Cosmetics Manufacturing for the United States
MoCRA split the paperwork between the factory and the brand. Here is which filing is ours, which is yours, our FEI number in full, and the two product categories that change the rules on you.
One law, two sets of paperwork
MoCRA was signed on 29 December 2022 as part of Public Law 117-328, and every statutory deadline in it counts from that date. Before it, cosmetics were the least regulated product category the FDA touched: no mandatory facility registration, no mandatory product listing, no requirement to hold safety substantiation on file. MoCRA introduced all three, added mandatory serious adverse event reporting and gave the FDA mandatory recall authority.
The part that decides whether your launch goes smoothly is not the law itself but who does what under it. Facility registration is the factory's obligation. Product listing is the brand's. Those two get merged in conversation constantly, usually by a supplier saying they will "handle the FDA side", and the gap surfaces after stock has shipped. Registration has been enforced since July 2024, and failure to register is a prohibited act under the FD&C Act, which puts goods from unregistered facilities at risk of import refusal.
Below is the split written out obligation by obligation, our own registration published in full so you can use it, and the two categories that behave differently from everything else in a US range.
Who owes what under MoCRA
Six obligations, and the honest answer on each. Four of them are yours, which is not what most factory websites will tell you.
Facility registration
OursThe manufacturing site registers itself, once, and one registration covers work done for every brand produced there. It is not filed per client and not filed per product. Renewal runs every two years from the date of initial registration, and any change to the registration is due within 60 days.
Product listing
YoursOwed by the responsible person, which the statute defines as the manufacturer, packer or distributor whose name appears on the label. On a private label or white label range that is you, not us. Our name is not on your label. Listings are updated annually, and anything first marketed after enactment is due within 120 days of entering interstate commerce.
Safety substantiation
Yours, from our fileYou must hold adequate substantiation of safety for each product. There is no prescribed test list; the standard is evidence a qualified expert would consider sufficient. This is the point where our technical file has to become yours, which is why it belongs in the contract rather than in a later email.
Serious adverse event reporting
YoursReports go to the FDA within 15 business days of the responsible person receiving them, with a further 15 business days for significant new medical information arriving within a year. Records are kept six years, or three if you qualify as a small business.
Labelling
Yours, we print itLabels must carry contact information through which adverse events can be reported to you, alongside existing Fair Packaging and Labeling Act requirements. Professional-use products carry their own requirement. We print what you approve; the wording obligation stays with the responsible person.
Good manufacturing practice
OursMoCRA directed the FDA to write binding GMP regulations for cosmetics. We already operate to ISO 22716 and GMPC, audited by Intertek, which is the evidence base a buyer can check today rather than a promise about a future rule.
Our registration, published in full
Our facility is registered with the FDA under MoCRA with FEI number 3038966060, valid through 29 July 2028. We publish it because it is the number you would need for your own product listing, and because a supplier who will not give you theirs is telling you something.
Now the part most pages leave out. You cannot look this up. Cosmetics Direct is a submission portal rather than a search tool, and the FEI Search Portal only lets a company find or confirm its own FEI number by name and address; it does not report MoCRA registration status. The FDA publishes aggregate figures for active registrations and listings, including a breakdown by country, but no company-by-company lookup exists. If a supplier invites you to verify their registration on the FDA website, they are describing a feature that is not there.
What is checkable is the entity. Our legal name, Jiumei (Guangzhou) Biomedical Co., Ltd. (Unified Social Credit Identifier 91440101MA59F7726Y), is the name printed on our Intertek ISO 22716:2007 and GMPC certificates, HBPCER20260352 and HBPCER20260353, issued 16 July 2026 and valid to 15 July 2029, both verifiable by anyone at certs.intertek.com.cn. A certificate held in the issuing body's own database is a different and stronger kind of evidence than a PDF in an email, and matching the entity name across independent documents is how you catch a trading company presenting a factory's paperwork as its own.
