Ep 174 – MoCRA Explained – Understanding the Modernization of Cosmetics Regulation Act of 2022

 

 

 

 

 

 

 

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0:01:31.8 Maggie Staszcuk: Hello and welcome to ASCP's Esty Talk. I'm your co-host, Maggie Staszcuk and ASCP's Education Program Manager. 

 

0:01:38.1 Ella Cressman: And I'm Ella Cressman, licensed aesthetician, certified organic formulator, ingredient junky, and content contributor for Associated Skin Care Professionals. Hey, Maggie. 

 

0:01:48.5 MS: Hi, Ella. 

 

0:01:49.8 EC: I'm still at home and I'm coming back soon. Two more weeks, I think. 

 

0:01:55.0 MS: We can't wait to have you in. 

 

0:01:56.0 EC: I know, I can't wait. But I wanted to let you know I'm still keeping a watchful eye on social media, and for that, I do wanna give a shout out to Adriana. She is an eyebrow artist, a permanent makeup artist, aesthetician, and she loves our podcast. So hey, Adriana. It's great that you're listening and we love that you tune in, and I can't wait for you to hear this. 

 

0:02:16.7 MS: Hey, Adriana. So we're gonna be talking today about the passing of MoCRA, and on December 29th of this past year, 2022, President Biden signed into law the Modernization of Cosmetics Regulation Act of 2022 or MoCRA. And this reform, it's bringing more regulation to the cosmetic industry, and it is the first FDA update over cosmetic regulation since 1938. That's huge. 

 

0:02:45.7 EC: Did you hear... Did you hear that though, [chuckle] all these companies like gasping at once?  

 

0:02:55.2 MS: Yeah. That's good. 

 

0:02:56.5 EC: A lot of companies. So I think this is an interesting... I'm very excited to talk about this today. It's a interesting revelation and an advancement, and there's a lot of pluses and a few miss. So let's get into it. 

 

0:03:11.7 MS: Yeah, for sure. 

 

0:03:12.2 EC: So MoCRA is requiring the following, product and facilities registration, which is key. Very, very important. So what does that mean for some professional products and a lot of other products, is that very similar in the food industry, they have... Production must be done in a controlled environment. So they have these clean kitchens, is what they call 'em in the food industry. So now the same thing will be required for all cosmetics, and what they're labeling as cosmetics is going to be skin care formulations and everything. So this is an advancement, no more as they call them so lovingly, bathtub bombs or farmers market mixes. And with that is the introduction of good manufacturing practices for facilities. So we've talked about this before with the regulatory podcast, but these GMP, as it's referred to is... It's like a club that you should be involved with, if you're not you're kind of poo pooed, but now it's going to be a requirement to follow these GMP practices. And with that, what comes with that is a bunch of auditing and it's a very stringent process to pass and then maintain. And then on top of that, we'll have safety testing and serious adverse event documentation. 

 

0:04:33.8 EC: So what happens when you've formulated a product? Some products, especially if they have what's considered drugs, like sunscreen for example, they have to be tested and passed to ensure that it is representing what is included. So that's the case for sunscreen or products that have salicylic acid or other... Whatever the FDA has deemed drugs at a certain percentage. And so now there's safety testing different from stability testing that's currently required. The safety testing is going to be something instilled for all products, no longer a, shouldn't be a problem, now they have to prove that it won't be a problem. And then the other thing would be labeling changes. So right now, there is labeling requirements, you cannot... And any lab that is GMP certified is very strict, and usually the lab is where the products are filled and finished. So they'll get the labels and they will review them, just to ensure their GMP is not at risk, their qualifications. And they'll review them and they'll kick off words like heal, like you can't say heal or you can't use certain other terms. So they'll remove that, but now it's... Apparently they're going to require, if something happens, this is what you must do based on that. 

 

0:05:51.1 EC: And then other additional regulations for products containing talc. Can we get a woohoo? This is awesome because talc by itself, not so bad, but talc... Because where you mine talc is very close approximately to asbestos usually, they're grown very close together, and then the... As we've covered in previous podcasts, the permissions for the amount of asbestos in talc products or talc raw material is alarming at best. So, that's gonna be a really good thing because they'll be more stringent versus... I think it was comparable, this was just a comparable testing that they were doing before for products containing talc when they were looking for asbestos. And they would take a sample which would be equivalent to a teaspoon compared to a truck-sized load of product, they'd take a teaspoon and if it didn't have x amount of parts per million of asbestos then it would pass. So that means they could have just got a good corner or whatever. And then there's also gonna be further investigation into the safety of Per and polyfluoroalkyl substances or PFAS in cosmetics. So that's gonna be really great for... And I see this is probably gonna be anything that is posing alarming reactions. So it's really an advancement towards health of the industry as well. 

