What Is MoCRA?
MoCRA (the Modernization of Cosmetics Regulation Act of 2022) was signed into law on December 29, 2022, as part of the Consolidated Appropriations Act, 2023. MoCRA added Section 607 to the Federal Food, Drug, and Cosmetic Act (FD&C Act), establishing — for the first time — a mandatory federal framework for cosmetic product facility registration and product listing.
This is the most significant change to U.S. cosmetics regulation in decades. Registration used to be entirely voluntary. Under MoCRA, it is now mandatory.
How Is MoCRA Different From the Old VCRP (Part 710/720) System?
Before MoCRA, FDA operated a voluntary registration system called the Voluntary Cosmetic Registration Program (VCRP), under 21 CFR Parts 710 and 720. Registering was optional, and there was no penalty for not registering.
FDA stopped accepting new submissions to VCRP as of March 27, 2023, while it built the new mandatory system required by MoCRA. Critically, information from the old VCRP was not carried over to the new system. Because the data required under MoCRA differs from what VCRP collected, FDA does not consider a past VCRP submission to satisfy MoCRA’s registration and listing requirements.
In short: if your company registered under VCRP years ago, that registration is no longer valid — you need to register again under MoCRA, in the correct format.
Who Must Register a Cosmetic Facility?
Under Section 607(a) of the FD&C Act, every person who owns or operates a facility engaged in manufacturing or processing a cosmetic product for distribution in the United States must register that facility with FDA.
Exceptions:
- Facilities whose responsible person, owner, or operator meets the small business definition under Section 612 — unless the facility manufactures certain higher-risk product categories (products that regularly contact eye mucous membranes, are injected, are intended for internal use, or alter appearance for more than 24 hours where removal isn’t part of customary use).
- Facilities already subject to the drug and device requirements under Chapter V of the FD&C Act — though registration is still required for any cosmetic products made at that facility that are not also regulated as drugs.
- For contract manufacturing, only one registration is required per facility — either the manufacturer or the responsible person (brand owner) may submit it.
What Is the Product Listing Requirement?
Under Section 607(c), the responsible person must submit a cosmetic product listing to FDA for each cosmetic product — a separate obligation from facility registration.
Exceptions: responsible persons qualifying for the small business exemption, and products that are also classified as drugs (in which case the product must be identified as both a drug and a cosmetic in the drug listing submission instead).
Key Deadlines
- Initial facility registration: facilities operating as of December 29, 2022 had until December 29, 2023. Facilities that began operating after that date had 60 days from starting operations, or until February 27, 2024, whichever was later.
- Initial product listing: products on the market as of December 29, 2022 had until December 29, 2023. Products first marketed after that date had 120 days, or until April 27, 2024, whichever was later.
- Amended registration: any change to registration information must be updated within 60 days.
- Renewal: facility registration must be renewed every two years.
- Listing updates: product listings must be updated annually, including when a product is discontinued.
Note on enforcement: In a guidance issued November 8, 2023, FDA stated it did not intend to enforce Section 607 registration and listing requirements until July 1, 2024. Enforcement timelines like this can shift — always confirm current status on FDA.gov before relying on it.
How Do You Submit Registration and Listing Information?
FDA built an electronic portal called Cosmetics Direct for MoCRA submissions. Alternatives include:
- Paper forms (FDA Form 5066 for facility registration, FDA Form 5067 for product listing)
- FDA’s Electronic Submissions Gateway (ESG), using Structured Product Labeling (SPL) format
FDA strongly encourages electronic submission.
Does Registration Mean FDA Approval?
No. Being registered with FDA, or having a product listed, does not mean the product or company has been approved by FDA. Registration is purely an administrative notification — FDA does not conduct premarket approval of cosmetic products. This is why claims like “FDA approved cosmetic” are considered misleading and should never appear on labeling or marketing materials.
What If My Product Is Both a Cosmetic and a Drug?
If a product meets the definition of both a cosmetic and a drug (for example, a moisturizer with sunscreen claims, or an acne-treatment cleanser), a separate cosmetic product listing is not required — but the product must be identified as both a drug and a cosmetic in the drug listing submission. This classification depends on the intended use claims made on the label, not just the formulation.
What Happens If You Don’t Register?
Failing to meet the registration or listing requirements under Section 607 is a prohibited act under Section 301(hhh) of the FD&C Act (21 U.S.C. § 331(hhh)).
What This Means for Turkish Cosmetic Brands
For Turkish manufacturers and brand owners planning to export cosmetics to the U.S., MoCRA is no longer a formality you can skip — it’s a mandatory entry requirement. Products shipped without proper registration and listing risk being held, returned, or seized at customs.
To get this right:
- Assess whether your business qualifies for the small business exemption,
- Register the facility with the correct responsible person / manufacturer distinction,
- Prepare a separate product listing for each SKU,
- Audit your labeling and marketing materials to ensure they don’t contain misleading claims like “FDA approved.”
Sources: FD&C Act Section 607 (21 U.S.C. § 364c); FDA Guidance for Industry — Registration and Listing of Cosmetic Product Facilities and Products (December 2024); FDA Constituent Update, FDA Has Stopped Accepting Submissions to the Voluntary Cosmetic Registration Program (VCRP).
This content is for general informational purposes and does not constitute legal advice. Confirm current requirements at FDA.gov/cosmetics or eCFR.gov.