To state the limit plainly: none of this approves your product. The FDA does not approve or certify cosmetics, and no FDA certificate exists for either of us to show you. Our registration means your goods are not coming from an unregistered facility. Your listing, your safety substantiation and your labelling remain yours. Read the full breakdown in our MoCRA compliance guide, or what certification does and does not prove in ISO 22716 and GMPC explained.
What the US regime changes about your range
Two categories leave the cosmetic route altogether, and one changes your packaging rather than your formula. These are the four points that come up in almost every US project.
Sunscreen leaves the cosmetic route entirely
In the US sunscreen is an over-the-counter drug under the OTC monograph system, and MoCRA specifically exempts facilities already subject to the drug requirements of Chapter V from cosmetic registration, listing, GMP and safety substantiation. Filing an SPF product as a cosmetic is the single most expensive mistake in a US launch plan. Your sunscreen goes down the drug route; your moisturiser does not.
Relevant formats: Aqua Shield Sun Essence SPF50 PA, Sport Water-Resistant Sunscreen SPF50
Eye-area products lose the small business exemption
The exemption is disapplied for certain product types regardless of turnover, including products that regularly contact the mucus membrane of the eye in normal use. Micellar waters and eye-makeup removers sit squarely in that group, and it is the category launch-stage brands trip over most often. If a remover is in your first range, plan to register and list from day one.
Relevant formats: Derma Calm Micellar Cleansing Water, Ultra Gentle Micellar Water for Sensitive Skin, Deep Cleansing Micellar Water
Fragrance allergen disclosure changes artwork, not formula
MoCRA directed the FDA to require fragrance allergen disclosure on labels. The formulation work is unaffected; the packaging work is not. If you are running fragranced lines, design artwork with room for a list rather than treating your current layout as final, because relaying a carton later costs more than leaving space now.
Relevant formats: Heartleaf Cleansing Oil, Camellia Deep Cleansing Balm
Claim wording decides the category, not the ingredient
A product becomes a drug in the US through what it claims, not through what is in it. An insect-repellent claim moves a botanical liquid under EPA pesticide registration; an anti-acne claim can pull a cleanser into the OTC monograph system. We formulate to the cosmetic route by default and flag where the claim, rather than the formula, is the constraint.
Relevant formats: Citronella Soothing Herbal Liquid, Anti-Pollution Lightweight Essence Lotion, Centella Soothing Repair Toner
Formulation baselines are adjustable for your target market and price point. Ingredient levels are set within the limits of your destination market rather than to a fixed house recipe, and claim wording is confirmed against the route your product will actually take.
Questions buyers ask about the US market
Are you an FDA registered cosmetics manufacturer, and can I verify it?
Our facility is registered with the FDA under MoCRA with FEI number 3038966060, valid through 29 July 2028. We publish the number in full because it is the number you would need for your own product listing. What we should be straight about is the limit of verification: Cosmetics Direct is a submission portal, not a search tool, and the FEI Search Portal only helps a company find or confirm its own FEI number by name and address. It does not report MoCRA registration status. The FDA publishes aggregate statistics on active registrations and listings, but no public company-by-company lookup. So any supplier telling you to go and look up their registration is describing something that does not exist. What you can do is cross-check the entity: our legal name, Jiumei (Guangzhou) Biomedical Co., Ltd., is the name printed on our Intertek ISO 22716 and GMPC certificates, HBPCER20260352 and HBPCER20260353, and those are checkable in Intertek's own database at certs.intertek.com.cn. Matching the entity name across independent documents is how you catch a trading company showing you a factory's paperwork.
Does your FDA registration mean my products are FDA approved?
No, and there is no version of this that is true. The FDA does not approve cosmetics, does not certify cosmetics facilities, and issues no certificate you or we can hold up. Facility registration is a filing, not an endorsement. Anyone selling you FDA approved cosmetics is either confused or counting on you being confused. Our registration means our site has met its own obligation and that your products are not coming from an unregistered facility, which matters because failure to register is a prohibited act under the FD&C Act and puts goods at risk of import refusal. It does not substitute for your product listing, your safety substantiation or your labelling compliance.
Which MoCRA filings do I have to do myself?
