrepreneur, those are things you look for.
7:12
SPEAKER_00: So that's great.
7:12
SPEAKER_01: Yeah, it's definitely a unique little space and it's it's very relationship driven too.
7:18
SPEAKER_01: So we're not sort of turning over pounds of ingredients or we're not turning through different types of um of packaging or materials.
7:29
SPEAKER_01: Every study really is custom developed from the ground up, and we're not always the right partner.
7:34
SPEAKER_01: And I think that's something that's important to let everyone know, too, is sometimes you're gonna hear a group say yes, just so that they can put something sort of into the sales pipeline.
7:45
SPEAKER_01: We say no all the time.
7:47
SPEAKER_01: And I would rather somebody comes back to me with a study that's a good fit for my team than we take something on that's not going to fulfill their expectations.
7:55
SPEAKER_00: I love that.
7:56
SPEAKER_00: What led to you creating the company?
7:58
SPEAKER_01: So I've been in skincare clinical support since 2009.
8:03
SPEAKER_01: I graduated school in 2008 and couldn't find a job in finance or IT to save my life as a result of the subprime mortgage crisis that sort of impacted industries across the board.
8:17
SPEAKER_01: I moved back in with my parents and I was gonna go to law school and actually ended up meeting gentlemen who owned a clinical research laboratory close to where I grew up in the skincare world.
8:29
SPEAKER_01: So that sort of piqued my interest.
8:32
SPEAKER_01: I got into the clinical study design side and I started in sales and moved into the more technical role over time.
8:40
SPEAKER_01: But basically, for the last 14 years, I've been behind the scenes in some way developing clinical studies to support consumer claims.
8:50
SPEAKER_01: And long story short, the first lab that I worked for wasn't doing things at the moral or ethical level that either myself, the FDA, or the greater judiciary process of the United States saw fit.
9:08
SPEAKER_01: And I quit over ethical terms.
9:10
SPEAKER_01: That company ended up going through a huge dilemma over illegitimately supported claims and projects.
9:18
SPEAKER_01: So that kind of sent me into a journey to try and find a home at another lab that I did see eye to eye with owners on, never actually found one and ventured off on my own because I love the industry.
9:32
SPEAKER_01: I love helping people to support their claims.
9:34
SPEAKER_01: But to me, it's really important that you do things the right way.
9:37
SPEAKER_01: You're not cutting corners.
9:39
SPEAKER_01: And that led to putting a team together and not not wasting another year or more trying to build trust with somebody who I didn't in the end see eye to eye with.
9:49
SPEAKER_00: Yeah.
9:50
SPEAKER_00: I mean, sometimes it's like you gotta do it on your own, right?
9:52
SPEAKER_00: Like you gotta fix something that you see.
9:54
SPEAKER_00: I mean, that's that's really commendable though, Brian.
9:56
SPEAKER_00: I'm glad that you realize that you know what, it's just not up to the standards it should be.
10:00
SPEAKER_00: So I really applaud you for that.
10:02
SPEAKER_00: That takes a lot of guts to do that.
10:04
SPEAKER_01: Yeah, thanks.
10:04
SPEAKER_01: I think it's one thing to see mistakes because people make mistakes all the time.
10:09
SPEAKER_01: It's another to cover them up and try and brush them under the rug.
10:14
SPEAKER_01: And in our organization here, I mean, people make mistakes.
10:17
SPEAKER_01: That's fine.
10:17
SPEAKER_01: The biggest thing in claims and clinical and any scientific field is that if you're open and you're honest about things that go wrong, whether they're clients, friends, employees, or coworkers, people respect that.
10:29
SPEAKER_01: And it's great to make mistakes.
10:31
SPEAKER_01: It shows that you're human.
10:32
SPEAKER_01: But if you try and cover stuff up, whether it's either because you did make a mistake or because you were doing something sort of nefarious or I guess untoward, the big thing is how you deal with it when there is a problem and you gotta be open.
10:46
SPEAKER_00: Yeah, absolutely.
10:47
SPEAKER_00: I I couldn't agree more, and I think it's a very interesting field that you're in because you know, from my science background, I know that every time I file the paperwork for a clinical trial or any study, it's just a huge headache, you know.
10:58
SPEAKER_00: I mean, but rightfully so, because you have to go through a lot of steps to make sure you're doing things on a level that is acceptable for our end.
11:05
SPEAKER_00: It's the academia side of things.
11:07
SPEAKER_00: You have to make sure it's in line, right, with the protocols, with the standards, with some sort of baseline.
11:12
SPEAKER_00: And I've also, as a consumer, to put it out there, I'm sure a lot of people can relate, I've struggled a lot with this understanding of what is it that we are doing for OTC products.
11:22
SPEAKER_00: You know what I mean?
11:23
SPEAKER_00: That's putting them in that same realm of very like rigorous testing, but making sure the findings that we're getting are actually reflective of the studies that were done.
11:32
SPEAKER_00: Like that's always been for me a very big struggle point in my understanding as a consumer.
11:36
SPEAKER_00: So I think it's truly an interesting field that you're in.
11:39
SPEAKER_00: And I want to learn from you about this.
11:41
SPEAKER_01: So well, yeah, I'm here.
11:42
SPEAKER_01: I'm happy to chat with you for sure.
11:44
SPEAKER_00: Yeah, and I I want to actually get started, Brian, with Makra, because I know it's the big topic right now.
11:49
SPEAKER_00: And for anyone that's in the beauty industry, I'm sure you guys have heard about it at this point.
11:53
SPEAKER_00: But for all of our listeners out there who aren't, Brian, can you give us like a little summary of what is Makra and a 101, I guess?
11:59
SPEAKER_01: Sure.
12:00
SPEAKER_01: So I'm gonna talk about it in sort of broad strokes to make it really easy to understand.
12:05
SPEAKER_01: Long story short, cosmetics is an area that there has not been a lot of FDA oversight in.
12:13
SPEAKER_01: And that's both a good and a bad thing.
12:16
SPEAKER_01: The good part of it is that the industry's been able to lead itself for a long time to sort of set its own defined guidelines as far as things, or let's say semi-defined guidelines for how products can be proven to be effective or how they can be proven to be safe.
12:35
SPEAKER_01: The reason I say that it's partially a good thing is because FDA picked up sunscreens on the OTC side, and we have a very limited number of approved active ingredients on the sunscreen side.
12:47
SPEAKER_01: We haven't had anything new past since I believe it was 1999.
12:51
SPEAKER_01: There's currently a new active that the team at DSM is pushing and really looking forward to a little bit more sort of expansive ingredient um so that we can we can develop new products, but the rest of the world is way ahead of us in sunscreen development.
13:08
SPEAKER_01: So the problem with FDA in the cosmetic space comes down to know-how and sort of trying to frame our industry with the same light as pharma or food.
13:20
SPEAKER_01: And in the end, skincare and cosmetics are very widely used.
13:24
SPEAKER_01: I mean, you got hundreds of billions of dollars in sales just in this country alone, but the problem is they're not the same.
13:30
SPEAKER_01: And cosmetics currently fall under the food side of FDA.
13:35
SPEAKER_01: I had read that historically the cosmetic group from the food arm of FDA gets about$10 million per year for all of their inspections, audits, and investigations across the board.
