January 29, 2026 • 18 mins
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
www.kulkarnilawfirm.com
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
SPEAKER_02 (00:00):
So there are these oil and gas chemical companies
who have access to what isconsidered gold at that time,
ethical, right?
To make hand sanitizers.
SPEAKER_00 (00:09):
Hey guys, welcome to another episode of Caliph Deep
Dive.
I'm here with Heather Bustos.
SPEAKER_02 (00:14):
I've been a an FDA compliance attorney for the past
10 years.
Um I'm not even gonna describethe horrors I saw out there as I
got there that I've got.
SPEAKER_00 (00:26):
Hey guys, welcome to another episode of Caliph Deep
Dive.
I'm here with Heather Bustos.
I'm hoping that unless I getderailed, I'm gonna land up
talking about inky names andwhatever 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 (00:42):
Yeah, absolutely.
Um, so just a little bit aboutme.
Uh I've been an FDA complianceattorney for the past 10 years.
Um, I took a very unique trackand essentially went straight
from law school into owning myown law firm.
Um, didn't really know muchabout this area until working
(01:03):
for a family friend and fell inlove with it.
If I was not doing this, I don'tthink I would be in law at all.
This is just a passion that I'vehad 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 umeverything from manufacturers,
distributors, importers, brandowners all across across the
(01:24):
supply chain.
And we provide uh full service,so label reviews, registrations,
gmp audits, and we work withclients in the food supplement,
cosmetic, and device industries.
SPEAKER_00 (01:35):
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 (01:47):
I N C I.
And I don't have the the theacronym in front of me, but it's
essentially, I want to sayinternational nomenclature.
So it's essentially aninternational naming convention
um that uh is run by thePersonal Care Products Council.
Um, and this is like you alludedto, this is a little new to me.
(02:10):
This is a project that I justworked on recently with a
client, but I found it superinteresting.
Um, I love when you get to kindof see the science.
So in this case, you know, thisis an ingredient supplier, and
they're really trying to sellthis ingredient to people, and
they're having a hard timebecause the current names that
are out there available for themto use are just not selling the
(02:30):
ingredient.
Like they're not enough, right?
And so the client's like, I wantall the bells and whistles, I
want something that's gonnareally describe this ingredient
for what it is.
And so my job was hey, howlikely is it that your
ingredient is novel enough toearn itself a unique name that
you can then use uh compliantlyon your cosmetic labels?
SPEAKER_00 (02:52):
It came as a marketing strategy, more as a
let me point out how unique Iam.
And you went to the PersonalCare Products Council, which is
an international organizationthat does this.
Now, so are we talking about aninternational organization based
in Europe?
Or are we still talking in theUS?
How does this work?
SPEAKER_02 (03:08):
No, no, US, US based.
Um, but they use this is aninternational naming convention.
Um, but you submit to the PCPC.
This is a trade organization,and they essentially have um,
you know, groups that sit downevery, I think it's like every
few months, they come together,they congregate, and then people
(03:29):
submit these applications.
Um, and then they'll vote onwhether you know they will make
a new name for a cosmeticingredient.
SPEAKER_00 (03:38):
Like, how big is this group?
Do you have any sense of that?
Like, is it two guys sitting inthe back in the back corner or
is it a bunch of software?
SPEAKER_02 (03:45):
This is a big, this is very big, and there's tons of
industry giants that are part ofthis group.
Okay, yeah, and they um they goto Congress, they you know try
to get legislation passed.
Okay, they have conversationswith 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 (04:05):
How does that naming give them unique rights?
So you get to say something likecontains magic formula number
one.
Is that is that the thoughtprocess?
SPEAKER_02 (04:15):
It's it's in the ingredient statement.
So FDA requires that in theingredient statement you use a
common or usual name, and mostmost of industry uses the inky
names as the common or usualname.
So if it's not an inky name,then usually you can't use it.
They don't give you a lot ofleeway.
Whereas, for example, and thiswas something the client was
(04:35):
saying is like, why is it thatyou know, uh, Starbucks can call
their ingredients like Starbucksflavored this and that, and I
can't do it for cosmetics.
The naming conventions aredifferent 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 tobuy the ingredient because
(04:56):
they're like, if I can only callit this, why would I why would I
buy it?
