US Agent for FDA Cosmetic Facility Registration (MoCRA)

Who Needs Cosmetic Facility Registration?

Facilities that manufacture or process cosmetic products for distribution in the United States must register with FDA. This includes foreign facilities exporting to the US. Product listing is the responsibility of the "responsible person", the manufacturer, packer or distributor whose name appears on the label.

Certain small businesses are exempt, but the exemption does not apply to some higher-risk products, such as products used in the eye area or products injected or intended for internal use. Products that are also drugs (such as sunscreens or anti-dandruff shampoos) follow drug facility registration rules instead.

Information Required

• Facility name, address and FEI or DUNS number
• Product categories manufactured or processed at the facility
• Brand names of products made at the facility
• Contact details of the owner or operator
• US Agent details (foreign facilities)
• For product listing: product name, ingredients, facility registration number and responsible person

FDA – Registration and listing of cosmetic product facilities and products

Renewal and Updates

Cosmetic facility registration must be renewed every two years. Changes to registration details must be reported within 60 days. Product listings must be updated every year, including new products and products no longer sold. FDA can suspend a facility registration in some safety situations, which stops products from that facility being distributed in the US.

US Agent for Cosmetic Facility Registration

Foreign cosmetic facilities must provide the name and contact details of a US Agent in their registration. The US Agent is FDA's contact in the United States for the facility. MedDeviceCorp provides this US FDA Agent service together with registration and listing.

Our Cosmetic Facility Registration Process

1. Scope check – we confirm whether your products are cosmetics, drugs or both, and whether any exemption applies.
2. Data collection – we gather facility, brand and ingredient details.
3. Registration – we submit your cosmetic facility registration in Cosmetics Direct.
4. Product listing – we list each product with its ingredients.
5. US Agent – MedDeviceCorp is named as your US Agent.
6. Ongoing compliance – annual listing updates and two-yearly registration renewal.

MoCRA Requirements Beyond Registration

MoCRA introduced more than facility registration and product listing. Responsible persons for cosmetic products sold in the US must also:

• Report serious adverse events to FDA within 15 business days
• Keep records showing the safety of each product (safety substantiation)
• Include a US address, phone number or electronic contact on the label for adverse event reports
• Prepare for FDA's cosmetic good manufacturing practice (GMP) and fragrance allergen labeling rules

A foreign manufacturer that registers its facility should plan for these duties at the same time. FDA – MoCRA overview

Small Business Exemption

Businesses with average gross annual sales in the US of less than one million US dollars over the previous three years may be exempt from facility registration and product listing. The exemption does not apply to businesses making certain higher-risk products, such as products that contact the eye area, are injected, are meant for internal use, or are meant to alter appearance for more than 24 hours. We assess whether your business qualifies before you rely on it.

Common Mistakes in Cosmetic Facility Registration

• Registering a brand owner's office instead of the facility where products are made
• Listing products with an incomplete ingredient list
• Treating sunscreens or anti-dandruff shampoos as cosmetics when they are drugs in the US
• Missing the two-yearly registration renewal or the annual listing update
• No US contact on the label for adverse event reports

How Long Does Cosmetic Facility Registration Take?

Most of the time goes into gathering accurate information rather than the submission itself. The usual steps are:

• Product review – confirming which products are cosmetics, which are drugs, and whether an exemption applies.
• Facility and ingredient data – collecting facility identifiers, brand names and full ingredient lists for every product.
• Submission in Cosmetics Direct – facility registration first, followed by product listing.
• Registration number – FDA issues a facility registration number that is then used in product listings.

Manufacturers with many products or private-label brands should allow extra time for ingredient data. We give you a clear timeline after reviewing your product range, and we keep listings up to date as your range changes.

Why Choose MedDeviceCorp for Cosmetic Facility Registration?

At MedDeviceCorp, one team of regulatory specialists prepares your cosmetic facility registration and product listing, acts as your US FDA Agent and tracks every renewal date, so you are not juggling separate providers.

• Registration prepared and checked by regulatory specialists, not a form-filling service
• US Agent confirmation handled promptly when FDA sends the request
• Renewal reminders well before each FDA window opens
• Support with related FDA, EU Representative and UK Responsible Person requirements

Cosmetic Facility Registration FAQs

Related services: FDA Registration · US FDA Agent · Food Facility Registration · Drug Establishment Registration · Medical Device Establishment Registration