MoCRA Facility Registration vs Product Listing Explained

MoCRA created two separate filing requirements that are easy to confuse: facility registration and product listing. They sound similar, they are both filed through Cosmetics Direct, and they are both free – but they cover different things, are filed by different parties, and follow different rules.

This guide explains what each requirement covers, who is responsible for each, how they differ, and what happens if you only do one.

What facility registration covers

Facility registration (section 607 of the FD&C Act) is about where cosmetics are made. Every facility that manufactures or processes cosmetic products for distribution in the United States must register with FDA.

The registration identifies:

• The facility’s legal name and physical address
• The Facility Establishment Identifier (FEI) number
• Contact information, including the U.S. agent for foreign facilities
• Types of cosmetic products manufactured or processed at the site

Registration is filed once per facility location, then renewed every two years. It tells FDA which physical sites are producing cosmetics for the U.S. market – essential for inspections, outbreak response, and supply-chain oversight.

What product listing covers

Product listing (section 608 of the FD&C Act) is about what is being sold. The responsible person – generally the manufacturer, packer, or distributor whose name appears on the product label – must list each cosmetic product marketed in the United States.

Each listing includes:

• Product name and category
• Ingredients and their concentrations
• The responsible person’s name and contact information
• The facility where the product is manufactured (linked by FEI)

Unlike facility registration, which is one filing per site, product listing is one filing per product. A company with 50 SKUs files 50 listings. New products must be listed as they are introduced.

Key differences at a glance

• What: Registration covers the manufacturing site; listing covers each individual product.
• Who files: Registration is filed by or for the facility; listing is filed by the responsible person (the brand owner named on the label).
• How many: One registration per facility; one listing per product.
• Renewal: Facility registrations renew every two years; product listings are updated as products change but do not follow the same biennial cycle.
• Legal basis: Registration under section 607; listing under section 608.

Who is responsible for each

For a company that manufactures its own products, the same business handles both – it registers its facility and lists its products. But in contract manufacturing arrangements, the duties split:

• The contract manufacturer registers the facility where production happens.
• The brand owner (responsible person whose name is on the label) lists each product.

This split is a common source of confusion. A private-label brand cannot assume its contract manufacturer handled product listing, and a manufacturer cannot assume the brand handled facility registration. Each party must confirm its own filings are complete.

Deadlines and timing

Both requirements are already in effect. Facilities that were operating when MoCRA’s registration provisions took effect were required to register by the statutory deadline; new facilities must register before beginning operations. Product listings follow a similar pattern – new products should be listed as they enter the market.

Facility registrations renew every two years from the initial registration date. Product listings do not expire on the same cycle, but they must be kept current – if a formulation changes, the listing should be updated.

Do not confuse the two: Registering your facility does not list your products, and listing your products does not register your facility. FDA requires both. Completing only one leaves you half-compliant.

Small-business exemption: who may skip these filings

MoCRA includes a limited small-business exemption (Section 612 of the FD&C Act (21 U.S.C. § 364h)) covering both facility registration and product listing. A facility generally qualifies if its average gross annual sales of cosmetic products in the United States were below $1,000,000 over the preceding three-year period. The exemption has important carve-outs: it does not apply to facilities that manufacture or process products contacting the mucous membrane of the eye, products that are injected, products intended for internal use, or products intended to alter appearance for more than 24 hours. Those must still be registered and listed regardless of sales volume. If you believe you qualify, confirm your status against FDA’s published MoCRA guidance before relying on the exemption.

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

Frequently asked questions

We only sell one product. Do we still need both?

Yes. Even a single-product company needs its facility registered and that one product listed. The requirements are not waived for small catalogs.

Our contract manufacturer says they handle all FDA filings. Is that enough?

Not necessarily. The manufacturer registers the facility, but product listing is the responsible person’s duty – and if your name is on the label, that is you. Get written confirmation of exactly which filings each party handles.

Do product listings need biennial renewal too?

No. The two-year renewal cycle applies to facility registration. Product listings are updated when products change, not on a fixed renewal schedule.

Is there a fee for either filing?

No. Both facility registration and product listing are free of FDA charges, as are renewals and updates.

US MoCRA Agent is a private service provider and is not affiliated with the FDA. Questions about registration vs listing: 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

• What Is an FDA FEI Number? — the identifier tied to your facility registration.
• Who Can Be Your MoCRA U.S. Agent? Requirements Explained — foreign facilities need an agent for registration.
• Private-Label Cosmetics: Who Registers Under MoCRA? — how the registration/listing split applies.