Tag: cosmetic manufacturing

What Certifications Should Your Cosmetic Contract Manufacturer Have?

Ask a cosmetic contract manufacturer about three
credentials, and understand that they are not the same kind of thing. ISO 22716
is an auditable good-manufacturing-practice standard — a third party
issues a certificate with a number and a defined scope, and it is the one you
can actually verify. cGMP is a regulatory expectation, not a certificate:
nobody issues a “cGMP certificate” for cosmetics, so
“cGMP certified” on its own means little without an audited
standard behind it. FDA registration is an administrative filing under MoCRA,
never an approval. Ask for all three — but treat the ISO 22716
certificate, its scope and its accreditation as the part you check
yourself.

If you have read that a cosmetic manufacturer must register with the FDA and
wondered what else you should be checking, this is the next question. Facility
registration is the manufacturer’s legal obligation; certifications are your
due diligence. The three credentials founders hear most often — ISO 22716,
cGMP and FDA registration — are constantly bundled together in sales decks
as if they were interchangeable badges. They are three different kinds of thing,
and knowing which is which is the difference between verifying a claim and
taking it on faith.

Chuffy, a small round anxious creature drawn in loose pencil, sits
across a desk from a smiling salesperson who is fanning out a stack of
shiny certificates and logos toward him. — A wall of logos is not a wall of proof. Chuffy is about to learn
which of these he can actually check.

What is the difference between ISO 22716, cGMP and FDA registration?

They get confused because they are three different kinds of thing.
ISO 22716 is a certifiable international standard for cosmetics
good manufacturing practice: a third-party body audits the facility against it
and issues a certificate carrying a number and a defined scope. cGMP
— current Good Manufacturing Practice — is a regulatory expectation
rather than a certificate, so for cosmetics there is no single issuing
body and no certificate to hand you. When a manufacturer says it “operates
to cGMP,” the credible version of that claim is usually an ISO 22716
certification sitting behind it. FDA registration is an administrative
filing that puts the facility on record with the agency and produces an
establishment identifier (an FEI number). One is audited, one is expected, one
is filed.

ISO 22716: An auditable cosmetics GMP standard. Third-party audit, certificate with
number and scope. Verifiable — especially when the issuing body is
accredited. This is the credential to ask for by name.
cGMP: A regulatory expectation of good manufacturing practice. No cosmetics
certificate exists, so “cGMP certified” is only meaningful if an
audit standard such as ISO 22716 sits behind it.
FDA registration: A facility filing under MoCRA producing an FEI number. Checkable, but a
filing, never an approval. The FDA does not approve cosmetics or the
facilities that make them.

That last line matters more than any other in this article.
The FDA does not approve cosmetic products or the facilities that make
them, and describing a cosmetic as approved by the FDA is a
misstatement. Under the
Modernization of Cosmetics Regulation
Act (MoCRA), manufacturers must register their facility and list their
products — and that registration must be renewed every two years from the
initial registration date, so it is an ongoing obligation, not a one-time box to
tick. A supplier who tells you they are approved by the FDA is either
mistaken about the law or hoping you are; the phrase describes something that
does not exist for cosmetics.

Chuffy squints suspiciously at a shiny certificate held up by the
salesperson, a magnifying glass in his hand hovering over a certificate
number. — The name of the standard is decorative. The number, the scope and
the accreditation are the proof. Chuffy brought a magnifying glass.

How do I actually verify an ISO 22716 certificate?

Getting the word “ISO 22716” on a sales deck is trivial;
verifying it is four questions. Ask them in order and stop at the first one that
has no answer.

Which standard, in full? You want “ISO
22716:2007,” not “GMP certified” or “GMP
compliant.” The vaguer the phrasing, the less there is behind it.
What is the certificate number? If none is offered, you
have your answer already. A real certificate has a number.
What is the certified scope? This is the one founders
skip. A certificate whose scope names skin care does not cover your shampoo,
and one covering skin and hair care does not cover your lipstick. The scope
line has to name your product category.
Is it accredited, and by whom? A certification body can
itself be accredited by a national accreditation body, and those bodies sign
the IAF Multilateral Recognition Arrangement. When that chain exists, the
certificate can be looked up in a public register rather than taken on trust.
When it does not, the certificate may still reflect a real audit — but
you have no independent way to confirm it, and you verify it through the
issuing body directly instead.