 

0:07:15.9 MS: So a lot of changes coming with this. Let's break down some of this a little further, starting with product and facilities registration. So there's already Voluntary Product Registration procedure in place with the FDA. So, this law in theory is gonna change that "voluntary" to mandatory. So by the end of the year facilities are going to have to register with the FDA, and there's a lot of manufacturers that are already complying with this. And you mentioned this already Ella, but a lot of manufacturers that are creating over-the-counter products that have "drugs" like the sunscreens or the acne products, the salicylic that you mentioned, they are registered with the FDA already. But there's those products out there, those manufacturers, that little... The kitchen beauticians, if you will, they're taking that big deep gasp and they're gonna have to comply with this law as well. 

 

0:08:12.1 EC: And there are some companies... This was back when I was... A few years ago, I was consulting for a lot of different brands in a certain space, and they were wanting to formulate these sunscreens, which were effective, very, very effective, but they weren't compliant. And I remember just having these young entrepreneurs super excited about developing products, they had this amazing formulation, they had tested it in our active lifestyle that we have here in Colorado. So it'll be interesting, like you said, that gasp. The FDA has provided guidance on GMP practices since 1997, but now those standards are going to be universally mandated by law. And what we kind of talked about before is you're adopting them or adapting the practices in. It's just very much similar to what Maggie was saying about the facilities registration, but now it's mandated. So there are going to be some facilities who are going to have to step up. Some of the product... Some of our favorites that are gonna have to step up and comply. So, I'm curious to see what that's gonna do to price point for some of the products that are out there. 

 

0:09:23.8 MS: Hold that thought. We'll be right back. 

 

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0:10:51.6 MS: Okay, here we go. Let's get back to the podcast. With regard with safety testing and serious adverse event documentation, this is now required for cosmetic products. It's unclear what those requirements are, but with the passing of this law, the FDA is now going to establish those guidelines. And then also they're going to require mandatory adverse events submission to the FDA. So this is going to be if somebody is having a negative reaction to a specific ingredient, that's gonna be things like rashes, burns, their hair starts falling out. Maybe they're getting burning in the eyes or whatever that reaction is, that all has to be submitted to the FDA, where in the past, it was not a requirement. 

 

0:11:35.1 EC: No, what was required was just the manufactures would take that on and they would do their own investigative things, like send MSDS sheets or whatever. And usually it would fall on the insurance companies, right?  

 

0:11:47.6 MS: Yeah. 

 

0:11:48.2 EC: Usually it would fall on... As a formulator, you would have to... Or as a product manufacturer, you have to have manufacturer's insurance. Even as a private label, oftentimes if you're gonna do some private label, you're required to have manufacturer's insurance for these things because that's where the liability fell. But now it sounds like it's gonna be more of a legal issue than just a monetary issue. 

 

0:12:13.3 MS: And I wonder too, how... I know that labeling is part of this passing of the law as well, but with regard to adverse events happening and safety testing, I imagine labeling is hugely gonna change also. 

 

0:12:28.4 EC: Again... And packaging, we know that's coming. There's... With the California laws requiring certain sustainable packaging requirements, this is gonna change a lot about our industry. Labeling requirements, where we give the MSDS sheets, and I'm curious and I'm interested in your perspective on this. What has tipped this over? Because us, consumers, we have been asking for safe pretty, [chuckle] safe beauty for decades, but now... I have my suspicions on what could be... Having tipped this over. We know that documentary... The four-part documentary that we've seen, and maybe it's more documentary-type things that have happened. But I'm curious why now it's happening. When we look back, let's take, for example, the Johnson & Johnson cases against the talc baby powder. And so that was kind of poo pooed in this good old boy society where they're still cranking out talc baby powder. It was not banned, but it was regulated, kind of. Well now it's gonna be even more regulated and like as we talked about previously, the testing methods are going to be more stringent and hopefully have a closer eye on those things. But I'm wondering, "How did we get here?" And hopefully, hopefully, this is progressive instead of going to have any kind of ill effect. You know what I mean?  

