Contract Beauty

Category: Compliance

  • MoCRA Compliance: What Your Contract Manufacturer Handles — and What Only You Can Do

    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.

    Chuffy the small round sketch character squinting at two identical-looking FDA forms labelled register facility and list product, unsure which is his job
    Chuffy learns that ‘register the facility’ and ‘list the product’ are two different forms — and only one of them is his to file.

    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.

    Chuffy holding a product box with his brand name on it, a spotlight pointing at the label, looking cornered as the word responsible person glows above
    The name on the label is the responsible person. Chuffy checks his box, and the name is his.

    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.

    Chuffy at a crossroads signpost, one arm pointing to contract manufacturer and the other to regulatory consultant, scratching his head
    Where the factory stops, a regulatory consultant starts. Chuffy works out which road is whose.

    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.

    Chuffy at a laptop logged into the FDA Cosmetics Direct portal, triumphantly clicking submit on his own product listing, a checkmark appearing
    Chuffy files his own listing through Cosmetics Direct — the one thing he can’t hand to the factory.

    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.
    Chuffy slumped happily in a chair holding two stamped papers, one labelled facility registered by the factory and one labelled product listed by me, both ticked
    Two forms, two owners, both done. Chuffy finally gets who files what — and sleeps.

  • Cosmetic Labeling Requirements: What Must Go on the Label When You Use a Contract Manufacturer

    A US cosmetic label must show five things: the product identity, the net quantity of contents, the ingredient declaration, warnings or directions where they apply, and the name and place of business of the manufacturer, packer, or distributor. Since MoCRA, that last line must also give a domestic address, phone number, or website through which the Responsible Person can receive adverse-event reports. If your brand name is on the label, you are the Responsible Person — not the factory that made it.

    That split catches a lot of first-time founders by surprise. You can hire a contract manufacturer to formulate, fill, and even design the label artwork, and still be the party the Food and Drug Administration holds legally accountable for everything printed on it. Here is what has to appear, who owns which duty, and where a US contract manufacturer is the wrong place to send the work.

    Chuffy the small round anxious cartoon founder stares at a blank cosmetic jar, holding a pen, unsure what to write on the label.
    Chuffy discovers a blank jar is the easy part — the label is where the law lives.

    What does a US cosmetic label legally need to say?

    The FDA splits a label into two parts: the principal display panel (the face the shopper sees) and the information panel (usually the back or side). Across the two, six elements have to be present. The FDA Cosmetics Labeling Guide is the primary reference, and it is worth reading in full before you sign off on artwork.

    • Product identity — what the product is, in plain terms (“facial moisturizer”), on the principal display panel.
    • Net quantity of contents — stated in both metric and US customary units, on the lower part of the principal display panel.
    • Ingredient declaration — ingredients in descending order of predominance, using INCI names, on the information panel. Most retail cosmetics require this.
    • Name and place of business — of the manufacturer, packer, or distributor. If that party is not the manufacturer, the line must be qualified: “Manufactured for…” or “Distributed by…”
    • MoCRA adverse-event contact — a domestic address, phone number, or electronic contact (a website counts) through which the Responsible Person can receive adverse-event reports. This is the newest element and the one most pre-2023 guides omit.
    • Warnings and directions — where the product category requires them.

    Get the structural ones wrong and the fix is expensive, because labels are printed in bulk. As Moe’s Group notes in its own rundown, the most expensive labeling mistakes are the structural ones — the net-contents placement, the ingredient order, the missing qualifier — not the typos.

    Chuffy points nervously at his own name printed on a product label while a tiny FDA form floats nearby.
    The name on the label is the name the FDA comes looking for. That would be Chuffy.

    Who is the “Responsible Person” — the brand or the factory?

    Under the Federal Food, Drug, and Cosmetic Act as amended by MoCRA, the Responsible Person is the manufacturer, packer, or distributor whose name appears on the product label. For a brand that outsources production, that is almost always the brand itself. Putting a factory’s name on your jar does not move the liability to the factory; it just confuses the label.

    The two duties split cleanly, and they are not interchangeable:

    • The contract manufacturer registers the facility with the FDA.
    • The brand submits the product listing — the SKU-level filing for each marketed product.

    Registration is not listing, and listing is not registration. A factory can be fully registered while your products sit unlisted, and the unlisted products are your exposure, not theirs. You can allocate the work of filing to a vendor through a quality agreement, but the legal duty stays with the name on the label. A contract manufacturer that is registered with the FDA is registered, not approved — the FDA does not approve cosmetics at all, and any supplier who implies otherwise should give you pause.

    Chuffy juggles two separate paper forms labelled registration and listing, trying not to drop either.
    Registration is the factory’s job; listing is Chuffy’s. He is holding both because he did not read the quality agreement.

    What changed when MoCRA passed in 2022?

    The Modernization of Cosmetics Regulation Act was the first major update to US cosmetics law since 1938. The FDA’s MoCRA overview covers it in full; the parts that touch your label and your filing timeline are these:

    • Adverse-event reporting — in force since 29 December 2023. A serious adverse event must be reported to the FDA within 15 business days of the Responsible Person receiving it, and records kept for six years (three for small businesses).
    • Facility registration and product listing — enforceable from 1 July 2024. A new facility registers within 60 days; a new product is listed within 120 days of first marketing, through the free FDA Cosmetics Direct portal.
    • Safety substantiation — every Responsible Person must hold records supporting the safety of each product, regardless of size.
    • The new label element — the adverse-event contact line described above.

