The short answer
MoCRA requires FDA to set Good Manufacturing Practice (GMP) regulations for cosmetics. The law set deadlines of December 29, 2024 for a proposed rule and December 29, 2025 for a final rule. FDA missed both. As of November 2026, no proposed cosmetic GMP rule has been published, and FDA’s Unified Agenda lists it as a long-term action with no date.
That does not mean anything goes. Cosmetics made under insanitary conditions are already adulterated under the Federal Food, Drug, and Cosmetic Act, FDA inspects cosmetic factories, and its 2013 draft GMP guidance — based partly on ISO 22716 — shows what inspectors expect.
Where things stand
| Item | Status in November 2026 |
|---|---|
| MoCRA GMP rule | Not proposed. Statutory deadlines (December 29, 2024 proposed; December 29, 2025 final) passed |
| Unified Agenda | Listed as a long-term action, no target date |
| FDA draft guidance “Cosmetic Good Manufacturing Practices” | June 2013 draft, docket FDA-2013-S-0610 — non-binding; FDA plans to withdraw or revise it once the rule is made |
| Insanitary conditions | Already a violation under current law |
| Small businesses | MoCRA exempts qualifying small businesses from the future GMP rule, with exceptions for higher-risk products |
What the rule is expected to cover
Industry observers expect the rule to draw mainly on ISO 22716 and to cover:
- management responsibility and a quality system
- personnel training and hygiene
- buildings, equipment, cleaning and pest control
- raw material control and supplier approval
- production and process controls, including batch records
- environmental and microbial monitoring
- laboratory testing, stability and release
- complaints, deviations and recalls
What to prepare now
- 1Use ISO 22716 as your baselineIf your factory is already certified, keep it current. If not, a gap assessment against ISO 22716 is the most practical step today.
- 2Fix sanitation firstInsanitary conditions are the main risk under current law — water systems, cleaning validation, pest control and microbial testing.
- 3Keep batch recordsEach batch should be traceable to its raw materials, equipment, test results and release decision.
- 4Link GMP to your MoCRA filesStability and microbiology data feed your safety substantiation; complaints feed adverse event reporting.
- 5Be inspection-readyFDA can inspect registered cosmetic facilities, including foreign ones. See what a Form 483 means.
Example: a skincare factory in Thailand
A Thai contract manufacturer makes creams and serums for several U.S. brands. It is registered under MoCRA but has no ISO 22716 certificate. It runs a gap assessment against ISO 22716, upgrades its purified water monitoring and cleaning records, and starts full batch records with raw-material lot numbers. Its sunscreen line is an OTC drug, so that line follows drug CGMP now — not the future cosmetic rule.
Cosmetic facility registration with U.S. Agent from $300 (1 year) or $450 (2 years). FEI number request $100. Product listing $150 per product.
Frequently asked questions
Is there a cosmetic GMP rule in the US?
Not yet. MoCRA requires one, but as of November 2026 FDA had not published a proposed rule.
Was there a deadline?
Yes. MoCRA required a proposed rule by December 29, 2024 and a final rule by December 29, 2025. Both passed.
Is ISO 22716 accepted by FDA?
FDA has not said it accepts ISO 22716 certificates in place of its own inspections. But FDA reviewed ISO 22716 when drafting its 2013 GMP guidance, and the coming rule is expected to draw on it.
Can FDA act against a cosmetic factory without a GMP rule?
Yes. A cosmetic prepared, packed or held under insanitary conditions is adulterated under current law.
Sources
- Crowell & Moring — Cosmetics under the microscope (April 8, 2026): GMP deadlines and Unified Agenda status
- FDA — Draft guidance: Cosmetic Good Manufacturing Practices (June 2013)
- Loeb & Loeb — MoCRA increases FDA oversight of the cosmetics industry
Status checked on November 11, 2026. This article is general information, not legal advice.