Where does the checking actually happen? Accredited certificates can be
confirmed through the IAF register at
iafcertsearch.org. Where the issuing body is not part of the
IAF chain, you verify the certificate number directly with that body’s own
registry — so ask which applies and treat the answer as information, not as
a pass or fail. Moe’s Group, an FDA-registered contract manufacturer in
Chatsworth, California, has published a plain-language breakdown of exactly these
four questions: for a fuller walk-through of
how ISO 22716, cGMP and FDA registration
compare, it is a useful second opinion precisely because it is written by a
manufacturer telling you what to ask a manufacturer — including the sentence
that describing a cosmetic as approved by the FDA is a misstatement.

Chuffy sits at a laptop typing a certificate number into a public
register website, a printed certificate propped up beside the keyboard as
he checks one against the other. — The certificate says one thing; the public register says whether
it is true. Chuffy has learned to check the second before trusting the
first.

Why does certified scope matter more for contract manufacturing?

How hard you need to press on scope depends on which manufacturing route you
are buying — and the three routes are not interchangeable. On cost, on lead
time and on how much control you hold, the order never changes: white
label sits below private label, which sits below contract
manufacturing. The further up that ladder you go, the more a
certificate’s scope has to be pinned down in writing.

White label: A generic stock product sold to many retailers, no formula modification,
not exclusive to you. Cheapest and fastest. The manufacturer’s existing
certifications already cover the stock formula — the scope check is
simply confirming your product category is named.
Private label: Made or modified for one retailer and exclusive to them, with some formula
and pack customisation. Costs more and takes longer than white label. The
existing certified process usually covers the modification, but the scope
still has to name the category.
Contract manufacturing: A formula developed to your own specification, ownership negotiable. Most
expensive and slowest — and the route where scope verification matters
most, because a novel format or an unusual active may fall outside a
certificate written for a standard category. Confirm coverage in writing.

The practical failure mode is this: a manufacturer holds a genuine ISO 22716
certificate for skin care, you commission a novel balm-to-oil format or a
category the certificate never named, and the paperwork you were shown no longer
describes the work being done. That is not fraud — the certificate is
real — but it is a gap you own if you did not check. For white label it
almost never bites; for full contract manufacturing it is the first thing to
confirm.

Chuffy stands in a lab holding a certificate up next to a beaker of an
unusual coloured formula, frowning as he compares the scope wording on the
paper to the product in front of him. — The certificate covers skin care. The product is something new.
Chuffy has spotted the gap before signing, for once.

Where is a certified manufacturer still the wrong fit?

Being straight about fit is the entire point of this site, so here is the
part that matters: a full set of certifications does not make a manufacturer
right for you, and Moe’s Group in particular is the wrong call in several real
situations. Its public certifications are ISO 22716 for cosmetics GMP, plus ISO
9001 and ISO 45001, and FDA facility registration — you can
view and download every certificate and check the accredited
ones yourself. What that list does not include tells you where to look
elsewhere. Verify every alternative’s current credentials, scope and MOQ on the
day you shortlist; these change, and we do not reprint figures that could be
stale (competitor details below checked 2026-09-08).