SPEAKER_00 (04:59):
So, this client, whoever they were, and I
appreciate you sort of walkingus through this thought process,
they came to you.
Now, do they tend to come to yougoing, I'm having sale problems
with my sales, help guide me?
And you go, here's a strategyyou hadn't thought of, or are
they coming in with, here's whatwe need to fix?
Um, can you help us fix this?
So, how does that usually workout for you?
SPEAKER_02 (05:20):
I mean, in this case with Inky, it's it's
specifically, I guess, from amarketing perspective.
And I have clients who askquestions like that all the time
is, you know, can we getcreative with how we name
ingredients on uh a product?
So if there's an ingredient, forexample, that might typically be
um, let's say considered to havesome intended use, but then the
(05:44):
client wants it to be a flavor,right?
Because they don't want to callit that.
So that's where a lot of thoseingredient-specific questions
come from, is obviously what arethe proper ways to list the
ingredients?
And then can we do some kind ofcreative working of how we're
gonna name this theseingredients on the label so that
(06:05):
we can, you know, meet theirintended purpose.
SPEAKER_00 (06:07):
Talk to me a little bit about that.
So you you're telling me thatthey come to you with um how how
do I get creative with names?
Walk me through that process.
How do you think through thatthat thought process?
SPEAKER_02 (06:18):
In in terms of you know, getting creative with
ingredients, there's also thingswhere you can call something a
processing aid or an incidentalingredient.
And so clients will ask me, youknow, can we lower the
percentage of this in theformulation so that it's
considered this and not that?
And so yeah, it's verystrategic, like how you know,
(06:40):
and you're really digging intothe regulations, you're reading
word by word and trying to finda way to kind of utilize the
rules, you know, and be creativeabout how we can solve those
problems.
SPEAKER_01 (06:54):
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SPEAKER_00 (07:01):
Is it fair to say that a lot of your practice is,
I mean, I recognize you do labelreview, but there there it
sounds like there's somemanufacturing element, a pretty
significant manufacturingelement from what you get into.
Is that fair?
SPEAKER_02 (07:15):
Yeah, yeah, definitely.
And it's funny because I justbrought 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'ssay the auditing or the
manufacturing side.
They've read through, they'veanswered warning letters, right?
From a technical perspective.
Something that I got into, whichI kind of fell into during
(07:36):
COVID.
So there are these oil and gaschemical companies who have
access to what is consideredgold at that time, ethanol,
right?
To make hand sanitizer.
They don't know how to make it.
I was basically going out tothese facilities out in West
Texas, walking the floors andauditing and helping them get
compliant with OTC regulations,which as you know, it's a pretty
(08:00):
high standard.
Um, I'm not even gonna describethe horrors I saw out there that
I'm I mean, yeah, it wasinteresting.
I was those are my horrorstories, but it gave me a really
great insight into how to kindof walk in these situations um
inside of a manufacturingfacility, understand how the
(08:22):
processes work in real time.
Um, and so that's how I kind ofstarted uh on the side of
auditing GMPs, and I'vecontinued doing that as well.
Um, and it it colors your wholeexperience.
Like when you're when you'reresponding to a warning letter
about a water system and you'veseen it in real time, what it
looks like, how it works, itjust it just makes it that much
(08:44):
better, and uh you're much moreable to serve your clients.
So, yes, that is a side thatI've gotten really good
experience with.
SPEAKER_00 (08:52):
It it you remind me of this is what I worry about
this when I talk with other foodand drug lawyers because we get
into sharing war stories, whichis what's about to happen.
Um, I I um I've I've walked onto I I used to be corporate
counselor for a company, and um,I just started off uh in that
role.
(09:12):
I landed um to just literallyfor the first time see our
manufacturing plant.
Um and the guy who's picking meup goes, the FDA just came and
we're we're having an audit aswe speak.
I don't even know what thefacility looks like.
But as you pointed out, it'sit's you're getting there,
you're getting to see the peoplein action, you're deciding who
(09:34):
needs to stay, who needs to go,you're deciding you're deciding
um what does the how do youprepare a war room uh and and
how do you respond to a warningletter afterwards or a 483 or
the like.
