MoCRA Requirements for Cosmetics Importers: Who Files What

MoCRA, the Modernization of Cosmetics Regulation Act of 2022, turned US cosmetics from a lightly regulated category into one with registration, listing, adverse event reporting and safety records. For an import program the hard part is not the rules themselves but who owns them. The duties attach to the responsible person named on the label and to the facility that makes the product, and on an imported lipstick or a children’s face cream those can be three different companies in three countries.

This guide is for brands, private-label programs and distributors that import color cosmetics, skincare and kids’ skincare. It covers who the responsible person is, how facility registration differs from product listing in Cosmetics Direct, the adverse event and safety substantiation records, the label changes MoCRA added, the duty you pay on typical cosmetics HTS lines in 2026 and what has to be in place before the container is booked.

Who Is the Responsible Person and What It Must File

MoCRA defines the responsible person as the manufacturer, packer or distributor of a cosmetic product whose name appears on the label under section 609(a) of the FD&C Act or the Fair Packaging and Labeling Act (21 U.S.C. 364(4)). The definition follows the label, not the invoice and not the importer of record. Whoever the carton names is the company FDA holds to the product-level duties.

That makes label copy a legal decision. Under 21 CFR 701.12, a company that does not make the product must qualify its name with a phrase such as “Manufactured for” or “Distributed by”. A US brand importing finished goods from a Korean or Chinese contract manufacturer is normally the name on the label and therefore the responsible person. A distributor that imports a foreign brand as-is, under the foreign company’s name, is usually not; the foreign brand is. A retailer that relabels to its own private label becomes the responsible person for those SKUs.

The responsible person carries four duties: product listing, serious adverse event reporting, safety substantiation records and the label contact for adverse event reports. Facility registration belongs to the owner or operator of the plant, although a responsible person may submit a contract manufacturer’s registration on its behalf (21 U.S.C. 364c(a)(3)).

Importing alone does not make a company a facility. The statute counts an importer’s establishment as a facility only if it manufactures or processes cosmetic products, and it excludes sites that solely label, relabel, package, repackage, hold or distribute (21 U.S.C. 364(3)). Filling a container with product is not packaging under that exclusion, so a US warehouse that fills bulk serum into retail bottles has to register. The importer of record on the entry can be a different company from all of these, which is why the roles should be written down per SKU.

Facility Registration vs Product Listing in Cosmetics Direct

Registration and listing are separate filings with different owners and different clocks. Both are made in FDA’s Cosmetics Direct portal, through ESG NextGen using Structured Product Labeling files, or on paper with Form FDA 5066 (registration) and Form FDA 5067 (listing). FDA uses the facility’s FEI number as its registration number, so a plant needs an FEI before it can register, and each listing must cite the registration number of every facility that makes the product. Register first, then list.

Renewal dates and the certificate problem

Renewal is not a national window. A facility that first registered on February 20, 2024 had to renew by February 20, 2026, and FDA added REGISTRATION STATUS and RENEWAL DATE fields to Cosmetics Direct in February 2026 so registrants can see their own date. An abbreviated renewal is available when nothing has changed since the last submission. For a foreign supplier base, the practical step is to collect each plant’s FEI and renewal date in the vendor file and check it before each production run, because a lapsed registration is the supplier’s failure but the importer’s problem at the port.

On September 9, 2026 FDA stated that it does not issue certificates or other documents to verify cosmetic facility registration. A “MoCRA registration certificate” sent by a supplier or a third-party agent is not an FDA document. Verification means seeing the registration confirmation in Cosmetics Direct or the SPL acknowledgement, not a branded PDF.

Listing one formula in many shades

One listing can cover products with identical formulas or formulas that differ only in color, fragrance, flavor or quantity (21 U.S.C. 364c(c)(4)(B)). A lip line in 24 shades on one base can usually be a single listing. A kids’ line that adds a new active botanical or swaps the emulsifier is a new formula and a new listing, due within 120 days of marketing.

The small business exemption and its limits

Responsible persons and facilities with average US cosmetic sales under $1,000,000 over the prior three years, adjusted for inflation, are exempt from registration and listing and from the future GMP rule (21 U.S.C. 364h). The exemption does not reach adverse event reporting, safety substantiation or labeling. It is also lost entirely by any responsible person or facility that makes products that regularly contact the eye’s mucous membrane, injected products, products for internal use, or products that alter appearance for more than 24 hours. A small brand that sells one eyeliner, mascara or long-wear tint therefore registers and lists its whole range regardless of size, which catches many small kids’ and teen makeup lines.

Adverse Event Reporting and Safety Substantiation Records

The responsible person must send FDA every report it receives of a serious adverse event associated with use of the product in the US, with a copy of the retail label, no later than 15 business days after receiving it (21 U.S.C. 364a(b)(1)). New and material medical information received within one year goes in within another 15 business days. Serious means death, a life-threatening experience, hospitalization, lasting disability, a birth defect, an infection, or significant disfigurement such as serious and persistent rashes, second- or third-degree burns or significant hair loss, or a case that needed medical or surgical intervention to prevent one of those outcomes.

Records of every adverse event report, serious or not, are kept for six years, or three years for a qualifying small business (21 U.S.C. 364a(e)). FDA can review them during an inspection. Where a fragrance may have contributed, FDA can request the fragrance ingredient list, due within 30 days, so a brand buying a compounded fragrance overseas needs a contract that obliges the fragrance house to disclose it.

