EasyComply
中文Contact Us
US MoCRA cosmetics compliance overview

United States Cosmetics Compliance

FDAMoCRAFacility RegistrationProduct ListingUS Agent

Regulatory Framework

US cosmetics compliance is built on the Federal Food, Drug, and Cosmetic Act, with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) adding modern obligations around facility registration, product listing, adverse event handling, records, and safety substantiation. The exact obligation depends on the business role, facility status, product type, and any applicable exemptions.

Cosmetic Definition

A cosmetic is an article intended to be rubbed, poured, sprinkled, sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance. Soap is excluded, and products with therapeutic intent may instead be regulated as drugs or combination products.

Important: Facility registration and product listing are regulatory information submissions. They do not mean FDA has approved, cleared, or endorsed the product.

Responsible Person Requirements

The Responsible Person is generally the manufacturer, packer, or distributor whose name appears on the label. Foreign facilities subject to facility registration also need a US agent contact. The Responsible Person is expected to support listing maintenance, serious adverse event reporting, and safety substantiation for products under its scope.

Compliance Process

  1. Business and Contact Setup
    1. Confirm the business role, label owner, applicable exemptions, and whether foreign facility registration is in scope.
    2. Prepare the business contact package and, where needed, align the US agent contact for the registered facility.
  2. Facility Registration
    1. Prepare facility identity details, address, phone number, FEI where applicable, and brand names handled by the site.
    2. Confirm the required registration timeline, renewal expectations, and any exceptions before filing.
  3. Product Listing
    1. Prepare product identity, category, formulation details, packaging, and associated facility information.
    2. File and maintain the product listing information under the applicable Responsible Person.
  4. Safety and Post-market Readiness
    1. Review artwork, claims, and supporting evidence to reduce cosmetic-versus-drug boundary risk.
    2. Set up adverse event intake, record retention, and update controls for future listing or facility changes.

US compliance often turns on how the product is positioned. Claims, ingredients, intended use, and presentation can shift the product outside the cosmetics pathway.

Deliverables

  • MoCRA applicability and role assessment
  • US facility registration preparation and filing support
  • Product listing package preparation and maintenance checklist
  • Formula and artwork review for cosmetic-versus-drug boundary risk
  • US agent coordination for foreign facilities
  • Safety substantiation and adverse event workflow support

Official Sources

#AuthorityDocumentLocatorPublished / EffectiveLink
1United States CongressFederal Food, Drug, and Cosmetic Act21 U.S.C. §§ 301–3922026-02-03 / —Official source
2United States CongressModernization of Cosmetics Regulation Act of 2022Sections 605–6062022-12-29 / —Official source
3U.S. Food and Drug AdministrationCosmetics Labeling GuideGeneral labeling requirements— / —Official source
4U.S. Food and Drug AdministrationCosmetics Direct2026 portal updates, biennial facility registration renewal, reminders and certificate clarification2026-02-11 / —Official source

Related Services

From regulatory intelligence to market-entry support, EasyComply helps cosmetic brands navigate global compliance with confidence.

Talk to Our ExpertsExplore Compliance Services