Why Cosmetic Ingredient Names Matter and What MOCRA Really Means - Interview with Heather Bustos

In this episode, I sit down with FDA compliance attorney Heather Butos to unpack two topics most cosmetic pros ignore until it’s too late: INCI (ingredient) names and MOCRA (the new cosmetic law).

We talk about how ingredient naming is not just labeling, it’s a strategic business decision that can make or break product marketing. Heather breaks down how the Personal Care Products Council influences naming conventions, why companies struggle to sell ingredients when they can’t describe them well, and what’s actually allowed under FDA rules.

We also dive into the Modernization of Cosmetics Regulation Act (MOCRA). We discuss what’s already in effect, what’s still vague, and why this transition period is both confusing and critical. Along the way we share real-world GMP audit stories, how COVID shaped compliance, and why walking the factory floor gives better regulatory insight than just reading guidance documents.

This is not your typical cosmetic compliance talk. If you make or sell cosmetics, personal care products, or ingredients, pay attention.

Show Notes (Bulleted)

• What are INCI names and why they exist
• The Personal Care Products Council and how INCI naming works
• How ingredient naming crosses into marketing strategy
• Real-world examples of label creativity and regulatory risk
• Making sense of MOCRA — what’s live, what’s stuck
• Why registration, adverse event reporting, and safety substantiation matter now
• What we still don’t know about cosmetic GMP enforcement
• GMP audits vs desk compliance — why experience matters
• U.S. vs EU regulatory contrast (quick take)
• Tips for staying compliant while FDA rules evolve

What You’ll Learn

• How to think about ingredient names as part of your product strategy
• What’s actually required vs what’s still vague in cosmetic regulation
• How the naming process works with industry groups
• How MOCRA changes the compliance landscape
• Real compliance lessons from factory audits

Resources Mentioned

• Personal Care Products Council
• MOCRA (Modernization of Cosmetics Regulation Act)
• Cosmetic registration and listing
• Adverse event reporting basics

Who This Is For

• Cosmetic brand owners and founders
• Ingredient suppliers and formulators
• Regulatory affairs professionals
• Legal and compliance teams
• Anyone confused by cosmetic labeling rules

Recommended Chapters (Timestamped)

Use these in Buzzsprout chapter markers:

0:00 — Intro
 1:30 — What INCI ingredient names are
 3:30 — How ingredient naming affects marketing
 7:00 — Creative labeling and regulatory limits
 10:00 — GMP audits and manufacturing reality
 13:50 — What MOCRA is
 16:30 — Which MOCRA rules are live
 19:00 — What’s still vague or coming
 21:30 — EU vs US differences
 24:00 — Tips for compliance
 27:00 — Outro

Transcript

SPEAKER_02 0:00

So there are these oil and gas chemical companies who have access to what is considered gold at that time, ethical, right? To make hand sanitizers.

SPEAKER_00 0:09

Hey guys, welcome to another episode of Caliph Deep Dive. I'm here with Heather Bustos.

SPEAKER_02 0:14

I've been a an FDA compliance attorney for the past 10 years. Um I'm not even gonna describe the horrors I saw out there as I got there that I've got.

SPEAKER_00 0:26

Hey guys, welcome to another episode of Caliph Deep Dive. I'm here with Heather Bustos. I'm hoping that unless I get derailed, I'm gonna land up talking about inky names and whatever that means. But before we go down that path, I'm gonna let Heather introduce herself. Heather, why don't you go first?

SPEAKER_02 0:42

Yeah, absolutely. Um, so just a little bit about me. Uh I've been an FDA compliance attorney for the past 10 years. Um, I took a very unique track and essentially went straight from law school into owning my own law firm. Um, didn't really know much about this area until working for a family friend and fell in love with it. If I was not doing this, I don't think I would be in law at all. This is just a passion that I've had for a very long time. Um, and so I have my own firm, Bustos Law Group, uh based in Houston. Um, and we serve clients um everything from manufacturers, distributors, importers, brand owners all across across the supply chain. And we provide uh full service, so label reviews, registrations, gmp audits, and we work with clients in the food supplement, cosmetic, and device industries.

SPEAKER_00 1:35

Today's conversation is inky names. So let's first do this right. Am I saying it right? Is it literally inky I-N-K-Y? Inky inky names?