So my point to everyone elselistening: there is a big
difference between someone whocan look at a warning letter or
look at a 483 and go, oh, here'show we respond based on the
(09:58):
regulations.
These regulations are therebecause they're protecting
patients, they're protecting theconsumers.
And someone who's walked thosefloors knows what that's like,
and that's why you want to hiresomeone with that experience.
You don't want someone who'sresponding technically because
the FDA is respondingpractically, 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 youwould 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 saidyou've thrown out some fancy
terms like PCPC and the personaloh, I guess that is the personal
care products council.
Yeah, see that sounded fancierwhen when I said PCPC, but I um
when does PCPC kick in?
(10:49):
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 thecosmetic side of things um and
other personal care products.
I think just because of theamount of also education they
provide.
So I've been to many conferenceswhere they'll send, you know,
their people and they'reeducating on things.
I went to one um Cosmoprop inMiami a couple years ago and
(11:13):
they did a whole presentation onMoCra.
And there were things I learnedin that presentation that you're
not gonna get off the FDAwebsite because they were able
to give you insights into well,we just had a meeting with FDA
and they said this is coming orthat's coming, or this is the
way they're gonna interpret thisrule.
Because if you're familiar withMoCra, it's so vague.
(11:35):
People are having troublefiguring out how to comply,
right?
So there I would say theireducation side of things is
incredible.
I've been to a bunch ofwebinars, um, and again, they
have that insider perspective,you know, that even the FDA is
not gonna give you on theirwebinars.
SPEAKER_00 (11:52):
What has been your experience?
What do you think people shouldtake away in the context of
MoCRA?
Oh, by the way, maybe you canintroduce Mokra to people as
well.
What is Mokra?
SPEAKER_02 (12:01):
MOCRA is the Modernization of Cosmetics
Regulation Act, a mouthmouthful, which is why everyone
says MOCRA.
Um, this was a law passed byCongress December 2022, and
essentially the law was passedthat gave then power to the FDA
to create regulations based onthose laws.
And so that's the process we'rein now is the rulemaking.
(12:22):
A lot of the rules are kind ofvague, and you know what tends
to happen with any regulationsas they come out is FDA will
release guidances where they'rekind of fleshing it out a little
bit so you can get a little moredetailed as to how to implement.
Um, it'll usually have like FAQsin there, they'll do entire
guidances of just FAQs, right?
And that's really helpful.
(12:43):
Um, so I think that's what hasmade it a little difficult as
it's rolling out.
But I would say, in my ownexperience, which I've been in
this industry uh less time thanyou.
So for me, when Mocha came out,I'm like, yay, there's like
updates, like there's new stuffhappening, you know.
For me, it was like it was a bigdeal.
Um, you know, and and watchingit kind of roll out, I think
(13:04):
this is one of my first like bigexperiences with that process.
Um, although again, I mean,during 2020, there was all these
guidances, the emergency useauthorizations.
I think there was a new onecoming 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 thephone.
I don't know.
You know, it was it was crazy,um, which was a really cool
(13:28):
experience.
But yeah, um in terms of kind ofwhere 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 asto like whether you need to
register or not, because eventhat was like really difficult.
(13:49):
There was I had to make thiswhole chart for clients um to
figure out whether you even needto or not.
Um, so registration, adverseevent reporting, um, safety
substantiation.
GMPs have not come out yet, sowe're waiting on that.
Fragrance allergens.
I don't think we've gotten thateither.
A lot of people in industry arelike confused, you know, as to
(14:12):
how to comply, what to do.
You know, they have goodintentions, but it's it's a
little difficult right now.
SPEAKER_00 (14:19):
Follow our page on LinkedIn.
So my advice for clients rightnow has been uh and I and I work
with drug device, cosmetics,I've worked with tobacco, uh,
I've worked with foodsupplements, um, so pretty much
most FDA regulatory stuff.
Be very careful what you askfor, you just might get it.
(14:42):
So if you ask for clarification,the FDA will eventually give you
the clarification.
But here's the good news whereyou are now, the Supreme Court
has come out and said, you can'tpunish someone for not doing
something if you didn't tellthem not to do it.