13:50
SPEAKER_01: And just for reference, the FDA's total budget that they're requesting for this year, I think, is like 7.7 billion.
13:56
SPEAKER_01: So it's an incredibly small portion of the regulatory budget.
14:02
SPEAKER_01: It means that you have people who don't have enough training, who don't really understand how skincare and beauty and cosmetics are different than the pharma world or the food world.
14:12
SPEAKER_01: So MoCard is designed in a lot of ways to bring everything together.
14:16
SPEAKER_01: It's not really all inclusive and upon itself.
14:20
SPEAKER_01: There's going to be some semblance of guidelines for product safety, but the issue with it is that it was sort of rushed.
14:26
SPEAKER_01: I mean, it's it's long overdue.
14:28
SPEAKER_01: But just yesterday we found out that the FDA's pushed the mandatory registration process back.
14:34
SPEAKER_01: So the deadline was supposed to be December 31st of this year for all manufacturers to register through the online portal.
14:41
SPEAKER_01: The portal is actually not live at this time.
14:44
SPEAKER_01: So registration is difficult when there is nowhere to register.
14:48
SPEAKER_01: That's really the main driver for pushing this back.
14:51
SPEAKER_01: They now have slated for July of next year.
14:54
SPEAKER_01: But to kind of tie it together and explain what it's all for, it's all about consumer protection.
14:59
SPEAKER_01: And since the regulations have sort of been, they're not necessarily lax, they're just not direct.
15:07
SPEAKER_01: So there is no FDA-approved safety test out there for skincare and cosmetics.
15:12
SPEAKER_01: In the industry, we talk about safety and use, we talk about repeat insult patch testing, cumulative irritation.
15:19
SPEAKER_01: All of these things are different ways of proving a product is safe or non-irritating.
15:24
SPEAKER_01: But FDA doesn't actually recognize any of them in our space.
15:27
SPEAKER_01: I hope beyond all hopes that there's some further direction about what safe means.
15:34
SPEAKER_01: Because right now, even if the portal was live and brands were registering, there's no guarantee that if you did an RIPT, which is uh continuous patch application on the back, if you did some ocular irritation, there's no guarantee today that this is what would be in line with what FDA wants you to show.
15:52
SPEAKER_01: So it's still one of those gray areas where the onus is on brands to determine if their product is safe, or at least to determine how to show that their product is safe.
16:01
SPEAKER_00: Yeah, no, that's so interesting though, that they're I mean, I can imagine why they're having to push this back because this is a really big, like it's a really big deal.
16:09
SPEAKER_00: And I remember, you know, Brian, when I first learned about it, right?
16:12
SPEAKER_00: I was like immediately like, okay, this is gonna take them a while to put this together because, like you said, there's so many different variables right now in the cosmetic space.
16:21
SPEAKER_00: I think, especially with skincare.
16:22
SPEAKER_00: I was talking to, you know, some of my colleagues a while ago about this, and we were talking about things like allergy testing.
16:28
SPEAKER_00: And there's so many different like levels when it comes to anything that you put on or in the human body that you have to consider.
16:34
SPEAKER_00: It just can't be for a long time.
16:36
SPEAKER_00: I think we've dealt with things like cosmetic chemistry being the end-all be-all for what consumers use to make their purchasing decisions, you know, in terms of how efficacious is something, how safe is something.
16:46
SPEAKER_00: But it's like there's a lot more to it.
16:48
SPEAKER_00: Medicine is not just one discipline.
16:50
SPEAKER_00: So even from that angle, when I look at it and imagine what the FDA would have to put together to make this big shift.
16:57
SPEAKER_00: I mean, that's there's a lot that's gonna go into this, especially in the long run, I think.
17:00
SPEAKER_00: But that's interesting that they pushed it back.
17:02
SPEAKER_01: Yeah, they've definitely pushed it back.
17:04
SPEAKER_01: And I mean, you're so right about how much goes into trying to effectively standardize an entire industry that basically has been sort of skirting around that level of regulation and insight.
17:17
SPEAKER_01: So, I mean, we'll see what happens, but in the end, I just hope that FDA and the powers that be can sort of lean on the industry know-how and best practices.
17:27
SPEAKER_01: The one thing I really don't want to see happen is what goes on with these sunscreen ingredients.
17:32
SPEAKER_01: So there's a phrase that's thrown around in pharma testing, which is bioavailability, which is all about how much of a material can be found in your bloodstream or in your body.
17:43
SPEAKER_01: And bioavailability is not the same as safety.
17:47
SPEAKER_01: The mere presence of something in your blood is not necessarily the same as something having a negative or adverse impact on your system or your body or your lifestyle.
17:57
SPEAKER_01: So we all know that the skin is a barrier that's constantly flowing both ways and things are absorbed.
18:03
SPEAKER_01: What's important is how safe they are when they are in contact with your body.
18:07
SPEAKER_01: We know that some of them are going to get into your bloodstream.
18:10
SPEAKER_01: So it's more about actual safety as opposed to just the presence of individual materials.
18:17
SPEAKER_00: Also, I mean, just to add to your point, yeah, I mean, bioavailability also from a pharmacinetic standpoint, it doesn't mean that just because it's in your bloodstream, like you said, it has to do with uh therapeutic index and stuff.
18:28
SPEAKER_00: Like you have to bioavailability is a measurement for drugs that we give you systemically most of the time.
18:34
SPEAKER_00: You know, it's not supposed to be.
18:35
SPEAKER_00: If I were looking at this or on a panel, I would have been a brand reporting something like bioavailability to me is kind of useless because it needs a reference point.
18:43
SPEAKER_00: You know what I mean?
18:44
SPEAKER_00: It needs some sort of framework in which you're talking about it.
18:46
SPEAKER_00: Like with pharma drugs or things that you take, for example, like for blood pressure, right?
18:50
SPEAKER_00: Like you're gonna, we as physicians are looking at what is the therapeutic load that you need to be able to actually impact versus toxicity concentrations.
18:58
SPEAKER_00: I don't think we as an industry can make claims like that at all right now, whether it's sunscreen or anything that gets absorbed through the skin.
19:05
SPEAKER_00: It would just be impossible to do that right now with the given the amount of data we have.
19:09
SPEAKER_00: So I think again, like correct me if I'm wrong, but it just feels like a lot of buzzwords, you know, just being thrown around.
19:15
SPEAKER_00: Like that doesn't make sense to me.
19:16
SPEAKER_01: No, that's totally right on.
19:18
SPEAKER_01: It is buzzwordy and it comes from the pharma side.
19:22
SPEAKER_01: So this is where I think the governance side of FDA sort of got lost in the weeds with the sunscreen ingredients, and they wanted tons of data on long-term bioavailability.
19:33
SPEAKER_01: Yeah, mutagenicity is another side.
19:35
SPEAKER_01: Of course, these are really important factors to consider, but at the end of the day, sunscreen is protecting you from the harmful UV effects of the sun.
19:44
SPEAKER_01: The skin cancer side is really probably the claim that is most of interest to FDA.
19:50
SPEAKER_01: But to put it a completely different way, there's no more reason for the FDA to be directly involved with the sunscreen ingredients than there is with them to start regulating hats and sombrellas and shirts and pants.