 

0:13:57.0 MS: Yeah, I do. And I think without getting too political, it's just the world that we're living in right now. We've done a lot of podcasts on clean beauty and sustainable beauty, and I think that's just what the consumer is demanding right now, and this is part of that. As aestheticians, we are the consumer also, and we're making demand for products from the manufacturer that are meeting certain guidelines also. 

 

0:14:24.2 EC: I have to think about that one part of the documentary where they were talking about it being a safe place to work, and they were justifying the nail industry at that point. Well, when we look at aesthetics or hair, I was doing some research, the past few weeks I've been doing a lot of research on hair products, hair professionals, haircare professionals and different things, and the scalp is... It absorbs 10 times more than the other areas of the skin, and just thinking about hair stylists with their hands in all those chemicals, same as us. Just, we wear gloves too, but anyways, just thinking about everything we're around. And I think that is spot on, the consumer and the professionals, and then we're speaking up and saying, "Hey, can you help us? Can you help us have a safe place to work, and can you help us ensure we have safe products to use on ourselves?" And I think you're right, I agree with you, it's the world that we live in now that feels really good. [laughter] This part feels great. 

 

0:15:24.2 MS: Regulations surrounding PFAs, just like with talc, they're not yet banned, but heavily regulated. And the FDA is required to assess the use safety and risk associated with them in cosmetics, and they will be publicly publishing its findings by December 29th of 2025. So I think that's interesting with the passing of this law, there's also standards being put on the FDA as well. So it's not just that this law is passed and now the FDA is regulating cosmetics, the FDA also is being held accountable to some degree. 

 

0:15:53.4 EC: I think that's important because... This is another subject I was looking at before, I think we should talk about it too. But there was alarms set off about... And PFAs are scary in my opinion, but there's other words, there's other ingredients that sound scary, and there's alarm bells that go off with some of them too, and I think they get a bad rap for being misunderstood, some of them. Poly Oxy ethanol for example, that sounds super scary. I know, I see the word ethanol and I get gassed, or like, "Ooh, that's... Poly sounds really scary." But it's not. It's naturally derived and it's a great alternative for a preservative, especially compared to parabens. So, there's... It can be... It can be scary in any large amount, but so can anything. So this, for me, having the accountability, because you're looking at reports, whether it's the cosmetic review board here in the States or the FDA in the States, or even what we do often is we look at other countries, we look at Australia, we're looking at the EU, what is permissible in those areas? Because somehow there's this thought process that their standards are higher and that they care more about their citizens. [chuckle] So, I think having the FDA be more accountable and transparent will help with product... With consumer confidence. 

 

0:17:14.1 MS: Yeah, I'm curious Ella, what your thoughts are on, if there are any downsides to the passing of MoCRA. And in my mind, what is... What I'm thinking of, are those aestheticians out there, or those chemists out there that are creating product in their kitchen or in their garage, or even those private label individuals. 

 

0:17:34.7 EC: I think there's a couple of downsides. Any time that you have regulation, then it changes things. As long as it's still an open market for the small businesses to thrive or have an opportunity, so that you're not pushing out those types of people and just leaving room for the big boys, if you will, I think that is going to be very important. So, if you're listening to this and you're thinking you wanna start a line, I think the private labels are fine, because private label labs are usually GMP-compliant and registered anyways, they file that. I think some of these newer brands that wanna start out, these aspiring aestheticians who wanna formulate their own product line, don't let this scare you, just follow. They have these kitchens you can rent, so as... If you wanna make cupcakes and sell them, and they will have clean rooms that you can rent for product development, just to make sure you're doing everything that you can. I get asked a lot where did I go to school to become a formulator. Send me an email, I'll let you know where. But they... There's a lot of this that they go through as well, the business part of it. So I would encourage you to stay excited and still go for it if that's what you... Don't get scared because at the end of the day, it's just passing a test and just staying safe and you're fine. But for some people, they're gonna have to catch up. 

 

0:19:02.7 MS: Now listeners, we wanna hear from you. Do you foresee potential problems with the passing of MoCRA, or is this a good thing for the industry? Share your thoughts with us on social media by commenting on our Instagram or Facebook posts or by emailing getconnected@ASCPSkincare.com.