By Vincent Cruz

Good Manufacturing Practice (GMP) is the part of MoCRA that confuses foreign brands the most. The law says FDA must issue GMP regulations for cosmetics, but as of September 2026, those regulations do not exist yet. That leaves many manufacturers asking a reasonable question: what rules actually apply to my facility today?

This guide gives you the straight answer: the current legal status, what FDA expects right now, why ISO 22716 is the standard to build toward, and the concrete documentation your facility should have in place. For the full compliance picture, start with the MoCRA Compliance Guide for Cosmetic Brands.

The legal status: required by law, not yet written

Section 606 of MoCRA (21 U.S.C. section 364b) directs FDA to establish regulations setting out Good Manufacturing Practice for cosmetic products. Congress set a deadline of December 29, 2024 for the proposed rule. FDA missed it.

As of early 2026, FDA has not issued proposed GMP regulations for cosmetics, and the agency’s Unified Agenda now classifies cosmetics GMP as a “long-term action,” which in practice means no proposal is expected within the next 12 months. Several factors contributed to the delay, including FDA reorganization, leadership changes, and the current administration’s regulatory policy.

This does not mean GMP is optional forever. The statute still requires it, and once FDA finalizes the rule, products made in non-compliant facilities will be deemed adulterated under federal law. The delay is a preparation window, not a free pass.

What applies to your facility right now

Two things are already real:

1. FDA’s 2013 draft guidance. Long before MoCRA, FDA published draft guidance on cosmetic Good Manufacturing Practices, closely aligned with the international standard ISO 22716. It was never finalized as binding regulation, and it is still technically draft guidance. But it is the clearest statement of what FDA considers good practice, and any future rule will almost certainly build on it.

2. Existing adulteration law. Even without a GMP rule, FDA can act against cosmetics that are adulterated: contaminated with filth, prepared or held under insanitary conditions, or otherwise unsafe. MoCRA also expanded FDA’s records access authority, and the agency issued guidance on that authority in January 2026. If FDA has reason to believe your product is adulterated or poses a serious health risk, it can demand your records, including safety substantiation files. See FDA Can Now Demand Your Records for what that means in practice.

In short: no binding GMP checklist exists yet, but the expectation of sanitary, documented, controlled manufacturing already does.

ISO 22716: the practical benchmark

ISO 22716 is the international standard for cosmetics GMP. FDA’s draft guidance mirrors it, and compliance consultants worldwide treat it as the target. If your facility aligns with ISO 22716 now, you will be ready for whatever FDA finalizes later.

The standard covers every stage of production:

Personnel. Staff must be trained for their roles, follow hygiene rules, and understand the procedures they execute. Training records must exist.
Premises. Facilities must be designed and maintained to prevent contamination: cleanable surfaces, controlled access, separation of production areas from storage, pest control.
Equipment. Equipment must be suitable for its purpose, calibrated on schedule, cleaned between uses, and maintained with records.
Raw materials and packaging. Incoming materials must be checked against specifications, with acceptance or rejection documented. Rejected materials must be segregated.
Production. Every batch must be made according to defined formulas and procedures, with in-process controls at critical steps.
Finished products. Finished batches must meet specifications before release, with testing and release decisions documented.
Laboratory. Quality control testing must use validated or standard methods, with equipment calibrated and results recorded.
Handling of out-of-specification results. Deviations, nonconforming batches, and complaints must be investigated, documented, and resolved. Rework must be controlled and approved.
Waste. Waste must be handled to avoid contaminating products or materials.
Subcontracting. Contract manufacturers and outside labs must be qualified, with written agreements defining responsibilities. This matters for foreign brands using OEM/ODM factories: see Private Label Cosmetics: Who Registers Under MoCRA.
Documentation. The system runs on paper or electronic records: SOPs, batch records, specifications, test results, training logs, calibration logs, complaint files. If it is not documented, it did not happen.