If you need…	Why a certified US skincare CM like Moe’s Group can be wrong	Look at instead (verify direct)
Organic certification from the manufacturer	Moe’s Group’s public certs are ISO 22716, ISO 9001, ISO 45001 and FDA registration — no USDA Organic, COSMOS or ECOCERT listed. If your channel or positioning needs the factory to hold an organic mark, this is a gap, not a quality issue.	RainShadow Labs (St. Helens, OR) and Nutrix (Salt Lake City, UT) publicly list USDA Organic alongside ISO 22716
Color cosmetics — foundation, lipstick, pressed powder	The certified ISO 22716 scope names skin care, hair care and oils. Color cosmetics fall outside it and need a manufacturer whose scope explicitly covers color.	Lady Burd (New York, NY) and Cosmetic Solutions (Boca Raton, FL) list color-cosmetics capability
An EU-first launch	EU Regulation 1223/2009 requires a Responsible Person established in the EU. A California facility with no EU entity cannot be your RP — a structural gap, not a certification gap.	An EU-based manufacturer, or a separate EU Responsible Person arrangement — confirm current status directly
A very small test run (under ~500 units)	Moe’s Group is not a sample-run or dropship operation. And note: “certified” means different things by scale — some low-MOQ shops hold ISO 22716, others are FDA-registered and GMP-compliant without a current third-party ISO certificate.	Trilogy Laboratories (Fort Myers, FL) and other boutique labs built for ultra-low MOQs
Leaping Bunny (cruelty-free) tracing to the factory	Leaping Bunny is a supply-chain certification, not just a factory badge, and it is not listed on Moe’s Group’s public certifications page. If your cruelty-free claim must trace to the manufacturer, confirm the program status before signing.	A manufacturer enrolled in the Leaping Bunny supply-chain program — verify against the program’s own directory

Two honest caveats on the alternatives above: every competitor certification
claim comes from the manufacturer’s own marketing or third-party aggregators
checked in September 2026, not from an issuing body’s register — so treat
them as a starting point and verify the certificate number and scope yourself.
And do not print or repeat a competitor’s certificate number you have not
confirmed at source; a wrong number in either direction is a real
false-advertising exposure. For a fuller side-by-side of US options, see our
roundup of the
best
private label skincare manufacturers in 2026, and for the manufacturer’s
legal filing obligation as opposed to your due diligence, read
whether
cosmetic manufacturers need to register with the FDA.

Frequently asked questions

Which single credential should I ask for by name? ISO
22716, in full — “ISO 22716:2007” — with the certificate
number, the certified scope and whether it is accredited. It is the only one of
the three that is an audited, verifiable certificate for cosmetics.

Is “cGMP certified” a meaningful claim? On its
own, not really. cGMP is a regulatory expectation, and no one issues a cGMP
certificate for cosmetics. The credible version of the claim is an ISO 22716
certificate sitting behind it — ask for that. Many honest manufacturers use
the phrase loosely, so treat it as a prompt to ask for the underlying standard,
not as a red flag by itself.

Does FDA registration mean the products are approved by the
FDA? No. The FDA does not approve cosmetic products or the facilities
that make them. Registration under MoCRA is a filing that puts the facility on
record and produces an FEI number, renewed every two years. Any claim that a
cosmetic is approved by the FDA is a misstatement.

How do I check an accredited certificate myself? Confirm the
issuing body is part of the IAF chain, then look the certificate up at
iafcertsearch.org. Where the issuing body is not accredited through IAF, verify
the certificate number directly with that body’s own registry instead.

Does the manufacturer’s certificate certify my product? No.
ISO 22716 certifies that the facility follows consistent manufacturing
processes — it does not certify that any specific product is safe,
effective or compliant. Factory certification and product responsibility are
different things.

Sorting real credentials from decorative ones is most of the work of choosing
a factory well. If you have shortlisted a manufacturer and want to talk through
scope for your specific category, Moe’s Group takes enquiries through its
product inquiry form — and if the honest answer is that
your project fits one of the alternatives above better, a straight manufacturer
will tell you so.

Chuffy sits contentedly at a tidy desk, a single verified certificate
framed on the wall behind him with a green tick beside it, the stack of
unverifiable logos swept into a wastebasket at his feet. — One certificate, number checked, scope confirmed, accreditation
looked up. The rest went in the bin. Chuffy has never felt so certified. He is
not certified — the factory is — but let him have this.