Safety substantiation is a records duty with no prescribed test. The responsible person must ensure, and keep records showing, adequate substantiation of safety: tests, studies, research, analyses or other evidence that qualified experts consider sufficient to support a reasonable certainty that the product is safe (21 U.S.C. 364d). Safe is judged under the conditions of use on the label or customary use. A face cream sold for children is assessed for use on children, so the file should address that population, not just the adult formula it was adapted from. FDA does not require animal testing.

Records FDA can reach

FDA can also access and copy records, safety substantiation data included, about a product it reasonably believes is adulterated in a way that threatens serious harm (21 U.S.C. 364f). Draft guidance on that authority appeared on January 22, 2026 (91 FR 2779) and final guidance on mandatory recalls on October 23, 2026 (91 FR 66851). The substantiation file must therefore be retrievable by the US responsible person, not only held at the overseas lab.

Labeling: The Domestic Contact and Professional-Use Products

Since December 29, 2024, every cosmetic label must carry a domestic address, a domestic phone number or electronic contact information, which may be a website, through which the responsible person receives adverse event reports (21 U.S.C. 364e(a)). This is the most common MoCRA defect on imported stock: packaging designed for Korea, Japan or the EU often shows only a foreign address and hotline, which does not meet the domestic requirement.

Products intended only for licensed professionals in cosmetology, nail care, barbering or esthetics must carry a clear and prominent statement that they are to be administered or used only by licensed professionals (21 U.S.C. 364e(c)). Salon-only peels, professional hair color and nail systems imported for distribution to salons need that statement on the label itself.

The pre-MoCRA rules still apply: an ingredient declaration in descending order of predominance (21 CFR 701.3) and the name and place of business with the right qualifier (21 CFR 701.12). Eye-area and kids’ products need a color additive check: under 21 CFR 70.5(a), a color additive may be used near the eye only if its listing specifically allows it, so a shimmer eyeshadow made with a non-approved colorant is adulterated whatever its MoCRA filings. Fragrance allergen labeling is also required by MoCRA, but no proposed rule naming the allergens had appeared in the Federal Register as of October 27, 2026.

Whether a product is a cosmetic at all is a separate question. A tinted moisturizer with SPF or an anti-acne wash is a drug, with different filings, as covered in our cosmetic vs OTC drug guide.

Duty on Typical Cosmetics HTS Lines in 2026

MoCRA compliance does not change the duty, but the duty decides the landed cost of the same SKU. Most finished cosmetics in Chapter 33 have a free MFN rate, so the 2026 cost difference between origins comes entirely from the additional duties. All six lines below are on Section 301 List 3, so China-origin goods carry 25% plus the 12.5% Section 301 forced labor tariffs in force since July 24, 2026. Korea-origin goods are topped up to a 12.5% total instead. Run a specific SKU through the Korea to US tariff calculator or the China version before moving a program.

Reading the table

China additional = 25% (Section 301 List 3, confirmed for each line in HTS chapter 99, U.S. note 20) plus 12.5% (9903.05.31). Korea additional is the amount that brings MFN plus Section 301 up to 12.5% (9903.05.70/.71), so it is 7.6 points on a 4.9% line. AD/CVD duties and any product exclusions are not included.

What an Importer Must Have Ready Before a Cosmetics Entry

FDA screens cosmetics in ACE under program code COS with industry code 50 or 53. Under FDA’s March 10, 2026 quick reference to the ACE Supplemental Guide, the product code, description, manufacturer, shipper and FDA importer are mandatory, while the cosmetic registration number is an optional Affirmation of Compliance. Transmitting it anyway helps FDA match the line to the registered site; a mismatch between the declared manufacturer and Cosmetics Direct is what sends an entry to review, covered in our FDA detention guide.

The pre-shipment file per SKU should hold:

• The responsible person, as named on the final label, and the qualifier used (“Distributed by”, “Manufactured for”).
• The manufacturing facility’s FEI, its Cosmetics Direct registration status and its renewal date.
• The product listing number, or confirmation that the 120-day listing clock has not yet run out for a new launch.
• Label proof showing the domestic adverse event contact, the INCI ingredient declaration and, where relevant, the professional-use statement.
• Safety substantiation file location and the adverse event intake process behind the label contact.
• Color additive check for eye-area and children’s products.
• The HTS line, origin and duty estimate, and confirmation that no SKU in the shipment makes a drug claim.

Kids' kits and mixed shipments

Cosmetics are excluded from the Consumer Product Safety Act’s definition of a consumer product (15 U.S.C. 2052(a)(5)(H)), so a children’s lip balm is an FDA product. A kit that pairs the balm with a toy, a bag or a mirror is different: the non-cosmetic components can bring CPSC testing into the same entry, as set out in our CPSC compliance guide. Splitting those decisions by component before the PO avoids a shipment that clears FDA and fails on the toy.

Our cosmetics and chemical logistics team works these files with brands and distributors as a licensed customs broker, from label review against the MoCRA checklist to ACE transmission. Foreign plants that also make OTC drugs or food carry separate FDA registrations, covered in the FDA registration guide.

Frequently Asked Questions