Regulatory roles · Cosmetic products · US
Your US Agent for cosmetic products
Cosmetic Products
The US route for cosmetics is facility registration and product listing with the US Food and Drug Administration (FDA), under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA, US). We can act as your US Agent and the FDA's contact point, contracted by CRITICAL CATALYST LLC, our US company.
What the role covers and who contracts it
What we do in the role
- We act as your US Agent and are the contact point for the FDA.
- FDA facility registration, including the DUNS number (Data Universal Numbering System) and the FEI (FDA Establishment Identifier).
- Renewal of the facility registration.
- FDA product listing, with the listing number for each product.
Who contracts it. CRITICAL CATALYST LLC, Sheridan, Wyoming. The US company belongs to CRITICAL CATALYST - Health Consulting, Lda., in Portugal, and contracts US clients and US Agent work.
Around the role. We can also review the formula and the label for the US market, including Proposition 65 and the California notification, and set up the adverse-event system under MoCRA.
United States
CRITICAL CATALYST LLC, Sheridan, Wyoming
Questions people ask
We registered under VCRP some years ago. Is that still valid?
No. The FDA no longer accepts submissions to its former Voluntary Cosmetic Registration Program (VCRP). Facility registration and product listing now follow MoCRA.
Our EU cosmetovigilance system works. Does it cover the US?
No. The US adverse-event system under MoCRA is separate from EU cosmetovigilance. We can set it up: procedures, a notification form, a review of each event and a periodic trend report.
Can a firm based in Portugal be our US Agent?
Yes. The role is contracted by CRITICAL CATALYST LLC, a US company in Wyoming that belongs to the Portuguese firm. US work goes through it.
Where this role sits
- Formula and testing
- Label, ingredients and claims
- Responsible Person and notificationThis role: US Agent
- After launch
- Step: Responsible Person and notification (US)
- Before it: Label, ingredients and claims (US formula and label review)
- After it: After launch (US adverse-event system)
- Related roles: EU Responsible Person · UK Responsible Person · all Regulatory roles
- Beside the role: Ongoing support for monthly regulatory support
What happens next
Our team replies to every enquiry and asks for the products, the facility and the date you are working to.