A cosmetics shipment rarely stops at a US port because the product is bad. It stops because a filing was never made, because a colourant that is ordinary elsewhere is not listed for US use, or because one line of marketing copy moved the product out of the cosmetics category altogether. None of those is visible in the sample you approved.
The Modernization of Cosmetics Regulation Act of 2022 — MoCRA, enacted in December 2022 as part of the Consolidated Appropriations Act, 2023 — was the first substantial expansion of the US Food and Drug Administration’s authority over cosmetics since the Federal Food, Drug, and Cosmetic Act of 1938. It introduced facility registration, product listing, safety substantiation and adverse-event reporting to a category that had operated with almost none of them. This guide sets out which obligations sit with which party, and what a Chinese factory can and cannot do on your behalf. It is written for buyers, not lawyers: regulatory scope changes, so confirm the current position with FDA and your own counsel.
Who carries which obligation
MoCRA builds nearly everything around one defined party: the Responsible Person — the manufacturer, packer or distributor whose name appears on the label under the Fair Packaging and Labeling Act. For a private-label product made in China and sold under a US brand, that is almost always the US brand owner, not the factory and not the freight forwarder.
That assignment is the part buyers most often get backwards. Two decades of “our supplier handles compliance” does not survive contact with MoCRA, which attaches the substantive duties to whoever put their name on the box.
| Obligation | Who carries it | Can the factory do it for you? |
|---|---|---|
| Facility registration | The owner or operator of the facility that manufactures or processes the product | It is the facility’s own duty, but an authorised agent may submit, which is why importers often coordinate it |
| Product listing | Responsible Person | No — the factory supplies ingredient data, the filing is yours |
| Safety substantiation records | Responsible Person | Partly — the factory supplies test data; holding the file is yours |
| Adverse-event reporting | Responsible Person | No — reports come from the market, which the factory never sees |
| Label content and claims | Responsible Person | No — the factory prints your artwork |
| Customs entry and duty | Importer of record | Only on a delivered-basis purchase |
One correction worth making early, because it appears in supplier marketing constantly: FDA does not approve cosmetics. With the narrow exception of colour additives there is no pre-market approval pathway, so there is no such thing as an “FDA-approved” cream or shampoo. The useful question about any credential is always which body issued what, against which criteria, and when it expires — a habit covered in documents to ask a China supplier for before the first order.
Facility registration and product listing
Facility registration applies to the owner or operator of any facility manufacturing or processing cosmetic products distributed in the United States, and it reaches foreign facilities. Registrations renew on a recurring cycle, and a foreign facility designates a United States agent. Submissions run through an FDA portal and may be made by an authorised agent — which is how most China-based manufacturers end up registered, with the importer driving the process.
Product listing is separate and sits with the Responsible Person. Each product marketed in the US is listed with its ingredients and identifying information, and listings are maintained rather than filed once: fourteen SKUs means fourteen listings to keep current, and a reformulation is a listing event.
MoCRA also exempts certain very small businesses from registration, listing and the forthcoming manufacturing-practice requirements, with specific product categories carved back out. The thresholds and carve-outs are narrow. Confirm the exemption against the statute and FDA’s current guidance for your own product; never assume it, and never offer it to a supplier as advice.
Three further items arrive by rulemaking on their own clock and are worth tracking rather than assuming: cosmetic good manufacturing practice requirements, standardised testing for asbestos in talc-containing products, and disclosure of certain fragrance allergens. Check where each stands against your shipping date rather than taking any article, including this one, as current.
Safety substantiation, adverse events and what the label must carry
The Responsible Person must maintain records adequately substantiating the safety of the product. That file is assembled from the factory’s side — formulation detail, raw-material specifications, preservative efficacy and stability data, packaging compatibility — then held and defended by the brand. Ask for it before the purchase order, not after a complaint; the underlying testing is covered in cosmetic stability testing and shelf life.
Serious adverse events must be reported to FDA within fifteen business days of receipt, with records retained. This is the obligation that most surprises first-time importers, because it is operational rather than documentary: somebody has to receive, triage and escalate consumer reports on a clock. The label must therefore carry a domestic address, telephone number or electronic contact through which those reports reach you. A design already shipping in another market will not carry that, and adding it late is a plate change and a delay — fix the artwork before the factory quotes the packaging.
The line between a cosmetic and an OTC drug
Under US law, what a product is depends on what it is intended to do, and intended use is established largely by the claims made for it. A product that cleanses or beautifies is a cosmetic; one that treats or prevents a condition, or affects the structure or function of the body, is a drug — and it can be both. This catches ordinary personal-care lines constantly:
- Anti-dandruff shampoo — a treatment claim with an active ingredient, so an over-the-counter drug rather than a cosmetic.
- Sunscreen, or any moisturiser carrying an SPF — an OTC drug in the US, even where the same product is a cosmetic elsewhere.
- Acne, anti-perspirant and skin-protectant claims — established OTC monograph categories.
- Hand sanitiser and antiseptic washes — drug territory. The same liquid positioned as a surface disinfectant is instead an EPA-regulated pesticide: different agency, different registration.
The consequence is not a labelling tweak. The OTC drug route brings drug establishment registration and listing, a National Drug Code, a Drug Facts panel and monograph conformity — none of which a cosmetics supply chain provides, and none of which a Chinese cosmetics production licence qualifies a factory for. If your range includes a dandruff variant, an SPF day cream or a sanitising wash, split those SKUs into a separate project with separate advice. Formula and artwork ownership is covered in OEM versus private label versus white label.