But so under the Fox v FCCdecision, uh the Supreme Court
(15:04):
decision, that's that's reallywhere it came out.
So I like to call it the JanJackson nipple uh showing case.
Um and they they went after FCC,the FCC went after Fox saying,
hey, you showed that and thatwas bad, and they were like,
tell me where that's wrong.
Same exact way.
If the FDA doesn't tell you notto do something, you can't
(15:24):
punish them for not doing it.
Um so in the same way, if youland up with you, FDA don't tell
me exactly what the GMPrequirements are.
I hate to break this to you, butyou can't hold me to
requirements you didn't put out.
So so use this as an opportunitybecause the FDA will keep
narrowing it down, will keepclamping down, and that's good
(15:45):
because you get clarity, butit's bad because what you're
whatever you're doing isprobably not compliant with
whatever they're gonna come upwith.
SPEAKER_02 (15:51):
Yeah, I don't even think we've seen.
I was just someone was justasking me this question whether
they've seen a warning letterspecifically just on cosmetic
GMPs.
I don't think there's been oneyet.
I could be wrong.
You know, what I tell clients,which to me the old standard was
don't be adulterated, don't bebe misbranded.
They don't tell you how to getthere.
It's open to interpretation,right?
(16:13):
So just get there in the waysthat you think.
Um, I mean, I think regulations,these regulations are good to an
extent, and one of the maindriving forces is that we want
to level the playing field withplaces like here in the EU, you
know, where the standards arelike 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 thegold standard.
Okay, I mean I've sat on panelswith people from EU.
I I did one recently here inAmsterdam.
Uh, and the every question thatthey were asking about, so
what's the US doing formicroplastics?
And what's nothing, nothing.
I felt like I had nothing tosay, and then the EU person is
(17:03):
just going on and on becausethey're more flushed out, and
that's in that's across all uhFDA regulated areas.
SPEAKER_00 (17:11):
No, I wouldn't I wouldn't agree with that
statement.
I I'd agree that that's truetrue 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 sixmonths, 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 moreconversations, and I hope we do,
because this was so much fun.
Before we go, um, Heather, howcan 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 onLinkedIn, of course.
That's how you and I wereintroduced.
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.
So there are these oil and gas chemical companies
who have access to what isconsidered gold at that time,
ethical, right?
To make hand sanitizers.
SPEAKER_00 (00:09):
Hey guys, welcome to another episode of Caliph Deep
Dive.
I'm here with Heather Bustos.
SPEAKER_02 (00:14):
I've been a an FDA compliance attorney for the past
10 years.
Um I'm not even gonna describethe horrors I saw out there as I
got there that I've got.
SPEAKER_00 (00:26):
Hey guys, welcome to another episode of Caliph Deep
Dive.
I'm here with Heather Bustos.
I'm hoping that unless I getderailed, I'm gonna land up
talking about inky names andwhatever 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 (00:42):
Yeah, absolutely.
Um, so just a little bit aboutme.
Uh I've been an FDA complianceattorney for the past 10 years.
Um, I took a very unique trackand essentially went straight
from law school into owning myown law firm.
Um, didn't really know muchabout this area until working
(01:03):
for a family friend and fell inlove with it.
If I was not doing this, I don'tthink I would be in law at all.
This is just a passion that I'vehad 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 umeverything from manufacturers,
distributors, importers, brandowners all across across the
(01:24):
supply chain.
And we provide uh full service,so label reviews, registrations,
gmp audits, and we work withclients in the food supplement,
cosmetic, and device industries.
SPEAKER_00 (01:35):
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 (01:47):
I N C I.
And I don't have the the theacronym in front of me, but it's
essentially, I want to sayinternational nomenclature.
So it's essentially aninternational naming convention
um that uh is run by thePersonal Care Products Council.
Um, and this is like you alludedto, this is a little new to me.
(02:10):
This is a project that I justworked on recently with a
client, but I found it superinteresting.
Um, I love when you get to kindof see the science.
So in this case, you know, thisis an ingredient supplier, and
they're really trying to sellthis ingredient to people, and
they're having a hard timebecause the current names that
are out there available for themto use are just not selling the
(02:30):
ingredient.
Like they're not enough, right?