SPEAKER_02 1:47

I N C I. And I don't have the the the acronym in front of me, but it's essentially, I want to say international nomenclature. So it's essentially an international naming convention um that uh is run by the Personal Care Products Council. Um, and this is like you alluded to, this is a little new to me. This is a project that I just worked on recently with a client, but I found it super interesting. Um, I love when you get to kind of see the science. So in this case, you know, this is an ingredient supplier, and they're really trying to sell this ingredient to people, and they're having a hard time because the current names that are out there available for them to use are just not selling the ingredient. Like they're not enough, right? And so the client's like, I want all the bells and whistles, I want something that's gonna really describe this ingredient for what it is. And so my job was hey, how likely is it that your ingredient is novel enough to earn itself a unique name that you can then use uh compliantly on your cosmetic labels?

SPEAKER_00 2:52

It came as a marketing strategy, more as a let me point out how unique I am. And you went to the Personal Care Products Council, which is an international organization that does this. Now, so are we talking about an international organization based in Europe? Or are we still talking in the US? How does this work?

SPEAKER_02 3:08

No, no, US, US based. Um, but they use this is an international naming convention. Um, but you submit to the PCPC. This is a trade organization, and they essentially have um, you know, groups that sit down every, I think it's like every few months, they come together, they congregate, and then people submit these applications. Um, and then they'll vote on whether you know they will make a new name for a cosmetic ingredient.

SPEAKER_00 3:38

Like, how big is this group? Do you have any sense of that? Like, is it two guys sitting in the back in the back corner or is it a bunch of software?

SPEAKER_02 3:45

This is a big, this is very big, and there's tons of industry giants that are part of this group. Okay, yeah, and they um they go to Congress, they you know try to get legislation passed. Okay, they have conversations with FDA, like this is a really big organization. So it's a lobbying group then, yeah, yeah, that's part of what they do.

SPEAKER_00 4:05

How does that naming give them unique rights? So you get to say something like contains magic formula number one. Is that is that the thought process?

SPEAKER_02 4:15

It's it's in the ingredient statement. So FDA requires that in the ingredient statement you use a common or usual name, and most most of industry uses the inky names as the common or usual name. So if it's not an inky name, then usually you can't use it. They don't give you a lot of leeway. Whereas, for example, and this was something the client was saying is like, why is it that you know, uh, Starbucks can call their ingredients like Starbucks flavored this and that, and I can't do it for cosmetics. The naming conventions are different across different FDA regulated product categories, what's allowed, what's not allowed, just like in drugs, like I said, the client was having trouble getting people to buy the ingredient because they're like, if I can only call it this, why would I why would I buy it?

SPEAKER_00 4:59

So, this client, whoever they were, and I appreciate you sort of walking us through this thought process, they came to you. Now, do they tend to come to you going, I'm having sale problems with my sales, help guide me? And you go, here's a strategy you hadn't thought of, or are they coming in with, here's what we need to fix? Um, can you help us fix this? So, how does that usually work out for you?

SPEAKER_02 5:20

I mean, in this case with Inky, it's it's specifically, I guess, from a marketing perspective. And I have clients who ask questions like that all the time is, you know, can we get creative with how we name ingredients on uh a product? So if there's an ingredient, for example, that might typically be um, let's say considered to have some intended use, but then the client wants it to be a flavor, right? Because they don't want to call it that. So that's where a lot of those ingredient-specific questions come from, is obviously what are the proper ways to list the ingredients? And then can we do some kind of creative working of how we're gonna name this these ingredients on the label so that we can, you know, meet their intended purpose.

SPEAKER_00 6:07

Talk to me a little bit about that. So you you're telling me that they come to you with um how how do I get creative with names? Walk me through that process. How do you think through that that thought process?

SPEAKER_02 6:18

In in terms of you know, getting creative with ingredients, there's also things where you can call something a processing aid or an incidental ingredient. And so clients will ask me, you know, can we lower the percentage of this in the formulation so that it's considered this and not that? And so yeah, it's very strategic, like how you know, and you're really digging into the regulations, you're reading word by word and trying to find a way to kind of utilize the rules, you know, and be creative about how we can solve those problems.

SPEAKER_01 6:54

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SPEAKER_00 7:01

Is it fair to say that a lot of your practice is, I mean, I recognize you do label review, but there there it sounds like there's some manufacturing element, a pretty significant manufacturing element from what you get into. Is that fair?