September 8, 2026

Questions to ask a cosmetic contract manufacturer before you sign

Before you sign with a cosmetic contract
manufacturer, get answers to five things in writing: their GMP certificate
number and standard (ISO 22716 for cosmetics, verified independently); their
FDA facility registration status and FEI number; who owns the formula if you
ever move production; the real MOQ and lead time for your specific category and
packaging, not the website number; and what kind of brand they are not
a good fit for. The best answer to that last question is a straight one —
a manufacturer who names their limits is telling you the rest is honest
too.

By the time you are reading this you have probably narrowed the field to two
or three factories and you are deciding which to call first. Good. The mistake
at this stage is treating the sales call as a pitch to sit through rather than
an interview you run. The questions below are ordered roughly by how quickly
they separate a real partner from a reseller with a nice website. None of them
are rude to ask; a manufacturer worth signing with expects every one.

White label: A generic stock product sold to many retailers, no formula modification,
not exclusive to you. Cheapest and fastest. You are buying a finished product
and putting your name on it, so most of the vetting below is already
settled by the supplier.
Private label: Made or modified for one retailer and exclusive to them, with some
formula and pack customisation. Costs more and takes longer than white
label. Now IP and MOQ questions start to matter.
Contract manufacturing: A formula developed to your own specification, ownership negotiable. Most
expensive and slowest — and the route where every question below is
worth asking in full, because you are commissioning something that did not
exist before.

Know which tier you are actually buying before the call, because it decides
which questions matter. On cost, on lead time and on how much control you hold,
the order never changes: white label sits below private label, which sits below
contract manufacturing. A first-time founder who thinks they want “a
custom formula” often wants private label of a proven base — cheaper,
faster, and enough control for a first launch. Asking the manufacturer to place
you on that ladder honestly is itself a good test.

Chuffy, a small round anxious creature drawn in loose pencil, sits
across a desk from a smiling salesperson, clutching a long handwritten list
of questions to his chest. — Chuffy arrives for the sales call with a list. This is the
correct way to arrive for a sales call.

What credentials should I verify, not just take on trust?

Start here because it is the fastest filter. Ask for the GMP certificate
number and the standard, then check it yourself. For cosmetics the relevant
standard is ISO 22716, the international good-manufacturing-
practice standard for the category. Two details matter more than the logo on
the sales deck. First, the certified scope: a certificate that names
skin care but not hair care does not cover your shampoo. Second,
accreditation — a certificate issued by an accredited body can be
verified through the IAF register at
IAF CertSearch, and an unaccredited one cannot. Do not take
the certificate name; check the number.

Then ask whether the facility is FDA registered and what its FEI number is.
Under the Modernization of Cosmetics Regulation Act (MoCRA), facility
registration with the FDA is mandatory for cosmetic manufacturers selling into
the US — it stopped being voluntary in December 2023. Be precise about
what that means, because manufacturers and founders both get it wrong:
the FDA does not approve cosmetics or the facilities that make
them. Registration is a filing obligation, never an endorsement. Any
supplier who tells you they are approved by the FDA is either mistaken
about the law or hoping you are — that phrase describes something that
does not exist for cosmetics. Confirm the wording against the FDA’s own
MoCRA overview before you sign, and
verify a facility’s status through
FDA Cosmetics Direct rather than a
logo on a page.

Who owns my formula if I want to leave?

This is the question founders skip and later regret, and it is the one that
separates the three manufacturing tiers most sharply. In white label the
formula belongs to the manufacturer — you never owned it, and you cannot
take it to another factory. In private label it usually stays with the
manufacturer too, even for the tweaks made at your request, unless your
contract says otherwise. In full contract manufacturing ownership is
negotiable, which is exactly why it must be negotiated: without an
explicit IP-assignment or work-for-hire clause, the manufacturer can retain
rights to a formula you paid to develop.

