Private-label cosmetics – where one company manufactures and another sells under its own brand – dominate the beauty industry. But when it comes to MoCRA compliance, this business model creates a critical question: who is responsible for FDA registration?

The answer is not one party. It is both, with different duties. This guide explains how facility registration and product listing split between contract manufacturers and brand owners, what the responsible person is, and how to avoid the gaps that leave products non-compliant.

The private-label model

In a typical private-label arrangement, a contract manufacturer produces cosmetics to a brand owner’s specifications. The brand owner’s name appears on the label, and the brand owner markets and sells the products. The manufacturer may produce for dozens of different brands from the same facility.

Under MoCRA, both parties have FDA obligations – but they are not the same obligations. Understanding the split is essential, because each side often assumes the other handled everything.

The responsible person: who it is

MoCRA centers many obligations on the responsible person – defined by FDA as the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label. In a private-label arrangement, that is the brand owner.

The responsible person is the party FDA holds accountable for:

Product listing – filing each product with FDA
Adverse event recordkeeping and reporting
Labeling compliance
Fragrance allergen disclosure where applicable

If your brand name is on the product, you are the responsible person – even if you never touched the manufacturing equipment.

Who registers the facility

Facility registration follows the physical location, not the brand. The contract manufacturer – the company operating the facility where products are actually made – registers that facility with FDA.

This makes practical sense: the manufacturer knows the facility’s details, controls the site, and can respond to FDA inspection requests. A brand owner with no presence at the factory cannot meaningfully register it.

FDA’s guidance notes that in contract manufacturing situations, the registration may be submitted by the responsible person or the manufacturer – but in practice, the manufacturer files for its own facility, often covering all the brands it produces for under a single registration.

Who lists the products

Product listing follows the brand, not the factory. Each responsible person (brand owner) must list its own products with FDA, including ingredients and the manufacturing facility’s FEI number.

This means:

A contract manufacturer making products for 20 brands does not list those 20 brands’ products. Each brand owner lists its own.
A brand owner using three different contract manufacturers lists its products once, referencing each manufacturing facility.
If you rebrand or reformulate, update your listings – the manufacturer cannot do this for you.

The dangerous assumption

The most common compliance failure in private label is mutual assumption: the brand owner assumes the manufacturer handled all FDA filings, while the manufacturer assumes the brand owner handled product listing. The result is products on the market with no listing at all.

Prevent this with a written agreement that specifies:

Which party files the facility registration (normally the manufacturer)
Which party files product listings (normally the brand owner)
Who provides the FEI number to whom, and when
Who tracks renewal dates and updates
How the parties share FDA correspondence

Get it in writing: A handshake understanding about FDA filings is not a compliance program. Your manufacturing agreement should name exactly who files what, with deadlines. If it does not, amend it.

What about the U.S. agent?

If the contract manufacturer is a foreign facility, it must designate its own U.S. agent for its facility registration. The brand owner – if also foreign and marketing in the U.S. – needs to consider its own obligations separately. The agent designation follows the registration, not the brand relationship.

In practice, many foreign brand owners engage a U.S. agent service that coordinates both the manufacturer’s facility registration and the brand’s product listings, keeping the entire compliance picture in one place.

New to MoCRA? Start with our complete MoCRA Compliance Guide for Cosmetic Brands (2026).

Frequently asked questions

We are a brand owner. Do we need to register the factory?

No – the contract manufacturer registers its own facility. But you must list your products, and you should confirm in writing that the manufacturer has actually registered the facility where your products are made.

Our manufacturer says they handle everything. Should we trust that?

Verify, do not just trust. Ask for the facility’s registration Submission ID and FEI number. Then confirm your product listings are filed under your own responsible-person account. Get the division of duties in your written agreement.

Can the manufacturer list our products for us?

Product listing is the responsible person’s obligation. While a manufacturer can technically submit on your behalf with authorization, the legal responsibility remains yours. Most brands file their own listings to maintain control.

What if we switch manufacturers?

Update your product listings to reference the new facility’s FEI. The old manufacturer’s facility registration is their responsibility, not yours – but your listings must reflect where products are currently made.

US MoCRA Agent is a private service provider and is not affiliated with the FDA. Questions about private-label responsibilities: usmocra@outlook.com – +1 909-997-0000 – pricing.

This article is for educational purposes only and is not legal advice. US MoCRA Agent is a private service provider and is not affiliated with or endorsed by the FDA. Regulatory details are based on FDA’s published guidance and are current as of September 2026; always verify requirements against FDA’s official sources before acting.

Related Guides

MoCRA Facility Registration vs. Product Listing Explained — the split that decides who files what.
What Is an FDA FEI Number? — the facility identifier.
Who Can Be Your MoCRA U.S. Agent? Requirements Explained — foreign facilities need an agent.

Private Label Cosmetics: Who Registers Under MoCRA?