20:04
SPEAKER_01: All these things also protect you from UV rays.
20:07
SPEAKER_01: So this bioavailability thing is a major buzzword right now based on what's happening in the sunscreen world.
20:14
SPEAKER_01: And I think things like phototoxicity and photoallergy potential, how things break down under UV light, whether there's either irritation or long-term sensitization, these are markers for topical safety that should be sort of more front and center.
20:29
SPEAKER_00: I 100% agree with you.
20:30
SPEAKER_00: I think you really hit the nail on the head.
20:32
SPEAKER_00: Like I, I you know, when it comes to something, because literally you're dealing with filters at this point.
20:37
SPEAKER_00: You know, you're not talking about like what I just went on a rant about.
20:40
SPEAKER_00: You know, it's like exactly what you said.
20:42
SPEAKER_00: I completely agree with you.
20:42
SPEAKER_00: I think that is so much more indicative, especially even when you're looking at warning consumers or alerting them on what to expect.
20:49
SPEAKER_00: That's so important.
20:50
SPEAKER_00: And I think that's definitely the better route.
20:52
SPEAKER_00: But I want to know because you know so much about the whole FDA thing and what they've been doing, but like what is the deal with the FDA registrations for the labs and the manufacturers?
21:01
SPEAKER_00: Like, what are they really putting in place for these manufacturers?
21:04
SPEAKER_00: If you could kind of give us a background on that.
21:06
SPEAKER_01: Sure.
21:07
SPEAKER_01: So the overall piece that's sort of most prevalent with this whole monker thing is that anybody historic who's manufacturing in the OTC space, even if it's um whether it's sunscreen or acne or dandruff, anywhere in the OTC realm, you had to do what's called the current drug establishment registration with FDA.
21:27
SPEAKER_01: So for a long time, labs across the board who were solely involved with non-regulated cosmetics, skincare and personal care products, they did not have any real sort of GMP oversight.
21:42
SPEAKER_01: They they would correctly state that they were not wholly subject to FDA regulations.
21:49
SPEAKER_01: For many years, FDA has sort of pushed that cosmetics is governed under the food branch, like I had mentioned earlier, but there wasn't really the same sort of regulation.
22:00
SPEAKER_01: Registration requirement for cosmetic manufacturers that there was for OTC.
22:04
SPEAKER_01: So you can imagine there's a lot of sort of gray areas there for people who touch OTC ingredients but don't necessarily specialize in them.
22:13
SPEAKER_01: So same thing for like the sunscreen filters out there.
22:16
SPEAKER_01: But basically now, anybody who's making topical cosmetics and is past the cutoff for what the FDA defined as a small business in this case, which I think is like 1.5 million for annual revenue.
22:30
SPEAKER_01: Anybody who's not at that small business cutoff or smaller now has to do this full registration if they're involved with any portion of manufacturing, analyzing, testing, or production of skincare and cosmetics.
22:45
SPEAKER_01: So the idea is that you're meant to log on to this um FDA registration portal, put in your company information, get your lab out there.
22:55
SPEAKER_01: And if you're manufacturing, you have to have a product representative who actually stands behind any of the safety-related issues that may arise with your product.
23:04
SPEAKER_01: So you're responsible for any long-term adverse events that may occur, for actually following up with anything that might end up in the media if people have product-related interactions.
23:16
SPEAKER_01: So that in upon itself is very good because it's it's a protection measure for consumers.
23:21
SPEAKER_01: And it sort of follows more of the like the European standards that have existed for a number of years now.
23:27
SPEAKER_01: The scary part is that there's a couple of not so clearly defined elements.
23:34
SPEAKER_01: So I mentioned that small business qualifier.
23:37
SPEAKER_01: If you're selling less than what I think it's around the 1.5 million mark, if you're selling less than that threshold, you have an exemption for the full registration.
23:47
SPEAKER_01: There are no exemptions granted for anything that's designed for use around the mucous membranes of the body.
23:56
SPEAKER_01: That's very loosely defined.
23:57
SPEAKER_01: So, you know, does that, in my mind, you have to be very conservative and you have to say that includes mascaras, eyeliners, lip glosses, you know, chapstick, any kind of facial product designed for use around the eye area.
24:11
SPEAKER_01: So all of those products have to be proven to be safe.
24:16
SPEAKER_01: And that goes back to what we were talking about earlier.
24:19
SPEAKER_01: There is no definition as to which particular tests are meant to qualify products as safe at this time.
24:27
SPEAKER_01: So that leaves these small brands, anyone from let's call it 1.5 million in sales all the way up to you know 50 million.
24:35
SPEAKER_01: You've got these small to mid-sized businesses who are selling effectively eye care makeup, um, you know, small batch mascaras and eyeliners, they now have to navigate this entire GMP FDA registration process.
24:51
SPEAKER_01: And it's so unclear.
24:53
SPEAKER_01: I mean, talking to you, I've listened to a number of your other podcasts as well.
24:58
SPEAKER_01: And there's like there's so much confusion about what this all means.
25:02
SPEAKER_01: So I mean, in the end, registration is meant to be a consumer protection element, but I just feel like you can't rush something like this because there's so many moving pieces and it's so hard for small businesses to comply.
25:16
SPEAKER_00: Absolutely.
25:16
SPEAKER_00: Oh my gosh.
25:17
SPEAKER_00: Yeah, this is a lot.
25:18
SPEAKER_00: I like that you brought up the whole idea of the mucus membranes.
25:21
SPEAKER_00: And I mean, that is gonna really require a lot of different types of testing.
25:25
SPEAKER_00: That's a whole different world.
25:26
SPEAKER_00: I mean, the way you absorb things through a mucous membrane, as you know, Brian, just for everyone listening out there that might not know, it's completely different than something like your skin, which has inbuilt barriers.
25:37
SPEAKER_00: Like your mucus membranes are designed to not have barriers, they're designed to absorb.
25:41
SPEAKER_00: So absolutely, I agree with you what you said, where the regulation around that has to be broad and you have to be in the sense of like include everything, like mascaras, eyelash serums, especially those growth serums and stuff, they gotta regulate that stuff because it's it's really, really touching a very interesting area of just medicine, I think, overall.
26:01
SPEAKER_00: And it scares me sometimes because people are putting these products out now, I think more so than ever, which is interesting because you have all this going on from the FDA side.
26:11
SPEAKER_00: But I keep seeing a lot of stuff pop up every time.
26:14
SPEAKER_00: I feel like we are pushing a boundary as an industry, you know, that's saying, okay, well, we still want to create these products and they might be from a great place.
26:22
SPEAKER_00: But I also think it goes two ways where it is gonna take the FDA, like you said, a long time or it should to regulate this.
26:29
SPEAKER_00: But at the same time, I really think businesses need to like reel it back a little bit because we're really treading into areas where it's like, you don't know what your product is capable of doing.
26:39
SPEAKER_00: You know what I mean?
26:40
SPEAKER_00: Like, you don't know.
26:41
SPEAKER_00: Like chemistry is one thing that it shows results that yes, your hair is growing or whatever it might be.