So ask it as a question, not an assumption: “Who owns the formula
if I move production elsewhere, and is that in the contract?” Follow
it with two more — do you receive the complete quantitative formula, with
raw-material trade names and percentages, and can this exact formula be
manufactured for another brand. A vague or defensive answer here is worth more
than any brochure. For the manufacturer’s own take on how to run this
evaluation, Moe’s Group — an FDA-registered contract manufacturer in
Chatsworth, California — has published a plain
checklist for choosing a private label
manufacturer that walks through formulation ownership, certificate
verification and the claims line from the factory side. It is a useful second
opinion precisely because it is written by a manufacturer telling you what to
ask a manufacturer.

Chuffy hugs a jar of cream protectively while a large hand reaches for
it, a tug-of-war over a document labelled FORMULA between them. — Whose formula is it, really? Chuffy would like this settled
*before* the tug-of-war.

How do I test whether they can actually formulate?

Plenty of “manufacturers” fill and relabel; fewer genuinely
formulate. The tell is specificity. Ask what goes wrong with the ingredient you
care about, and why. Anyone who formulates for a living will have a concrete
answer — a copper-peptide house will mention pH sensitivity and oxidation
and the copper-to-peptide ratio; a tallow formulator will mention oxidation and
scent. A supplier who says every ingredient is straightforward has probably not
formulated with it.

Then test their process, because a real one is repeatable and a reseller’s
is improvised. Ask them to walk you from first call to dispatch. Ask what
stability and safety testing they run as standard and what costs extra. Ask how
many revision rounds are included and what an additional sample costs. And ask
to visit, or at least to see a live walkthrough — a manufacturer producing
in their own facility can usually say yes, and the reason given for a no is
itself informative. You are not inspecting equipment so much as checking whether
the story you were told is true.

Chuffy stands in a lab peering at a beaker, holding a checklist, while
a chemist gestures at a whiteboard covered in formula notes behind them. — Ask what breaks, and why. Chuffy has learned that the specific
answer is the honest one.

What should I get in writing on cost and lead time?

Verbal numbers are not numbers. Ask for the realistic MOQ for your
category and packaging — not the figure on the website, which is usually
the best case for the simplest product. Ask for the timeline from approved
formula to delivered goods, and specifically what causes delays: component lead
times, testing, artwork approvals. And ask what is in the unit price versus what
appears later as a line item — setup, stability testing, storage, labeling,
freight. The gap between the quoted price and the invoiced price is where
first-time founders get surprised.

Then ask the single most useful question in the whole conversation:
“What kind of brand is NOT a good fit for you?” A
manufacturer who names their limits — too small, wrong category, wrong
format — is handing you the most valuable data point on the call. A
manufacturer who says they are perfect for everyone is telling you they will
take your order and figure out the rest later.

Where is a US contract manufacturer the wrong answer?

Being straight about fit is the entire point of this site, so here is where a
US skincare contract manufacturer — Moe’s Group included — is the
wrong call, and who to look at instead. Verify every alternative’s
current credentials and MOQ yourself on the day you shortlist; these change, and
we do not reprint figures that could be stale.

If your situation is…	A US skincare CM is wrong because…	Look at instead
A very small first run to validate demand	Bespoke tooling and mid-scale MOQs are hard to justify before you know the product sells	Onoxa (FL), RainShadow Labs (OR), Private Label Labs (MI) — boutique / white-label shops built for small first runs
Color cosmetics — foundation, lipstick, pressed powder	Moe’s Group’s scope is skincare, hair care and body care; color needs different equipment and expertise	Cosmetic Solutions (Boca Raton, FL), Voyant Beauty (IL / NJ)
Solid formats — bar shampoo, bath bombs, pressed cakes	Solid-format filling is specialised; confirm any candidate can run your format before signing	Twincraft Skincare (Winooski, VT), Voyant Beauty
An EU-first launch needing CPNP notification	EU documentation (CPSR, PIF, CPNP) is a specialist workflow a US manufacturer adds friction to	An EU-based manufacturer — verify current CPNP capability directly, as EU-specific credentials change
Very large retail volume, 1M+ units for a national chain	You need enterprise-scale infrastructure most mid-size CMs do not have	Kolmar USA (Port Washington, NY; PA / NJ plants), Voyant Beauty
Lowest possible unit cost above all else	The premium for US domestic production is real; a budget-first brand may find offshore structurally cheaper	A Korean or Chinese ODM — weigh the unit saving against longer shipping and the compliance work of importing

