U.S. FDA registration & U.S. Agent services · Casper, Wyoming, USA info@regovant.com+1 307-301-7465
Regovant LLCFDA Registration & U.S. Agent
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MoCRA Cosmetic Facility Registration & Product Listing

We register your cosmetic manufacturing or processing facility with FDA under MoCRA, list your products, and act as your U.S. Agent. Fixed prices, no long contracts.

  • Facility registration with U.S. Agent service: $369 a year
  • Product listing with ingredients: $269 per product
  • Small-business exemption checked before we file
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Cosmetics pricing

USD
Facility registration + U.S. AgentPer facility, per year$369
Product listingPer product$269
Cosmetic label reviewPer product$369
FDA charges no fee for MoCRA registrationNo VAT

What MoCRA requires

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) added two requirements for cosmetics sold in the United States:

  • Facility registration: every facility in the U.S. or abroad that manufactures or processes cosmetics for U.S. distribution must register with FDA. Facilities outside the U.S. must include a U.S. Agent. Registrations are renewed every two years.
  • Product listing: the Responsible Person, the company named on the label, must list each cosmetic product with FDA, including its ingredients, and update the listing every year.

FDA uses the facility's FEI number as its registration number, so an FEI is needed before the facility can register. If your facility doesn't have one yet, we help you request it.

Do you qualify for the small-business exemption?

MoCRA exempts some small businesses, generally those with average U.S. cosmetic sales under $1 million a year over the past three years (adjusted for inflation). The exemption does not apply to products that:

  • regularly come into contact with the mucous membrane of the eye
  • are injected or intended for internal use
  • are meant to change appearance for more than 24 hours, where removal by the consumer isn't part of normal use

We check this before filing. If you're not sure whether you're exempt, ask us before you order.

What's included in facility registration

  • Check of the facility's role (manufacturing or processing) and exemption status
  • Help obtaining an FEI number if the facility has none
  • Preparation and submission of the facility registration
  • U.S. Agent service for one year for facilities outside the U.S.
  • Responsible Person details linked to the registration
  • Your registration number and a Regovant certificate of registration you can verify online
  • A reminder before the two-year renewal is due

How it works

  1. Order online for each facility, and each product you want listed.
  2. Send your details using our registration form: facility address, product categories, brands and Responsible Person.
  3. We check and file. We confirm the exemption status, sort out the FEI, and submit.
  4. You receive confirmation of the registration and product listings.

Questions

Is the facility or the brand owner responsible for registering?

The facility that makes or processes the cosmetics registers the facility. The Responsible Person, usually the brand owner named on the label, lists the products. They can be different companies, and we can handle both.

We only label, pack or store products. Do we need to register?

Usually not. MoCRA excludes establishments that only label, relabel, package, repackage, hold or distribute cosmetics. If you also mix, fill or otherwise process the product, you probably do. We'll confirm when we review your details.

Does registration mean FDA approved our cosmetics?

No. FDA does not approve cosmetics before they are sold. Registration and listing are legal requirements, and your products and labels must still meet FDA rules.

Does FDA charge a fee?

No. FDA does not charge for MoCRA facility registration or product listing.