26:46
SPEAKER_00: But when it comes to actually understanding what this chemical does in the human body, I think there should be some responsibility falling on the shoulders of these brands that says you need to fill out a little bit with what you're making.
26:58
SPEAKER_00: So I don't know.
26:59
SPEAKER_00: I'm I'm kind of torn there.
27:00
SPEAKER_00: That's my little like fork in the road, I guess, with where I feel.
27:03
SPEAKER_00: But that's interesting that the FDA has a lot to really think about.
27:06
SPEAKER_00: I don't know if they've had time, like you said, to even think about this stuff.
27:09
SPEAKER_01: Yeah, I just I don't know if it's really been front and center just based on the way that the budget gets broken down every year.
27:16
SPEAKER_01: So people just haven't been in the right positions of authority to think about it the way that we do in the industry.
27:24
SPEAKER_01: And to your point, the safety and efficacy of products are really closely related.
27:30
SPEAKER_01: Efficacy historically is what sells.
27:33
SPEAKER_01: So I'm gonna give you like a crazy real-world example in the sunscreen world about how these things actually sort of go on behind the scenes at a clinical or claim support lab.
27:46
SPEAKER_01: So, with sunscreen testing, without going too far into the weeds, a clinical study to prove that you have an SPF 30 is gonna cost you somewhere between 2,000 and 6,000 US dollars on average.
28:02
SPEAKER_01: If you want to do water resistance, it's gonna be about double that.
28:07
SPEAKER_01: So let's just say all in, you're spending about 10 grand for the sunscreen on the clinical side.
28:13
SPEAKER_01: That is something that is extremely cost sensitive.
28:16
SPEAKER_01: So there's labs all over the world who compete to win this SPF testing from major multinational brands.
28:23
SPEAKER_01: Now, let's say you have just a standalone moisturizer product and you want to do some consumer perception, a little bit of instrumentation to determine what percentage of hydration is changing in the skin, maybe talk about barrier protection.
28:38
SPEAKER_01: That study is going to cost you somewhere between$15 and$20,000 to basically get off the ground, maybe a little less.
28:47
SPEAKER_01: But you got this moisturizer product and now you want to throw in some before and after photos.
28:52
SPEAKER_01: People and brands have no problem spending that much money on these efficacy studies, and they can cost significantly more than that.
29:00
SPEAKER_01: The crazy thing is that SPF is something that's actually protecting you from skin cancer and the aging-related effects of the sun, like DNA damage.
29:08
SPEAKER_01: And they're so price sensitive on that safety and protection side.
29:13
SPEAKER_01: But the industry consensus or the sales side of the consensus is that people shop for the outside-the-box claims and the anti-aging, you know, the wrinkle reduction, the skin firmness.
29:26
SPEAKER_01: Those things are all really important for people's well-being, how people feel about themselves, but they're not necessarily protecting you from the number one factor that's going to lead to you aging visibly, which is your UV exposure.
29:41
SPEAKER_01: So the whole safety versus efficacy thing is just, it's one of those crazy scenarios where safety should be more in the spotlight.
29:49
SPEAKER_01: And it's not.
29:50
SPEAKER_01: Efficacy is what sells all the products that from like the founders that come onto your show with New Beauty Ventures.
29:56
SPEAKER_01: Most of the time, people aren't pushing the safety side.
29:58
SPEAKER_01: It's just something that they sort of have to tick boxes for.
30:02
SPEAKER_01: And I personally, I'd like to see more boxes and more defined boxes from FDA and other regulatory bodies.
30:09
SPEAKER_00: Absolutely.
30:10
SPEAKER_00: That's such an interesting.
30:11
SPEAKER_00: I'm glad that you went into that, the safety versus efficacy, because you're absolutely right.
30:16
SPEAKER_00: I think with safety, I don't think I've ever really heard anyone speak about it as a founder or someone who's representing a brand because I think they just don't know how to measure that.
30:26
SPEAKER_00: Like in terms of with efficacy, we have all these things.
30:29
SPEAKER_00: Like, you know, remember the whole Sephora thing where it was like 98% people or whatever, all those like little tystical claims.
30:35
SPEAKER_00: I feel like with efficacy, it's easier for brands to show that.
30:38
SPEAKER_00: But with safety, what are they gonna say?
30:40
SPEAKER_00: You know, 99% of people didn't have teary eyes or something.
30:44
SPEAKER_00: It's just it's harder, I think, for them to get their head around.
30:47
SPEAKER_00: I agree with you in the sense that it's way more important.
30:50
SPEAKER_00: I mean, safety, it's like when you see a drug ad on TV, right?
30:53
SPEAKER_00: I mean, how many times if we watch something like an SSRI or like an antidepressant, and they'll say, first side effect is blah, blah, blah.
31:01
SPEAKER_00: Basically, everything you're trying to avoid is one of their side effects.
31:04
SPEAKER_00: But at the end of the day, they're telling you right there.
31:07
SPEAKER_00: I mean, it's in your face, it's right there.
31:09
SPEAKER_00: You know it as a consumer.
31:11
SPEAKER_00: So I think that culture, it needs to come into our industry, especially with beauty, that people should know off the bat.
31:18
SPEAKER_00: I think I was reading, just to give you an example, I was reading something a while back about, I'm not gonna name the brand, but about how there was a woman suing them because she thought that the product that she was utilizing was different than what it really was.
31:31
SPEAKER_00: And it made her use it in a different way.
31:34
SPEAKER_00: So she was very annoyed as a consumer that why wasn't I told that this product is meant for this rather than just a normal cosmetic product?
31:41
SPEAKER_00: And I was like shocked when I was reading that because I'm like, yeah, this is a common problem.
31:45
SPEAKER_00: We don't disclose this.
31:47
SPEAKER_00: You know, I don't think it's done nearly enough on the part of brands.
31:50
SPEAKER_00: And that's why I say I think we end up tiptoeing around safety when in reality, it's exactly what you said.
31:56
SPEAKER_00: That should be front and center, it should be almost a selling point for brands, I feel like.
32:01
SPEAKER_01: So, in some ways, it actually there is a couple of really commonly used claims that do come from safety studies.
32:08
SPEAKER_01: So the way that consumers can identify with these types of products are you'll see stuff out there that says, let's go with so there's non-irritating, non-sensitizing, hypoallergenic, even stuff like you see claims all the time about dermatologists tested.
32:26
SPEAKER_01: Generally speaking, any of those things I just mentioned are referring back to a 50 or 100 subjects repeat insult patch test on the skin.
32:36
SPEAKER_01: So those are actually the claims that people make on the products.
32:39
SPEAKER_01: That's what they want, right?
32:40
SPEAKER_01: It's not necessarily about proving something is safe, it's about getting that core marketing language on your label most of the time.
32:50
SPEAKER_01: In some ways, that's okay.
32:51
SPEAKER_01: Like it's good if we make those the benchmarks.
32:54
SPEAKER_01: At least there's been a panel which has had this product exposed to them for, you know, let's say five or four weeks of time, which is more than they would have continuous applications on their body.
33:08
SPEAKER_01: So like these are entry-level safety tests that are helpful and they do give you an idea about what you're putting on your body and if it's going to cause a reaction, at least on a very small sample.
33:20
SPEAKER_00: Yeah.
