MoCRA compliance for international beauty brands
Updated
MoCRA compliance for an international beauty brand comes down to a short list: register the facilities that make your products, list each product, name a U.S. agent for each foreign facility, put a U.S. adverse event contact on the label, report serious adverse events within 15 business days and keep safety substantiation records. None of it is FDA approval, and FDA charges no fee for registration or listing. This guide explains each duty, who owns it and what is still pending.
MoCRA sits on top of the long-standing FDA rules on cosmetic classification, color additives and labeling, which are covered in FDA cosmetics requirements for foreign brands. Read that first if you are unsure whether a product is a cosmetic or also a drug: OTC drugs such as sunscreens follow drug registration rules instead.
What MoCRA is, and what it is not
The Modernization of Cosmetics Regulation Act of 2022 was enacted on December 29, 2022. It gave FDA new tools over cosmetics: mandatory facility registration and product listing, serious adverse event reporting, safety substantiation, new label requirements, mandatory recall authority, and rules still to come on manufacturing practices and fragrance allergens (FDA, MoCRA). FDA began enforcing registration and listing on July 1, 2024, according to law firm summaries of FDA's guidance.
What MoCRA did not do is create premarket approval. Apart from color additives, cosmetics still need no FDA approval before sale, and registration is a record, not a permission.
Who the responsible person is
Most MoCRA duties fall on the responsible person: "the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label" (21 U.S.C. 364). For a foreign brand this is a choice with consequences:
- If your company's name is on the label, you are the responsible person, and listing, adverse event reporting and safety records are yours.
- If a U.S. importer or distributor is named on the label (for example "Distributed by"), that company becomes the responsible person, which gives it a strong say over your compliance and often over the commercial relationship.
Decide this before you print labels, and write it into any distribution agreement.
Facility registration and the U.S. agent
Every facility that manufactures or processes cosmetics for U.S. distribution must be registered with FDA, foreign facilities included (21 U.S.C. 364c). The key points:
- Who: the factory that makes or processes the product, whether that is your own plant or a contract manufacturer.
- U.S. agent: a foreign facility's registration includes the contact of its U.S. agent. FDA's December 2024 final guidance, as summarized by law firms, describes the agent as helping FDA communicate with the facility, answering questions about imported products, helping schedule inspections and receiving FDA documents.
- Timing: changes must be reported within 60 days, and registrations are renewed every two years.
- Not facilities: beauty shops and salons that do not make products, retailers, hospitals and clinics, hotels and airlines giving out free products, trade show sample distribution, research-only sites, and sites that only label, package or distribute.
That last exclusion matters for logistics: a U.S. site that only labels, packages or distributes your finished products is not a facility under MoCRA. An importer's site can become one if it manufactures or processes.
Product listing in Cosmetics Direct
The responsible person must list each cosmetic product with FDA, including its full ingredient list with fragrances, flavors and colors. A new product must be listed within 120 days of being marketed, and listings are updated annually.
Filing happens through Cosmetics Direct, FDA's electronic submission tool, or through SPL submissions via ESG NextGen, or on paper Forms FDA 5066 and 5067 (FDA, Registration and Listing). FDA added registration-status and renewal-date fields in February 2026. A listing references the registration of the facility that makes the product, so you need your manufacturer's registration details before you can list.
Label changes under MoCRA
- Adverse event contact. Since December 29, 2024, each cosmetic label must include "a domestic address, domestic phone number, or electronic contact information" through which the responsible person can receive adverse event reports. The statute says "or": one of the three is enough, so a brand without a U.S. address can use electronic contact information.
- Professional use. Products intended for professionals must state that they are to be used only by licensed professionals. This matters for salon and back bar lines, covered in how to sell haircare products to U.S. salons.
- Fragrance allergens. MoCRA requires FDA to set rules for disclosing fragrance allergens on labels. No allergen list is in force yet (see pending rules below).
Serious adverse event reporting
The responsible person must report each serious adverse event to FDA within 15 business days of receiving the report, with a copy of the label (21 U.S.C. 364a). "Serious" covers outcomes such as death, a life-threatening event, hospitalization and lasting disability, among others defined in the statute. New medical information received within one year of the report must also be sent within 15 business days.
