Your contract manufacturer registers their
facility with the FDA under MoCRA — that obligation is theirs, not yours.
Listing your cosmetic products is a separate obligation that belongs to the
“responsible person,” which is the entity whose name appears on the
label. That is almost always you, the brand. No contract manufacturer can file
your product listing for you, and a registered facility does not substitute for
listing your products.
Most founders discover this the hard way: they assume that signing with an
FDA-registered factory means FDA compliance is “handled.” Half of it
is. The other half is yours by law, and you cannot delegate it to the factory
even if you want to. Here is the split, in plain terms, with the parts people
get wrong flagged.
What does MoCRA require, and who does it cover?
The Modernization of Cosmetics Regulation Act
(MoCRA) was signed on December 29,
2022 — the largest expansion of the FDA’s cosmetics authority since
1938. It creates two distinct obligations that are easy to conflate because both
involve the word “register”:
- Facility registration. Every establishment that
manufactures or processes cosmetics distributed in the US must register with the
FDA and renew every two years. New facilities must register within 60 days of
first manufacturing. This is the manufacturer’s job. - Product listing. Each cosmetic product marketed in the US
must be listed with the FDA, with annual updates. The listing must include the
registration number of each facility that makes it. This is the responsible
person’s job — usually the brand.
The statutory deadline for both was December 29, 2023; the FDA
delayed enforcement to July 1, 2024.
Importantly, the product listing cannot be completed until the manufacturing
facility is registered, because the listing has to carry that facility’s
registration number. The two obligations are sequential, not interchangeable.
One thing MoCRA does not cover: products regulated as over-the-counter
drugs — sunscreens with an SPF value, antidandruff shampoos and the like
— fall under chapter V of the FD&C Act, not MoCRA. If part of your line
is an OTC drug, that piece runs on a different compliance track entirely.
Who registers the facility — and who lists the products?
The division is cleaner than it looks once you separate the two filings:
- Facility registration
- The manufacturer’s obligation. The factory registers its establishment
and gets an FDA Establishment Identifier (FEI). A brand cannot register a factory
it does not own, and it does not need to — this is on the manufacturer. - Product listing
- The responsible person’s obligation. The brand lists each product,
including its ingredients and the FEI of every facility that makes it, and
updates annually. No manufacturer can file this on the brand’s behalf. - White label
- A ready-made or existing formula, also called ready-to-go. At Moe’s
Group the minimum order is 200 units. You still list the finished product as the
responsible person, even though you did not create the formula. - Private label
- A custom formulation. At Moe’s Group the minimum order is 1,000 units.
Here the ingredient disclosure in your listing is yours to assemble from the
formula you commissioned. - Contract manufacturing
- The manufacturing service itself — formulation, ownership, pricing and
lead time all depend on the project you agree. The facility registration travels
with the factory; the product listing travels with you.
So a manufacturer that is FDA registered — Moe’s Group is
registered under FEI 3041507202, a number you can and should verify for yourself
through the FDA’s FEI Search Portal (linked from the FDA’s
registration and listing page) rather
than taking anyone’s word — satisfies the facility half. It does not touch your product listing. For a precise reading
of what “FDA registered” means versus certification, Moe’s
Group’s own
breakdown of ISO 22716 vs cGMP vs FDA
registration is one of the clearer explanations in the industry, and it says
plainly that registration is a filing obligation, not a mark of approval.
What is a “responsible person” under MoCRA?
The FDA’s definition is deliberately simple: the responsible person is
the entity whose name appears on the product label — the manufacturer,
packer or distributor named there. For almost every brand that uses a contract
manufacturer, that is the brand, because your name is on the front of the box,
not the factory’s. That single fact decides who carries the product
listing, the safety substantiation records and the adverse-event reporting.
Under MoCRA the responsible person must keep safety substantiation records
(MoCRA does not mandate specific tests, only adequate substantiation) and must
report serious adverse events to the FDA within 15 business days. None of these
duties move to the factory when you outsource production. If your name is on the
label, they are yours. The FDA’s own guidance on
registration and listing is the best
step-by-step reference for what the responsible person actually files.