33:21
SPEAKER_00: No, I mean, that is good though.
33:22
SPEAKER_00: But like at the same time, like I want to play devil's advocate and say, I agree that that's a great point, but there's a lot more, right?
33:29
SPEAKER_00: That needs to go behind it.
33:30
SPEAKER_00: Like dermatologist tested to me, like doesn't mean anything.
33:33
SPEAKER_00: Like, I'll be honest with you, Brian.
33:35
SPEAKER_00: Like, I see that and I'm like, okay, and you know, like it's doesn't mean anything to me.
33:40
SPEAKER_00: And it just doesn't, it doesn't resonate anymore for me as a consumer.
33:44
SPEAKER_00: So I feel like, yeah, you're right, but I think we need to see a lot more, you know.
33:48
SPEAKER_00: It's not enough.
33:49
SPEAKER_00: Yeah, exactly.
33:51
SPEAKER_01: And even then, like when this test that people are mainly selling this dermatologist tested claim from, it's really minimal and it's done on your back.
34:01
SPEAKER_01: It's done with semi-occlusive gauze or an occlusive, what's called the fin chamber on the back.
34:07
SPEAKER_01: But it's kind of like the allergy testing that you would do if you go to the doctor where stuff is left in contact with your skin.
34:12
SPEAKER_01: It's really not a real-world measure of how things are going to be absorbed on your face or when they are coming in contact with your eyes or other mucous membranes.
34:22
SPEAKER_01: So that is not enough of a measure.
34:24
SPEAKER_01: I see hair care brands all the time talking about safety because of this patch testing.
34:30
SPEAKER_01: Whether or not something causes a little bit of redness or erythema or dryness on your back has nothing to do with whether it's going to damage your hair or your scalp.
34:40
SPEAKER_01: So it's really important to differentiate and not make again these like sort of one-off blanket, I guess, rules, whether they're bioavailability or this nonsensitizing sort of side.
34:53
SPEAKER_01: Like that's not enough for every product out there.
34:56
SPEAKER_01: And there's so many different categories of products.
34:58
SPEAKER_00: Yeah, exactly.
34:59
SPEAKER_00: No, and also that made me think of how people want to say, like, this product is good for everybody.
35:04
SPEAKER_00: Even something like that, like really irks me because, like, for example, like teenagers have way thicker skin than someone who's like in their 50s.
35:12
SPEAKER_00: So, like, when you're reacting something of doing a patch test on someone's skin of a certain age group, you have to be, you should be disclosing that information.
35:20
SPEAKER_00: Okay, we tested 50 people within this age bracket.
35:23
SPEAKER_00: And that's how I feel like it should be standard now because that's gonna really impact those little parameters, impact everything from the level of sensitization to the amount of reaction it's having, the chemical or whatever you're testing.
35:36
SPEAKER_00: These kind of things just aren't, I just I don't know.
35:38
SPEAKER_00: We just haven't done it, you know, in the industry.
35:40
SPEAKER_00: But yeah, I'm curious to see how brands moving forward with Macra and everything that's being done now or introduced, like how this impacts the way brands think going forward, because it's definitely a very, very gray zone and it needs to be fixed at this point.
35:55
SPEAKER_01: Let me ask you a question about the sort of all skin types thing, because that's a claim that's almost constantly sought after in our world when people want to test the product.
36:04
SPEAKER_01: So if you see the language out there that says tested on all skin types, to you, does that mean oily combination dry, or does that mean tones of skin or type like Fitzpatrick types of skin?
36:19
SPEAKER_00: It means a lot more, honestly, Brian.
36:22
SPEAKER_00: It means all of that plus more.
36:23
SPEAKER_00: When I think tested on all skin types, I immediately see that as a gimmick, like honest to God, like as a consumer.
36:30
SPEAKER_00: Why?
36:30
SPEAKER_00: Because I know from a science perspective, like one of the parameters which I laid out a minute ago about the thickness of the skin, I know that matters.
36:37
SPEAKER_00: Also, if you have any underlying, like, for example, autoimmune conditions, even something like Hashimoto's, which I know a lot of women are affected by, you can be much more reactive to something than someone who has nothing like that.
36:51
SPEAKER_00: Or where you have grown up in the world matters as well.
36:54
SPEAKER_00: I mean, there are so many things that for me come into play when I think of all skin types.
36:59
SPEAKER_00: For example, like darker skin tones, there is a difference between, I mean, for so long, people thought there's no difference between highly melanated skin versus non.
37:07
SPEAKER_00: And it's absolutely incorrect to think that way because we're now in cotton covering that there's a huge difference.
37:12
SPEAKER_00: So, yeah, skin tone absolutely matters, age matters, where you're testing on their skin matters is so much.
37:19
SPEAKER_00: So I think personally, right now, as is, I see it as a gimmick and I don't believe it.
37:24
SPEAKER_00: Just like the dermatologist testing thing, because I don't think it means anything right now.
37:28
SPEAKER_00: It could, we could grow into a place where now we're properly doing this from a scientific perspective of like, okay, we're being thorough with our testing, but I just don't think it's there yet.
37:39
SPEAKER_01: It's not there.
37:39
SPEAKER_01: I love your answer.
37:40
SPEAKER_01: Basically, no matter how people are testing these products, at the end, the big brands are doing 75 or 110 subjects in a clinical study.
37:50
SPEAKER_01: That's not all skin types.
37:52
SPEAKER_01: That's one subset of people who all live in generally the same geographic area, whether the clinical testing site is in New York or Tokyo or London.
38:04
SPEAKER_01: The people all have a relatively similar exposure on the outside, at least some type of like cultural norms and similarities, but it's not all skin types at all.
38:14
SPEAKER_01: Whether you consider the oiliness or the Fitzpatrick types, there's so many other variables, and it is definitely a gimmicky claim.
38:21
SPEAKER_01: And it's something that comes into play with almost every study we look at.
38:25
SPEAKER_01: And there's other limiting factors too.
38:27
SPEAKER_01: So sometimes there's brands out there who want to make that claim, and they're only going to look at the Fitzpatrick, they're only going to look at the oiliness.
38:34
SPEAKER_01: Like that's less important than the scattered age range and the other conditions that come in with people's past history, interactions with products, any types of like topical or atopical conditions that they might have.
38:47
SPEAKER_01: So it's really those are definitely loose and light claims, and people buy based on them.
38:53
SPEAKER_01: So those are places that honestly, like there really shouldn't be as much focus.
38:57
SPEAKER_00: No, there I completely agree with you.
38:59
SPEAKER_00: And you know what?
39:00
SPEAKER_00: Honestly, my from what I've noticed as a consumer, right?
39:03
SPEAKER_00: It's coming down to the idea that as soon as something new comes out, like a little bit of regulation, not even regulation, but just like, hey, we can validate you a little bit on like, you know what I mean?
39:13
SPEAKER_00: One part of whatever people jump on, like brands jump on that and they don't look any further.
39:18
SPEAKER_00: They just say, okay, well, here's this new test, and this is just going to validate everything that we've ever done.
39:24
SPEAKER_00: That's just not the case.
39:25
SPEAKER_00: That holistic approach absolutely cannot go out the window.
39:28
SPEAKER_00: We have to really sit down.
