FDA Final Guidance on Cosmetic Facility Registration & Product Listing: What You Need to Know

The FDA has made big changes to how cosmetics are regulated in the U.S. For the first time since 1938, companies that make or process cosmetics have to follow strict rules about registering their facilities and listing every product they sell. These changes come from a law called the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), and they’re designed to make beauty products safer, more transparent, and easier to trace if something goes wrong.

Under the new rules, cosmetic companies must register where their products are made and share details about what’s in them. This includes everything from makeup and lotions to shampoos and fragrances. The FDA will keep much of this information public so consumers can see which companies are compliant, although some sensitive details will stay private.

Why this matters to you:

  • Better oversight: The FDA will now know who is making your cosmetics and where.
  • Improved safety: If a product is contaminated or mislabeled, it can be tracked and removed more quickly.
  • More transparency: You’ll be able to find more information about the products you use.

The FDA is also making it easier for companies to file their information using an online portal called Cosmetics Direct. While smaller businesses may be exempt from the rules, that exemption does not apply to products that go near your eyes, are injected, taken internally, or last more than 24 hours without removal.

Registration & Listing Requirements Overview

Facility Registration (Section 607(a)):

Required for each facility manufacturing or processing cosmetic products distributed in the U.S.

  • Deadline:
    • Facilities in operation as of December 29, 2022: register by December 29, 2023.
    • Facilities starting after that date: register within 60 days of start, but no later than February 27, 2024.
  • Renewal: Required biennially (every two years); an abbreviated renewal is allowed if no changes have occurred.
  • Updates: Must be submitted within 60 days of any change such as address, ownership, etc.

Product Listing (Section 607(c)):

  • Every cosmetic product must be listed with the FDA.
  • Deadline:
    • Products marketed as of December 29, 2022: listing due by December 29, 2023.
    • For products marketed after that: listing due within 120 days of marketing, or by April 27, 2024, whichever is later.
  • Updates: Must be submitted annually; abbreviated renewal allowed when there are no changes.
    • A single listing submission may cover multiple products with identical formulations or differences only in fragrance, color, or quantity.

Exemptions

MoCRA allows certain small businesses to be exempt from registration and listing if their U.S. sales average under $1 million over the past three years (inflation-adjusted). However, this exemption does not apply to businesses dealing with:

  • Products contacting the eye’s mucous membranes
  • Injectables
  • Products for internal use
  • Products meant to alter appearance for over 24 hours without consumer removal

Additionally, products regulated under drug or device categories are exempt from cosmetic listing requirements (e.g., medicated products dual-listed as cosmetics and drugs)

Why It Matters

This comprehensive guidance marks a seismic shift in cosmetic regulation, pushing the industry toward formalization, traceability, and accountability. Key takeaways for cosmetic firms:

  • Stay compliant: Know your deadlines and respond with accurate submissions.
  • Use electronic channels: Cosmetics Direct is the preferred method for registration and listing.
  • Track exemptions: Determine if your business qualifies for small-business exemptions—and whether your products are excluded.
  • Consider public visibility: Expect much of your registration data to become public.
  • Act on the updated FAQs: If you handle free samples, have multiple-site facilities, or require U.S. Agents, consider commenting on Appendix B before mid‑January 2025.

The agency delayed enforcement until July 1, 2024, giving companies extra time to adjust. It has also released new FAQs to clarify questions about U.S. Agents, multi-building facilities, and even the rules for free samples and gift sets.

For consumers, the takeaway is simple: over the next year, expect to see a beauty industry that’s more accountable and more transparent. These changes give you more confidence that what’s in your makeup bag meets safety standards—and that if something does go wrong, the FDA can act faster to protect you.

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