What your facility should have documented today

If an FDA inspector or a major retailer’s auditor walked in tomorrow, these are the records they would expect to find:

Written SOPs for manufacturing, cleaning, maintenance, calibration, training, complaint handling, and recalls.
Batch manufacturing records tracing each finished batch back to its raw materials, with quantities, lot numbers, operators, dates, and in-process checks.
Specifications and test results for incoming raw materials and finished products, including microbial testing where relevant.
Stability data supporting the product’s shelf life.
Calibration and maintenance logs for production and lab equipment.
Training records showing who was trained, on what, and when.
A complaint and adverse event file, with investigation records. Serious adverse events must be reported to FDA within 15 business days; see MoCRA Adverse Event Reporting.
A recall procedure, even if you have never used it.

Foreign brands should ask their contract manufacturer for evidence of these systems before signing, not after a problem. A factory that cannot produce batch records or calibration logs is a liability you are importing along with the product.

The small-business exemption

Section 612 of the FD&C Act (21 U.S.C. section 364h) exempts qualifying small businesses from the GMP requirements (Section 606) and from facility registration and product listing (Section 607). To qualify, average gross annual U.S. sales over the prior three years must be under $1 million.

The exemption does not cover products that contact the mucous membrane of the eye, are injected, are intended for internal use, or are intended to alter appearance for more than 24 hours. Those products must comply fully regardless of business size. And the exemption never covers labeling, safety substantiation, or adverse event reporting. Use the small-business exemption worksheet to check whether you qualify.

What to do now: a practical action list

Audit your facility (or your manufacturer’s) against ISO 22716. Identify gaps in documentation first; paperwork gaps are the most common and cheapest to fix.
Write or update SOPs for the core processes listed above. One page that is actually followed beats fifty pages nobody reads.
Start batch traceability now if you do not have it. Lot-level traceability from raw material to finished unit is non-negotiable under any future GMP rule.
Qualify your suppliers and contract manufacturers in writing, with agreements that define quality responsibilities.
Keep safety substantiation files current. GMP and safety substantiation are separate requirements, but inspectors and retailers look at both; see MoCRA Safety Substantiation.
Watch for the proposed rule. When FDA publishes it, there will be a public comment period. That is the industry’s chance to shape requirements that reflect how cosmetics are actually made.

FAQ

Is GMP currently mandatory for cosmetics in the US?
Not as a standalone regulation. MoCRA requires FDA to issue GMP regulations, but no proposed rule has been published yet. However, existing adulteration law already prohibits manufacturing under insanitary conditions, and FDA’s 2013 draft guidance describes what the agency considers good practice.

What is ISO 22716?
The international standard for cosmetics Good Manufacturing Practices, published by the International Organization for Standardization. It covers personnel, premises, equipment, materials, production, quality control, and documentation. FDA’s draft guidance is closely aligned with it, making it the safest benchmark to build toward.

Will the future FDA GMP rule apply to foreign facilities?
Yes. MoCRA’s GMP provisions apply to facilities manufacturing cosmetics for the U.S. market regardless of location. Foreign facilities will need to meet the same standards as domestic ones.

Are small businesses exempt from GMP?
Qualifying small businesses (under $1 million average annual U.S. sales over three years) are exempt from Section 606 GMP requirements, with exceptions for eye-area products, injectables, internal-use products, and long-wear appearance-altering products. The exemption is in Section 612 of the FD&C Act (21 U.S.C. section 364h).

Does my U.S. agent handle GMP compliance?
No. The U.S. agent is FDA’s contact for your facility and handles correspondence; it does not run your quality system. GMP compliance is the facility’s responsibility. See How to Choose a MoCRA U.S. Agent for what the agent role actually covers.

What happens if my products are made under poor manufacturing conditions?
FDA can deem the products adulterated, which can lead to warning letters, import detention, mandatory recall, and suspension of your facility registration. See What Happens If You Don’t Register Under MoCRA and FDA Detained My Cosmetic Shipment.

Next step: Getting the paperwork side right starts with knowing your facility’s FDA standing. Run the free FEI check to see whether your facility already has an FDA Establishment Identifier, or contact us with questions about MoCRA compliance for your facility.