Product listing, safety substantiation, serious adverse event reporting and labelling compliance. Those four sit with the responsible person, and on a private label range the responsible person is you, because your name is on the label. We handle facility registration and GMP on our side. The split trips people up because facility registration sounds like it should cover everything happening in the facility. It does not: it describes the site, while listing describes your product. Practically, budget for your listing to be filed within 120 days of the product entering interstate commerce, and treat the annual listing update and the two-year facility renewal as separate items in your calendar. The 60-day rule is often quoted in the wrong place; it attaches to changes in facility registration, not to routine listing updates.
Do I qualify for the small business exemption?
Possibly, and you have to decide it yourself, which is the part worth sitting with. If your average gross annual US cosmetic sales over the previous three years fall below one million dollars, adjusted for inflation, you may be exempt from GMP requirements and from registration and listing. Three cautions. First, the exemption is disapplied for certain product types regardless of size: products that regularly contact the mucus membrane of the eye in normal use, injected products, products intended for internal use, and products intended to alter appearance for more than 24 hours where consumer removal is not part of normal use. Eye products catch the most brands. Second, the exemption never covers safety substantiation, adverse event reporting or labelling; those apply to every responsible person at every size. Third, the FDA does not issue exemption certificates or ask you to file anything to claim it, so the determination and the risk of getting it wrong sit entirely with you.
Can you manufacture sunscreen for the US market?
We manufacture SPF products, and the honest answer about the US is that the regulatory route matters more than the formulation. US sunscreen is an OTC drug, which means drug establishment registration, drug listing and pharmaceutical GMP rather than the cosmetic pathway, and MoCRA explicitly exempts drug-route products from the cosmetic provisions. Brands that plan an SPF hero product for a US launch should scope that pathway before sampling, because discovering it after artwork is printed is expensive. For markets where sunscreen is a cosmetic or a quasi-drug, the same formulas move much more easily. Tell us your destination list in priority order and we will tell you which products change route and which do not.
What documentation do you provide for safety substantiation?
Formula and ingredient documentation, product specifications, Certificates of Analysis per batch, and stability and testing data, with third-party testing through SGS available on request where you or a retailer want independent verification. The reason to settle this in the contract rather than later is that safety substantiation has no prescribed test list, so what counts as adequate depends on the product and the claims you make about it. If your claims go beyond what our standard file supports, the extra testing is scoped and quoted separately rather than assumed. A related point on records: if you change manufacturer later, the underlying data sits with whoever generated it, so agree in writing what transfers to you before you need it.
US market guides
Each written against the named statute or standard rather than summarised from other sites.
MoCRA Compliance for Cosmetics: What Brands Must File in 2026
MoCRA compliance: your factory registers its facility, you list your products. The real enforcement dates, the 120-day rule, and why no FDA certificate exists.
ISO 22716 & GMPC Certification: Meaning, Cost & Verification
ISO 22716 is the international GMP standard for cosmetics; GMPC confirms a factory follows it. What each covers, verification steps, and cost.
How to Read a Cosmetic Stability Testing Report (2026)
There is no legally prescribed protocol for cosmetic stability testing, so a report that only says "pass" tells you almost nothing. The five things to check before you trust a shelf life.
How to Verify a Cosmetics Manufacturer's Formulation Capability
How to verify a cosmetics manufacturer's formulation capability with evidence: the documents to request, the stability data to insist on, and the red flags.
Cosmetic Contract Manufacturers: Scope, MOQ and How to Vet a China Factory
What cosmetic contract manufacturers cover, how to vet a China factory beyond the certificate, realistic MOQ and lead times, and the questions that matter.
How to Start a Private Label Skincare Line: MOQ, Costs & Timeline
How to start a private label skincare line, step by step: what private label means, realistic MOQ, cost breakdown, timeline, and how to vet a manufacturer.
Is the US your first market or your third?
The answer changes what you file and when. Tell us your range and your destination list in priority order, and we will flag which products leave the cosmetic route before you pay for a sample.
Response within 24 hours · WhatsApp available · Factory visits welcome