And so the client's like, I wantall the bells and whistles, I
want something that's gonnareally describe this ingredient
for what it is.
And so my job was hey, howlikely is it that your
ingredient is novel enough toearn itself a unique name that
you can then use uh compliantlyon your cosmetic labels?
SPEAKER_00 (02:52):
It came as a marketing strategy, more as a
let me point out how unique Iam.
And you went to the PersonalCare Products Council, which is
an international organizationthat does this.
Now, so are we talking about aninternational organization based
in Europe?
Or are we still talking in theUS?
How does this work?
SPEAKER_02 (03:08):
No, no, US, US based.
Um, but they use this is aninternational naming convention.
Um, but you submit to the PCPC.
This is a trade organization,and they essentially have um,
you know, groups that sit downevery, I think it's like every
few months, they come together,they congregate, and then people
(03:29):
submit these applications.
Um, and then they'll vote onwhether you know they will make
a new name for a cosmeticingredient.
SPEAKER_00 (03:38):
Like, how big is this group?
Do you have any sense of that?
Like, is it two guys sitting inthe back in the back corner or
is it a bunch of software?
SPEAKER_02 (03:45):
This is a big, this is very big, and there's tons of
industry giants that are part ofthis group.
Okay, yeah, and they um they goto Congress, they you know try
to get legislation passed.
Okay, they have conversationswith 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 (04:05):
How does that naming give them unique rights?
So you get to say something likecontains magic formula number
one.
Is that is that the thoughtprocess?
SPEAKER_02 (04:15):
It's it's in the ingredient statement.
So FDA requires that in theingredient statement you use a
common or usual name, and mostmost of industry uses the inky
names as the common or usualname.
So if it's not an inky name,then usually you can't use it.
They don't give you a lot ofleeway.
Whereas, for example, and thiswas something the client was
(04:35):
saying is like, why is it thatyou know, uh, Starbucks can call
their ingredients like Starbucksflavored this and that, and I
can't do it for cosmetics.
The naming conventions aredifferent 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 tobuy the ingredient because
(04:56):
they're like, if I can only callit this, why would I why would I
buy it?
SPEAKER_00 (04:59):
So, this client, whoever they were, and I
appreciate you sort of walkingus through this thought process,
they came to you.
Now, do they tend to come to yougoing, I'm having sale problems
with my sales, help guide me?
And you go, here's a strategyyou hadn't thought of, or are
they coming in with, here's whatwe need to fix?
Um, can you help us fix this?
So, how does that usually workout for you?
SPEAKER_02 (05:20):
I mean, in this case with Inky, it's it's
specifically, I guess, from amarketing perspective.
And I have clients who askquestions like that all the time
is, you know, can we getcreative with how we name
ingredients on uh a product?
So if there's an ingredient, forexample, that might typically be
um, let's say considered to havesome intended use, but then the
(05:44):
client wants it to be a flavor,right?
Because they don't want to callit that.
So that's where a lot of thoseingredient-specific questions
come from, is obviously what arethe proper ways to list the
ingredients?
And then can we do some kind ofcreative working of how we're
gonna name this theseingredients on the label so that
(06:05):
we can, you know, meet theirintended purpose.
SPEAKER_00 (06:07):
Talk to me a little bit about that.
So you you're telling me thatthey come to you with um how how
do I get creative with names?
Walk me through that process.
How do you think through thatthat thought process?
SPEAKER_02 (06:18):
In in terms of you know, getting creative with
ingredients, there's also thingswhere you can call something a
processing aid or an incidentalingredient.
And so clients will ask me, youknow, can we lower the
percentage of this in theformulation so that it's
considered this and not that?
And so yeah, it's verystrategic, like how you know,
(06:40):
and you're really digging intothe regulations, you're reading
word by word and trying to finda way to kind of utilize the
rules, you know, and be creativeabout how we can solve those
problems.
SPEAKER_01 (06:54):
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SPEAKER_00 (07:01):
Is it fair to say that a lot of your practice is,
I mean, I recognize you do labelreview, but there there it
sounds like there's somemanufacturing element, a pretty
significant manufacturingelement from what you get into.
Is that fair?
SPEAKER_02 (07:15):
Yeah, yeah, definitely.