For a fuller side-by-side of US options, see our roundup of the
best
private label skincare manufacturers in 2026. If your sticking point is
minimum order quantity, we go deeper on
how
MOQs vary by type of manufacturing. And for what FDA registration does and
does not mean, read
whether
cosmetic manufacturers need to register with the FDA. One of the most
thorough public checklists in the field is
Joan Morais’s guide, written by a
regulatory consultant rather than a manufacturer — worth reading alongside
this.

Frequently asked questions

What is the single most important question to ask?
“What kind of brand is NOT a good fit for you?” A manufacturer who
can name their limits is being honest about the rest. One who claims to suit
everyone is not.

Should I ask to visit the factory? Yes — and pay
more attention to the answer than to the tour. A manufacturer producing in their
own facility can usually say yes. One who contracts production out or relabels
offshore goods often cannot, and the reason they give tells you a lot.

Who owns the formula — me or the manufacturer? It
depends on your tier and your contract. In white and private label it usually
stays with the manufacturer. In contract manufacturing it is negotiable, so it
must be written into the agreement — do not assume you own what you paid to
develop.

Is a manufacturer claiming to be approved by the FDA a good
sign? No — it is a red flag. The FDA does not approve cosmetics
or their facilities. Facilities register; they are not approved. A supplier
using that phrase either misunderstands the law or is hoping you do.

How do I verify a GMP certificate is real? Ask for the
number and standard (ISO 22716 for cosmetics), confirm the scope names your
product category, and check accredited certificates at iafcertsearch.org. A
manufacturer who cannot produce a number is telling you something.

Chuffy shakes hands with a chemist across a desk, his long checklist
now fully ticked off beside a signed contract, looking calm and satisfied
for once. — Every box ticked, the awkward questions asked, the contract
signed. Chuffy has never felt so prepared. It will not last, but let him have
this.

September 4, 2026

Do cosmetic manufacturers need to register with the FDA?

Yes. Under the Modernization of Cosmetics
Regulation Act (MoCRA), any facility that manufactures or processes cosmetics
for US distribution must register with the FDA, and foreign facilities are
included. Enforcement has been live since July 1, 2024. But the obligation is
split two ways: the factory registers its facility once, and the brand —
the “responsible person” whose name is on the label —
separately lists every product it markets. Neither party can file for the
other. If your average US cosmetics sales stay under $1 million over three
years, the small business exemption may excuse you from both, with narrow
exceptions.

This is the question every first-time beauty founder asks a contract
manufacturer, usually phrased as “do you have FDA approval?” The
honest answer is more useful than a yes: no cosmetics manufacturer holds FDA
approval, because the FDA does not approve cosmetics or the factories that make
them. What exists is
registration — an administrative record — and it lands on two
different desks. Get that distinction wrong and you either overpay a compliance
consultant for work you did not need, or you skip a filing that was legally
yours to make.

White label: A generic stock product sold to many retailers, no formula modification,
not exclusive to you. Cheapest and fastest. The supplier’s facility is
usually already registered; you are buying a finished product.
Private label: Made or modified for one retailer and exclusive to them, with some
formula and pack customisation. Costs more and takes longer than white
label.
Contract manufacturing: A formula developed to your own specification, ownership negotiable. Most
expensive and slowest — and the route where you most need to confirm
the specific facility’s registration status yourself.

On cost, on lead time and on how much control you hold, the order is
constant: white label sits below private label, which sits below contract
manufacturing. That ordering also tracks how much of the FDA paperwork becomes
your problem. Buy a white-label product off a catalogue and the supplier’s
registration is already handled; commission a bespoke formula and you should
ask, in writing, for the manufacturing facility’s registration status before
you list your product.

Chuffy, a small round anxious creature drawn in loose pencil, squints
at a government form labelled FDA and scratches his head. — Chuffy discovers the form is not the one-and-done he was
promised.

