Responsible person requirements under MoCRA
Every cosmetic product marketed in the US must have a designated Responsible Person — the entity accountable for adverse event reporting, safety substantiation, labeling compliance, and record-keeping. This page explains who qualifies, what they must do, and common pitfalls.
Core responsibilities
The Responsible Person is accountable for the following MoCRA obligations.
Adverse event reporting
Report serious adverse events to FDA within 15 business days and maintain records for 6 years.
Safety substantiation
Ensure adequate substantiation of product safety before marketing.
Facility registration oversight
Coordinate with manufacturing facilities to ensure they are registered with FDA.
Product listing accuracy
Ensure product listings in FDA's Cosmetics Direct portal are complete and up to date.
Labeling compliance
Labels must include INCI ingredient names, responsible person contact, and adverse event reporting info.
Record maintenance
Maintain records of safety substantiation and adverse events as required by FDA.
Who qualifies
The Responsible Person is typically the manufacturer, packer, or distributor whose name appears on the product label.
Domestic companies
The manufacturer, packer, or distributor whose name appears on the label is the Responsible Person. For private-label products, this is typically the brand owner or distributor whose name is on the label.
Foreign companies
Foreign manufacturers must designate a U.S.-based Responsible Person for their cosmetic products. This can be the U.S. importer, a subsidiary, or a third-party that agrees to assume Responsible Person obligations. The U.S. contact information must appear on the product label.
Common mistakes
Avoid these pitfalls when designating and managing your Responsible Person role.
Confusing Responsible Person with U.S. Agent
These are separate roles. The U.S. Agent is for facility registration; the Responsible Person is for each product and handles adverse events, safety substantiation, and labeling. You may need both.
Not updating when ownership changes
If your company is acquired, rebrands, or changes distributors, the Responsible Person designation may need to be updated on labels and product listings.
Missing adverse event deadlines
The 15-business-day reporting deadline is strict. Without a clear intake and triage process, companies risk late or missed reports and FDA enforcement.
Responsible Person FAQs
Common questions about MoCRA Responsible Person obligations.
Who can be the Responsible Person?
The Responsible Person is the manufacturer, packer, or distributor whose name appears on the product label. For domestic companies, this is typically the company whose name/brand is on the label. For foreign manufacturers, they must designate a U.S.-based Responsible Person — often the importer or a third-party entity that agrees to assume these obligations.
What is the difference between Responsible Person and U.S. Agent?
They are distinct roles. The U.S. Agent is required for facility registration — a domestic contact for FDA regarding the manufacturing facility. The Responsible Person is required for each cosmetic product — the entity accountable for adverse event reporting, safety substantiation, and labeling. A company can use different entities for each role, or the same entity if it meets both sets of requirements.
What happens if we don't have a designated Responsible Person?
Products without a properly designated Responsible Person may be deemed adulterated or misbranded under MoCRA. FDA can take enforcement action including warning letters, product seizure, mandatory recalls, and import detention. The Responsible Person's name and contact must appear on the product label.
How do we designate a Responsible Person?
The Responsible Person is identified by whose name appears on the product label. You must ensure the label includes the Responsible Person's name and U.S. contact information (address, phone, or electronic contact). Product listings in FDA's Cosmetics Direct portal must also include Responsible Person information.
What are the penalties for Responsible Person violations?
Failures to meet Responsible Person obligations — including adverse event reporting, safety substantiation, and record-keeping — can result in FDA enforcement. Penalties include warning letters, mandatory recalls, import detention, and civil penalties. FDA has expanded authority under MoCRA to enforce cosmetics compliance.
Need help with Responsible Person compliance?
Assurentry helps cosmetic companies meet MoCRA requirements, including Responsible Person designation, adverse event workflows, and facility registration.
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