And it's funny because I justbrought 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'ssay the auditing or the
manufacturing side.
They've read through, they'veanswered warning letters, right?
From a technical perspective.
Something that I got into, whichI kind of fell into during
(07:36):
COVID.
So there are these oil and gaschemical companies who have
access to what is consideredgold at that time, ethanol,
right?
To make hand sanitizer.
They don't know how to make it.
I was basically going out tothese facilities out in West
Texas, walking the floors andauditing and helping them get
compliant with OTC regulations,which as you know, it's a pretty
(08:00):
high standard.
Um, I'm not even gonna describethe horrors I saw out there that
I'm I mean, yeah, it wasinteresting.
I was those are my horrorstories, but it gave me a really
great insight into how to kindof walk in these situations um
inside of a manufacturingfacility, understand how the
(08:22):
processes work in real time.
Um, and so that's how I kind ofstarted uh on the side of
auditing GMPs, and I'vecontinued doing that as well.
Um, and it it colors your wholeexperience.
Like when you're when you'reresponding to a warning letter
about a water system and you'veseen it in real time, what it
looks like, how it works, itjust it just makes it that much
(08:44):
better, and uh you're much moreable to serve your clients.
So, yes, that is a side thatI've gotten really good
experience with.
SPEAKER_00 (08:52):
It it you remind me of this is what I worry about
this when I talk with other foodand drug lawyers because we get
into sharing war stories, whichis what's about to happen.
Um, I I um I've I've walked onto I I used to be corporate
counselor for a company, and um,I just started off uh in that
role.
(09:12):
I landed um to just literallyfor the first time see our
manufacturing plant.
Um and the guy who's picking meup goes, the FDA just came and
we're we're having an audit aswe speak.
I don't even know what thefacility looks like.
But as you pointed out, it'sit's you're getting there,
you're getting to see the peoplein action, you're deciding who
(09:34):
needs to stay, who needs to go,you're deciding you're deciding
um what does the how do youprepare a war room uh and and
how do you respond to a warningletter afterwards or a 483 or
the like.
So my point to everyone elselistening: there is a big
difference between someone whocan look at a warning letter or
look at a 483 and go, oh, here'show we respond based on the
(09:58):
regulations.
These regulations are therebecause they're protecting
patients, they're protecting theconsumers.
And someone who's walked thosefloors knows what that's like,
and that's why you want to hiresomeone with that experience.
You don't want someone who'sresponding technically because
the FDA is respondingpractically, 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 youwould 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 saidyou've thrown out some fancy
terms like PCPC and the personaloh, I guess that is the personal
care products council.
Yeah, see that sounded fancierwhen when I said PCPC, but I um
when does PCPC kick in?
(10:49):
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 thecosmetic side of things um and
other personal care products.
I think just because of theamount of also education they
provide.
So I've been to many conferenceswhere they'll send, you know,
their people and they'reeducating on things.
I went to one um Cosmoprop inMiami a couple years ago and
(11:13):
they did a whole presentation onMoCra.
And there were things I learnedin that presentation that you're
not gonna get off the FDAwebsite because they were able
to give you insights into well,we just had a meeting with FDA
and they said this is coming orthat's coming, or this is the
way they're gonna interpret thisrule.
Because if you're familiar withMoCra, it's so vague.
(11:35):
People are having troublefiguring out how to comply,
right?
So there I would say theireducation side of things is
incredible.
I've been to a bunch ofwebinars, um, and again, they
have that insider perspective,you know, that even the FDA is
not gonna give you on theirwebinars.
SPEAKER_00 (11:52):
What has been your experience?
What do you think people shouldtake away in the context of
MoCRA?
Oh, by the way, maybe you canintroduce Mokra to people as
well.
What is Mokra?
SPEAKER_02 (12:01):
MOCRA is the Modernization of Cosmetics
Regulation Act, a mouthmouthful, which is why everyone
says MOCRA.
Um, this was a law passed byCongress December 2022, and
essentially the law was passedthat gave then power to the FDA
to create regulations based onthose laws.
And so that's the process we'rein now is the rulemaking.