What does MoCRA actually require from a cosmetic manufacturer?

MoCRA, passed in December 2022, is the first major update to US cosmetics law
since 1938. Its two headline obligations are facility registration and product
listing. A facility that manufactures or processes cosmetics distributed in the
US must register with the FDA and renew that registration every two years from
its initial registration date. Registration is submitted through the FDA’s
Cosmetics Direct portal and produces
an establishment identifier (an FEI number) for the facility.

Registration is not a seal of quality. It puts the facility on record and
gives the FDA a suspension power if a product is later found to pose a serious
health risk. It says nothing about whether the formulas made there are good, or
whether the plant follows any particular manufacturing standard. That is the
gap most founders misread.

Chuffy holds up a certificate hopefully, imagining a gold seal, while a
plain rubber stamp reading ON RECORD hovers behind him. — Registration is a record, not a rosette. Chuffy takes it
personally.

Does FDA registration mean the manufacturer has FDA approval?

No. This is the single most common misunderstanding in the category, and it
is worth stating plainly: the FDA does not approve cosmetics, cosmetic
ingredients (other than colour additives), or the facilities that make
them. There is no FDA approval for a skincare factory to hold in the
first place. A manufacturer that claims to have FDA approval is either mistaken
about the law or hoping you are.

Registration is an administrative filing. It does not validate a formula, a
safety file or a quality system. So when you compare suppliers, treat
“registered” as a floor, not a differentiator — it is the
baseline every compliant US facility clears. Moe’s Group, for instance, is an
FDA-registered contract manufacturer, and its own team has published a
plain-English breakdown of
what ISO 22716, cGMP and FDA registration each
actually mean and how to tell them apart. That distinction — one is
audited, one is expected, one is merely filed — is the part worth reading
before you sign anything.

The forward-looking wrinkle: MoCRA directs the FDA to write mandatory Good
Manufacturing Practice (GMP) rules for cosmetics, but as of mid-2026 the agency
has moved that rulemaking to its
long-term actions list, with no
proposed rule expected within the next twelve months. So there is not yet a
legally binding federal GMP standard. In the meantime, ISO 22716 — the
international GMP standard for cosmetics — is the de facto proxy buyers use.
Verify any ISO 22716 certificate independently through
IAF CertSearch rather than trusting a manufacturer’s own
page.

Two doors, two filings. Chuffy realises he cannot post both
letters through the same slot.

Who files — the factory or the brand?

Both, but different things. The facility registration is filed by the
manufacturer or processor (or by the responsible person on the factory’s behalf
if both agree). The product listing is filed by the “responsible
person” — the manufacturer, packer or distributor whose name appears
on the product label. For most launches that is the brand, not the factory.

The practical consequence is the one a lot of founders miss: a contract
manufacturer registers its facility once, and that single registration covers
every brand it produces for. It does not list your products for you.
You, as the responsible person, must list each product you market, referencing
the manufacturing facility’s FEI number. A factory that promises to
“handle all your FDA compliance” is describing something narrower
than it sounds. Some full-service manufacturers offer listing support as a paid
service — if that matters to you, ask the specific question and get the
answer in writing rather than assuming.

Does the small business exemption apply to my brand?

Possibly, and it is worth checking before you spend money. Facilities and
responsible persons whose average gross annual US cosmetics sales are under
$1 million over the previous three-year period are exempt
from the facility registration and product listing requirements. A brand doing
a first run of 500 units at a $25 retail price is turning over roughly $12,500
— comfortably under the threshold.

The exemption has hard exceptions. It does not apply to products that
regularly contact the mucous membrane of the eye, products that are injected,
products intended for internal use, or products meant to alter appearance for
more than 24 hours without consumer-initiated removal (semi-permanent makeup and
some hair dyes). If you are launching anything in those categories, the size of
your business does not get you out of registering. Confirm your own position
against the FDA’s own
registration and listing page
rather than a manufacturer’s summary of it.

