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MoCRA for Men’s Care Brands: Facility Registration & Product Listing (Who Does What)

Under the Modernization of Cosmetics Regulation Act (MoCRA), men’s grooming and skincare brands selling in the U.S. must comply with new FDA registration and listing rules. This impacts all suppliers and private-label brand owners…

Category: Men Care Sourcing Guides Author: laeyo Published: 2026-01-11 Views: 53

Under the Modernization of Cosmetics Regulation Act (MoCRA), men’s grooming and skincare brands selling in the U.S. must comply with new FDA registration and listing rules. This impacts all suppliers and private-label brand owners in the men’s personal care space — from beard oils and shampoos to face serums and aftershaves. The following guide outlines who is responsible for each step, how to verify compliance, and how to prepare documentation before market launch.

Key Roles and Responsibilities Under MoCRA

Every stakeholder in your supply chain — facility, brand, and distributor — now plays a defined role in safety and registration. Understanding this division ensures no gaps during FDA audits or retailer onboarding.

Role Primary Responsibility Required Evidence
Manufacturer / Facility Register the manufacturing site with the FDA and assign a facility registration number. FDA Facility Registration confirmation, renewal proof (biennial).
Brand Owner / Responsible Person Submit product listing and maintain formula, label, and safety substantiation records. FDA Product Listing number, formulation safety summary, ingredient dossier.
Distributor / Retail Partner Confirm that all listed products come from an active, registered facility. Manufacturer’s registration certificate and brand compliance letter.

How Men’s Care Brands Should Prepare

  • Map your manufacturing chain: Identify all facilities involved in formulation, filling, and labeling. Each must register with the FDA.
  • Confirm product listing accuracy: Each SKU, size, and formulation variation must be listed individually.
  • Keep safety data on hand: Maintain test reports and stability/microdata that substantiate product safety.
  • Review labeling: Ensure ingredient names, warnings, and claims meet 21 CFR cosmetic labeling standards.
  • Renew annually: Facility registration renewals are required every two years, listings updated when changes occur.

Documentation to Request from Your Manufacturer

  • FDA Facility Registration number and current status
  • Safety Substantiation File (includes toxicological assessments and test summaries)
  • Stability and Microbiological Test reports
  • Accurate INCI ingredient list and formula sheet
  • Label proofs aligned to MoCRA requirements

Example Timeline for Compliance Before Market Launch

  1. Month 1–2: Facility registration confirmation and documentation exchange.
  2. Month 3–4: Product listing submissions and label compliance review.
  3. Month 5: Final verification before shipments to U.S. distributors.

Common Pitfalls and How to Avoid Them

  • Assuming the manufacturer will list your product: Only the designated “Responsible Person” can list it.
  • Outdated test files: Use current stability and micro tests; expired reports raise red flags in audits.
  • Private label confusion: If multiple brand owners share the same facility, confirm all listings are separate.

FAQ for Men’s Care Brand Owners

1. Do small batch or artisanal men’s care brands need to register?

Yes, MoCRA applies to all facilities manufacturing for U.S. sale, regardless of scale or batch size.

2. Who should be the “Responsible Person” in product listings?

Typically the brand or legal entity named on the product label; they are accountable for reporting and documentation accuracy.

3. Are barbershop or salon-branded products included?

Yes, if the products are sold or distributed to consumers, even within a single store location.

4. What happens after submission?

Once filed, the FDA issues a registration and listing identifier, which must be kept on record and updated when changes occur.

5. How long does facility registration take?

Registration can be completed online within days, but verification and internal audit preparation may take several weeks.

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Hi, I'm Alex Zong, hope you like this blog post.

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