(12:22):
A lot of the rules are kind ofvague, and you know what tends
to happen with any regulationsas they come out is FDA will
release guidances where they'rekind of fleshing it out a little
bit so you can get a little moredetailed as to how to implement.
Um, it'll usually have like FAQsin there, they'll do entire
guidances of just FAQs, right?
And that's really helpful.
(12:43):
Um, so I think that's what hasmade it a little difficult as
it's rolling out.
But I would say, in my ownexperience, which I've been in
this industry uh less time thanyou.
So for me, when Mocha came out,I'm like, yay, there's like
updates, like there's new stuffhappening, you know.
For me, it was like it was a bigdeal.
Um, you know, and and watchingit kind of roll out, I think
(13:04):
this is one of my first like bigexperiences with that process.
Um, although again, I mean,during 2020, there was all these
guidances, the emergency useauthorizations.
I think there was a new onecoming 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 thephone.
I don't know.
You know, it was it was crazy,um, which was a really cool
(13:28):
experience.
But yeah, um in terms of kind ofwhere 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 asto like whether you need to
register or not, because eventhat was like really difficult.
(13:49):
There was I had to make thiswhole chart for clients um to
figure out whether you even needto or not.
Um, so registration, adverseevent reporting, um, safety
substantiation.
GMPs have not come out yet, sowe're waiting on that.
Fragrance allergens.
I don't think we've gotten thateither.
A lot of people in industry arelike confused, you know, as to
(14:12):
how to comply, what to do.
You know, they have goodintentions, but it's it's a
little difficult right now.
SPEAKER_00 (14:19):
Follow our page on LinkedIn.
So my advice for clients rightnow has been uh and I and I work
with drug device, cosmetics,I've worked with tobacco, uh,
I've worked with foodsupplements, um, so pretty much
most FDA regulatory stuff.
Be very careful what you askfor, you just might get it.
(14:42):
So if you ask for clarification,the FDA will eventually give you
the clarification.
But here's the good news whereyou are now, the Supreme Court
has come out and said, you can'tpunish someone for not doing
something if you didn't tellthem not to do it.
But so under the Fox v FCCdecision, uh the Supreme Court
(15:04):
decision, that's that's reallywhere it came out.
So I like to call it the JanJackson nipple uh showing case.
Um and they they went after FCC,the FCC went after Fox saying,
hey, you showed that and thatwas bad, and they were like,
tell me where that's wrong.
Same exact way.
If the FDA doesn't tell you notto do something, you can't
(15:24):
punish them for not doing it.
Um so in the same way, if youland up with you, FDA don't tell
me exactly what the GMPrequirements are.
I hate to break this to you, butyou can't hold me to
requirements you didn't put out.
So so use this as an opportunitybecause the FDA will keep
narrowing it down, will keepclamping down, and that's good
(15:45):
because you get clarity, butit's bad because what you're
whatever you're doing isprobably not compliant with
whatever they're gonna come upwith.
SPEAKER_02 (15:51):
Yeah, I don't even think we've seen.
I was just someone was justasking me this question whether
they've seen a warning letterspecifically just on cosmetic
GMPs.
I don't think there's been oneyet.
I could be wrong.
You know, what I tell clients,which to me the old standard was
don't be adulterated, don't bebe misbranded.
They don't tell you how to getthere.
It's open to interpretation,right?
(16:13):
So just get there in the waysthat you think.
Um, I mean, I think regulations,these regulations are good to an
extent, and one of the maindriving forces is that we want
to level the playing field withplaces like here in the EU, you
know, where the standards arelike 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 thegold standard.
Okay, I mean I've sat on panelswith people from EU.
I I did one recently here inAmsterdam.
Uh, and the every question thatthey were asking about, so
what's the US doing formicroplastics?
And what's nothing, nothing.
I felt like I had nothing tosay, and then the EU person is
(17:03):
just going on and on becausethey're more flushed out, and
that's in that's across all uhFDA regulated areas.
SPEAKER_00 (17:11):
No, I wouldn't I wouldn't agree with that
statement.
I I'd agree that that's truetrue 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 sixmonths, 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 moreconversations, and I hope we do,
because this was so much fun.
Before we go, um, Heather, howcan 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 onLinkedIn, of course.
That's how you and I wereintroduced.
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.
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