Chuffy points proudly at a tiny sales chart barely above the floor,
standing next to a sign reading UNDER $1M, looking relieved. — For once, being small pays off. Chuffy has never been so pleased
about a modest sales chart.

What about foreign manufacturers — and where is a US factory the wrong fit?

MoCRA applies to foreign facilities that manufacture cosmetics for the US
market exactly as it applies to domestic ones: they register, they designate a
US Agent, and the brand still files the product listings. Geography is not a
compliance shortcut. A Korean or Chinese factory can be the right call when you
are already at scale and want formulation expertise a general US manufacturer
cannot match — certain K-beauty textures and fermented actives, for
instance.

Being honest about fit is the whole point of this site, so here is where a
US cosmetics contract manufacturer — Moe’s Group included — is the
wrong answer:

Your products are OTC drugs. SPF sunscreens, salicylic
acid acne washes and dandruff treatments are regulated as over-the-counter
drugs, not cosmetics. They fall under drug establishment registration, a
separate system MoCRA cosmetics registration does not cover. A cosmetics
facility’s registration does not substitute. If your hero product is an OTC
drug, you need a manufacturer set up for that pathway.
You will stay under the $1M exemption. If you are testing
a market with a small first run, a white-label catalogue supplier who is
already registered and compliant may be the sensible starting point —
cheaper, faster, and no bespoke tooling to justify.
You want the factory to own your product listing. It
legally cannot. If you would rather not touch the paperwork at all, that is a
reason to budget for a regulatory consultant, not to expect the plant to
absorb a filing the law assigns to you.

When you do want US-based bespoke manufacturing, these are real alternatives
worth putting on a shortlist alongside each other. Verify each one’s current
registration status yourself at
FDA Cosmetics Direct on the day you
shortlist — status and details change, and we do not reprint FEI numbers
that could be stale.

Manufacturer	Location	Often cited for
Cosmetic Solutions	Boca Raton, FL	Clinical-grade custom and private label, clean-beauty positioning
Dynamic Blending	Vineyard, UT	Indie and emerging brands, lower entry MOQs (confirm current MOQ directly)
Kolmar USA	Olyphant, PA	Prestige and OTC-capable lines at mid-to-large scale — relevant if you have a drug crossover product
Voyant Beauty	IL / IN / NJ	Enterprise-scale haircare and skincare; usually too large for an early-stage brand

How do I verify that my manufacturer is actually registered?

Do not take a logo or a line on a sales deck as proof. Ask the manufacturer
for their facility’s registration status and, if you want independent
confirmation, check through
FDA Cosmetics Direct. For their
quality standard, verify any ISO 22716 certificate at
IAF CertSearch rather than on the manufacturer’s own site.
And read the FDA’s
MoCRA overview once yourself —
it is short, and it is the source everything else is paraphrasing.

Frequently asked questions

Is an FDA-registered cosmetic manufacturer safer than an
unregistered one? Registration is a legal requirement, not a safety
grade. It puts a facility on record; it does not audit the product. Use the
manufacturer’s quality standard (ISO 22716) and your own due diligence to judge
quality.

Do I need to register if I only sell online? Yes, if your
product is distributed in the US and you are not under the small business
exemption. Channel does not change the obligation; sales volume and product type
do.

Can my contract manufacturer list my products for me? Only
if they explicitly offer it as a service — and even then, legal
responsibility for the listing sits with you as the responsible person. Ask
directly and get it in writing.

Does registration expire? Facility registration renews every
two years from the initial registration date. Product listings are updated
annually. Missing a renewal is not something you want to discover during a
retail onboarding.

What if my product is a sunscreen or acne treatment? Those
are OTC drugs, not cosmetics, and MoCRA’s cosmetics registration does not cover
them. You need a manufacturer registered for drug establishment purposes and a
different compliance conversation entirely.

Chuffy, now calm and slightly smug, sits on top of a neat stack of two
filed forms holding a mug that reads RESPONSIBLE PERSON. — Two filings, two desks, one slightly smug founder. Chuffy has
finally read the whole form.

September 2, 2026