Key Facts · 2026-09-27
- US cosmetic facility registration is biennial, so the facility re-registers every two years, and the first round of that new registration cycle was due on 2026-07-01.
- A factory already registered with the FDA as an OTC drug manufacturer may reuse the same registration number, so 1 registration can cover 2 product categories.
- Every cosmetic product must be listed with the FDA within 120 days after it is first placed on the US market.
- Serious adverse events must be reported to the FDA within 15 working days of the responsible person becoming aware of them.
- Under MoCRA the brand, not the factory, is the Responsible Person, and that party carries 2 filing duties: labeling accuracy and the safety dossier.
- The Cosmetic Product Safety Report, or CPSR, is the dossier the Responsible Person must keep on file, and it is written for 1 specific product rather than per factory.
- Good manufacturing practice itself stays voluntary in the US, with ISO 22716 the recognized standard a factory can be audited against.
The Responsible Person is you, not your factory
The single most useful thing to understand about MoCRA is that it is built around a role called the Responsible Person. For most imported brands that role is the brand itself. The Chinese manufacturer in your supply chain does not become the Responsible Person because it does the mixing, filling and packing.
That assignment matters for two practical reasons. First, the Responsible Person decides what goes on the label, including the name and address that the FDA can act against. Second, the Responsible Person is the party expected to hold the safety documentation and answer questions about a product that was made in another country. Contracts with the factory decided long before MoCRA arrived now have to support that.
Facility registration: the two-year clock
Every facility that manufactures, packages or repacks cosmetic products for the US market must register with the FDA, and registration runs on a two-year cycle rather than annually. The first round of the current biennial registration cycle fell due on 2026-07-01, so a factory sitting on a stale registration is a live problem for any brand placing orders now.
There is a useful shortcut worth checking: a facility already registered with the FDA as a manufacturer of OTC drugs may use the same registration number for its cosmetic registration. That applies to a surprisingly large number of Chinese plants that were built to serve US drug or sunscreen monograph business, and it can save a new registration. What it does not do is remove the duty from you.
- Ask the factory for its current facility registration number in writing, with the date it was issued.
- Confirm the registration covers cosmetic manufacturing and is current for the current two-year cycle.
- Check whether the number was carried over from an existing OTC drug facility registration.
- Re-verify the number before every new purchase order, because registration lapses silently between cycles.
Product listing within 120 days
Registration covers the building. Listing covers the product. Every cosmetic product you place on the US market must be listed with the FDA, and the clock starts when the product goes on sale rather than when the formula was developed. One hundred and twenty days is the allowance, not the target.
Listing is done by the Responsible Person, and in a China-sourced program that means your team, not your supplier's. If your range has 24 SKUs and they launch in three waves, each wave has its own 120-day window. That is the failure mode we see most often: the first six SKUs get filed, and the last twelve quietly fall off the end of the cycle.
- List every product including those made for the US market only, and keep the listing reference against each SKU.
- Start the clock at first sale in the US, not at shipment or at formula completion.
- Treat a wave launch as several separate 120-day obligations rather than one.
- Keep the listing data aligned with the label artwork, because discrepancies are the easiest thing for an inspector to find.
Serious adverse events: 15 working days
This is the clause that changes how a brand behaves in practice. The Responsible Person must report a serious adverse event to the FDA within 15 working days of becoming aware of it, and the obligation attaches to the brand, not the factory. A Chinese supplier that learns about a reaction and tells nobody has not protected you.
Working days are the operative detail. A complaint that lands on a Friday in Shenzhen and is relayed to a brand owner in Los Angeles on the following Tuesday can burn most of a 15-working-day allowance before anyone has even started drafting. The practical fix is a reporting clause in the supply contract and a named contact who can escalate on a weekend.
MoCRA does not care how far the factory is from your office. The 15 working days run from the moment you know, not from the moment your supplier tells you.
What a Chinese factory can and cannot do for you
A good Chinese manufacturer can do a great deal of useful work inside this framework, but most of it sits on the wrong side of the line if you expect it to discharge your obligations. It can hold records, it can open its own files, and it can be audited against ISO 22716. It cannot register on your behalf in a way that transfers liability, and it cannot sign a responsible person statement.
What you should insist on instead is evidence you can put in a file: the facility registration number with its issue date, batch records that trace a returned unit back to a specific production run, and written confirmation that the factory will notify you of any serious adverse event it becomes aware of. Those three items cover most of the gap between a compliant program and a fragile one.
- Request the facility registration number and its issue date as a document, not as a line in an email signature.
- Require batch traceability down to production run level before you approve a new supplier.
- Put the serious adverse event notification duty into the supply contract with a named escalation contact.
- Keep the CPSR alive as a living document that gets revised when the formula or the supplier changes.
Frequently Asked Questions
Check your supply chain against the MoCRA checklist
Send us your factory list and we will tell you which facilities carry a current registration, which can reuse an OTC drug number, and what documentation you need in the file before the next purchase order.
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