SPEAKER_02 7:15

Yeah, yeah, definitely. And it's funny because I just brought this up to someone else recently. A lot of attorneys in the space, I think, uh, maybe don't have as much experience on, like, let's say the auditing or the manufacturing side. They've read through, they've answered warning letters, right? From a technical perspective. Something that I got into, which I kind of fell into during COVID. So there are these oil and gas chemical companies who have access to what is considered gold at that time, ethanol, right? To make hand sanitizer. They don't know how to make it. I was basically going out to these facilities out in West Texas, walking the floors and auditing and helping them get compliant with OTC regulations, which as you know, it's a pretty high standard. Um, I'm not even gonna describe the horrors I saw out there that I'm I mean, yeah, it was interesting. I was those are my horror stories, but it gave me a really great insight into how to kind of walk in these situations um inside of a manufacturing facility, understand how the processes work in real time. Um, and so that's how I kind of started uh on the side of auditing GMPs, and I've continued doing that as well. Um, and it it colors your whole experience. Like when you're when you're responding to a warning letter about a water system and you've seen it in real time, what it looks like, how it works, it just it just makes it that much better, and uh you're much more able to serve your clients. So, yes, that is a side that I've gotten really good experience with.

SPEAKER_00 8:52

It it you remind me of this is what I worry about this when I talk with other food and drug lawyers because we get into sharing war stories, which is what's about to happen. Um, I I um I've I've walked on to I I used to be corporate counselor for a company, and um, I just started off uh in that role. I landed um to just literally for the first time see our manufacturing plant. Um and the guy who's picking me up goes, the FDA just came and we're we're having an audit as we speak. I don't even know what the facility looks like. But as you pointed out, it's it's you're getting there, you're getting to see the people in action, you're deciding who needs to stay, who needs to go, you're deciding you're deciding um what does the how do you prepare a war room uh and and how do you respond to a warning letter afterwards or a 483 or the like. So my point to everyone else listening: there is a big difference between someone who can look at a warning letter or look at a 483 and go, oh, here's how we respond based on the regulations. These regulations are there because they're protecting patients, they're protecting the consumers. And someone who's walked those floors knows what that's like, and that's why you want to hire someone with that experience. You don't want someone who's responding technically because the FDA is responding practically, so exactly, and there's a lot of nuance, right?

SPEAKER_02 10:19

Exactly, like a technical response might not hit on some of the nuances that you would know from walking that floor. I agree a hundred percent.

SPEAKER_00 10:28

Um, so so now we're talking a little bit about these. I mean, you you you've said you've thrown out some fancy terms like PCPC and the personal oh, I guess that is the personal care products council. Yeah, see that sounded fancier when when I said PCPC, but I um when does PCPC kick in? Why do I care about the PCPC?

SPEAKER_02 10:51

Like I said, it's a it's a trade organization, they're very involved in the cosmetic side of things um and other personal care products. I think just because of the amount of also education they provide. So I've been to many conferences where they'll send, you know, their people and they're educating on things. I went to one um Cosmoprop in Miami a couple years ago and they did a whole presentation on MoCra. And there were things I learned in that presentation that you're not gonna get off the FDA website because they were able to give you insights into well, we just had a meeting with FDA and they said this is coming or that's coming, or this is the way they're gonna interpret this rule. Because if you're familiar with MoCra, it's so vague. People are having trouble figuring out how to comply, right? So there I would say their education side of things is incredible. I've been to a bunch of webinars, um, and again, they have that insider perspective, you know, that even the FDA is not gonna give you on their webinars.

SPEAKER_00 11:52

What has been your experience? What do you think people should take away in the context of MoCRA? Oh, by the way, maybe you can introduce Mokra to people as well. What is Mokra?

