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.
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.
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.
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.
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.
finally read the whole form.