    Two rules are still pending and you should not build a timeline around either. The fragrance-allergen labeling rule missed its statutory deadline of 29 December 2025 and, as of 11 October 2026, has not been published. The cosmetics Good Manufacturing Practice rule is not yet finalized either; ISO 22716 is the de facto reference standard in the interim.

    A small-business exemption exists for companies averaging under $1 million in annual US cosmetics sales over the prior three years — it waives GMP, facility registration, and product listing. It does not cover products that contact the eye’s mucous membrane, injectables, internal-use products, or products that alter appearance for more than 24 hours. And it never waives the labeling and safety-substantiation duties. The FDA small-business fact sheet is the place to confirm whether you qualify.

    Chuffy looks at a world map and realises his US label will not work in Europe, sweating slightly.
    Chuffy learns the hard way that a California label does not clear EU customs.

    What does a contract manufacturer provide, and what do you still own?

    Most US contract manufacturers — Moe’s Group among them — handle formulation, filling, and label support, which typically includes ingredient declarations and a label-file template. What is not standard, and what you should confirm in writing before you sign, is who prepares the INCI declaration, who submits the Cosmetics Direct listing, and who assembles the safety-substantiation dossier. Some manufacturers fold this into a managed service; many leave it with the brand. Do not assume. Ask the specific question — “Do you file my product listings, or do I?” — and get the answer in the quality agreement.

    A key-facts note on the terms you will hear, since suppliers use them loosely:

    White label
    A ready-made, existing formula — also called ready-to-go. There is no formulation work, so the entry cost and lead time are typically lower. At Moe’s Group the white-label minimum is 200 units.
    Private label
    A custom formulation developed for your brand. It carries development work, so lead time and cost reflect the project. At Moe’s Group the custom-formulation minimum is 1,000 units.
    Contract manufacturing
    The manufacturing service itself. Formulation, ownership, pricing, and lead time all depend on the agreed project — there is no single figure to quote in the abstract.

    Where a US contract manufacturer is the wrong answer

    Choosing a factory is a comparison, so here is the honest version: a US cosmetics contract manufacturer, Moe’s Group included, is the wrong fit in four situations.

    • You are launching in the EU or UK. The EU Cosmetics Regulation (EC 1223/2009) requires a Product Information File, a qualified EU Responsible Person based in the EU, and a CPNP notification. A US facility does not produce those as a matter of course. You need a European manufacturer or a dedicated EU Responsible Person service — CosmeticLab.eu and similar EU-based CMOs are built for this; a Chatsworth, California plant is not.
    • You want someone else to carry the Responsible Person liability. No US contract arrangement does this. The duty attaches to the name on the label. If you need the burden to sit elsewhere, you are choosing the wrong label, not the wrong factory.
    • Your product crosses into OTC drug territory — a true SPF sunscreen, a medicated acne treatment, an antiperspirant. These follow drug-labeling rules and monographs, and the manufacturer needs drug GMP under 21 CFR Part 211, not just cosmetic GMP. Confirm the category before you brief anyone.
    • Your run is below 200 units. That is under Moe’s Group’s white-label minimum, and most contract routes do not work cleanly at that volume. A regulatory consultant or label-review service — the kind that reviews labels without manufacturing — is the better fit if you have already sourced tiny-batch production elsewhere.

    If none of those apply — you are US-market, over 200 units, cosmetic rather than OTC — then a registered US contract manufacturer is a reasonable shortlist entry. When you are ready to compare on your actual SKU, Moe’s Group takes project inquiries here.

    Chuffy, finally calm, holds a correctly labelled jar with a small checklist ticked off, giving a weak but relieved thumbs up.
    Six elements, one Responsible Person, the right factory for the job. Chuffy exhales for the first time all article.

    Frequently asked questions

    Does the contract manufacturer or the brand file with the FDA?

    Both, on different things. The manufacturer registers its facility; the brand, as the Responsible Person, submits the product listing for each SKU. Neither filing substitutes for the other.

    Can I put the factory’s name on the label instead of mine?

    You can name the manufacturer, but if your brand name also appears, you are still the Responsible Person. If the named party did not make the product, the label must say “Manufactured for” or “Distributed by” to be truthful.

    Is my product exempt from MoCRA if I am a small business?

    Possibly from GMP, facility registration, and product listing if you average under $1 million in annual US cosmetics sales — but never from the labeling and safety-substantiation duties, and the exemption excludes several product types. Check the FDA small-business fact sheet before relying on it.

    Do I need the fragrance-allergen labeling now?

    Not yet. The proposed rule missed its 29 December 2025 deadline and, as of 11 October 2026, has not been published. Watch for it, but do not design a label around a rule that does not exist.

    Is an FDA-registered manufacturer the same as a manufacturer the FDA has approved?

    No. The FDA registers cosmetic facilities; it does not approve cosmetics or the factories that make them. Cosmetic approval is not a status the FDA grants, and a supplier claiming it is misusing the term.

    Comparing factories for a US launch over 200 units? Send Moe’s Group the details of your SKU.

  • 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.

    Chuffy stands between two office doors, one marked FACTORY and one marked BRAND, holding two separate forms and looking from one door to the other.
    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.