39:30
SPEAKER_00: And I swear to God, Brian, I've gotten heat about this, but I mean no harm when I say it.
39:35
SPEAKER_00: I don't think, like, literally, I love cosmetic chemists.
39:38
SPEAKER_00: Some of them I know so many, and they're just brilliant, brilliant people.
39:41
SPEAKER_00: But chemistry is not the end all be all.
39:43
SPEAKER_00: It's just not.
39:44
SPEAKER_00: Where is your medicine?
39:45
SPEAKER_00: Where's your the allergy specialist, the toxicologist?
39:48
SPEAKER_00: There's so many disciplines that we are just not looking at.
39:52
SPEAKER_00: And the amount of money that some of these brands have, I absolutely refuse to believe that there's any excuse at this point for them to not go and reference these professionals.
40:01
SPEAKER_00: Like just go out of your way.
40:03
SPEAKER_00: Like, even if there's something not in place, take it upon yourself if you have the budget and say, no, I'm going to get a toxicologist involved.
40:10
SPEAKER_00: I'm going to get such and such person involved.
40:12
SPEAKER_00: And then I'm going to send a set of standards for people to follow because that's where I think the most impact is going to happen is setting a bar.
40:20
SPEAKER_00: And with that, I actually want to ask you something, Brian.
40:22
SPEAKER_00: And it's for the smaller brands out there, but you know, brands that could afford, right?
40:26
SPEAKER_00: What are the things they should look for when it comes to clinical or safety testing, you know, in terms of a lab?
40:31
SPEAKER_00: Um, if you could tell us.
40:33
SPEAKER_01: Sure.
40:33
SPEAKER_01: So the biggest thing is going to be openness and transparency.
40:38
SPEAKER_01: And I don't mean that from like corny, one group is better than another kind of way.
40:42
SPEAKER_01: What I mean is that there is not a specific sort of playbook that you're meant to follow.
40:48
SPEAKER_01: So you need to work with somebody who's willing to look at how big your company is, what the risk exposure is, what your designated market is, and sort of what competitors out there are doing.
41:00
SPEAKER_01: So every safety and efficacy package is going to end up being customizable and it's going to end up being tailored to your particular SKU or your individual product.
41:11
SPEAKER_01: If it doesn't feel that way from the start, you should move on and find another partner.
41:16
SPEAKER_01: There's a million different ways to go about substantiating even a claim like hydrates the skin in as little as one use.
41:24
SPEAKER_01: So what you want to do is really get options.
41:27
SPEAKER_01: Speak to a number of different labs and see if you get stuck with salespeople, see if you get stuck with someone who actually knows what they're talking about.
41:35
SPEAKER_01: And then see if you if you talk to somebody who's willing to open up and sort of refer you to other groups and industry professionals.
41:43
SPEAKER_01: You want to get as many opinions as you can, even when it comes to efficacy and the number of participants that you're meant to use in clinical studies, those are dictated mainly by the supply chain at this point.
41:56
SPEAKER_01: You know, if you're going out to Sephora or HSN, QVC, if you're going to Target, these are the areas that actually have a minimum in place for the number of participants you're meant to use, not necessarily FDA, not necessarily any other group out there.
42:11
SPEAKER_01: So the biggest thing is knowing that your product is unique and different, knowing what stage your business is at and looking to get a really sort of heartfelt, customized approach to getting you what you need, maybe not going over the top and selling you the Rolls Royce before you're ready for it, but at the same time, looking at least a year or two down the road so that if you're gonna invest time and money into some clinical studies for efficacy or safety, you tick boxes for the next couple of growth stages that you have.
42:43
SPEAKER_01: You don't want to sort of be caught with your pants down in a year as you expand into a new supply chain channel just to realize that if you tested on five more subjects last year, you wouldn't have to go and do a whole other set of efficacy.
42:57
SPEAKER_01: So yeah, it's really about going through that and opening up.
43:00
SPEAKER_01: And then the other most important thing is getting marketing and research and development both on the line because marketing way too often dictates what the claims are supposed to be.
43:14
SPEAKER_01: And as you know, that's not how it works.
43:17
SPEAKER_01: The product has to have its own efficacy, like you have to see how something interacts.
43:23
SPEAKER_01: It's not about marketing to sort of steer the ship.
43:26
SPEAKER_01: It's okay to have goals, but each product has to be tested before you can start printing labels and telling people what works and what doesn't.
43:34
SPEAKER_01: And all too often, that's not the way that it works.
43:38
SPEAKER_00: Yeah, I love that.
43:39
SPEAKER_00: And I love what you said about this differentiation because I think when it comes to safety, I completely agree with you.
43:45
SPEAKER_00: You have to let scientists make that decision and you have to let RD make that decision.
43:49
SPEAKER_00: If you have marketing people sitting in those calls and making, you know, decisions about what you need and don't need as a brand, that automatically just it completely messes everything up.
43:59
SPEAKER_00: So I completely agree.
44:00
SPEAKER_00: You, I think that you know, there needs to definitely be a little bit more understanding.
44:04
SPEAKER_00: Like, if you are if you're really trying to do this as a brand, you need to do it the right way.
44:08
SPEAKER_00: And you just can't have when it comes to science, you can't have opinions involved and budgets that limiting your budget or stuff.
44:14
SPEAKER_00: You gotta do what you gotta do and get it out there, and then you're probably gonna sell more products.
44:18
SPEAKER_00: I mean, let's be honest.
44:20
SPEAKER_00: If you're honest, and this is what I don't get, Brian, about brands is like if you're honest and you're upfront, and you know, we love talking about transparency and stuff.
44:27
SPEAKER_00: If you're truly transparent, it's gonna show in your testing, and that is going to make your brand sell because a lot of consumers out here, we wanna know.
44:35
SPEAKER_00: And more of us are out here now than ever before, in my opinion.
44:39
SPEAKER_00: So it's like it's you know, it's an investment, but it's the right investment.
44:42
SPEAKER_00: So I don't know why brands don't do it, you know, more or just I guess more thoroughly, I should say, but they really should.
44:48
SPEAKER_01: They definitely should.
44:50
SPEAKER_01: I think sort of tying that back together with one of your former points, too, with which is no offense to anyone listening, but that cosmetic chemists don't know everything.
44:59
SPEAKER_01: We're in a place now where it's easier than ever to launch and scale a brand based on a concept or a dream.
45:08
SPEAKER_01: So you can skip a lot of steps that you used to have to go through.
45:13
SPEAKER_01: And scalability can happen almost overnight when you hit one of these like direct-to-consumer mass supply chain sort of boosting outlets.
45:22
SPEAKER_01: So, based on that, it's scary because a lot of steps get skipped as companies go from five or$10 million in sales to$500 million over the course of a six or eight month period.
45:33
SPEAKER_01: So that's when it starts to get risky because now you have a product that's hit the mass market that a couple of people basically formulated and loved and tested on a really small sort of subpopulation or panel, and they don't have real world data outside of a tight geographic area across multiple skin types and multiple markets.
45:53
SPEAKER_01: So yeah, it's great that it's easier than ever to launch a brand, but at the same time, it's so important that new beauty upstart ventures look at safety and they don't sort of brush over that stuff.