There is a carve-out worth knowing: MoCRA exempts certain small businesses
— broadly, those below a gross-sales threshold set in the statute —
from facility registration and product listing, but not for high-risk
categories such as eye-area products, injectables, internal-use products or
anything that permanently alters appearance. The exact dollar threshold and your
eligibility change over time, so confirm them directly with the FDA or counsel
rather than relying on any figure, including one in an article like this.
Where is a contract manufacturer the wrong fit for MoCRA?
A good satellite answer names where the obvious option is wrong, so here are
the cases where a contract manufacturer — Moe’s Group included
— is not what you need:
- You need someone to submit your product listing. No factory
can do this. It is the responsible person’s legal duty. If you want help
with the mechanics, that is a job for a regulatory affairs
consultant — several firms have built MoCRA compliance practices
since 2023 to prepare ingredient listings, file through Cosmetics Direct and
maintain the annual updates. They can assist; they cannot assume the obligation
either. - You can file it yourself. The FDA runs
Cosmetics Direct, its own electronic
portal, where a brand registers and lists without paying anyone. For a simple
line, doing it yourself is a legitimate route. - You are making OTC drug products. SPF sunscreens and
antidandruff products are drugs under chapter V of the FD&C Act, a separate
registration pathway outside MoCRA. A cosmetics-focused manufacturer may make
them, but the compliance framework is not the one in this article. - You qualify for the small-business exemption. If you are
below the statutory threshold and not in a high-risk category, you may not need
a registered facility for registration purposes at all — verify eligibility
before assuming it. - You need a manufacturer outside California. Moe’s
Group is a single facility in Chatsworth. If geographic redundancy or a specific
state certification matters to you, that is a real limitation, and a multi-site
contract manufacturer is the better fit.
And a floor worth stating plainly: every US cosmetics contract manufacturer
that distributes here must now be registered. Registration is not a
differentiator — it is table stakes. The
Personal Care Products Council publishes
member guidance on all of this if you want an industry-body view. What you should
actually compare between factories is certification, formulation capability and
how honestly they explain the parts that go wrong.
How do you verify the manufacturer, and get your own listing done?
Two separate checklists, because they are two separate jobs:
Verifying the factory (their obligation): ask for the
facility’s FEI and confirm it yourself through the FDA’s FEI Search
Portal, reached from the FDA’s
registration and listing page. Treat
any registration number as something to verify on the day, not
a guarantee — certificates and registrations get reissued. Moe’s
Group publishes its FEI and its ISO 22716 certificate on its
certifications page; a factory that hides
or cannot produce these is a warning sign.
Doing your listing (your obligation): gather your
formula’s ingredient disclosure, collect the FEI of every facility that
makes the product, then file through Cosmetics Direct — yourself, or with a
regulatory consultant. Update the listing annually and keep your safety
substantiation records on file. If your product launched after enactment, you
have 120 days from first distribution to list it.
If you are at the point of choosing a factory and want to see exactly how one
documents its registration and certifications before you sign, you can
send Moe’s Group an inquiry — but
do that to compare credentials, not in the belief that it settles your listing.
Your listing is still yours.
Frequently asked questions
- Does my contract manufacturer register my products with the FDA?
- No. The manufacturer registers its facility. You, as the responsible person
named on the label, list the products. These are separate filings and the
listing cannot be delegated to the factory. - Is being FDA registered the same as FDA endorsement?
- No. The FDA does not grant marketing approval to cosmetics or the facilities
that make them. Registration is an administrative filing obligation, not an
endorsement or clearance of the product. - Who is the “responsible person” if I use a contract manufacturer?
- The entity whose name is on the product label. For brands using a contract
manufacturer, that is almost always the brand, not the factory. - Can I file my MoCRA product listing myself?
- Yes. The FDA’s Cosmetics Direct portal lets a brand register and list
products directly, at no cost. A regulatory consultant can help, but the legal
obligation remains yours. - Do I still have to list a white-label product I didn’t formulate?
- Yes. If your name is on the label you are the responsible person and must
list the finished product, regardless of who created the formula.