SPEAKER_02 12:01

MOCRA is the Modernization of Cosmetics Regulation Act, a mouth mouthful, which is why everyone says MOCRA. Um, this was a law passed by Congress December 2022, and essentially the law was passed that gave then power to the FDA to create regulations based on those laws. And so that's the process we're in now is the rulemaking. A lot of the rules are kind of vague, and you know what tends to happen with any regulations as they come out is FDA will release guidances where they're kind of fleshing it out a little bit so you can get a little more detailed as to how to implement. Um, it'll usually have like FAQs in there, they'll do entire guidances of just FAQs, right? And that's really helpful. Um, so I think that's what has made it a little difficult as it's rolling out. But I would say, in my own experience, which I've been in this industry uh less time than you. So for me, when Mocha came out, I'm like, yay, there's like updates, like there's new stuff happening, you know. For me, it was like it was a big deal. Um, you know, and and watching it kind of roll out, I think this is one of my first like big experiences with that process. Um, although again, I mean, during 2020, there was all these guidances, the emergency use authorizations. I think there was a new one coming out like almost every day where I would talk to someone, and I had to say, there might be another guidance as we're on the phone. I don't know. You know, it was it was crazy, um, which was a really cool experience. But yeah, um in terms of kind of where we're at now, there are some things that already apply. So registration already applies, you're required to register and product and list your products, which even that people are confused. I had to make a whole graph as to like whether you need to register or not, because even that was like really difficult. There was I had to make this whole chart for clients um to figure out whether you even need to or not. Um, so registration, adverse event reporting, um, safety substantiation. GMPs have not come out yet, so we're waiting on that. Fragrance allergens. I don't think we've gotten that either. A lot of people in industry are like confused, you know, as to how to comply, what to do. You know, they have good intentions, but it's it's a little difficult right now.

SPEAKER_00 14:19

Follow our page on LinkedIn. So my advice for clients right now has been uh and I and I work with drug device, cosmetics, I've worked with tobacco, uh, I've worked with food supplements, um, so pretty much most FDA regulatory stuff. Be very careful what you ask for, you just might get it. So if you ask for clarification, the FDA will eventually give you the clarification. But here's the good news where you are now, the Supreme Court has come out and said, you can't punish someone for not doing something if you didn't tell them not to do it. But so under the Fox v FCC decision, uh the Supreme Court decision, that's that's really where it came out. So I like to call it the Jan Jackson nipple uh showing case. Um and they they went after FCC, the FCC went after Fox saying, hey, you showed that and that was bad, and they were like, tell me where that's wrong. Same exact way. If the FDA doesn't tell you not to do something, you can't punish them for not doing it. Um so in the same way, if you land up with you, FDA don't tell me exactly what the GMP requirements are. I hate to break this to you, but you can't hold me to requirements you didn't put out. So so use this as an opportunity because the FDA will keep narrowing it down, will keep clamping down, and that's good because you get clarity, but it's bad because what you're whatever you're doing is probably not compliant with whatever they're gonna come up with.

SPEAKER_02 15:51

Yeah, I don't even think we've seen. I was just someone was just asking me this question whether they've seen a warning letter specifically just on cosmetic GMPs. I don't think there's been one yet. I could be wrong. You know, what I tell clients, which to me the old standard was don't be adulterated, don't be be misbranded. They don't tell you how to get there. It's open to interpretation, right? So just get there in the ways that you think. Um, I mean, I think regulations, these regulations are good to an extent, and one of the main driving forces is that we want to level the playing field with places like here in the EU, you know, where the standards are like we're not matching up, um, and we need to yeah, be higher.

SPEAKER_00 16:33

I I don't do too much European um cosmetics law at all. So how how different is it?

SPEAKER_02 16:40

Oh no, I I don't practice that either. I just know that they are the gold standard. Okay, I mean I've sat on panels with people from EU. I I did one recently here in Amsterdam. Uh, and the every question that they were asking about, so what's the US doing for microplastics? And what's nothing, nothing. I felt like I had nothing to say, and then the EU person is just going on and on because they're more flushed out, and that's in that's across all uh FDA regulated areas.

SPEAKER_00 17:11

No, I wouldn't I wouldn't agree with that statement. I I'd agree that that's true true for cosmetics and food, for example. But yeah, drugs and stuff, they're they're drugs, not as much. Yeah, okay. Um changed a lot in the last six months, but outside that part.

SPEAKER_01 17:25

Yeah, yeah, yeah, yeah, yeah.

SPEAKER_00 17:26

Uh, but uh I I think this is fascinating, and I think we can have a million more conversations, and I hope we do, because this was so much fun. Before we go, um, Heather, how can people reach you?

SPEAKER_02 17:39

So you can go to our website www.bustosloggroup.com, or you can shoot us an email, info at boostoslawgroup.com. You can also find me on LinkedIn, of course. That's how you and I were introduced. Heather Bustos. Yep.

SPEAKER_00 17:55

Heather, this was amazing. Thank you so much for coming on. This was a wonderful. We'll catch up soon.

SPEAKER_02 18:00

Yeah, sounds good. Thank you.

SPEAKER_00 18:03

Call, click, or email.