46:06
SPEAKER_01: Like you need to prove that your product is unique.
46:09
SPEAKER_01: Not everything out there works as well as it says it does, and that's the bottom line.
46:14
SPEAKER_00: Absolutely.
46:14
SPEAKER_00: Yeah, 100%.
46:15
SPEAKER_00: And I actually I wanted to ask you actually if there's anything that you know of that's in place on the side of manufacturers, where if I go to a manufacturer, right, and I say, I want to create a serum with hyaluronic acid, these types, I did my homework, say I'm a founder, I know my stuff, and I did my homework on the ingredients, and I go to them and I say, These are the ingredients I want, make sure that they're all safe, right?
46:36
SPEAKER_00: And I want them to do that testing before they even make the product to know that that ingredient in the concentration I'm gonna need it in my product.
46:43
SPEAKER_00: Does something like that exist at all in manufacturing facilities?
46:46
SPEAKER_01: Or so there's listing services out there.
46:49
SPEAKER_01: I have some friends at the Good Face Project and Ethos Global, which both sort of do regulatory compliance and you can put the ingredients that you're looking to, I guess, to determine if there's if you could pop them into an online registry, you can see sort of what flags there are and what's good for what area.
47:09
SPEAKER_01: The the problem with it is that every formulation is unique.
47:12
SPEAKER_01: And as we all know on the chemistry side, when you combine different ingredients, unexpected things can happen.
47:19
SPEAKER_01: So you can get a good preliminary feel for whether or not um different concentrations are going to be either acceptable in regulatory environments or known to be irritating, but it's all about that final end formulation.
47:34
SPEAKER_01: And that's why it's so important that each specific end skew is tested.
47:39
SPEAKER_00: Yeah, yeah.
47:40
SPEAKER_00: No, I get that.
47:41
SPEAKER_00: That that makes sense.
47:42
SPEAKER_00: I'm just curious from like, because we were talking about bioavailability before and stuff, there's like any kind of metric already in place that lets you know, like, oh, this ingredient is because I know with you know, with with drugs, it's like you don't want to take certain drugs with other ones because they'll inhibit certain enzymes that break down the drug.
47:57
SPEAKER_00: And so that's there, systemically speaking.
48:00
SPEAKER_00: But with topical product, I mean, I'm just curious.
48:02
SPEAKER_00: If there's not one, there needs to become like this directory of information that lets you know, okay, this ingredient at these concentrations is going to be viable in a formula versus not.
48:13
SPEAKER_00: It's just something like that.
48:14
SPEAKER_00: I don't know.
48:15
SPEAKER_01: They always think it's a lot of science, but it's so proprietary in our world here.
48:20
SPEAKER_01: So unlike with pharma studies or supplement or vitamin studies, you're in a different world because each brand really sits on their clinical results.
48:30
SPEAKER_01: Nobody's out there publishing for the most part.
48:32
SPEAKER_01: I'm not gonna say nobody, but for the most part, brands don't actually publish the entirety of an efficacy study, like you were saying, or a safety study.
48:41
SPEAKER_01: So they're not doing more than the claim.
48:43
SPEAKER_01: They're not doing more than saying suitable for all skin types.
48:46
SPEAKER_01: So at the same time, when they've proven that they have something that is safe or that hydrates up to 150% in as little as one use, they're not publishing this in a public environment, nor are they required to.
49:00
SPEAKER_01: So there's no way that other companies could look at the pre-existing data and make any sort of assessment.
49:07
SPEAKER_01: And I think it would be it's a big change to sort of go the other way with that.
49:12
SPEAKER_01: I think that publishing studies and peer review are critical and it would be a great improvement for skincare and beauty if that was the way things went.
49:20
SPEAKER_01: I mean, that's one of the things that safety and FDA and MoCRA could theoretically, I guess, sort of bottleneck people into.
49:28
SPEAKER_01: It would be amazing if people had to publish the studies behind their claims.
49:33
SPEAKER_01: That's a way of making things more safe and ensuring that consumers understand more about how the individual claims arise and what types of populations that products are tested on.
49:43
SPEAKER_01: So, I mean, that's one way we could go about it.
49:45
SPEAKER_01: But until that happens, I think it's tough to try and get people to voluntarily just commit those sort of proprietary bits of information and what they consider core competencies.
49:56
SPEAKER_00: Absolutely.
49:56
SPEAKER_00: That's a that's a very, very strong point.
49:58
SPEAKER_00: I agree with you.
49:59
SPEAKER_00: I think it, yeah, it's gonna take a lot, I think, at this point.
50:02
SPEAKER_00: I know that we're getting there, but yeah, there's a lot to consider and there's a lot of different moving pieces to this, but I'm hopeful.
50:09
SPEAKER_00: You know, I hope that we eventually get to a place as an industry where we can pride ourselves on the safety aspect of the products that are we're putting out there.
50:16
SPEAKER_00: You know, I think we're there's a lot of people that I've met in the industry that are very proactive.
50:22
SPEAKER_00: Like they want this, but it's kind of like, you know, who's gonna do it, right?
50:26
SPEAKER_00: Like who's gonna really get in there and figure out all the details and like you said, with the studies, but a lot more, you know, also like figuring out every step of what you need to say a product is truly efficacious and safe.
50:37
SPEAKER_00: I mean, that's a very big task, and I just hope the FDA they put a lot a lot more time into this because it's gonna take time.
50:43
SPEAKER_00: There's no way to figure this out overnight.
50:45
SPEAKER_00: And I feel like honestly, I think Makara did kind of pop up for me at least overnight.
50:50
SPEAKER_00: Like I all of a sudden learned about it and I was like, what is going on?
50:53
SPEAKER_00: Like we are just we're doing this now.
50:55
SPEAKER_00: Okay, cool.
50:56
SPEAKER_00: I didn't know I didn't even know it was coming.
50:58
SPEAKER_01: So I think it was one of those sort of overnight congressional sessions where they renamed a bunch of bridges and highways, and then all of a sudden also decided to reshape the entire skincare industry in one fell swoop.
51:13
SPEAKER_00: Yeah, no, I think you're right because it really did it hit me, came from the left, and I was like, okay, I guess we're just gonna get on board with this and see where it goes.
51:21
SPEAKER_00: But yeah, I'm curious to see what happens.
51:23
SPEAKER_00: But Brian, this has been so fun.
51:24
SPEAKER_00: I love how much you know.
51:25
SPEAKER_00: Before we go though, I want to talk about your company because we haven't had a chance to talk about the work you do with Validated.
51:31
SPEAKER_00: If you could tell us a little bit about it so that the brands and the founders listening in could maybe avail your services.
51:36
SPEAKER_00: Sure.
51:36
SPEAKER_01: Yeah, I'd be happy to.
51:37
SPEAKER_01: So Validated Claim Support is a primarily efficacy-focused testing lab that specializes wholly on the in vivo side of clinical studies.
51:48
SPEAKER_01: So we can help source the safety testing work at labs that we trust all over the world, but our main area of expertise is in clinical expert grading, instrumental assays to see what's changing on the surface of the skin, like electroconductivity for hydration or sebum or oil production.
52:08
SPEAKER_01: We're FDA registered and inspected on the OTC drug side of the fence.
