If you are waiting for the FDA to tell you what cosmetic Good Manufacturing Practice looks like before you act, you will be waiting a while longer. The MoCRA GMP rule — the mandatory manufacturing standard the 2022 law promised — is late, and the smart importers are not treating that delay as a reprieve. They are treating it as time to get ahead of a standard everyone already knows is coming.
Here is where things actually stand in mid-2026, and why ISO 22716 is the benchmark to build against now.
The GMP rule is delayed — confirm it, then plan around it
The Modernization of Cosmetics Regulation Act of 2022 directed the FDA to propose cosmetic GMP regulations and then finalize them on a roughly two- and three-year timeline. Those dates have slipped. As of January 2026, the FDA had not issued final GMP regulations for cosmetics (Foley & Lardner, March 2026) — and it has not issued even a proposed rule. Legal trackers describe the rulemaking as having moved onto the agency’s long-term agenda, with no firm publication date and a final rule unlikely before late 2026 at the earliest (Wiley; REACH24H).
Read that carefully, because the delay is narrow. It applies to GMP. It does not roll back the parts of MoCRA already in force — and those are the parts the FDA is already enforcing.
What is already in effect
The structural obligations of MoCRA went live at the end of 2023 and are operational:
- Facility registration and product listing. Live and active — the FDA recorded 14,299 registered facilities and 992,907 product listings as of January 6, 2026 (Foley & Lardner). Registrations renew every two years, and new facilities must register within 60 days of starting manufacturing.
- Responsible Person designation. A named Responsible Person must, among other duties, “maintain records demonstrating adequate substantiation of safety.”
- Safety substantiation. Products must be backed by tests or studies sufficient to support a reasonable certainty of no harm.
- Adverse event recordkeeping. Now visible to the public — the FDA launched its adverse-event dashboard on September 12, 2025.
One adjacent rule is still pending alongside GMP: as of January 2026 the FDA had not yet issued its fragrance-allergen labeling regulations either. We covered the preparation playbook for that separately — but the pattern is the same. The requirement is coming; the paperwork is the part you control today.
ISO 22716 is the standard hiding inside the delay
You do not need the final FDA text to know what cosmetic GMP will require, because the agency has signaled it will draw heavily on existing national and international standards — and a large share of public comments supported adopting ISO 22716, the GMP guideline already required across the EU. When the rule lands, it is expected to span management responsibility, personnel training, production and process controls, environmental monitoring, laboratory controls, corrective-and-preventive-action (CAPA) systems, and documentation practices — the ISO 22716 spine.
That is the gift inside the delay. A manufacturer already operating to ISO 22716 is not guessing. It is building to the framework the final rule will most likely mirror, and it can show that work today instead of scrambling when a compliance date is finally set.
One carve-out worth knowing: MoCRA exempts certain small businesses — those with average annual gross sales under $1 million over the prior three years — from the GMP requirements. Most serious importers and the factories that serve them are well past that line, so the exemption is rarely the plan.
What this means for importing Korean cosmetics
For a US importer, the uncomfortable structural fact is that the obligations tend to land on you. If you are the entity bringing a Korean brand into the US, you are frequently the Responsible Person — which means the FDA’s registration, listing, safety-substantiation, and adverse-event duties are yours to discharge, regardless of how the manufacturer half a world away operates.
So the diligence is concrete:
- Verify the factory’s ISO 22716 status — certification or audited conformance — and get it in writing, not as a marketing line.
- Collect the safety substantiation dossier for each product now, in a form you could hand to the FDA, rather than assuming the brand owner has it filed.
- Confirm your registration and listing are current and calendar the two-year renewal.
- Pre-stage GMP evidence — batch records, CAPA logs, environmental monitoring — so that when a compliance date is finally published, your factories are ready instead of reactive.
The operator’s view
Regulatory delay reliably produces the wrong instinct: relief, then inaction. The operators who get hurt by MoCRA will not be the ones who missed a deadline — there isn’t one yet for GMP. They will be the ones who let “no final rule” become “no preparation,” and then face a short runway when the rule lands on factories that were never audited to ISO 22716.
How Luxmetics works this: we vet Korean manufacturing partners against ISO 22716 before product moves, assemble the safety-substantiation and registration documentation that a US Responsible Person actually has to hold, and keep the compliance file current so a future GMP date is a formality, not a fire drill. The rule being late is not a reason to wait. It is the window.