US Responsible Person for Cosmetics (12 Months)
Phoenix Safety Consultants LLC acts as the MoCRA responsible person named on your cosmetic labels for 12 months.
- Signed by a qualified safety assessor
- Regulator-ready, or we revise it free
- Delivered in 24, 48 or 72 hours
Trusted by brands including
Service details
Everything included, explained
Quick answer
Under MoCRA, the responsible person is the company named on a cosmetic's label, with a US address or contact for adverse event reports. Phoenix Safety Consultants LLC can take this role for 12 months, after reviewing your products, and handles product listing duties with you. Serious adverse events must be reported to FDA within 15 business days. £1,950 per year.
What's included in your responsible person service
| Document | What it is |
|---|---|
| Product review | Your products, labels and safety information reviewed before we accept the role |
| US label details | Phoenix Safety Consultants LLC's name and US contact for your labels |
| Product listing role | Listings submitted in the responsible person's name |
| Adverse event intake | Reports received at our US contact and passed to you |
| Written agreement | Duties, data you supply and how either side can end the arrangement |
Who this service is for
- Non-US cosmetic brands with no US company of their own
- Brands selling on Amazon US and other US marketplaces
- Brands that need a US address on the label
What this service does not include
- Serious adverse event reports. Investigating and filing reports is our separate Adverse Event Reporting Service.
- Safety substantiation. The records showing your products are safe are a separate service.
- Products sold with drug claims. We may decline products whose claims make them drugs.
- Legal advice.
How it works
- Send your products Labels, formulas, CPSR or other safety data, and where you sell.
- Review We review the products and confirm whether we can act as responsible person.
- Agreement You sign the responsible person agreement and update your labels.
- Cover starts Our US contact appears on your labels for 12 months.
What is a US responsible person for cosmetics?
Under MoCRA, the responsible person is the manufacturer, packer or distributor of a cosmetic whose name appears on the label (FD&C Act section 604). The label must include a domestic US address, phone number or electronic contact for adverse event reports. The responsible person must list products with FDA, report serious adverse events within 15 business days, keep records for 6 years (3 for small businesses) and hold safety substantiation records. Phoenix Safety Consultants LLC can take this role.
What the responsible person role involves
On the label:
- Name and US contact: For adverse event reports.
Duties under MoCRA:
- Product listing: Each product listed and updated annually.
- Adverse events: Serious events reported within 15 business days.
- Records: Kept for 6 years, or 3 for small businesses.
- Safety substantiation: Records held for each product.
What you receive
- Product review outcome
- Signed responsible person agreement
- The exact name and US contact wording for your labels
- Your 12-month term and renewal date
Legal framework
- FD&C Act section 604 — definition of responsible person
- Section 605 — serious adverse event reporting within 15 business days and record keeping
- Section 607(c) — product listing by the responsible person
- Section 608 — safety substantiation records
- Section 609 — label must include domestic contact information
Official sources:
- Modernization of Cosmetics Regulation Act of 2022 (FDA)
- Registration and Listing of Cosmetic Product Facilities and Products (FDA)
Why brands choose Phoenix as responsible person
- Phoenix Safety Consultants LLC (USA), our sister company on your label.
- Products reviewed first — so we know what we are responsible for.
- Works with our other MoCRA services — listing, adverse events and safety files.
- Reviewed by Syed Muhammad Shamuel Shees, US Regulatory Lead.
Get a US name on your label. Order above, or message us on WhatsApp on +44 7346 009332.
Frequently asked questions
What is a MoCRA responsible person?
The manufacturer, packer or distributor whose name appears on a cosmetic's label, with duties for listing, adverse event reporting, records and safety substantiation.
Can your company be the responsible person on my label?
Yes. Phoenix Safety Consultants LLC can take the role for 12 months after reviewing your products and signing an agreement with you.
What must the label show?
The responsible person's name and a domestic US address, phone number or electronic contact for adverse event reports.
Who reports serious adverse events?
The responsible person must report serious adverse events to FDA within 15 business days. Report handling is our separate Adverse Event Reporting Service.
Is the responsible person the same as a US agent?
No. A US agent is named in a foreign facility's registration; the responsible person is named on the product label.
How much does the responsible person service cost?
£1,950 per year.