Adverse event records must be kept for 6 years (3 years for qualifying small businesses). In practice, the label contact must reach someone who reads it, logs it and knows the clock is running. If a U.S. retailer or distributor receives complaints, your agreement should require them to pass them on at once.
Safety substantiation and records
The responsible person must ensure, and keep records showing, "adequate substantiation of safety": evidence that qualified experts consider sufficient to support "a reasonable certainty that a cosmetic product is safe" (21 U.S.C. 364d). For most foreign brands, the safety assessment prepared for the home market or the EU is the starting point, reviewed against U.S. use and claims.
FDA states that animal testing is not a requirement. Coal-tar hair dyes that carry the statutory caution are outside the substantiation duty, though records are still required.
The small business exemption
A business qualifies if its average gross annual U.S. sales of cosmetics over the previous three years are less than $1,000,000, adjusted for inflation (21 U.S.C. 364h). Confirm the current inflation-adjusted figure before you rely on it.
| Exempt | Not exempt |
|---|---|
| Facility registration and product listing | Serious adverse event reporting |
| Future GMP rules | Safety substantiation |
| Labeling, including the adverse event contact |
The exemption does not apply to products that regularly contact the mucous membrane of the eye, are injected, are intended for internal use, or alter appearance for more than 24 hours. Many eye products, such as mascara and eyeliner, and hair color that lasts beyond 24 hours are therefore outside it. The test applies per business, so a contract manufacturer that does not itself qualify still has to register its facility.
Recalls, suspension and pending rules
Mandatory recall. If there is a reasonable probability that a cosmetic is adulterated or misbranded and will cause serious adverse health consequences or death, and the responsible person declines a voluntary recall, FDA can order one, with an informal hearing within 10 days. Suspension. FDA can suspend a facility's registration on the same serious-harm standard, and products from a suspended facility may not be distributed in the U.S.
Status of the rules still to come, as of October 14, 2026:
- GMP: the statute set deadlines of December 29, 2024 for a proposed rule and December 29, 2025 for a final rule. No proposed rule has been published.
- Fragrance allergen labeling: at the proposed rule stage on the federal regulatory agenda, with trade press reporting a November 2026 target. Not yet proposed.
- Formaldehyde in hair smoothing and straightening products: also at the proposed rule stage, not yet proposed. California already bans intentionally added formaldehyde in cosmetics, as covered in California beauty market entry.
- Talc asbestos testing: proposed in December 2024 and withdrawn effective November 28, 2025. FDA says it will issue a new proposal.
- PFAS: FDA published its report on PFAS in cosmetics on December 29, 2025.
MoCRA checklist for a first launch
| Obligation | Owner | Timing | Small business exempt? |
|---|---|---|---|
| Facility registration, with U.S. agent for foreign sites | Each manufacturing or processing facility | Changes within 60 days; renew every two years | Yes, except excluded product types |
| Product listing with full ingredients | Responsible person | Within 120 days of marketing; update annually | Yes, except excluded product types |
| U.S. adverse event contact on label | Responsible person | Required since December 29, 2024 | No |
| Professional-use statement | Responsible person | On professional products | No |
| Serious adverse event reports | Responsible person | Within 15 business days | No |
| Adverse event records | Responsible person | Keep 6 years | No (3 years) |
| Safety substantiation records | Responsible person | Before sale, kept current | No |
Sales channels may check this paperwork; Amazon, for example, lists products subject to MoCRA among those that may need approval, as covered in Amazon FBA vs. retail for beauty brands. Once your file is in order, the Beauty & Personal Care market entry program puts your products in front of up to 25 selected Southern California salons, barbershops, beauty supply stores, boutiques and specialty retailers for three months, at $3,950 with one SKU included and a 25% commission only on sales Abanro generates, without first hiring U.S. staff or leasing a warehouse. Abanro does not register products with FDA unless that is quoted as a separate specialist service.
This guide is general information, not legal or regulatory advice. MoCRA guidance and rulemaking are still developing; confirm current requirements with FDA or a qualified U.S. regulatory specialist.