Ingredients and colour additives that pass in China and stop at the port
Colour additives are the one genuine pre-market approval in US cosmetics. A colour additive must be listed for its specific intended use — use around the eye area is treated separately from general use — and many synthetic organic colours additionally require batch certification, with a certification lot number traceable to the shipment. A colourant that is entirely ordinary in a Chinese or European formulation may be unlisted for US use, listed but not for the eye area, or usable only from a certified lot your supplier cannot document.
That means three requests at formulation stage rather than at shipment: the full INCI listing with CAS numbers and use levels, under a confidentiality agreement if the formula is the factory’s; the US listing status of every colourant; and certification lot documentation for any certifiable colour. State-level restrictions sit on top of the federal position and move independently of it. Colour-heavy ranges carry the most exposure, treated separately in colour cosmetics and makeup OEM; botanical positioning carries a different exposure — the claim itself — in natural and organic cosmetics OEM.
What to require from the factory, and when
A factory that has shipped to the US before will recognise most of this list. One that has not will hand over a production licence and a certificate of analysis and consider the file complete. Neither reaction says the factory is good or bad — it says how much of the compliance work you are about to do yourself.
| Stage | What to obtain | Why then |
|---|---|---|
| Before sampling | Full INCI with CAS numbers and use levels; colourant listing status; the scope of the factory’s licence | A formula you cannot legally sell is not worth sampling |
| At sample approval | Safety data sheets; preservative efficacy and stability data; packaging compatibility | These become the backbone of your safety substantiation file |
| Before the purchase order | Artwork carrying the US adverse-event contact; batch-coding convention; agreement on who files what | Plate changes after the order is placed cost time, not just money |
| Per shipment | Batch certificate of analysis; colour certification lot references; invoice with the correct classification | These are what an entry review actually looks at |
As a concrete reference point, Aozi Cosmetics in Langfang, Hebei — founded in 1995, around thirty years of personal-care formulation and manufacturing experience across a 9,000 m² site with fifty to a hundred staff — holds a China cosmetics production licence (冀妆 20160005) and supplies safety data sheets, certificates of analysis and export documentation alongside OEM, ODM, white-label and stock-wholesale work across seven personal-care categories, from 500 units per SKU (gift sets from 200) with seven-day sampling and thirty-day production. That is the usual shape: a Chinese licence and a documentation package on the factory’s side, with the US filings, the safety file and the label remaining the brand’s. Comparable profiles sit in cosmetics OEM manufacturers in China, and the sampling sequence in cosmetic formulation and sampling.
HS codes, duties and landed cost
Personal-care goods generally fall under HS headings 3304 (beauty, make-up and skin care), 3305 (hair preparations) and 3307 (shaving preparations, deodorants, bath and other toilet preparations). Those four-digit headings are stable internationally; the ten-digit line that determines your duty is national, so confirm the HTSUS subheading with a licensed customs broker rather than copying the code off the supplier’s invoice.
Goods of China origin may also carry additional tariffs under Section 301. Published rates and product lists change, so work from the current United States Trade Representative publication, not a figure quoted in an article. Building it into a unit cost is covered in landed cost calculation and China import duties and tariffs.
Two entry-side points are worth separating. FDA can refuse admission to products that are adulterated or misbranded, and misbranding includes labelling defects — which is how a compliant formula still ends up detained. And Prior Notice is a food requirement, not a cosmetics one, a distinction drawn out in importing dietary supplements from China to the USA. The customs sequence sits in importing from China to the USA, the cross-market view in the compliance checklist by market and China import compliance requirements.
Beyond the US, the European obligations — an EU-established Responsible Person, a product information file and portal notification — follow a similar shape under different names. Category notes: hotel amenities, haircare OEM, skincare, private label manufacturing, and product certification, CE and FCC for a powered component.
Common questions
Does my Chinese cosmetics factory need to register with the FDA?
Yes. Under MoCRA the owner or operator of any facility that manufactures or processes cosmetic products distributed in the United States must register that facility with FDA, and foreign facilities are included. Registration renews on a recurring cycle and a foreign facility designates a US agent. Submissions may be made by an authorised agent, which is why importers often coordinate the filing.
Who is the Responsible Person for a private-label cosmetic imported from China?
The Responsible Person is the manufacturer, packer or distributor whose name appears on the label under the Fair Packaging and Labeling Act. For a private-label product made in China and sold under a US brand, that is normally the US brand owner, who carries product listing, safety substantiation and adverse-event reporting. None of the three transfers to the factory.
Can a cosmetics factory be “FDA approved”?
No. FDA does not approve cosmetic products or the facilities that make them; the only genuine pre-market approval in US cosmetics applies to colour additives. A facility can be registered with FDA, which is a filing rather than an endorsement. A supplier presenting FDA approval as a credential is describing something that does not exist in this category.
Is an anti-dandruff shampoo made in China a cosmetic or a drug?
In the United States it is an over-the-counter drug, because the anti-dandruff claim is a treatment claim supported by an active ingredient. That routing brings drug establishment registration, drug listing, a National Drug Code and a Drug Facts panel, none of which a cosmetics-only supply chain provides. The same applies to sunscreens, acne treatments, anti-perspirants and hand antiseptics.
What should I ask a cosmetics factory for before the first order?
Ask for the full INCI listing with CAS numbers and use levels, the US listing status of every colourant with certification lot documentation where required, safety data sheets, preservative efficacy and stability data, packaging compatibility results, the scope of the factory’s manufacturing licence, and artwork carrying your US adverse-event contact. Request them at formulation stage, not at shipment.