What is MoCRA and who does it affect?

The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 requires manufacturers, packers, and distributors of cosmetics sold in the US to register their facilities and list their products with FDA.

When did MoCRA registration deadlines apply?

Initial registration deadlines were December 29, 2023 (large companies) and December 29, 2024 (small businesses with under $1M annual sales). New facilities must register within 60 days of first engaging in manufacturing or processing.

Is facility registration the same as product listing?

No. Facility registration covers the manufacturing location. Product listing covers each cosmetic product (name, ingredients, labelling, responsible person). Both are required.

Do imported cosmetics need MoCRA registration?

Yes. Foreign manufacturers whose products are imported into the US must register if they manufacture, process, or pack the cosmetics, or if they are the US Responsible Party.

Book MOCRA Cosmetics Facility Registration & Product Listing

Book MOCRA cosmetics facility registration and product listing (FD&C Act §607) online. Compare vetted FDA compliance specialists with instant pricing.

✓ 3 active providers available right now · USD 480 – 592

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Compare providers (instant pricing + book)

Provider	Estimated base price	Accept SLA	Turnaround	Start
Alpha Regulatory Partners	USD 520	24h	3–7 days	Within 2 business days
Beta Compliance Group	USD 592	24h	3–7 days	Within 2 business days
Gamma RegTech Solutions	USD 480	24h	3–7 days	Within 2 business days

Estimates are derived from each provider’s published pricing rules (and may vary by your inputs).

What affects pricing

These are the inputs providers use to price your order. Enter them once, then compare providers and book instantly.

facilitiesCount (Required)
min 1
productsCount (Required)
min 1
complexity (Required)
simple|normal|complex
turnaround (Required)
standard|rush
desiredOutputs (Required)
min 1
hasPortalAccessReady (Optional)
informational
uploads (Optional)
recommended; can upload after checkout
buyerNotes (Optional)

🇺🇸

Market

United States

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Regulation

MoCRA / FD&C §607

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Turnaround

3–10 business days

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Pricing

Per facility + per product

How it works

1

Describe your facilities and product range

Tell us how many manufacturing facilities and products need registration or listing.
2

Compare MOCRA registration specialists

View per-facility and per-product fees from providers experienced with FDA Cosmetics Direct and SPL submissions.
3

Receive your registration numbers and certificates

Your specialist completes the FDA CDER portal filings and provides you with registration confirmation.

What is MoCRA and why was it introduced?

The Modernization of Cosmetics Regulation Act (MoCRA) was signed into US law in December 2022, representing the most significant update to FDA's authority over cosmetics in decades. Before MoCRA, the FDA had very limited ability to regulate cosmetics pre-market — there was no mandatory registration, no safety substantiation requirements, and no recall authority. MoCRA changed all of that by introducing mandatory facility registration, product listing, Good Manufacturing Practice requirements, serious adverse event reporting, and new safety substantiation obligations. Compliance is enforced by FDA under the FD&C Act, with penalties for non-compliant facilities.

Who must register under MoCRA?

Any person (including foreign manufacturers) who owns or operates a facility that manufactures or processes cosmetics distributed in the United States must register with FDA under FD&C Act §607. This includes contract manufacturers, private label manufacturers, and facilities that repackage finished cosmetics. Companies with less than USD 1,000,000 in average annual cosmetics gross sales globally and domestically qualify as small businesses with extended deadlines. Note: the registration obligation applies to the facility, not just the brand — if you use a contract manufacturer, they must also be registered, or the brand owner must register on their behalf.

Product listing vs. facility registration under MoCRA

Facility registration and product listing are two separate MoCRA obligations. Facility registration covers each manufacturing or processing location — you provide the facility name, address, registration number (if previously assigned), and the cosmetic categories produced there. Product listing covers each distinct cosmetic product marketed in the US — you must provide the product name, brand name, all cosmetic ingredients (INCI list), labelling copy, and the responsible person's details. Products must be listed within 120 days of first marketing in the US, and updates are required within 60 days of any material change.

What happens after MoCRA registration?

Once registered, facilities must renew registration biennially. Facilities must also comply with FDA's forthcoming GMP regulations for cosmetics (based on ISO 22716) once finalized. The serious adverse event reporting requirement is already in force: if your cosmetic product is associated with a serious adverse event (hospitalization, significant disfigurement, physician visit), you must report to FDA within 15 business days. FDA now also has mandatory recall authority for cosmetics under MoCRA — they can order a recall without voluntary manufacturer cooperation. Non-compliance can result in fines, import alerts, and product detentions at US ports of entry.

Frequently asked questions

What is MoCRA and who does it affect?: The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 requires manufacturers, packers, and distributors of cosmetics sold in the US to register their facilities and list their products with FDA.
When did MoCRA registration deadlines apply?: Initial registration deadlines were December 29, 2023 (large companies) and December 29, 2024 (small businesses with under $1M annual sales). New facilities must register within 60 days of first engaging in manufacturing or processing.
Is facility registration the same as product listing?: No. Facility registration covers the manufacturing location. Product listing covers each cosmetic product (name, ingredients, labelling, responsible person). Both are required.
Do imported cosmetics need MoCRA registration?: Yes. Foreign manufacturers whose products are imported into the US must register if they manufacture, process, or pack the cosmetics, or if they are the US Responsible Party.

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