MoCRA: what US cosmetics law now asks of brands and manufacturers
Some MoCRA duties apply today; the GMP rule does not exist yet. Here is what to do now, and what to watch for.
In Short
- Serious adverse events: report within 15 business days.
- Facilities register; the label's responsible person lists products.
- No final FDA cosmetic GMP rule yet; many use ISO 22716 meanwhile.
The Cosmetics Manufacturing Guide
The right formula. Stable batches. Traceable jars.
- MoCRA, EU 1223/2009 and Canada
- Formulas, water and materials
- Phases, bulk tests and microbiology holds
- Filling, codes, complaints and recall
Plus Evidence map and four worksheets.
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The Cosmetics Manufacturing Guide
The right formula. Stable batches. Traceable jars.
MoCRA, signed in December 2022, is the biggest change to US cosmetics law since 1938. It is law, administered by FDA. Some duties are already in force, such as facility registration, product listing and serious adverse event reporting. Others depend on FDA rules that are not yet final: when we checked on 2 Oct 2026, FDA had not published the proposed cosmetic good manufacturing practice rule that MoCRA required by 29 Dec 2024, and fragrance allergen labeling rules were also pending. This guide separates what applies now from what is coming. Small businesses have some exemptions; check FDA's MoCRA page.
The Responsible Person
MoCRA defines the responsible person as the manufacturer, packer or distributor whose name appears on the label. The responsible person lists products, reports serious adverse events, keeps adverse event records, ensures safety substantiation and ensures the label carries domestic contact information for adverse event reports.
MoCRA: in Force or Pending
- LawFacility Registration and Product ListingIn force
Facilities register (renew every 2 years); responsible person lists products.
- LawSerious Adverse Event Reports (FD&C 605)In force
Report within 15 business days of receipt.
- LawSafety Substantiation and RecordsIn force
Responsible person keeps records showing adequate substantiation.
- LawMandatory Recall AuthorityIn force
FDA can order a recall after offering a voluntary one.
- LawCosmetic GMP rule (planned 21 CFR 711)Not yet proposed at 2 Oct 2026
Statutory deadline for the proposal (29 Dec 2024) has passed.
- VoluntaryISO 22716Voluntary standard
Common working basis for cosmetics GMP.
Registration and Listing
Facilities that manufacture or process cosmetic products distributed in the US must register with FDA and renew every two years; foreign facilities name a US agent. The responsible person lists each product with its ingredients and updates the listing annually.
More on registration and Listing
FDA can suspend a facility's registration in limited circumstances.
Serious Adverse Events
The responsible person must report each serious adverse event to FDA no later than 15 business days after receiving the report (FD&C Act section 605), with follow-up information within 15 business days of receiving it for one year. Records of all adverse events are kept for six years, or three years for certain small businesses.
Worked Example: a Serious Adverse Event
- Day 0Consumer reports a second-degree burn after using hair product HP-12, lot 2409Customer service
- Day 1Medical review: meets the serious adverse event definition; reason recordedSafety lead
- Day 3Batch record and complaints for lot 2409 reviewedQA
- Day 8 (business)Report submitted to FDA, inside 15 business daysRegulatory lead
- OngoingNew medical information reported within 15 business days for one yearRegulatory lead
More on serious Adverse Events
People decide whether an event is serious under the law and record why.
Safety Substantiation and Recall
The responsible person must ensure, and keep records showing, adequate substantiation of each product's safety. FDA can now order a mandatory recall if it finds a reasonable probability that a cosmetic is adulterated or misbranded and could cause serious adverse health consequences, after offering the company the chance to recall voluntarily.
GMP: what to do while the rule is pending
MoCRA requires FDA to issue cosmetic GMP regulations. Until a final rule exists, there is no FDA cosmetic GMP rule to certify against.
More on gMP: what to do while the rule is pending
Many companies use ISO 22716, the international cosmetics GMP guideline, as a working basis; it is a voluntary standard, and FDA's final rule may differ from it. FDA's existing cosmetic GMP checklist and inspections continue under the adulteration provisions.
Questions
How fast must a serious adverse event be reported under MoCRA?
No later than 15 business days after the responsible person receives the report, under section 605 of the FD&C Act, using FDA's reporting route. New medical information received within a year is reported within 15 business days.
Is the FDA cosmetic GMP rule final?
No. When we checked on 2 Oct 2026, FDA had not published the proposed rule. Check FDA's MoCRA page for current status.
Does MoCRA require ISO 22716 certification?
No. ISO 22716 is a voluntary standard. Many companies use it as a basis for their GMP while FDA's rule is pending.
Who registers, the brand or the manufacturer?
Facilities that manufacture or process cosmetics register. The responsible person, whose name is on the label, lists products. One company can be both.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
Global Cosmetics Regulatory Readiness: EU, UK, US, ISO 22716
EU Fragrance Allergen Labelling: Regulation 2023/1545 Readiness
Cosmetic Microbiological Quality (ISO 17516) Readiness Guide
Cosmetic Stability and Preservative Efficacy (ISO 11930)- EU Cosmetics Regulation 1223/2009: Responsible Person, Safety Report, PIF and CPNP
ISO 22716 Cosmetics GMP Guide: Structure, EU Role and Practical Controls