Your skincare product may look like a cosmetic, but one wrong claim can legally turn it into an unapproved drug.
In this episode of KLF Deep Dive, we break down the exact words, phrases, and influencer mistakes that push cosmetic brands straight into FDA drug territory. Anti-inflammatory claims. Acne treatment language. Collagen rebuilding promises. Detox buzzwords. These are not harmless marketing fluff. They are regulatory landmines.
We explain how the FDA actually classifies products, why intent does not matter, how influencers can sink your brand, and what cosmetic companies should do right now to stay compliant.
If you work in beauty, skincare, or wellness marketing, this episode can save your next launch.
If compliance, enforcement, or deals matter to your business, subscribe to KLF Deep Dive.
www.kulkarnilawfirm.com
Episode Transcript
What if your cosmetic claim suddenly turned your
lotion into an unapproved drug?
Yeah, this is a regulatory jumpscare nobody wants, but everyone
needs to understand.
The line between cosmetics anddrugs is not as blurry as you
might think.
Cosmetics are only supposed todo one thing.
Make you look good, smell good,make you feel a little fancy.
(00:23):
Drugs are gonna be treatingdiseases, affecting structure or
function, providing therapeuticbenefits.
Most companies mean to stay onthe cosmetic side of the fence,
but then marketing happens.
Suddenly, that moisturizingcream is anti-inflammatory.
The serum stimulates collagenproduction.
The exfoliant treats acne.
(00:44):
These are not cosmetic claims.
They are drug claims, they'redrug claims wearing lip gloss.
Any brand saying, but I didn'tintend it to be a drug, will
learn very quickly that intentdoes not matter in these cases.
The claim defines the category,not the formula, not the
marketing plan, and not thefounder's vision board.
(01:05):
If you claim your lotion reducespain, heals eczema, reverses
aging, you're no longer in thebeauty aisle.
You're in drug land, whether youlike it or not.
The claims that trigger troubleinclude these following phrases.
Anti-inflammatory, the FDA's nota big fan, pain relief or muscle
soothing, that can move you todrug territory, treats acne,
(01:28):
rhosacea, eczema, psoriasis,drug claims, restores collagen
or rebuilds elastin, correctshyperpigmentation caused by
diseases, stimulatescirculation, kills bacteria,
antimicrobial.
Here's the big one, we see thisa lot.
Detoxifies.
If your brand is even using oneof these, you're making
therapeutic, structural, orfunctional claims.
(01:51):
And influencers, they can makeor break you.
If you say that your mascarastops lash loss or your toner
heals hormonal acne, the agencytreats it as the same as you
saying it.
They are acting as your agent.
Influencer disclaimers do notprotect you.
Opinions are my own.
They help them to sleep atnight, but it won't stop you
(02:12):
from getting a warning letter.
Especially if you have anagreement with them.
Most cosmetic entrepreneurs,even these large brands, and
this is surprising to me.
Even these large brands, theyassume it's a cosmetic, so FDA
won't bother us.
Incorrect.
If it's natural, it's safe.
Irrelevant.
Everyone else says this stuff,so it must be okay.
(02:33):
Nope.
If we get into trouble, it'sjust a minor label change.
Try adulteration is brandingrecalls online platform
takedowns.
The agency has been crackingdown recently on cosmetics and
drug confusion, and you've seenthis actually happen for a few
years.
They're accelerating on the riseof DERM-inspired, medically
(02:53):
backed, and clinical gradebranding.
Now, some brands say, but wehave science, we did a study.
That's great.
You should validate every claim.
But substantiation does notchange the classification.
If a claim sounds like you'retreating a disease or altering
human physiology, it's a drugclaim, even if you have
peer-reviewed data.
Because medic claims can havesubstantiation.
(03:16):
Drug claims require approval.
These are very different worlds,very expensive, different
worlds, very differentpaperwork.
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Darshan (03:35):
Nobody in marketing wakes up thinking, I'm gonna
cause a federal regulatoryreclassification today.
But it does happen.
An enthusiastic intern writes,heals dry skin.
The influencer says, Cures acne.
The founder adds, boostimmunity.
To someone on TikTok said it'strending.
Suddenly, you need regulatorytriage.
(03:57):
If panic were a cosmeticingredient, every brand would be
using it.
So here's how you stay on theright side of the drug cosmetic
boundary.
This is what we use at KLF.
Keep claims on the cosmeticslane.
Moisturizes, smooths, brightens,cleanses, it softens,
exfoliates.
Stay superficial.
There's no shame in it.
(04:17):
Train your marketing influencerteams.
Should understand what theycannot say.
One bad caption can turn alotion into a drug.
Build a review process.
Have a compliance workflow.
Preferably, it's not a Googledocument called final final.
This one actually final versionthree.
(04:38):
Cosmetics claims do requireevidence.
Clinically proven should justsimply mean proven.
Document everything.
And this is where Sarah shines.
It's a document control thatversion tracks, shows
auditability, and makes sure theleft hand knows what the
influencer hand is doing.
Review labels, websites, ads,social media, and affiliate
(04:59):
content regularly.
Because let's be honest, the FDAlooks everywhere.
And if the FDA is not, you knowthat lawyers are.
Follow our page on LinkedIn.
Now here's where Kayla fits inand why brands call us before
they get that warning letter.
It's what we do.
We do it every single day.
We help cosmetic brands.
We build legally sound claimframeworks.
(05:22):
We train marketing, product, andregulatory teams.
We review influencer andaffiliate content.
We design promotional reviewprocesses, evaluate whether a
claim crosses into drugterritory.
We develop substantiationstrategies, audit labeling and
packaging.
You help prepare for mockeryexpectations, substantiation.
You want to avoid calling meafter that warning letter.
(05:44):
Call me before you get one.
Visit www.clcarneylawfirm.com,schedule a consult.
Here's where CERS can actuallyhelp you.
CERS is built for exactly thistype of brand system.
You centralize document sharing.
You control access to claims,drafts, and marketing content.
You track what influencer hassaid what.
You ensure that outdated claimsdo not resurface.
(06:06):
You maintain clean audit trails.
You document every step of thepromotional process.
The agency wants to know whoapproved this, want to be able
to answer this in one click andnot a frantic Slack channel at
midnight.
So that's the big takeaway.
What if your cosmetics claimturned your lotion into an
unapproved drug that happensfast, it happens often, and it's
(06:29):
preventable.
Stay in the cosmetics lane,substantiate your claims, manage
influencers, and have a solidpromotional review process
supported by the right tool andthe right legal team.
And of course, subscribe to theKLF Deep Dive because next week,
a topic that you might listen tomight save your next launch.
Call, click, or email.
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