To sell a New Zealand or Australian skincare product in the United States, you must meet MoCRA: your US-facing brand owner registers as the Responsible Person, your manufacturing facility registers with the FDA, every product is listed, safety is substantiated on file, and serious adverse events are reported within 15 business days.
The United States used to be the easiest export market for an indie NZ or Australian brand — no pre-market approval, no notification portal, no fee. That changed with the Modernization of Cosmetics Regulation Act (MoCRA). Here's what actually applies to a small brand formulating here and selling there.
What is MoCRA, and does it apply to New Zealand and Australian brands?
MoCRA is the first meaningful overhaul of US cosmetic law since 1938, and it applies based on where a product is distributed, not where it is made. If your cream is manufactured in Auckland or Melbourne and sold to a US consumer — through your own store, an Amazon listing, or a US retailer — you are inside the regime.
The core obligations are facility registration, product listing, adequate substantiation of safety, compliant labelling, and serious adverse event reporting. There is no "we're small and offshore" carve-out that removes all of these, though there is a partial small-business exemption covered below.
Who is the "Responsible Person" if my brand is based in NZ or Australia?
Under MoCRA the Responsible Person is the manufacturer, packer or distributor whose name appears on the product label. For most indie brands, that is you — the brand owner — not your formulation studio and not your contract manufacturer.
That matters, because the Responsible Person carries the product listing obligation, the safety substantiation file and the adverse event reporting duty. Separately, a foreign facility must designate a US agent for FDA communications. These are two different roles, and brands routinely confuse them — your US distributor acting as "the agent" does not make them responsible for your safety file.
Does my formulation studio's facility need to register with the FDA?
Yes — facilities that manufacture or process cosmetics for US distribution register with the FDA, foreign facilities included. Registration is renewed every two years, with renewal dates keyed to your original registration date rather than a single industry-wide date.
Product listings are separate. A listing must be submitted within 120 days of first marketing a product in the US, and updated annually to confirm the formulation and facility linkage are still accurate. If you reformulate — a preservative swap, a fragrance change — the listing needs to reflect it.
What does "adequate substantiation of safety" actually mean?
This is the requirement that catches indie founders off guard, because it is the one with no form to fill in. MoCRA requires you to hold evidence supporting the safety of the finished product before it goes to market — and to produce it on request. For a typical leave-on or rinse-off skincare product, that file looks like:
- A toxicological assessment of each ingredient at its use level
- Accelerated stability data — we run a standard 12-week protocol at multiple temperatures
- Preservative efficacy (challenge) testing to ISO 11930, from NZ$1,200 per formula
- Packaging compatibility results for the actual pack you're shipping in
- Batch records and specifications from manufacturing
The good news for NZ and Australian brands: this is very close to the dossier you already need for the NZ Cosmetic Products Group Standard and for AICIS in Australia. Built once, properly, it travels.
Am I exempt as a small indie brand?
Possibly, but less than you'd hope. Businesses averaging under approximately US$1,000,000 in US gross annual sales over the previous three years — a threshold adjusted for inflation — are exempt from facility registration, product listing and the (still-pending) GMP requirements.
They are not exempt from safety substantiation, labelling requirements, or adverse event reporting. And the exemption is lost entirely if you make even one product that contacts the mucous membrane of the eye (mascara, liquid liner, lash adhesive), is injected, is for internal use, or alters appearance for more than 24 hours without consumer removal.
So a small brand selling a serum and a cleanser may well be exempt from registration. That same brand adding a mascara is not — for its whole range.
What's still changing in 2026 — GMP and fragrance allergens?
Two rules are worth watching honestly rather than anxiously.
Cosmetic GMP. MoCRA required the FDA to propose GMP regulations by December 2024 and finalise them by December 2025. Neither happened. The rule now sits on the FDA's Unified Agenda as a long-term action with no proposed date. It is not finalised in 2026 — but the FDA already expects manufacturers to demonstrate structured manufacturing controls, and building to ISO 22716 now is the sensible hedge.
Fragrance allergen labelling. The FDA missed its December 2025 statutory deadline; the proposed rule was expected around May 2026. Nothing is enforceable yet, but if you sell into the EU you are likely already declaring allergens, and aligning your US labels early costs almost nothing.
How does US compliance fit alongside NZ and AICIS requirements?
Sequence it. Test once against the strictest applicable standard, then map the same evidence to each market. A brand launching in New Zealand, then Australia, then the US typically needs one stability programme, one challenge test and one ingredient safety assessment — but three sets of labelling and administrative filings. What changes per market is paperwork and claims, not chemistry. Our guide to claims substantiation and labelling requirements guide cover the NZ and AU side.
How The INCI Lab supports US-market launches
We're an award-winning, cruelty-free formulation studio in Auckland working with indie brands across New Zealand and Australia. We build formulations with export in mind from the first bench trial — vegan and fragrance-free capability, ingredients screened against NZ, AU, EU and US restricted lists, and full IP transfer to you before manufacturing.
Our pathways: The Accelerator (semi-custom, 4–6 months, starting from NZ$2,000) and The Visionary (bespoke, 9–12 months, starting from NZ$4,000), both with MOQs of 100–500 units. For a second opinion on whether your existing file would survive an FDA request, Ask The Chemist is a 30-minute consult from NZ$150.
Frequently asked questions
Do I need to register with the FDA before I can sell skincare in the US?
If you are not a qualifying small business, yes — your manufacturing facility must be registered and each product listed within 120 days of first US marketing. Small businesses under the sales threshold are exempt from registration and listing, but not from safety substantiation, labelling or adverse event reporting.
Can my New Zealand formulation studio be the Responsible Person for MoCRA?
No. The Responsible Person is whoever's name appears on the product label — normally the brand owner. A foreign facility must also nominate a US agent for FDA communications, which is a separate role from the Responsible Person.
How quickly must I report an adverse event under MoCRA?
Serious adverse events must be reported to the FDA within 15 business days of the Responsible Person receiving the report. You must also retain adverse event records — small businesses for three years.
Does MoCRA require animal testing?
No. MoCRA requires adequate safety substantiation but does not mandate animal testing, and the FDA has been explicit that it does not require it. Cruelty-free formulation and US compliance are entirely compatible.
Is the US cosmetic GMP rule in force in 2026?
Not yet. The FDA missed both MoCRA's proposed-rule and final-rule deadlines and the GMP rulemaking is now listed as a long-term action with no set date. Manufacturing to ISO 22716 in the meantime is the practical approach.
Planning a US launch from New Zealand or Australia? Explore our formulation pathways or book a discovery call — we'll tell you honestly what your existing formula and file need before it ships.