52:14
SPEAKER_01: So we can test medical devices, we can test OTC products, we could do skincare cosmetics.
52:19
SPEAKER_01: So our four main focuses are the biophysical instrumentation, expert clinical grading, subjective consumer perception, and then clinical before and after photography.
52:31
SPEAKER_01: And the latter piece is something that we're really industry or world leading in.
52:37
SPEAKER_01: My partner, James Vanzetta, is, I think, perhaps the most renowned clinical photographer out there for before and after photos.
52:45
SPEAKER_01: It's all about showing what really happens when a product and time get to have their way with skin, trying to minimize all of the other variables that generally become apparent.
52:57
SPEAKER_01: So it's really the efficacy side that we focus on and we custom tailor our studies based on the needs of individual brands.
53:05
SPEAKER_01: I work with major multinational pharma companies and then we'll work with ingredient supplier or novel raw material groups that want to get efficacy work on something that they've just discovered.
53:17
SPEAKER_01: So there is a study out there that can fit most people's needs.
53:22
SPEAKER_01: It's never going to be something that there's a there's not necessarily like a right and a wrong with catalogs on how to go about efficacy.
53:30
SPEAKER_01: So what I mentioned earlier is really important for either Upstart Beauty or sort of growing, developing companies.
53:36
SPEAKER_01: It's get a number of opinions, reach out to as many different labs as you can, see what kind of expertise people have and determine what's the best fit for your product.
53:48
SPEAKER_01: And also don't skimp on knowing about where you're going over the next two years at a minimum.
53:54
SPEAKER_01: If you can look out further, then great.
53:56
SPEAKER_01: But honestly, think about it as how unique you sell your product and how you know that it's different than everything else out there.
54:03
SPEAKER_01: You have to prove it too.
54:04
SPEAKER_00: Yeah, yeah, absolutely.
54:06
SPEAKER_00: I love that you do that though.
54:07
SPEAKER_00: That's so important.
54:08
SPEAKER_00: And I think that, you know, when it when it comes to efficacy, there's never enough information.
54:11
SPEAKER_00: I feel like we need as much as we can get as consumers.
54:14
SPEAKER_00: I mean, there's just been too many years of BS claims.
54:17
SPEAKER_00: And honestly, as much as we talked about safety here, efficacy is, I think, just now coming into full bloom where brands are saying, okay, now we have to prove that our stuff really works.
54:26
SPEAKER_00: So I really suggest if there are any founders listening in, really check out the Brian's company and what they do.
54:31
SPEAKER_00: Because, like I said, you know, you got to tell consumers as much as you can.
54:34
SPEAKER_00: It's just the age we're in.
54:36
SPEAKER_00: We all want that information.
54:37
SPEAKER_00: We all want to know, you know, is this eye cream actually going to do something?
54:41
SPEAKER_00: You know, like is it gonna actually get rid of dark circles or whatever it is you're claiming?
54:45
SPEAKER_00: Like we have to be transparent.
54:47
SPEAKER_00: And I think you can never invest enough into that, in my honest opinion.
54:50
SPEAKER_00: So I'm a huge fan.
54:52
SPEAKER_00: Thank you, Brian, for coming onto the show, for sharing all this knowledge with us.
54:55
SPEAKER_00: You know, I didn't know it most of what you told us here today.
54:57
SPEAKER_00: So I really appreciate it.
54:58
SPEAKER_01: Yeah, sure thing.
54:59
SPEAKER_01: It's been an absolute pleasure.
55:00
SPEAKER_01: Thank you for chatting with me, Dr.
55:02
SPEAKER_01: Ecta.
55:03
SPEAKER_00: Thank you so much.
55:03
SPEAKER_00: And for everyone listening, if you have any questions, any comments, if you'd like to chime in, please don't hesitate.
55:08
SPEAKER_00: Send us an email, comment, whatever it fits you best, but let us know and let's keep this conversation going because it's definitely a big one.
55:15
SPEAKER_00: And maybe, Brian, you can come back on the show sometime.
55:17
SPEAKER_00: So I'd love to continue it.
55:18
SPEAKER_01: I'd absolutely love to.
55:19
SPEAKER_01: And just to add to what you just said, too, my intention is to totally sort of bring the veil down a little bit on what claims and safety mean.
55:29
SPEAKER_01: So for full disclosure, I mean, I have no stake in safety testing, and I'm happy to sort of comment and help direct people to other avenues, you know, to look at what somebody might need and give them some options.
55:42
SPEAKER_01: That's not something that I sell or do in my day-to-day life.
55:46
SPEAKER_01: So, I mean, I'm really happy to be a resource as it works out.
55:50
SPEAKER_01: On the efficacy side, I'm happy to build you a study too.
55:53
SPEAKER_01: But there, that's where I do actually sort of make my money.
55:57
SPEAKER_00: I think a lot of people should take you up on the advisory thing, though, Brian, because I mean, we need that.
56:01
SPEAKER_00: You need, I feel like you know, companies need to have you on board because people need to understand what it really means to be safe or to be even efficacious.
56:10
SPEAKER_00: You have to get people's opinions who know what they're talking about.
56:13
SPEAKER_00: And that's something I think our industry is starting to do, but we definitely don't see enough of it.
56:16
SPEAKER_00: So I'm a huge supporter, and just from learning from you today, like I know you definitely know your stuff.
56:21
SPEAKER_00: So if there's any founders out there and you guys are looking to get into this space a little bit more and understand more for your own brand, yeah, definitely reach out to us and we will get you in touch with Ryan.
56:30
SPEAKER_00: And I can also send you his information if that helps.
56:33
SPEAKER_00: But thank you so much, and I will be back next time.
56:35
SPEAKER_01: Thank you.
56:36
SPEAKER_00: Hey guys, so I hope you love that episode.
56:38
SPEAKER_00: Please make sure to hit subscribe if you're tuning in to us on any podcast platform.
56:43
SPEAKER_00: We are available on so many different platforms.
56:45
SPEAKER_00: So wherever it is that you're tuning in, just go hit subscribe.
56:49
SPEAKER_00: You will be immediately notified when we publish new episodes.
56:52
SPEAKER_00: This way, you're able to tune in to amazing insights from experts, brand founders, industry leaders, authors, all the wonderful people that we host.
57:00
SPEAKER_00: And that's very important for me because I love to hear from you guys and really understand what you love and what you want to hear more of.
57:08
SPEAKER_00: Also, make sure to give us a follow on all of our social media outlets.
57:11
SPEAKER_00: We are available on Instagram, TikTok, X, you name it, we're there.
57:15
SPEAKER_00: We also have a blog on Medium.
57:17
SPEAKER_00: So if you're a reader and you love medium blogs, check us out on Medium.
57:21
SPEAKER_00: We publish some really great articles on there that do deeper dives than just what's available on the podcast.
57:26
SPEAKER_00: And it's really a great place for all of you science geeks out there that want to learn a little bit more.
57:31
SPEAKER_00: We go above and beyond with our research and making sure we're bringing you information that you usually probably won't hear about in other outlets.
57:38
SPEAKER_00: So check us out, leave us a comment, leave us a review, and we'll be back next time with another episode.
57:43
SPEAKER_00: Thank you.